Cheap kamagra oral jelly online

We thank the buy kamagra without prescription Yale Environmental Health and Safety cheap kamagra oral jelly online department for allowing safe working environments with the erectile dysfunction kamagra. We also thank the patient donors, and clinicians who helped with the collection of CSF for neutralization assays. We also thank the members of the Yale Center cheap kamagra oral jelly online for Genome Analysis who have helped with all aspects of sequencing. Finally, we thank the members of the Iwasaki laboratory for insightful discussions regarding the project.

This study was supported by National Institutes of Health grants R01AI157488 (A. Iwasaki, S.F cheap kamagra oral jelly online. Farhadian), R01NS111242 (A. Iwasaki), T32GM007205 (Medical Scientist Training Program training grant), F30CA239444 (E.

Song), 2T32AI007517 (B cheap kamagra oral jelly online. Israelow), and K23MH118999 (S.F. Farhadian). The Women’s Health Research at Yale University Pilot Project Program (A.

Iwasaki and A. Ring). Fast Grant from Emergent Ventures at the Mercatus Center (A. Iwasaki, E.

Song, and C.B. Wilen). The Mathers Foundation (A. Ring, C.B.

Wilen, and A. Iwasaki). And the Ludwig Family Foundation (A. Iwasaki, A.

Ring, and C.B. Wilen). A. Iwasaki is an investigator of the Howard Hughes Medical Institute.

Bilguvar, and A. Iwasaki planned the project and analyzed data. E. Song, C.

Zhang, and A. Iwasaki wrote the manuscript. E. Song, C.

Zhang, B. Israelow, A. Lu-Culligan, A.V. Prado, and S.

Skriabine performed experiments. P. Lu, O-E. Weizman, F.

Liu, Y. Dai, K. Szigeti-Buck, Y. Yasumoto, G.

Wang, J. Heltke, E. Ng, J. Wheeler, and M.M.

Alfajaro assisted with experiments. E. Levavasseur, S.A.J. Kazmi, K.

Zhang, C. Castaldi, B. Fontes, D. Van Dijk, S.

Horvath, I. Plu, N.G. Ravindra, S. Haik, J-L.

Thomas, A. Huttner, D. Seilhean, A. Louvi, S.F.

Farhadian, and K. Bilguvar provided expertise and materials for analysis of data. A.V. Prado, S.

Skriabine, and N. Renier performed iDISCO+ imaging and analysis of mice. E. Levavasseur, S.A.J.

Thomas, A. Huttner, and D. Seilhean provided human samples and analysis of images. A.

Iwasaki and K. Bilguvar supervised the project and secured funding..

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Cases of Myocarditis Table 1 kamagra price comparison. Table 1 kamagra price comparison. Reported Myocarditis Cases, According to Timing of First or Second treatment Dose.

Table 2 kamagra price comparison. Table 2. Classification of kamagra price comparison Myocarditis Cases Reported to the Ministry of Health.

Among 9,289,765 Israeli residents who were included during the surveillance period, 5,442,696 received a first treatment dose and 5,125,635 received two doses (Table 1 and Fig. S2). A total of 304 cases of myocarditis (as defined by the ICD-9 codes for myocarditis) were reported to the Ministry of Health (Table 2).

These cases were diagnosed in 196 persons who had received two doses of the treatment. 151 persons within 21 days after the first dose and 30 days after the second dose and 45 persons in the period after 21 days and 30 days, respectively. (Persons in whom myocarditis developed 22 days or more after the first dose of treatment or more than 30 days after the second dose were considered to have myocarditis that was not in temporal proximity to the treatment.) After a detailed review of the case histories, we ruled out 21 cases because of reasonable alternative diagnoses.

Thus, the diagnosis of myocarditis was affirmed for 283 cases. These cases included 142 among vaccinated persons within 21 days after the first dose and 30 days after the second dose, 40 among vaccinated persons not in proximity to vaccination, and 101 among unvaccinated persons. Among the unvaccinated persons, 29 cases of myocarditis were diagnosed in those with confirmed erectile dysfunction treatment and 72 in those without a confirmed diagnosis.

Of the 142 persons in whom myocarditis developed within 21 days after the first dose of treatment or within 30 days after the second dose, 136 received a diagnosis of definite or probable myocarditis, 1 received a diagnosis of possible myocarditis, and 5 had insufficient data. Classification of cases according to the definition of myocarditis used by the CDC 4-6 is provided in Table S1. Endomyocardial biopsy samples that were obtained from 2 persons showed foci of endointerstitial edema and neutrophils, along with mononuclear-cell infiates (monocytes or macrophages and lymphocytes) with no giant cells.

No other patients underwent endomyocardial biopsy. The clinical features of myocarditis after vaccination are provided in Table S3. In the 136 cases of definite or probable myocarditis, the clinical presentation in 129 was generally mild, with resolution of myocarditis in most cases, as judged by clinical symptoms and inflammatory markers and troponin elevation, electrocardiographic and echocardiographic normalization, and a relatively short length of hospital stay.

However, one person with fulminant myocarditis died. The ejection fraction was normal or mildly reduced in most persons and severely reduced in 4 persons. Magnetic resonance imaging that was performed in 48 persons showed findings that were consistent with myocarditis on the basis of at least one positive T2-based sequence and one positive T1-based sequence (including T2-weighted images, T1 and T2 parametric mapping, and late gadolinium enhancement).

Follow-up data regarding the status of cases after hospital discharge and consistent measures of cardiac function were not available. Figure 1. Figure 1.

Timing and Distribution of Myocarditis after Receipt of the BNT162b2 treatment. Shown is the timing of the diagnosis of myocarditis among recipients of the first dose of treatment (Panel A) and the second dose (Panel B), according to sex, and the distribution of cases among recipients according to both age and sex after the first dose (Panel C) and after the second dose (Panel D). Cases of myocarditis were reported within 21 days after the first dose and within 30 days after the second dose.The peak number of cases with proximity to vaccination occurred in February and March 2021.

The associations with vaccination status, age, and sex are provided in Table 1 and Figure 1. Of 136 persons with definite or probable myocarditis, 19 presented after the first dose of treatment and 117 after the second dose. In the 21 days after the first dose, 19 persons with myocarditis were hospitalized, and hospital admission dates were approximately equally distributed over time.

A total of 95 of 117 persons (81%) who presented after the second dose were hospitalized within 7 days after vaccination. Among 95 persons for whom data regarding age and sex were available, 86 (91%) were male and 72 (76%) were under the age of 30 years. Comparison of Risks According to First or Second Dose Table 3.

Table 3. Risk of Myocarditis within 21 Days after the First or Second Dose of treatment, According to Age and Sex. A comparison of risks over equal time periods of 21 days after the first and second doses according to age and sex is provided in Table 3.

Cases were clustered during the first few days after the second dose of treatment, according to visual inspection of the data (Figure 1B and 1D). The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19). The overall risk difference was 3.19 (95% CI, 2.37 to 4.02) among male recipients and 0.39 (95% CI, 0.10 to 0.68) among female recipients.

The highest difference was observed among male recipients between the ages of 16 and 19 years. 13.73 per 100,000 persons (95% CI, 8.11 to 19.46). In this age group, the percent attributable risk to the second dose was 91%.

The difference in the risk among female recipients between the first and second doses in the same age group was 1.00 per 100,000 persons (95% CI, −0.63 to 2.72). Repeating these analyses with a shorter follow-up of 7 days owing to the presence of a cluster that was noted after the second treatment dose disclosed similar differences in male recipients between the ages of 16 and 19 years (risk difference, 13.62 per 100,000 persons. 95% CI, 8.31 to 19.03).

These findings pointed to the first week after the second treatment dose as the main risk window. Observed versus Expected Incidence Table 4. Table 4.

Standardized Incidence Ratios for 151 Cases of Myocarditis, According to treatment Dose, Age, and Sex. Table 4 shows the standardized incidence ratios for myocarditis according to treatment dose, age group, and sex, as projected from the incidence during the prekamagra period from 2017 through 2019. Myocarditis after the second dose of treatment had a standardized incidence ratio of 5.34 (95% CI, 4.48 to 6.40), which was driven mostly by the diagnosis of myocarditis in younger male recipients.

Among boys and men, the standardized incidence ratio was 13.60 (95% CI, 9.30 to 19.20) for those 16 to 19 years of age, 8.53 (95% CI, 5.57 to 12.50) for those 20 to 24 years, 6.96 (95% CI, 4.25 to 10.75) for those 25 to 29 years, and 2.90 (95% CI, 1.98 to 4.09) for those 30 years of age or older. These substantially increased findings were not observed after the first dose. A sensitivity analysis showed that for male recipients between the ages of 16 and 24 years who had received a second treatment dose, the observed standardized incidence ratios would have required overreporting of myocarditis by a factor of 4 to 5 on the assumption that the true incidence would not have differed from the expected incidence (Table S4).

Rate Ratio between Vaccinated and Unvaccinated Persons Table 5. Table 5. Rate Ratios for a Diagnosis of Myocarditis within 30 Days after the Second Dose of treatment, as Compared with Unvaccinated Persons (January 11 to May 31, 2021).

Within 30 days after receipt of the second treatment dose in the general population, the rate ratio for the comparison of the incidence of myocarditis between vaccinated and unvaccinated persons was 2.35 (95% CI, 1.10 to 5.02) according to the Brighton Collaboration classification of definite and probable cases and after adjustment for age and sex. This result was driven mainly by the findings for males in younger age groups, with a rate ratio of 8.96 (95% CI, 4.50 to 17.83) for those between the ages of 16 and 19 years, 6.13 (95% CI, 3.16 to 11.88) for those 20 to 24 years, and 3.58 (95% CI, 1.82 to 7.01) for those 25 to 29 years (Table 5). When follow-up was restricted to 7 days after the second treatment dose, the analysis results for male recipients between the ages of 16 and 19 years were even stronger than the findings within 30 days (rate ratio, 31.90.

95% CI, 15.88 to 64.08). Concordance of our findings with the Bradford Hill causality criteria is shown in Table S5.To the Editor. Previous studies have shown that the BNT162b2 (Pfizer–BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Johnson &.

Johnson–Janssen) treatments provide robust protective efficacy against erectile dysfunction disease 2019 (erectile dysfunction treatment). Here, we report comparative kinetics of humoral and cellular immune responses elicited by the two-dose BNT162b2 treatment (in 31 participants), the two-dose mRNA-1273 treatment (in 22 participants), and the one-dose Ad26.COV2.S treatment (in 8 participants). We evaluated antibody and T-cell responses from peak immunity at 2 to 4 weeks after the second immunization in recipients of the messenger RNA (mRNA) treatments or after the first immunization in recipients of the Ad26.COV2.S treatment to 8 months (Table S1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org).

Figure 1. Figure 1. Kinetics of Humoral and Cellular Immune Responses Elicited by the BNT162b2, mRNA-1273, and Ad26.COV2.S treatments.

Shown are immune responses after vaccination with BNT162b2, mRNA-1273, and Ad26.COV2.S at peak immunity (2 to 4 weeks after the second dose in recipients of the messenger RNA treatments or 4 weeks after one dose in recipients of the Ad26.COV2.S treatment) and at 6 months, 8 months, or both after the first dose. Panel A shows the serum 50% inhibitory dilution (ID50) titers in the live-kamagra neutralizing antibody assay. Red bars indicate medians, dashed lines the limit of detection for each assay, and each dot a single participant.

Panel B shows the serum dilution for 50% reduction (NT50) expressed in relative light units in the pseudokamagra neutralizing antibody assay. Panel C shows the binding IgG antibody titers against the receptor-binding domain (RBD) in the serum enzyme-linked immunosorbent assay. Intracellular cytokine-staining assays were performed to measure the percentage of interferon-γ production in T cells.

Panel D shows this percentage in CD4+ T cells, and Panel E shows this percentage in CD8+ T cells. Flow cytometric gating was performed to identify T cells (which are CD3+) rather than other CD4+- or CD8+-expressing immune cells. All assays were performed with the use of the erectile dysfunction WA1/2020 strain.

The Ad26.COV2.S treatment data in Panels B through E were published previously3 and are included here for comparative purposes.At peak immunity, the BNT162b2 treatment induced a high median live-kamagra neutralizing antibody titer (1789), a high median pseudokamagra neutralizing antibody titer (700), and a high median binding antibody titer against the receptor-binding domain (RBD) (21,564). However, these titers declined sharply by 6 months after vaccination, as previously reported,1,2 and they declined further by 8 months (Figure 1A through 1C, S1, and S2). By 8 months after BNT162b2 vaccination, the median live-kamagra neutralizing antibody titer (53), pseudokamagra neutralizing antibody titer (160), and RBD-specific binding antibody titer (755) elicited by the treatment were lower than the peak titers by a factor of 34, 4, and 29, respectively.

At peak immunity, the mRNA-1273 treatment also elicited a high median live-kamagra neutralizing antibody titer (5848), pseudokamagra neutralizing antibody titer (1569), and RBD-specific binding antibody titer (25,677). By 8 months after mRNA-1273 vaccination, the median live-kamagra neutralizing antibody titer was 133, the pseudokamagra neutralizing antibody titer was 273, and the median RBD-specific binding antibody titer was 1546. These titers were lower than the peak titers by a factor of 44, 6, and 17, respectively.

The Ad26.COV2.S treatment induced substantially lower median titers than the mRNA treatments at peak immunity. At 4 weeks after single-shot Ad26.COV2.S immunization, the median live-kamagra neutralizing antibody titer was 146, the median pseudokamagra neutralizing antibody titer was 391, and the median RBD-specific binding antibody titer was 1361. However, these titers remained relatively stable over 8 months.3 At 8 months, the median live-kamagra neutralizing antibody titer was 629, the median pseudokamagra neutralizing antibody titer was 185, and the median RBD-specific binding antibody titer was 843.

These titers were similar to the titers at week 4. With all three treatments, there were generally stable antibody-dependent cellular phagocytosis and antibody-dependent complement deposition responses (Fig. S3).

Recipients of the BNT162b2 and mRNA-1273 treatments also had decreases in titers of live-kamagra neutralizing antibodies, pseudokamagra neutralizing antibodies, and RBD- and spike protein (S)–specific binding antibody responses against severe acute respiratory syndrome erectile dysfunction 2 (erectile dysfunction) variants from peak immunity to 8 months. After Ad26.COV2.S vaccination, however, there were stable or in some cases increasing antibody titers against these variants (Figs. S4 and S5).

At 8 months, the median pseudokamagra neutralizing antibody titers against the erectile dysfunction B.1.617.2 (delta) variant were similar with the BNT162b2 treatment (67), the mRNA-1273 treatment (76), and the Ad26.COV2.S treatment (107). T-cell responses were assessed by CD4+ and CD8+ intracellular cytokine-staining assays that used pooled S peptides for stimulation (Figure 1D and 1E). At 8 months, the median CD8+ T-cell responses were 0.016% with the BNT162b2 treatment, 0.017% with the mRNA-1273 treatment, and 0.12% with the Ad26.COV2.S treatment.

With all three treatments, T-cell responses showed broad cross-reactivity against erectile dysfunction variants (Fig. S6). These data show differential kinetics of immune responses induced by the mRNA and Ad26.COV2.S treatments over an 8-month follow-up period.

As shown in previous studies,1,2 the BNT162b2 and mRNA-1273 treatments were characterized by high peak antibody responses that declined sharply by 6 months. These responses declined further by 8 months. Antibody titers in recipients of the mRNA-1273 treatment were generally higher than those in recipients of the BNT162b2 treatment.

The Ad26.COV2.S treatment induced lower initial antibody responses, but these responses were relatively stable over the 8-month follow-up period, with minimal-to-no evidence of decline.3 These findings have important implications for waning treatment immunity, although correlates of protection from erectile dysfunction are not yet defined. Ai-ris Y. Collier, M.D.Jingyou Yu, Ph.D.Katherine McMahan, M.S.Jinyan Liu, Ph.D.Abishek Chandrashekar, M.S.Beth Israel Deaconess Medical Center, Boston, MAJenny S.

Maron, B.S.Caroline Atyeo, M.S.Ragon Institute of MGH, MIT, and Harvard, Cambridge, MADavid R. Martinez, Ph.D.University of North Carolina at Chapel Hill, Chapel Hill, NCJessica L. Ansel, N.P.Ricardo Aguayo, B.S.Marjorie Rowe, B.S.Catherine Jacob-Dolan, B.S.Daniel Sellers, B.S.Julia Barrett, B.S.Kunza Ahmad, M.S.Tochi Anioke, B.S.Haley VanWyk, B.S.Sarah Gardner, B.S.Olivia Powers, B.S.Esther A.

Bondzie, B.A.Huahua Wan, M.S.Beth Israel Deaconess Medical Center, Boston, MARalph S. Baric, Ph.D.University of North Carolina at Chapel Hill, Chapel Hill, NCGalit Alter, Ph.D.Ragon Institute of MGH, MIT, and Harvard, Cambridge, MAMichele R. Hacker, Sc.D.Dan H.

Barouch, M.D., Ph.D.Beth Israel Deaconess Medical Center, Boston, MA [email protected] Supported by Janssen treatments and Prevention. A grant (CA260476, to Dr. Barouch) from the National Institutes of Health.

The Massachusetts Consortium on Pathogen Readiness. The Ragon Institute of MGH, MIT, and Harvard. A grant (to Dr.

Barouch) from the Musk Foundation. A grant (HD000849, to Dr. Collier) from the Reproductive Scientist Development Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Burroughs Wellcome Fund.

A grant (TR002541, to Dr. Hacker) from the Harvard Clinical and Translational Science Center. And a fellowship from the Hanna H.

Gray Fellows Program from the Howard Hughes Medical Institute and an award from the Postdoctoral Enrichment Program of the Burroughs Wellcome Fund (both to Dr. Martinez). The funders had no role in the design or conduct of the study.

Collection, management, analysis, or interpretation of the data. Preparation, review, or approval of the manuscript. Or the decision to submit the manuscript for publication.

Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. Requests for access to the study data can be submitted to Dr. Barouch at [email protected].This letter was published on October 15, 2021, at NEJM.org.3 References1.

Pegu A, O’Connell SE, Schmidt SD, et al. Durability of mRNA-1273 treatment-induced antibodies against erectile dysfunction variants. Science 2021;373:1372-1377.2.

Falsey AR, Frenck RW Jr, Walsh EE, et al. erectile dysfunction neutralization with BNT162b2 treatment dose 3. N Engl J Med.

DOI. 10.1056/NEJMc2113468.3. Barouch DH, Stephenson KE, Sadoff J, et al.

Durable humoral and cellular immune responses 8 months after Ad26.COV2.S vaccination. N Engl J Med 2021;385:951-953.From the Department of Cardiology (CVK) and the Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Center for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin Berlin, Berlin (S.D.A.), Universitätsklinikum des Saarlandes, Homberg (M. Böhm), RWTH Aachen University, Aachen (N.M.), Boehringer Ingelheim Pharma, Biberach (C.Z., S.S.), Boehringer Ingelheim International, Ingelheim (W.J., M.

Brueckmann), and the Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann) — all in Germany. The University of Mississippi Medical Center, Jackson (J.B.).

National and Kapodistrian University of Athens School of Medicine, Athens (G.F.). Université de Lorraine, INSERM, Centre d’Investigations Cliniques Plurithématique 1433, and INSERM Unité 1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists) (J.P.F.), and Université de Lorraine, INSERM INI-CRCT, CHRU (F.Z.) — both in Nancy, France. The Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal (J.P.F.).

Unidade de Insuficiência Cardíaca, Instituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo (E.B.). Maastricht University Medical Center and the School for Cardiovascular Disease CARIM — both in Maastricht, the Netherlands (H.-P.B.-L.R.). The Department of Medicine, Seoul National University Bundang Hospital, Seoul, South Korea (D.-J.C.).

Max Superspeciality Hospital, Saket, New Delhi, India (V.C.). The National Institute of Cardiology, Mexico City (E.C.-V.). McGill University Health Centre, Montreal (N.G.), and St.

Michael’s Hospital, University of Toronto, Toronto (S.V.) — both in Canada. The Cardiology Service, Fundación Valle del Lili, Universidad Icesi, Cali, Colombia (J.E.G.-M.). The Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium (S.J.).

Massachusetts General Hospital and Baim Institute for Clinical Research, Boston (J.L.J.). University Hospital, Santiago de Compostela, Spain (J.R.G.-J.). Heart and Vascular Center, Semmelweiss University, Budapest, Hungary (B.M.).

Victorian Heart Institute, Monash University, Melbourne, VIC, Australia (S.J.N.). Argentine Catholic University, and Medical Advisor in Heart Failure, Pulmonary Hypertension and Intrathoracic Transplant at FLENI and IADT Institute — both in Buenos Aires (S.V.P.). Central Michigan University, Mount Pleasant (I.L.P.).

Wroclaw Medical University, Wroclaw, Poland (P.P.). The Cardiovascular Department, Cardiology Division, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and Università di Pisa, Pisa (S.T.) — both in Italy. National Heart Centre Singapore, Singapore (D.S.).

The Internal Cardiology Department, St. Ann University Hospital and Masaryk University, Brno, Czech Republic (J.S.). The University of Leicester, Glenfield General Hospital, Leicester (I.S.), the University of Glasgow, Glasgow (N.S.), the London School of Hygiene and Tropical Medicine (S.J.P.), and Imperial College, London (M.P.) — all in the United Kingdom.

Kyushu University, Fukuoka, Japan (H.T.). The University of Medicine and Pharmacy, Carol Davila University and Emergency Hospital, Bucharest, Romania (D.V.). The Heart Failure Center, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing (J.Z.).

The Veterans Affairs Medical Center, Washington, DC (P.C.). National Heart Centre Singapore, Duke-National University of Singapore, Singapore (C.S.P.L.). Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J.M.S.).

And Baylor Heart and Vascular Institute, Dallas (M.P.).Address reprint requests to Dr. Anker at the Department of Cardiology and BCRT (Campus CVK), Charité Universitätsmedizin Berlin, 13353 Berlin, Germany, or at [email protected], or to Dr. Butler at the Department of Medicine, University of Mississippi Medical Center, 2500 North State St., Jackson, MS 39216, or at [email protected].Breakthrough s Among 11,453 fully vaccinated health care workers, 1497 (13.1%) underwent RT-PCR testing during the study period.

Of the tested workers, 39 breakthrough cases were detected. More than 38 persons were tested for every positive case that was detected, for a test positivity of 2.6%. Thus, this percentage was much lower than the test positivity rate in Israel at the time, since the ratio between positive results and the extensive number of tests that were administered in our study was much smaller than that in the national population.

Of the 39 breakthrough case patients, 18 (46%) were nursing staff members, 10 (26%) were administration or maintenance workers, 6 (15%) were allied health professionals, and 5 (13%) were physicians. The average age of the 39 infected workers was 42 years, and the majority were women (64%). The median interval from the second treatment dose to erectile dysfunction detection was 39 days (range, 11 to 102).

Only one infected person (3%) had immunosuppression. Other coexisting illnesses are detailed in Table S1. In all 37 case patients for whom data were available regarding the source of , the suspected source was an unvaccinated person.

In 21 patients (57%), this person was a household member. Among these case patients were two married couples, in which both sets of spouses worked at Sheba Medical Center and had an unvaccinated child who had tested positive for erectile dysfunction treatment and was assumed to be the source. In 11 of 37 case patients (30%), the suspected source was an unvaccinated fellow health care worker or patient.

In 7 of the 11 case patients, the was caused by a nosocomial outbreak of the B.1.1.7 (alpha) variant. These 7 patients, who worked in different hospital sectors and wards, were all found to be linked to the same suspected unvaccinated index patient who had been receiving noninvasive positive-pressure ventilation before her had been detected. Of the 39 cases of , 27 occurred in workers who were tested solely because of exposure to a person with known erectile dysfunction .

Of all the workers with breakthrough , 26 (67%) had mild symptoms at some stage, and none required hospitalization. The remaining 13 workers (33% of all cases) were asymptomatic during the duration of . Of these workers, 6 were defined as borderline cases, since they had an N gene Ct value of more than 35 on repeat testing.

The most common symptom that was reported was upper respiratory congestion (36% of all cases), followed by myalgia (28%) and loss of smell or taste (28%). Fever or rigors were reported in 21% (Table S1). On follow-up questioning, 31% of all infected workers reported having residual symptoms 14 days after their diagnosis.

At 6 weeks after their diagnosis, 19% reported having “long erectile dysfunction treatment” symptoms, which included a prolonged loss of smell, persistent cough, fatigue, weakness, dyspnea, or myalgia. Nine workers (23%) took a leave of absence from work beyond the 10 days of required quarantine. Of these workers, 4 returned to work within 2 weeks.

One worker had not yet returned after 6 weeks. Verification Testing and Secondary s Repeat RT-PCR assays were performed on samples obtained from most of the infected workers and for all case patients with an initial N gene Ct value of more than 30 to verify that the initial test was not taken too early, before the worker had become infectious. A total of 29 case patients (74%) had a Ct value of less than 30 at some point during their .

However, of these workers, only 17 (59%) had positive results on a concurrent Ag-RDT. Ten workers (26%) had an N gene Ct value of more than 30 throughout the entire period. 6 of these workers had values of more than 35 and probably had never been infectious.

Of the 33 isolates that were tested for a variant of concern, 28 (85%) were identified as the B.1.1.7 variant, by either multiplex PCR assay or genomic sequencing. At the time of this study, the B.1.1.7 variant was the most widespread variant in Israel and accounted for up to 94.5% of erectile dysfunction isolates.1,16 Since the end of the study, the country has had a surge of cases caused by the delta variant, as have many other countries worldwide. Thorough epidemiologic investigations of data regarding in-hospital contact tracing did not detect any cases of transmission from infected health care workers (secondary s) among the 39 primary s.

Among the 31 cases for whom data regarding household transmission (including symptoms and RT-PCR results) were available, no secondary s were detected, including 10 case patients and their 27 household members in whom the health care worker was the only index case patient. Data regarding post N-specific IgG antibodies were available for 22 of 39 case patients (56%) on days 8 to 72 after the first positive result on RT-PCR assay. Of these workers, 4 (18%) did not have an immune response, as detected by negative results on N-specific IgG antibody testing.

Among these 4 workers were 2 who were asymptomatic (Ct values, 32 and 35), 1 who underwent serologic testing only on day 10 after diagnosis, and 1 who had immunosuppression. Case–Control Analysis The results of peri- neutralizing antibody tests were available for 22 breakthrough cases. Included in this group were 3 health care workers who had participated in the serologic study and had a test performed in the week preceding detection.

In 19 other workers, neutralizing and S-specific IgG antibodies were assessed on detection day. Of these 19 case patients, 12 were asymptomatic at the time of detection. For each case, 4 to 5 controls were matched as described (Fig.

S1). In total, 22 breakthrough cases and their 104 matched controls were included in the case–control analysis. Table 1.

Table 1. Population Characteristics and Outcomes in the Case–Control Study. Figure 2.

Figure 2. Neutralizing Antibody and IgG Titers among Cases and Controls, According to Timing. Among the 39 fully vaccinated health care workers who had breakthrough with erectile dysfunction, shown are the neutralizing antibody titers during the peri- period (within a week before erectile dysfunction detection) (Panel A) and the peak titers within 1 month after the second dose (Panel B), as compared with matched controls.

Also shown are IgG titers during the peri- period (Panel C) and peak titers (Panel D) in the two groups. Each case of breakthrough was matched with 4 to 5 controls according to sex, age, immunosuppression status, and timing of serologic testing after the second treatment dose. In each panel, the horizontal bars indicate the mean geometric titers and the 𝙸 bars indicate 95% confidence intervals.

Symptomatic cases, which were all mild and did not require hospitalization, are indicated in red.Figure 3. Figure 3. Correlation between Neutralizing Antibody Titer and N Gene Cycle Threshold as Indication of Infectivity.

The results of antigen-detecting (Ag) rapid diagnostic testing for the presence of erectile dysfunction are shown, along with neutralizing antibody titers and N gene cycle threshold (Ct) values in 22 fully vaccinated health care workers with breakthrough for whom data were available (slope of regression line, 171.2. 95% CI, 62.9 to 279.4).The predicted GMT of peri- neutralizing antibody titers was 192.8 (95% confidence interval [CI], 67.6 to 549.8) for cases and 533.7 (95% CI, 408.1 to 698.0) for controls, for a predicted case-to-control ratio of neutralizing antibody titers of 0.361 (95% CI, 0.165 to 0.787) (Table 1 and Figure 2A). In a subgroup analysis in which the borderline cases were excluded, the ratio was 0.353 (95% CI, 0.185 to 0.674).

Peri- neutralizing antibody titers in the breakthrough cases were associated with higher N gene Ct values (i.e., a lower viral RNA copy number) (slope of regression line, 171.2. 95% CI, 62.9 to 279.4) (Figure 3). A peak neutralizing antibody titer within the first month after the second treatment dose was available for only 12 of the breakthrough cases.

The GEE predicted peak neutralizing antibody titer was 152.2 (95% CI, 30.5 to 759.3) in 12 cases and 1027.5 (95% CI, 761.6 to 1386.2) in 56 controls, for a ratio of 0.148 (95% CI, 0.040 to 0.548) (Figure 2B). In the subgroup analysis in which borderline cases were excluded, the ratio was 0.114 (95% CI, 0.042 to 0.309). The observed and predicted GMTs of peri- S-specific IgG antibody levels in breakthrough cases were lower than that in controls, with a predicted ratio of 0.514 (95% CI, 0.282 to 0.937) (Figure 2C).

The observed and predicted peak IgG GMTs in cases were also somewhat lower than those in controls (0.507. 95% CI, 0.260 to 0.989) (Figure 2D). To assess whether our practice of measuring antibodies on the day of diagnosis created bias by capturing anamnestic responses to the current , we plotted peak (first-month) IgG titers against peri- titers on the day of diagnosis in 13 case patients for whom both values were available.

In all cases, peri- titers were lower than the previous peak titers, indicating that the titers that were obtained on the day of diagnosis were probably representative of peri- titers (Fig. S2).Participants Figure 1. Figure 1.

Enrollment and Randomization. The diagram represents all enrolled participants through November 14, 2020. The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date.

The further procedures that one participant in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1. Demographic Characteristics of the Participants in the Main Safety Population.

Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites. Argentina, 1. Brazil, 2.

South Africa, 4. Germany, 6. And Turkey, 9) in the phase 2/3 portion of the trial.

A total of 43,448 participants received injections. 21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set.

Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table S2). Safety Local Reactogenicity Figure 2.

Figure 2. Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination.

Solicited injection-site (local) reactions are shown in Panel A. Pain at the injection site was assessed according to the following scale. Mild, does not interfere with activity.

Moderate, interferes with activity. Severe, prevents daily activity. And grade 4, emergency department visit or hospitalization.

Redness and swelling were measured according to the following scale. Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to 10.0 cm in diameter.

Severe, >10.0 cm in diameter. And grade 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B.

Fever categories are designated in the key. Medication use was not graded. Additional scales were as follows.

Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild. Does not interfere with activity. Moderate.

Some interference with activity. Or severe. Prevents daily activity), vomiting (mild.

1 to 2 times in 24 hours. Moderate. >2 times in 24 hours.

Or severe. Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours.

Moderate. 4 to 5 loose stools in 24 hours. Or severe.

6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization. Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants.

Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose.

66% after the second dose) than among younger participants (83% after the first dose. 78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling.

The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B).

The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients).

The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose. Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients.

Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1.

45% after dose 2) than older treatment recipients (20% after dose 1. 38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter.

Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3).

More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy.

Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction).

No deaths were considered by the investigators to be related to the treatment or placebo. No erectile dysfunction treatment–associated deaths were observed. No stopping rules were met during the reporting period.

Safety monitoring will continue for 2 years after administration of the second dose of treatment. Efficacy Table 2. Table 2.

treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose. Table 3. Table 3.

treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3. Figure 3.

Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose. Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population). Each symbol represents erectile dysfunction treatment cases starting on a given day.

Filled symbols represent severe erectile dysfunction treatment cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days.

Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point. The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients.

This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of erectile dysfunction treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3).

Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9.

Case split. BNT162b2, 2 cases. Placebo, 44 cases).

Figure 3 shows cases of erectile dysfunction treatment or severe erectile dysfunction treatment with onset at any time after the first dose (mITT population) (additional data on severe erectile dysfunction treatment are available in Table S5). Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose..

Cases of Myocarditis Table cheap kamagra oral jelly online 1. Table 1 cheap kamagra oral jelly online. Reported Myocarditis Cases, According to Timing of First or Second treatment Dose.

Table 2 cheap kamagra oral jelly online. Table 2. Classification of Myocarditis Cases Reported to the Ministry cheap kamagra oral jelly online of Health.

Among 9,289,765 Israeli residents who were included during the surveillance period, 5,442,696 received a first treatment dose and 5,125,635 received two doses (Table 1 and Fig. S2). A total of 304 cases of myocarditis (as defined by the ICD-9 codes for myocarditis) were reported to the Ministry of Health (Table 2).

These cases were diagnosed in 196 persons who had received two doses of the treatment. 151 persons within 21 days after the first dose and 30 days after the second dose and 45 persons in the period after 21 days and 30 days, respectively. (Persons in whom myocarditis developed 22 days or more after the first dose of treatment or more than 30 days after the second dose were considered to have myocarditis that was not in temporal proximity to the treatment.) After a detailed review of the case histories, we ruled out 21 cases because of reasonable alternative diagnoses.

Thus, the diagnosis of myocarditis was affirmed for 283 cases. These cases included 142 among vaccinated persons within 21 days after the first dose and 30 days after the second dose, 40 among vaccinated persons not in proximity to vaccination, and 101 among unvaccinated persons. Among the unvaccinated persons, 29 cases of myocarditis were diagnosed in those with confirmed erectile dysfunction treatment and 72 in those without a confirmed diagnosis.

Of the 142 persons in whom myocarditis developed within 21 days after the first dose of treatment or within 30 days after the second dose, 136 received a diagnosis of definite or probable myocarditis, 1 received a diagnosis of possible myocarditis, and 5 had insufficient data. Classification of cases according to the definition of myocarditis used by the CDC 4-6 is provided in Table S1. Endomyocardial biopsy samples that were obtained from 2 persons showed foci of endointerstitial edema and neutrophils, along with mononuclear-cell infiates (monocytes or macrophages and lymphocytes) with no giant cells.

No other patients underwent endomyocardial biopsy. The clinical features of myocarditis after vaccination are provided in Table S3. In the 136 cases of definite or probable myocarditis, the clinical presentation in 129 was generally mild, with resolution of myocarditis in most cases, as judged by clinical symptoms and inflammatory markers and troponin elevation, electrocardiographic and echocardiographic normalization, and a relatively short length of hospital stay.

However, one person with fulminant myocarditis died. The ejection fraction was normal or mildly reduced in most persons and severely reduced in 4 persons. Magnetic resonance imaging that was performed in 48 persons showed findings that were consistent with myocarditis on the basis of at least one positive T2-based sequence and one positive T1-based sequence (including T2-weighted images, T1 and T2 parametric mapping, and late gadolinium enhancement).

Follow-up data regarding the status of cases after hospital discharge and consistent measures of cardiac function were not available. Figure 1. Figure 1.

Timing and Distribution of Myocarditis after Receipt of the BNT162b2 treatment. Shown is the timing of the diagnosis of myocarditis among recipients of the first dose of treatment (Panel A) and the second dose (Panel B), according to sex, and the distribution of cases among recipients according to both age and sex after the first dose (Panel C) and after the second dose (Panel D). Cases of myocarditis were reported within 21 days after the first dose and within 30 days after the second dose.The peak number of cases with proximity to vaccination occurred in February and March 2021.

The associations with vaccination status, age, and sex are provided in Table 1 and Figure 1. Of 136 persons with definite or probable myocarditis, 19 presented after the first dose of treatment and 117 after the second dose. In the 21 days after the first dose, 19 persons with myocarditis were hospitalized, and hospital admission dates were approximately equally distributed over time.

A total of 95 of 117 persons (81%) who presented after the second dose were hospitalized within 7 days after vaccination. Among 95 persons for whom data regarding age and sex were available, 86 (91%) were male and 72 (76%) were under the age of 30 years. Comparison of Risks According to First or Second Dose Table 3.

Table 3. Risk of Myocarditis within 21 Days after the First or Second Dose of treatment, According to Age and Sex. A comparison of risks over equal time periods of 21 days after the first and second doses according to age and sex is provided in Table 3.

Cases were clustered during the first few days after the second dose of treatment, according to visual inspection of the data (Figure 1B and 1D). The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19). The overall risk difference was 3.19 (95% CI, 2.37 to 4.02) among male recipients and 0.39 (95% CI, 0.10 to 0.68) among female recipients.

The highest difference was observed among male recipients between the ages of 16 and 19 years. 13.73 per 100,000 persons (95% CI, 8.11 to 19.46). In this age group, the percent attributable risk to the second dose was 91%.

The difference in the risk among female recipients between the first and second doses in the same age group was 1.00 per 100,000 persons (95% CI, −0.63 to 2.72). Repeating these analyses with a shorter follow-up of 7 days owing to the presence of a cluster that was noted after the second treatment dose disclosed similar differences in male recipients between the ages of 16 and 19 years (risk difference, 13.62 per 100,000 persons. 95% CI, 8.31 to 19.03).

These findings pointed to the first week after the second treatment dose as the main risk window. Observed versus Expected Incidence Table 4. Table 4.

Standardized Incidence Ratios for 151 Cases of Myocarditis, According to treatment Dose, Age, and Sex. Table 4 shows the standardized incidence ratios for myocarditis according to treatment dose, age group, and sex, as projected from the incidence during the prekamagra period from 2017 through 2019. Myocarditis after the second dose of treatment had a standardized incidence ratio of 5.34 (95% CI, 4.48 to 6.40), which was driven mostly by the diagnosis of myocarditis in younger male recipients.

Among boys and men, the standardized incidence ratio was 13.60 (95% CI, 9.30 to 19.20) for those 16 to 19 years of age, 8.53 (95% CI, 5.57 to 12.50) for those 20 to 24 years, 6.96 (95% CI, 4.25 to 10.75) for those 25 to 29 years, and 2.90 (95% CI, 1.98 to 4.09) for those 30 years of age or older. These substantially increased findings were not observed after the first dose. A sensitivity analysis showed that for male recipients between the ages of 16 and 24 years who had received a second treatment dose, the observed standardized incidence ratios would have required overreporting of myocarditis by a factor of 4 to 5 on the assumption that the true incidence would not have differed from the expected incidence (Table S4).

Rate Ratio between Vaccinated and Unvaccinated Persons Table 5. Table 5. Rate Ratios for a Diagnosis of Myocarditis within 30 Days after the Second Dose of treatment, as Compared with Unvaccinated Persons (January 11 to May 31, 2021).

Within 30 days after receipt of the second treatment dose in the general population, the rate ratio for the comparison of the incidence of myocarditis between vaccinated and unvaccinated persons was 2.35 (95% CI, 1.10 to 5.02) according to the Brighton Collaboration classification of definite and probable cases and after adjustment for age and sex. This result was driven mainly by the findings for males in younger age groups, with a rate ratio of 8.96 (95% CI, 4.50 to 17.83) for those between the ages of 16 and 19 years, 6.13 (95% CI, 3.16 to 11.88) for those 20 to 24 years, and 3.58 (95% CI, 1.82 to 7.01) for those 25 to 29 years (Table 5). When follow-up was restricted to 7 days after the second treatment dose, the analysis results for male recipients between the ages of 16 and 19 years were even stronger than the findings within 30 days (rate ratio, 31.90.

95% CI, 15.88 to 64.08). Concordance of our findings with the Bradford Hill causality criteria is shown in Table S5.To the Editor. Previous studies have shown that the BNT162b2 (Pfizer–BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Johnson &.

Johnson–Janssen) treatments provide robust protective efficacy against erectile dysfunction disease 2019 (erectile dysfunction treatment). Here, we report comparative kinetics of humoral and cellular immune responses elicited by the two-dose BNT162b2 treatment (in 31 participants), the two-dose mRNA-1273 treatment (in 22 participants), and the one-dose Ad26.COV2.S treatment (in 8 participants). We evaluated antibody and T-cell responses from peak immunity at 2 to 4 weeks after the second immunization in recipients of the messenger RNA (mRNA) treatments or after the first immunization in recipients of the Ad26.COV2.S treatment to 8 months (Table S1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org).

Figure 1. Figure 1. Kinetics of Humoral and Cellular Immune Responses Elicited by the BNT162b2, mRNA-1273, and Ad26.COV2.S treatments.

Shown are immune responses after vaccination with BNT162b2, mRNA-1273, and Ad26.COV2.S at peak immunity (2 to 4 weeks after the second dose in recipients of the messenger RNA treatments or 4 weeks after one dose in recipients of the Ad26.COV2.S treatment) and at 6 months, 8 months, or both after the first dose. Panel A shows the serum 50% inhibitory dilution (ID50) titers in the live-kamagra neutralizing antibody assay. Red bars indicate medians, dashed lines the limit of detection for each assay, and each dot a single participant.

Panel B shows the serum dilution for 50% reduction (NT50) expressed in relative light units in the pseudokamagra neutralizing antibody assay. Panel C shows the binding IgG antibody titers against the receptor-binding domain (RBD) in the serum enzyme-linked immunosorbent assay. Intracellular cytokine-staining assays were performed to measure the percentage of interferon-γ production in T cells.

Panel D shows this percentage in CD4+ T cells, and Panel E shows this percentage in CD8+ T cells. Flow cytometric gating was performed to identify T cells (which are CD3+) rather than other CD4+- or CD8+-expressing immune cells. All assays were performed with the use of the erectile dysfunction WA1/2020 strain.

The Ad26.COV2.S treatment data in Panels B through E were published previously3 and are included here for comparative purposes.At peak immunity, the BNT162b2 treatment induced a high median live-kamagra neutralizing antibody titer (1789), a high median pseudokamagra neutralizing antibody titer (700), and a high median binding antibody titer against the receptor-binding domain (RBD) (21,564). However, these titers declined sharply by 6 months after vaccination, as previously reported,1,2 and they declined further by 8 months (Figure 1A through 1C, S1, and S2). By 8 months after BNT162b2 vaccination, the median live-kamagra neutralizing antibody titer (53), pseudokamagra neutralizing antibody titer (160), and RBD-specific binding antibody titer (755) elicited by the treatment were lower than the peak titers by a factor of 34, 4, and 29, respectively.

At peak immunity, the mRNA-1273 treatment also elicited a high median live-kamagra neutralizing antibody titer (5848), pseudokamagra neutralizing antibody titer (1569), and RBD-specific binding antibody titer (25,677). By 8 months after mRNA-1273 vaccination, the median live-kamagra neutralizing antibody titer was 133, the pseudokamagra neutralizing antibody titer was 273, and the median RBD-specific binding antibody titer was 1546. These titers were lower than the peak titers by a factor of 44, 6, and 17, respectively.

The Ad26.COV2.S treatment induced substantially lower median titers than the mRNA treatments at peak immunity. At 4 weeks after single-shot Ad26.COV2.S immunization, the median live-kamagra neutralizing antibody titer was 146, the median pseudokamagra neutralizing antibody titer was 391, and the median RBD-specific binding antibody titer was 1361. However, these titers remained relatively stable over 8 months.3 At 8 months, the median live-kamagra neutralizing antibody titer was 629, the median pseudokamagra neutralizing antibody titer was 185, and the median RBD-specific binding antibody titer was 843.

These titers were similar to the titers at week 4. With all three treatments, there were generally stable antibody-dependent cellular phagocytosis and antibody-dependent complement deposition responses (Fig. S3).

Recipients of the BNT162b2 and mRNA-1273 treatments also had decreases in titers of live-kamagra neutralizing antibodies, pseudokamagra neutralizing antibodies, and RBD- and spike protein (S)–specific binding antibody responses against severe acute respiratory syndrome erectile dysfunction 2 (erectile dysfunction) variants from peak immunity to 8 months. After Ad26.COV2.S vaccination, however, there were stable or in some cases increasing antibody titers against these variants (Figs. S4 and S5).

At 8 months, the median pseudokamagra neutralizing antibody titers against the erectile dysfunction B.1.617.2 (delta) variant were similar with the BNT162b2 treatment (67), the mRNA-1273 treatment (76), and the Ad26.COV2.S treatment (107). T-cell responses were assessed by CD4+ and CD8+ intracellular cytokine-staining assays that used pooled S peptides for stimulation (Figure 1D and 1E). At 8 months, the median CD8+ T-cell responses were 0.016% with the BNT162b2 treatment, 0.017% with the mRNA-1273 treatment, and 0.12% with the Ad26.COV2.S treatment.

With all three treatments, T-cell responses showed broad cross-reactivity against erectile dysfunction variants (Fig. S6). These data show differential kinetics of immune responses induced by the mRNA and Ad26.COV2.S treatments over an 8-month follow-up period.

As shown in previous studies,1,2 the BNT162b2 and mRNA-1273 treatments were characterized by high peak antibody responses that declined sharply by 6 months. These responses declined further by 8 months. Antibody titers in recipients of the mRNA-1273 treatment were generally higher than those in recipients of the BNT162b2 treatment.

The Ad26.COV2.S treatment induced lower initial antibody responses, but these responses were relatively stable over the 8-month follow-up period, with minimal-to-no evidence of decline.3 These findings have important implications for waning treatment immunity, although correlates of protection from erectile dysfunction are not yet defined. Ai-ris Y. Collier, M.D.Jingyou Yu, Ph.D.Katherine McMahan, M.S.Jinyan Liu, Ph.D.Abishek Chandrashekar, M.S.Beth Israel Deaconess Medical Center, Boston, MAJenny S.

Maron, B.S.Caroline Atyeo, M.S.Ragon Institute of MGH, MIT, and Harvard, Cambridge, MADavid R. Martinez, Ph.D.University of North Carolina at Chapel Hill, Chapel Hill, NCJessica L. Ansel, N.P.Ricardo Aguayo, B.S.Marjorie Rowe, B.S.Catherine Jacob-Dolan, B.S.Daniel Sellers, B.S.Julia Barrett, B.S.Kunza Ahmad, M.S.Tochi Anioke, B.S.Haley VanWyk, B.S.Sarah Gardner, B.S.Olivia Powers, B.S.Esther A.

Bondzie, B.A.Huahua Wan, M.S.Beth Israel Deaconess Medical Center, Boston, MARalph S. Baric, Ph.D.University of North Carolina at Chapel Hill, Chapel Hill, NCGalit Alter, Ph.D.Ragon Institute of MGH, MIT, and Harvard, Cambridge, MAMichele R. Hacker, Sc.D.Dan H.

Barouch, M.D., Ph.D.Beth Israel Deaconess Medical Center, Boston, MA [email protected] Supported by Janssen treatments and Prevention. A grant (CA260476, to Dr. Barouch) from the National Institutes of Health.

The Massachusetts Consortium on Pathogen Readiness. The Ragon Institute of MGH, MIT, and Harvard. A grant (to Dr.

Barouch) from the Musk Foundation. A grant (HD000849, to Dr. Collier) from the Reproductive Scientist Development Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Burroughs Wellcome Fund.

A grant (TR002541, to Dr. Hacker) from the Harvard Clinical and Translational Science Center. And a fellowship from the Hanna H.

Gray Fellows Program from the Howard Hughes Medical Institute and an award from the Postdoctoral Enrichment Program of the Burroughs Wellcome Fund (both to Dr. Martinez). The funders had no role in the design or conduct of the study.

Collection, management, analysis, or interpretation of the data. Preparation, review, or approval of the manuscript. Or the decision to submit the manuscript for publication.

Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. Requests for access to the study data can be submitted to Dr. Barouch at [email protected].This letter was published on October 15, 2021, at NEJM.org.3 References1.

Pegu A, O’Connell SE, Schmidt SD, et al. Durability of mRNA-1273 treatment-induced antibodies against erectile dysfunction variants. Science 2021;373:1372-1377.2.

Falsey AR, Frenck RW Jr, Walsh EE, et al. erectile dysfunction neutralization with BNT162b2 treatment dose 3. N Engl J Med.

DOI. 10.1056/NEJMc2113468.3. Barouch DH, Stephenson KE, Sadoff J, et al.

Durable humoral and cellular immune responses 8 months after Ad26.COV2.S vaccination. N Engl J Med 2021;385:951-953.From the Department of Cardiology (CVK) and the Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Center for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin Berlin, Berlin (S.D.A.), Universitätsklinikum des Saarlandes, Homberg (M. Böhm), RWTH Aachen University, Aachen (N.M.), Boehringer Ingelheim Pharma, Biberach (C.Z., S.S.), Boehringer Ingelheim International, Ingelheim (W.J., M.

Brueckmann), and the Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann) — all in Germany. The University of Mississippi Medical Center, Jackson (J.B.).

National and Kapodistrian University of Athens School of Medicine, Athens (G.F.). Université de Lorraine, INSERM, Centre d’Investigations Cliniques Plurithématique 1433, and INSERM Unité 1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists) (J.P.F.), and Université de Lorraine, INSERM INI-CRCT, CHRU (F.Z.) — both in Nancy, France. The Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal (J.P.F.).

Unidade de Insuficiência Cardíaca, Instituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo (E.B.). Maastricht University Medical Center and the School for Cardiovascular Disease CARIM — both in Maastricht, the Netherlands (H.-P.B.-L.R.). The Department of Medicine, Seoul National University Bundang Hospital, Seoul, South Korea (D.-J.C.).

Max Superspeciality Hospital, Saket, New Delhi, India (V.C.). The National Institute of Cardiology, Mexico City (E.C.-V.). McGill University Health Centre, Montreal (N.G.), and St.

Michael’s Hospital, University of Toronto, Toronto (S.V.) — both in Canada. The Cardiology Service, Fundación Valle del Lili, Universidad Icesi, Cali, Colombia (J.E.G.-M.). The Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium (S.J.).

Massachusetts General Hospital and Baim Institute for Clinical Research, Boston (J.L.J.). University Hospital, Santiago de Compostela, Spain (J.R.G.-J.). Heart and Vascular Center, Semmelweiss University, Budapest, Hungary (B.M.).

Victorian Heart Institute, Monash University, Melbourne, VIC, Australia (S.J.N.). Argentine Catholic University, and Medical Advisor in Heart Failure, Pulmonary Hypertension and Intrathoracic Transplant at FLENI and IADT Institute — both in Buenos Aires (S.V.P.). Central Michigan University, Mount Pleasant (I.L.P.).

Wroclaw Medical University, Wroclaw, Poland (P.P.). The Cardiovascular Department, Cardiology Division, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and Università di Pisa, Pisa (S.T.) — both in Italy. National Heart Centre Singapore, Singapore (D.S.).

The Internal Cardiology Department, St. Ann University Hospital and Masaryk University, Brno, Czech Republic (J.S.). The University of Leicester, Glenfield General Hospital, Leicester (I.S.), the University of Glasgow, Glasgow (N.S.), the London School of Hygiene and Tropical Medicine (S.J.P.), and Imperial College, London (M.P.) — all in the United Kingdom.

Kyushu University, Fukuoka, Japan (H.T.). The University of Medicine and Pharmacy, Carol Davila University and Emergency Hospital, Bucharest, Romania (D.V.). The Heart Failure Center, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing (J.Z.).

The Veterans Affairs Medical Center, Washington, DC (P.C.). National Heart Centre Singapore, Duke-National University of Singapore, Singapore (C.S.P.L.). Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J.M.S.).

And Baylor Heart and Vascular Institute, Dallas (M.P.).Address reprint requests to Dr. Anker at the Department of Cardiology and BCRT (Campus CVK), Charité Universitätsmedizin Berlin, 13353 Berlin, Germany, or at [email protected], or to Dr. Butler at the Department of Medicine, University of Mississippi Medical Center, 2500 North State St., Jackson, MS 39216, or at [email protected].Breakthrough s Among 11,453 fully vaccinated health care workers, 1497 (13.1%) underwent RT-PCR testing during the study period.

Of the tested workers, 39 breakthrough cases were detected. More than 38 persons were tested for every positive case that was detected, for a test positivity of 2.6%. Thus, this percentage was much lower than the test positivity rate in Israel at the time, since the ratio between positive results and the extensive number of tests that were administered in our study was much smaller than that in the national population.

Of the 39 breakthrough case patients, 18 (46%) were nursing staff members, 10 (26%) were administration or maintenance workers, 6 (15%) were allied health professionals, and 5 (13%) were physicians. The average age of the 39 infected workers was 42 years, and the majority were women (64%). The median interval from the second treatment dose to erectile dysfunction detection was 39 days (range, 11 to 102).

Only one infected person (3%) had immunosuppression. Other coexisting illnesses are detailed in Table S1. In all 37 case patients for whom data were available regarding the source of , the suspected source was an unvaccinated person.

In 21 patients (57%), this person was a household member. Among these case patients were two married couples, in which both sets of spouses worked at Sheba Medical Center and had an unvaccinated child who had tested positive for erectile dysfunction treatment and was assumed to be the source. In 11 of 37 case patients (30%), the suspected source was an unvaccinated fellow health care worker or patient.

In 7 of the 11 case patients, the was caused by a nosocomial outbreak of the B.1.1.7 (alpha) variant. These 7 patients, who worked in different hospital sectors and wards, were all found to be linked to the same suspected unvaccinated index patient who had been receiving noninvasive positive-pressure ventilation before her had been detected. Of the 39 cases of , 27 occurred in workers who were tested solely because of exposure to a person with known erectile dysfunction .

Of all the workers with breakthrough , 26 (67%) had mild symptoms at some stage, and none required hospitalization. The remaining 13 workers (33% of all cases) were asymptomatic during the duration of . Of these workers, 6 were defined as borderline cases, since they had an N gene Ct value of more than 35 on repeat testing.

The most common symptom that was reported was upper respiratory congestion (36% of all cases), followed by myalgia (28%) and loss of smell or taste (28%). Fever or rigors were reported in 21% (Table S1). On follow-up questioning, 31% of all infected workers reported having residual symptoms 14 days after their diagnosis.

At 6 weeks after their diagnosis, 19% reported having “long erectile dysfunction treatment” symptoms, which included a prolonged loss of smell, persistent cough, fatigue, weakness, dyspnea, or myalgia. Nine workers (23%) took a leave of absence from work beyond the 10 days of required quarantine. Of these workers, 4 returned to work within 2 weeks.

One worker had not yet returned after 6 weeks. Verification Testing and Secondary s Repeat RT-PCR assays were performed on samples obtained from most of the infected workers and for all case patients with an initial N gene Ct value of more than 30 to verify that the initial test was not taken too early, before the worker had become infectious. A total of 29 case patients (74%) had a Ct value of less than 30 at some point during their .

However, of these workers, only 17 (59%) had positive results on a concurrent Ag-RDT. Ten workers (26%) had an N gene Ct value of more than 30 throughout the entire period. 6 of these workers had values of more than 35 and probably had never been infectious.

Of the 33 isolates that were tested for a variant of concern, 28 (85%) were identified as the B.1.1.7 variant, by either multiplex PCR assay or genomic sequencing. At the time of this study, the B.1.1.7 variant was the most widespread variant in Israel and accounted for up to 94.5% of erectile dysfunction isolates.1,16 Since the end of the study, the country has had a surge of cases caused by the delta variant, as have many other countries worldwide. Thorough epidemiologic investigations of data regarding in-hospital contact tracing did not detect any cases of transmission from infected health care workers (secondary s) among the 39 primary s.

Among the 31 cases for whom data regarding household transmission (including symptoms and RT-PCR results) were available, no secondary s were detected, including 10 case patients and their 27 household members in whom the health care worker was the only index case patient. Data regarding post N-specific IgG antibodies were available for 22 of 39 case patients (56%) on days 8 to 72 after the first positive result on RT-PCR assay. Of these workers, 4 (18%) did not have an immune response, as detected by negative results on N-specific IgG antibody testing.

Among these 4 workers were 2 who were asymptomatic (Ct values, 32 and 35), 1 who underwent serologic testing only on day 10 after diagnosis, and 1 who had immunosuppression. Case–Control Analysis The results of peri- neutralizing antibody tests were available for 22 breakthrough cases. Included in this group were 3 health care workers who had participated in the serologic study and had a test performed in the week preceding detection.

In 19 other workers, neutralizing and S-specific IgG antibodies were assessed on detection day. Of these 19 case patients, 12 were asymptomatic at the time of detection. For each case, 4 to 5 controls were matched as described (Fig.

S1). In total, 22 breakthrough cases and their 104 matched controls were included in the case–control analysis. Table 1.

Table 1. Population Characteristics and Outcomes in the Case–Control Study. Figure 2.

Figure 2. Neutralizing Antibody and IgG Titers among Cases and Controls, According to Timing. Among the 39 fully vaccinated health care workers who had breakthrough with erectile dysfunction, shown are the neutralizing antibody titers during the peri- period (within a week before erectile dysfunction detection) (Panel A) and the peak titers within 1 month after the second dose (Panel B), as compared with matched controls.

Also shown are IgG titers during the peri- period (Panel C) and peak titers (Panel D) in the two groups. Each case of breakthrough was matched with 4 to 5 controls according to sex, age, immunosuppression status, and timing of serologic testing after the second treatment dose. In each panel, the horizontal bars indicate the mean geometric titers and the 𝙸 bars indicate 95% confidence intervals.

Symptomatic cases, which were all mild and did not require hospitalization, are indicated in red.Figure 3. Figure 3. Correlation between Neutralizing Antibody Titer and N Gene Cycle Threshold as Indication of Infectivity.

The results of antigen-detecting (Ag) rapid diagnostic testing for the presence of erectile dysfunction are shown, along with neutralizing antibody titers and N gene cycle threshold (Ct) values in 22 fully vaccinated health care workers with breakthrough for whom data were available (slope of regression line, 171.2. 95% CI, 62.9 to 279.4).The predicted GMT of peri- neutralizing antibody titers was 192.8 (95% confidence interval [CI], 67.6 to 549.8) for cases and 533.7 (95% CI, 408.1 to 698.0) for controls, for a predicted case-to-control ratio of neutralizing antibody titers of 0.361 (95% CI, 0.165 to 0.787) (Table 1 and Figure 2A). In a subgroup analysis in which the borderline cases were excluded, the ratio was 0.353 (95% CI, 0.185 to 0.674).

Peri- neutralizing antibody titers in the breakthrough cases were associated with higher N gene Ct values (i.e., a lower viral RNA copy number) (slope of regression line, 171.2. 95% CI, 62.9 to 279.4) (Figure 3). A peak neutralizing antibody titer within the first month after the second treatment dose was available for only 12 of the breakthrough cases.

The GEE predicted peak neutralizing antibody titer was 152.2 (95% CI, 30.5 to 759.3) in 12 cases and 1027.5 (95% CI, 761.6 to 1386.2) in 56 controls, for a ratio of 0.148 (95% CI, 0.040 to 0.548) (Figure 2B). In the subgroup analysis in which borderline cases were excluded, the ratio was 0.114 (95% CI, 0.042 to 0.309). The observed and predicted GMTs of peri- S-specific IgG antibody levels in breakthrough cases were lower than that in controls, with a predicted ratio of 0.514 (95% CI, 0.282 to 0.937) (Figure 2C).

The observed and predicted peak IgG GMTs in cases were also somewhat lower than those in controls (0.507. 95% CI, 0.260 to 0.989) (Figure 2D). To assess whether our practice of measuring antibodies on the day of diagnosis created bias by capturing anamnestic responses to the current , we plotted peak (first-month) IgG titers against peri- titers on the day of diagnosis in 13 case patients for whom both values were available.

In all cases, peri- titers were lower than the previous peak titers, indicating that the titers that were obtained on the day of diagnosis were probably representative of peri- titers (Fig. S2).Participants Figure 1. Figure 1.

Enrollment and Randomization. The diagram represents all enrolled participants through November 14, 2020. The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date.

The further procedures that one participant in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1. Demographic Characteristics of the Participants in the Main Safety Population.

Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites. Argentina, 1. Brazil, 2.

South Africa, 4. Germany, 6. And Turkey, 9) in the phase 2/3 portion of the trial.

A total of 43,448 participants received injections. 21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set.

Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table S2). Safety Local Reactogenicity Figure 2.

Figure 2. Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination.

Solicited injection-site (local) reactions are shown in Panel A. Pain at the injection site was assessed according to the following scale. Mild, does not interfere with activity.

Moderate, interferes with activity. Severe, prevents daily activity. And grade 4, emergency department visit or hospitalization.

Redness and swelling were measured according to the following scale. Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to 10.0 cm in diameter.

Severe, >10.0 cm in diameter. And grade 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B.

Fever categories are designated in the key. Medication use was not graded. Additional scales were as follows.

Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild. Does not interfere with activity. Moderate.

Some interference with activity. Or severe. Prevents daily activity), vomiting (mild.

1 to 2 times in 24 hours. Moderate. >2 times in 24 hours.

Or severe. Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours.

Moderate. 4 to 5 loose stools in 24 hours. Or severe.

6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization. Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants.

Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose.

66% after the second dose) than among younger participants (83% after the first dose. 78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling.

The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B).

The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients).

The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose. Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients.

Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1.

45% after dose 2) than older treatment recipients (20% after dose 1. 38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter.

Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3).

More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy.

Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction).

No deaths were considered by the investigators to be related to the treatment or placebo. No erectile dysfunction treatment–associated deaths were observed. No stopping rules were met during the reporting period.

Safety monitoring will continue for 2 years after administration of the second dose of treatment. Efficacy Table 2. Table 2.

treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose. Table 3. Table 3.

treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3. Figure 3.

Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose. Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population). Each symbol represents erectile dysfunction treatment cases starting on a given day.

Filled symbols represent severe erectile dysfunction treatment cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days.

Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point. The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients.

This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of erectile dysfunction treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3).

Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9.

Case split. BNT162b2, 2 cases. Placebo, 44 cases).

Figure 3 shows cases of erectile dysfunction treatment or severe erectile dysfunction treatment with onset at any time after the first dose (mITT population) (additional data on severe erectile dysfunction treatment are available in Table S5). Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose..

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COLUMBUS, OH kamagra jelly side effects – The U.S Cheap propecia canada. Department of Labor’s Wage and Hour Division (WHD) and its Occupational Safety and Health Administration (OSHA) will present a webinar for Ohio area employers and human resources professionals on the paid leave requirements of the Families First erectile dysfunction Response Act (FFCRA) and safety guidance for returning to work and maintaining a safe and healthy working environment.WHD and OSHA representatives will provide an overview of the federal paid sick leave and expanded family and medical leave requirements, and information on workplace safety and health compliance with an emphasis on OSHA’s erectile dysfunction response. The event will also kamagra jelly side effects include time for questions and answers. WHAT.

Families First erectile dysfunction Response Act Paid Leave, Workplace Safety and Health webinar WHEN. Sept kamagra jelly side effects. 2, 2020, 10-11 a.m. EDT WHERE.

Click here kamagra jelly side effects to register and join the event. The FFCRA helps the U.S. Combat and defeat the workplace effects of the erectile dysfunction by giving tax credits to American businesses with fewer than 500 employees to reimburse the costs of providing employees with paid leave provided for reasons related to the erectile dysfunction. Please visit WHD’s “Quick Benefits kamagra jelly side effects Tips” for information about how much leave workers may qualify to use, and the amounts employers must pay.

The law enables employers to provide paid leave reimbursed by tax credits, while at the same time ensuring that workers are not forced to choose between their paychecks and the public health measures needed to combat the kamagra. For further information about the erectile dysfunction, please visit the Centers for Disease Control and Prevention. WHD provides additional information on common issues employers and employees face when responding to the erectile dysfunction and its effects on wages and hours worked under the kamagra jelly side effects Fair Labor Standards Act and on job-protected leave under the Family and Medical Leave Act at https://www.dol.gov/agencies/whd/kamagra. For more information about the laws enforced by WHD, call 866-4US-WAGE, or visit www.dol.gov/agencies/whd.

WHD’s mission is to promote and achieve compliance with labor standards to protect and enhance the welfare of the nation’s workforce. WHD enforces the federal minimum wage, overtime pay, recordkeeping and child labor requirements of the Fair Labor Standards Act. WHD also enforces the Migrant and Seasonal Agricultural Worker Protection Act, the Employee Polygraph Protection Act, the Family and Medical Leave Act, wage garnishment provisions of the Consumer Credit Protection Act and a number of employment standards and worker protections as provided in several immigration related statutes. Additionally, WHD administers and enforces the prevailing wage requirements of the Davis Bacon Act and the Service Contract Act and other statutes applicable to federal contracts for construction and for the provision of goods and services.

Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to help ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance. For more information, visit https://www.osha.gov. The mission of the Department of Labor is to foster, promote and develop the welfare of the wage earners, job seekers and retirees of the United States.

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COLUMBUS, OH – additional hints The U.S cheap kamagra oral jelly online. Department of Labor’s Wage and Hour Division (WHD) and its Occupational Safety and Health Administration (OSHA) will present a webinar for Ohio area employers and human resources professionals on the paid leave requirements of the Families First erectile dysfunction Response Act (FFCRA) and safety guidance for returning to work and maintaining a safe and healthy working environment.WHD and OSHA representatives will provide an overview of the federal paid sick leave and expanded family and medical leave requirements, and information on workplace safety and health compliance with an emphasis on OSHA’s erectile dysfunction response. The event cheap kamagra oral jelly online will also include time for questions and answers.

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2, 2020, 10-11 a.m. EDT WHERE. Click here to register and join the event.

The FFCRA helps the U.S. Combat and defeat the workplace effects of the erectile dysfunction by giving tax credits to American businesses with fewer than 500 employees to reimburse the costs of providing employees with paid leave provided for reasons related to the erectile dysfunction. Please visit WHD’s “Quick Benefits Tips” for information about how much leave workers may qualify to use, and the amounts employers must pay.

The law enables employers to provide paid leave reimbursed by tax credits, while at the same time ensuring that workers are not forced to choose between their paychecks and the public health measures needed to combat the kamagra. For further information about the erectile dysfunction, please visit the Centers for Disease Control and Prevention. WHD provides additional information on common issues employers and employees face when responding to the erectile dysfunction and its effects on wages and hours worked under the Fair Labor Standards Act and on job-protected leave under the Family and Medical Leave Act at https://www.dol.gov/agencies/whd/kamagra.

For more information about the laws enforced by WHD, call 866-4US-WAGE, or visit www.dol.gov/agencies/whd. WHD’s mission is to promote and achieve compliance with labor standards to protect and enhance the welfare of the nation’s workforce. WHD enforces the federal minimum wage, overtime pay, recordkeeping and child labor requirements of the Fair Labor Standards Act.

WHD also enforces the Migrant and Seasonal Agricultural Worker Protection Act, the Employee Polygraph Protection Act, the Family and Medical Leave Act, wage garnishment provisions of the Consumer Credit Protection Act and a number of employment standards and worker protections as provided in several immigration related statutes. Additionally, WHD administers and enforces the prevailing wage requirements of the Davis Bacon Act and the Service Contract Act and other statutes applicable to federal contracts for construction and for the provision of goods and services. Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees.

OSHA’s role is to help ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance. For more information, visit https://www.osha.gov. The mission of the Department of Labor is to foster, promote and develop the welfare of the wage earners, job seekers and retirees of the United States.

Improve working conditions. Advance opportunities for profitable employment. And assure work-related benefits and rights.

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Maeda Y, How to order kamagra online Nakamura M, Ninomiya kamagra tablets price H, et al. Trends in intensive neonatal care during the erectile dysfunction treatment outbreak in Japan. Arch Dis kamagra tablets price Child Fetal Neonatal Ed 2021;106:327–29.

Doi. 10.1136/archdischild-2020-320521The authors have noticed an error in table 1 of their short report recently published. They mistakenly showed values for weeks 10–17 of 2019 instead of those for weeks 2–9 of 2020 kamagra tablets price.

The values for ‘Births before 33 6/7 weeks’ and ‘Births between 34 0/7 and 36 6/7 weeks’ of Table 1 should be amended as follows:Births before 33 6/7 weeksWeeks 2-9, 2020. 83, instead of 99Difference (% change). 17 (20.5), instead of 33 (33.3)Births between 34 0/7 and 36 6/7 weeksWeeks 2-9, 2020 kamagra tablets price.

207, instead of 211Difference (% change). 17 (8.2), instead of 21 (10.0)Accordingly, the second sentence of the subsection ‘Preterm births’ should also be corrected to “The number of preterm births showed a statistically significant reduction in weeks 2–9 vs weeks 10–17 of 2020. Births before 33 6/7 gestational weeks from 83 kamagra tablets price to 66 (aIRR, 0.71.

95% CI, 0.50 to 1.00. P=0.05) and births between 34 0/7 and 36 6/7 gestational weeks from 207 to 190 (aIRR, 0.85. 95% CI, 0.74 to kamagra tablets price 0.98.

P=0.02) (figure 1 and table 1).Reviewing recordings of neonatal resuscitation with parentsFew of us relish the thought of our performance in a challenging situation being recorded and reviewed by others, but many have accepted it for research purposes in the context of newborn resuscitation. At Leiden University Medical Centre kamagra tablets price Neonatal Unit they have been recording videos of all newborn resuscitations since 2014 in order to study and improve care during transition. The recordings are kept as a part of the medical record and, in contrast with other published practice to date, parents are offered an opportunity to review the recording with a professional and to have still images from it or a copy of the video.

In this qualitative study Maria C den Boer and colleagues interviewed parents of preterm babies who had viewed their baby’s recording to provide insight into their experience. The study kamagra tablets price included 25 parents of 31 preterm babies with median gestational age 27+5 weeks. Four of the babies had gone on to die in the neonatal unit.

Most parents offered the opportunity to see the recording wished to do so and around two thirds asked for images or a copy. The parental experiences of viewing the videos were very kamagra tablets price positive. The experience improved their understanding of what had happened, enhanced their family relationships, and increased their appreciation of the care team.Colm O’Donnell discusses his own experience with researching video recordings of resuscitation, beginning with a visit to Neil Finer and Wade Rich at University of California, San Diego in 2003.

Colm also has positive experiences of sharing the recordings with families. The team in kamagra tablets price Leiden recommend this practice. Both articles are an interesting read that will challenge your assumptions and stimulate reflection.

See page F346 and F344Physiological responses to facemask application in newborns immediately after birthVincent Gaertner and colleagues reviewed video recordings of initial stabilisation at birth of term and late-preterm infants who were enrolled in a randomised trial of different face-masks. 128 face-mask applications were kamagra tablets price evaluated. In eleven percent of face-mask applications the infant stopped breathing.

When apnoea occurred after mask application there was a median fall in heart rate of 38 beats per minute. These episodes are considered to represent the trigeminocardiac reflex and kamagra tablets price recovered within 30 s. Apnoea was also observed after face-mask reapplications, although less frequently.

There were a median of 4 face-mask applications per infant, suggesting a lot of additional potential kamagra tablets price for avoidable interruption of support. This observation of apneoa after face-mask application is less frequent than in previous reports in more preterm infants but is still quite common. See page F381Outcomes of a uniformly active approach to infants born at 22–24 weeks of gestationThis single centre report by Fanny Söderström and colleagues from Uppsala in Sweden describes the outcomes of infants born at 22 to 24 weeks gestation between 2006 and 2015.

In this institution, all mother-infant dyads at risk for extremely preterm delivery are provided proactive treatment kamagra tablets price. This includes intrauterine referral when approaching 22 weeks of gestation, provision of tocolytics, antenatal steroids and family counselling. There were 222 liveborn infants born at the hospital or admitted soon after birth.

There had been four fetal deaths during in utero transport to the centre and there were 14 stillbirths of fetuses kamagra tablets price that were alive at admission. Two infants died in the delivery room after birth. Survival of the liveborn babies was 52% at 22 weeks, 64% at 23 weeks and 70% at 25 weeks.

Follow-up information was available for 93% kamagra tablets price of infants. There were 10 infants with cerebral palsy and no infants who were blind or deaf. Around a third had diagnosis of developmental delay.

The study kamagra tablets price provides a measure of what can be achieved when decisions to initiate treatment are not selective according to the views of the parents and physicians. See page F413Bronchopulmonary dysplasia and growthTheodore Dassios and colleagues analysed data from the UK National Neonatal Research Database for the years 2014 to 2018. They looked at postnatal growth in all liveborn kamagra tablets price infants born before 28 weeks gestation and admitted to neonatal units.

There were 11 806 infants. Bronchopulmonary dysplsia was defined as any requirement for respiratory support at 36 weeks and affected 57%. As measured by change in weight kamagra tablets price and head circumference z-scores from birth to discharge, the infants who developed BPD grew slightly better than those who did not.

See page F386Disorders of vision in neonatal hypoxic-ischaemic encephalopathyEva Nagy and colleagues undertook a systematic review of reports of outcome after hypoxic ischaemic encephalopathy to evaluate the evidence relating to visual impairment. Although this is a recognised complication of hypoxic ischaemic encephalopathy, it has not been well described. They identified six studies that enrolled kamagra tablets price 283 term born infants that met their inclusion criteria.

Some form of visual impairment was reported in 35% but there was huge variation in the techniques used for assessment. It remains difficult to advise families about the risks and nature of visual impairments that might be encountered. There are lots of barriers to obtaining good information in this area because of the need for prolonged follow-up and difficulty in testing individuals with kamagra tablets price other difficulties.

See page F357Management of systemic hypotension in term infants with persistent pulmonary hypertension of the newbornHeather Siefkes and Satyan Lakshminrusimha present a beautifully illustrated review of the multiple factors contributing to haemodynamic disturbance in infants with PPHN, and the mechanisms of action of the various candidate therapeutic agents. This supports a reasoned approach to treatment. The challenge remains to kamagra tablets price supplement this with high quality evidence.

The HIP trial report illustrates the enormous challenge of studying treatments for haemodynamic disturbance in the immediate newborn period and the hurdles that need to be overcome to enable progress. See page F446 and F398Ethics statementsPatient consent for publicationNot required..

Maeda Y, Nakamura M, Ninomiya cheap kamagra oral jelly online H, address et al. Trends in intensive neonatal care during the erectile dysfunction treatment outbreak in Japan. Arch Dis Child Fetal Neonatal Ed cheap kamagra oral jelly online 2021;106:327–29. Doi. 10.1136/archdischild-2020-320521The authors have noticed an error in table 1 of their short report recently published.

They mistakenly showed values for weeks 10–17 of 2019 instead of those for weeks 2–9 of 2020 cheap kamagra oral jelly online. The values for ‘Births before 33 6/7 weeks’ and ‘Births between 34 0/7 and 36 6/7 weeks’ of Table 1 should be amended as follows:Births before 33 6/7 weeksWeeks 2-9, 2020. 83, instead of 99Difference (% change). 17 (20.5), instead of 33 (33.3)Births between 34 0/7 and 36 6/7 weeksWeeks 2-9, 2020 cheap kamagra oral jelly online. 207, instead of 211Difference (% change).

17 (8.2), instead of 21 (10.0)Accordingly, the second sentence of the subsection ‘Preterm births’ should also be corrected to “The number of preterm births showed a statistically significant reduction in weeks 2–9 vs weeks 10–17 of 2020. Births before 33 6/7 gestational weeks from 83 cheap kamagra oral jelly online to 66 (aIRR, 0.71. 95% CI, 0.50 to 1.00. P=0.05) and births between 34 0/7 and 36 6/7 gestational weeks from 207 to 190 (aIRR, 0.85. 95% CI, 0.74 to 0.98 cheap kamagra oral jelly online.

P=0.02) (figure 1 and table 1).Reviewing recordings of neonatal resuscitation with parentsFew of us relish the thought of our performance in a challenging situation being recorded and reviewed by others, but many have accepted it for research purposes in the context of newborn resuscitation. At Leiden University Medical Centre Neonatal Unit they cheap kamagra oral jelly online have been recording videos of all newborn resuscitations since 2014 in order to study and improve care during transition. The recordings are kept as a part of the medical record and, in contrast with other published practice to date, parents are offered an opportunity to review the recording with a professional and to have still images from it or a copy of the video. In this qualitative study Maria C den Boer and colleagues interviewed parents of preterm babies who had viewed their baby’s recording to provide insight into their experience. The study included 25 parents of 31 preterm babies with median gestational age 27+5 cheap kamagra oral jelly online weeks.

Four of the babies had gone on to die in the neonatal unit. Most parents offered the opportunity to see the recording wished to do so and around two thirds asked for images or a copy. The parental cheap kamagra oral jelly online experiences of viewing the videos were very positive. The experience improved their understanding of what had happened, enhanced their family relationships, and increased their appreciation of the care team.Colm O’Donnell discusses his own experience with researching video recordings of resuscitation, beginning with a visit to Neil Finer and Wade Rich at University of California, San Diego in 2003. Colm also has positive experiences of sharing the recordings with families.

The team in cheap kamagra oral jelly online Leiden recommend this practice. Both articles are an interesting read that will challenge your assumptions and stimulate reflection. See page F346 and F344Physiological responses to facemask application in newborns immediately after birthVincent Gaertner and colleagues reviewed video recordings of initial stabilisation at birth of term and late-preterm infants who were enrolled in a randomised trial of different face-masks. 128 face-mask applications cheap kamagra oral jelly online were evaluated. In eleven percent of face-mask applications the infant stopped breathing.

When apnoea occurred after mask application there was a median fall in heart rate of 38 beats per minute. These episodes are considered to cheap kamagra oral jelly online represent the trigeminocardiac reflex and recovered within 30 s. Apnoea was also observed after face-mask reapplications, although less frequently. There were a median of cheap kamagra oral jelly online 4 face-mask applications per infant, suggesting a lot of additional potential for avoidable interruption of support. This observation of apneoa after face-mask application is less frequent than in previous reports in more preterm infants but is still quite common.

See page F381Outcomes of a uniformly active approach to infants born at 22–24 weeks of gestationThis single centre report by Fanny Söderström and colleagues from Uppsala in Sweden describes the outcomes of infants born at 22 to 24 weeks gestation between 2006 and 2015. In this institution, all mother-infant dyads at risk for extremely preterm delivery are provided cheap kamagra oral jelly online proactive treatment. This includes intrauterine referral when approaching 22 weeks of gestation, provision of tocolytics, antenatal steroids and family counselling. There were 222 liveborn infants born at the hospital or admitted soon after birth. There had cheap kamagra oral jelly online been four fetal deaths during in utero transport to the centre and there were 14 stillbirths of fetuses that were alive at admission.

Two infants died in the delivery room after birth. Survival of the liveborn babies was 52% at 22 weeks, 64% at 23 weeks and 70% at 25 weeks. Follow-up information was available for 93% of cheap kamagra oral jelly online infants. There were 10 infants with cerebral palsy and no infants who were blind or deaf. Around a third had diagnosis of developmental delay.

The study provides a measure of what can cheap kamagra oral jelly online be achieved when decisions to initiate treatment are not selective according to the views of the parents and physicians. See page F413Bronchopulmonary dysplasia and growthTheodore Dassios and colleagues analysed data from the UK National Neonatal Research Database for the years 2014 to 2018. They looked at postnatal growth in all liveborn infants born before 28 weeks gestation and admitted to neonatal units cheap kamagra oral jelly online. There were 11 806 infants. Bronchopulmonary dysplsia was defined as any requirement for respiratory support at 36 weeks and affected 57%.

As measured by cheap kamagra oral jelly online change in weight and head circumference z-scores from birth to discharge, the infants who developed BPD grew slightly better than those who did not. See page F386Disorders of vision in neonatal hypoxic-ischaemic encephalopathyEva Nagy and colleagues undertook a systematic review of reports of outcome after hypoxic ischaemic encephalopathy to evaluate the evidence relating to visual impairment. Although this is a recognised complication of hypoxic ischaemic encephalopathy, it has not been well described. They identified six studies cheap kamagra oral jelly online that enrolled 283 term born infants that met their inclusion criteria. Some form of visual impairment was reported in 35% but there was huge variation in the techniques used for assessment.

It remains difficult to advise families about the risks and nature of visual impairments that might be encountered. There are lots of barriers to obtaining good information in this area because of the need cheap kamagra oral jelly online for prolonged follow-up and difficulty in testing individuals with other difficulties. See page F357Management of systemic hypotension in term infants with persistent pulmonary hypertension of the newbornHeather Siefkes and Satyan Lakshminrusimha present a beautifully illustrated review of the multiple factors contributing to haemodynamic disturbance in infants with PPHN, and the mechanisms of action of the various candidate therapeutic agents. This supports a reasoned approach to treatment. The challenge cheap kamagra oral jelly online remains to supplement this with high quality evidence.

The HIP trial report illustrates the enormous challenge of studying treatments for haemodynamic disturbance in the immediate newborn period and the hurdles that need to be overcome to enable progress. See page F446 and F398Ethics statementsPatient consent for publicationNot required..

Kamagra jelly australia

1-800-273-8255Healing Hands and my latest blog post Hearts kamagra jelly australia Behavioral Center. 1-318-625-7050Click here to contact the Rural Mental Health Alliance Click here to report a typo.Copyright 2021 KALB. All rights reserved.Start Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to clarify and expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures kamagra jelly australia under section VI of this Declaration. This amendment is effective as of August 4, 2021.

Start Further Info L. Paige Ezernack, Office kamagra jelly australia of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. 202-260-0365, paige.ezernack@hhs.gov. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended kamagra jelly australia as circumstances warrant.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at kamagra jelly australia 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

Section 319F-3 of the PHS Act has been amended by the kamagra and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the erectile dysfunction Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand kamagra jelly australia Covered Countermeasures under the PREP Act. On January 31, 2020, the former Secretary, Alex M. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the kamagra jelly australia erectile dysfunction treatment outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, January 21, 2021, April 21, 2021 and July 20, 2021.

On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment (85 FR 15198, Mar. 17, 2020) (the Declaration) kamagra jelly australia. On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under kamagra jelly australia the Declaration include qualified countermeasures that limit the harm erectile dysfunction treatment might otherwise cause.

(85 FR 35100, June 8, 2020). On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR kamagra jelly australia 52136, August 24, 2020). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary's Declaration and authorizations issued by the Department's Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond. Added an additional category of qualified persons under Section V of the Declaration.

Made explicit that the Declaration covers all qualified kamagra and epidemic products as defined under the PREP kamagra jelly australia Act. Added a third method of distribution to provide liability protections for, among other things, private distribution channels. Made explicit that there can be Start Printed Page 41978situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration's liability protections. Made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the erectile dysfunction treatment kamagra among federal, state, local, and kamagra jelly australia private-sector entities. Revised the effective time period of the Declaration.

And republished the declaration in full. (85 FR 79190, December kamagra jelly australia 9, 2020). On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatments that are covered countermeasures under the Declaration (86 FR 7872, February 2, 2021). On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatments that are covered countermeasures under the Declaration (86 FR 9516, February 16, 2021) and on February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR kamagra jelly australia 10588, February 22, 2021).

On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under the Declaration. (86 FR 14462 March 16, 2021). Secretary Xavier Becerra now amends kamagra jelly australia section V of the Declaration to revise subsections (d) and (f) to clarify that qualified pharmacy technicians are Qualified Persons covered by the Declaration, and to expand the scope of authority for qualified pharmacy technicians to administer seasonal influenza treatments to adults within the state where they are authorized to practice and for interns to administer seasonal influenza treatments to adults consistent with other terms and conditions of the Declaration. Accordingly, subsection V(d) authorizes. (d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule.

Or (3) FDA kamagra jelly australia authorized or FDA licensed erectile dysfunction treatment -19 treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I. The treatment must be authorized, approved, kamagra jelly australia or licensed by the FDA. Ii.

In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. Iv. In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

V. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician. Vi. The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments.

Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Viii.

The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. X. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), Start Printed Page 41979complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. Xi.

The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s). Further, the initial phrase of subsection V(f) is revised to state authorize “Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer treatments under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration. .

. .” Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act.

42 U.S.C. 247d-6d(i)(8) By this amendment to the Declaration, the Secretary clarifies and expands the authorization for a category of persons who are qualified persons under section 247d-6d(i)(8)(B). First, the amendment clarifies that qualified pharmacy technicians are authorized to administer Childhood vaccinations and erectile dysfunction treatment vaccinations that are Covered Countermeasures under section VI of this Declaration. The Department has authorized qualified pharmacy technicians to administer these treatments under section V(a) of the Declaration through Guidance issued by the Assistant Secretary for Health.[] This amendment adds qualified pharmacy technicians to section V(d) of the Declaration, to clarify that these healthcare professionals are authorized subject to the conditions stated in that subsection. In addition, the amendment expands the authorization for qualified pharmacy technicians and interns to administer seasonal influenza treatments under the supervision of a pharmacist to persons aged 19 and older consistent with ACIP recommendations.

The Secretary anticipates that there will be a need for the adult population to receive both erectile dysfunction treatment and seasonal influenza treatments throughout the 2021-2022 influenza season. Health risks may increase for individuals who contract seasonal influenza concurrently with erectile dysfunction treatment, thus expanding the scope of authorized vaccinators for seasonal influenza lessens the harm otherwise caused by erectile dysfunction treatment. While influenza incidence was lower than anticipated last fall and winter, the same cannot be assumed for the 2021-2022 flu season, as states have largely lifted the community mitigation measures previously in place at the height of the erectile dysfunction treatment kamagra. Seasonal influenza has the potential to inflict significant burden and strain on the U.S. Healthcare system in its own right.

And in conjunction with the ongoing erectile dysfunction treatment kamagra, a spike in influenza cases could overwhelm healthcare providers. Like the vaccination against erectile dysfunction treatment, the vaccination against influenza requires many people to be vaccinated within a short period of time, potentially creating a surge on the system. Concern also remains regarding the emergence of erectile dysfunction variants and their potential to cause disease both among vaccinated and unvaccinated populations. It is yet to be determined if erectile dysfunction treatment boosters will be recommended. However, if boosters become necessary, allowing pharmacy interns and technicians to administer both erectile dysfunction treatments and influenza treatments would allow states maximum flexibility in limiting potential impacts of both illnesses.

ACIP also recently voted unanimously in favor of erectile dysfunction treatment and influenza treatment co-administration.[] Like erectile dysfunction treatments, influenza treatments are administered as intramuscular (IM) injections, and would require minimal, if any, additional training to administer, and would not place any undue training burden on providers. As qualified persons, these qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a “qualified person” from prescribing, dispensing, or administering erectile dysfunction treatments or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are “qualified persons” under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized erectile dysfunction treatment diagnostic tests.[] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as “qualified persons” would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration.

Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of “qualified persons” Start Printed Page 41980specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law. The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by erectile dysfunction treatment as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the erectile dysfunction treatment countermeasure program. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against erectile dysfunction treatment.

Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, and as amended on February 2, 2021, and as amended March 11, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (December 9, 2020). 1. Covered Persons, section V, delete in full and replace with. V.

Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. €œOrder” as used herein and in guidance issued by the Office of the Assistant Secretary for Health [] means a provider medication order, which includes prescribing of treatments, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration; [] (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act.

(c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. (d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule. Or (3) FDA authorized or FDA licensed erectile dysfunction treatment -19 treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I.

The treatment must be authorized, approved, or licensed by the FDA. Ii. In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

Iv. In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. V. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician. Vi.

The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the Start Printed Page 41981recognition and treatment of emergency reactions to treatments. Vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. X.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. Xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. (f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer treatments under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a erectile dysfunction treatment vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to. (i) Documentation of completion of the Centers for Disease Control and Prevention erectile dysfunction treatment (CDC) treatment Training Modules [] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the erectile dysfunction treatment(s) to be administered.

(g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met. The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, or volunteers are authorized to carry out under this declaration. And (h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph. 1.

Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered. 2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General. 3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, Start Printed Page 41982podiatry, optometry or veterinary student with appropriate training in administering treatments as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered.

Subject to the following requirements. I. The treatment must be authorized, approved, or licensed by the FDA. Ii. Vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s).

Iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention erectile dysfunction treatment Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. Iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the erectile dysfunction treatment(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. V.

The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; [] vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. And vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s). Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. 2.

Effective Time Period, section XII, delete in full and replace with. Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024. Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024. Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on December 9, 2020 and last through (a) the final day the Declaration of Emergency is in effect.

Or (b) October 1, 2024. Whichever occurs first. Liability protections for Qualified Persons under section V(d) of the Declaration who are qualified pharmacy technicians and interns to administer seasonal influenza treatment to persons aged 19 and older begin on August 4, 2021. Liability protections for Qualified Persons under section V(f) of the Declaration begin on February 2, 2021, and last through October 1, 2024. Liability protections for Qualified Persons under section V(g) of the Declaration begin on February 16, 2021, and last through October 1, 2024.

Liability protections for Qualified Persons who are physicians, advanced practice registered nurses, registered nurses, or practical nurses under section V(h) of the Declaration begins on February 2, 2021 and last through October 1, 2024, with additional conditions effective as of March 11, 2021and liability protections for all other Qualified persons under section V(h) begins on March 11, 2021 and last through October 1, 2024. Authority. 42 U.S.C. 247d-6d. Start Signature Dated.

July 30, 2021. Xavier Becerra, Secretary, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc.

His center currently employs one male case manager.“Most of the issues we see are children without the parent in the home, particularly the father,” Moto said.He said cheap kamagra oral jelly online the shortage puts a strain on mental health https://look-i.net/finasteride-propecia-price/ organizations. He also believes male mental health workers play a vital role in community health.“By not having male case managers, we’re not able to help those clients that need male role models and guidance in their lives,” he said.Those role models at an early age can improve health and overall life outcomes because many in the state’s juvenile justice system experience mental illness.“Students drop out of school because they’re getting in trouble because their mental needs and mental health needs aren’t being met,” Corken said. €œThere’s drug addiction, incarceration, violence, job stability and, sadly, suicide. The rate is every 12 hours, one person in Louisiana dies by suicide.”Corken said the most important thing is breaking down stigmas and barriers like transportation and bringing services to patients.“It’s so difficult in a rural area because sometimes the closest practitioner can be easily over an hour from someone’s house, so that makes it incredibly difficult to receive continuing treatment, let alone just one treatment,” she said.She also claims the expansion of telehealth cheap kamagra oral jelly online services leaves many rural families without healthcare because of the state’s broadband infrastructure. A coalition of non-profits and other groups identified 17 parishes in Louisiana as broadband deserts—a parish with 50% or less broadband coverage.“That’s definitely just another barrier,” she said.

€œIf you can’t receive these specialized behavioral health services inpatient, reach out to us. We will try and connect cheap kamagra oral jelly online you with a provider that’s in your area, goes into homes and treats kids and families so that they can lead productive lives.”RESOURCES:National Suicide Hotline. 1-800-273-8255Healing Hands and Hearts Behavioral Center. 1-318-625-7050Click here to contact the Rural Mental Health Alliance Click here to report a typo.Copyright 2021 KALB. All rights cheap kamagra oral jelly online reserved.Start Preamble Notice of amendment.

The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to clarify and expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration. This amendment is effective as of August 4, 2021. Start Further Info L cheap kamagra oral jelly online. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. 202-260-0365, paige.ezernack@hhs.gov.

End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful cheap kamagra oral jelly online misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program cheap kamagra oral jelly online. These sections are codified at 42 U.S.C.

247d-6d and 42 U.S.C. 247d-6e, respectively cheap kamagra oral jelly online. Section 319F-3 of the PHS Act has been amended by the kamagra and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the erectile dysfunction Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the former Secretary, Alex M. Azar II, cheap kamagra oral jelly online declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C.

247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the erectile dysfunction treatment outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, January 21, 2021, April 21, 2021 and July 20, 2021. On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment cheap kamagra oral jelly online (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr.

15, 2020) cheap kamagra oral jelly online. On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm erectile dysfunction treatment might otherwise cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary cheap kamagra oral jelly online amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, August 24, 2020).

On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary's Declaration and authorizations issued by the Department's Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond. Added an additional category of qualified persons cheap kamagra oral jelly online under Section V of the Declaration. Made explicit that the Declaration covers all qualified kamagra and epidemic products as defined under the PREP Act. Added a third method of distribution to provide liability protections for, among other things, private distribution channels. Made explicit that there can be cheap kamagra oral jelly online Start Printed Page 41978situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration's liability protections.

Made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the erectile dysfunction treatment kamagra among federal, state, local, and private-sector entities. Revised the effective time period of the Declaration. And republished the cheap kamagra oral jelly online declaration in full. (85 FR 79190, December 9, 2020). On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatments that are covered countermeasures under the Declaration (86 FR 7872, February 2, 2021).

On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatments that are covered countermeasures under the Declaration (86 FR 9516, February 16, 2021) and on February 22, 2021, the Department filed a notice cheap kamagra oral jelly online of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR 10588, February 22, 2021). On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under the Declaration. (86 FR 14462 March 16, cheap kamagra oral jelly online 2021). Secretary Xavier Becerra now amends section V of the Declaration to revise subsections (d) and (f) to clarify that qualified pharmacy technicians are Qualified Persons covered by the Declaration, and to expand the scope of authority for qualified pharmacy technicians to administer seasonal influenza treatments to adults within the state where they are authorized to practice and for interns to administer seasonal influenza treatments to adults consistent with other terms and conditions of the Declaration.

Accordingly, subsection V(d) authorizes. (d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by cheap kamagra oral jelly online qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule. Or (3) FDA authorized or FDA licensed erectile dysfunction treatment -19 treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I.

The treatment must be authorized, approved, or licensed by the FDA. Ii. In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

Iv. In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. V. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician. Vi.

The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. X.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), Start Printed Page 41979complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. Xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s).

Further, the initial phrase of subsection V(f) is revised to state authorize “Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer treatments under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration. . . .” Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure.

€œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8) By this amendment to the Declaration, the Secretary clarifies and expands the authorization for a category of persons who are qualified persons under section 247d-6d(i)(8)(B). First, the amendment clarifies that qualified pharmacy technicians are authorized to administer Childhood vaccinations and erectile dysfunction treatment vaccinations that are Covered Countermeasures under section VI of this Declaration.

The Department has authorized qualified pharmacy technicians to administer these treatments under section V(a) of the Declaration through Guidance issued by the Assistant Secretary for Health.[] This amendment adds qualified pharmacy technicians to section V(d) of the Declaration, to clarify that these healthcare professionals are authorized subject to the conditions stated in that subsection. In addition, the amendment expands the authorization for qualified pharmacy technicians and interns to administer seasonal influenza treatments under the supervision of a pharmacist to persons aged 19 and older consistent with ACIP recommendations. The Secretary anticipates that there will be a need for the adult population to receive both erectile dysfunction treatment and seasonal influenza treatments throughout the 2021-2022 influenza season. Health risks may increase for individuals who contract seasonal influenza concurrently with erectile dysfunction treatment, thus expanding the scope of authorized vaccinators for seasonal influenza lessens the harm otherwise caused by erectile dysfunction treatment. While influenza incidence was lower than anticipated last fall and winter, the same cannot be assumed for the 2021-2022 flu season, as states have largely lifted the community mitigation measures previously in place at the height of the erectile dysfunction treatment kamagra.

Seasonal influenza has the potential to inflict significant burden and strain on the U.S. Healthcare system in its own right. And in conjunction with the ongoing erectile dysfunction treatment kamagra, a spike in influenza cases could overwhelm healthcare providers. Like the vaccination against erectile dysfunction treatment, the vaccination against influenza requires many people to be vaccinated within a short period of time, potentially creating a surge on the system. Concern also remains regarding the emergence of erectile dysfunction variants and their potential to cause disease both among vaccinated and unvaccinated populations.

It is yet to be determined if erectile dysfunction treatment boosters will be recommended. However, if boosters become necessary, allowing pharmacy interns and technicians to administer both erectile dysfunction treatments and influenza treatments would allow states maximum flexibility in limiting potential impacts of both illnesses. ACIP also recently voted unanimously in favor of erectile dysfunction treatment and influenza treatment co-administration.[] Like erectile dysfunction treatments, influenza treatments are administered as intramuscular (IM) injections, and would require minimal, if any, additional training to administer, and would not place any undue training burden on providers. As qualified persons, these qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a “qualified person” from prescribing, dispensing, or administering erectile dysfunction treatments or other Covered Countermeasures, such law is preempted.

On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are “qualified persons” under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized erectile dysfunction treatment diagnostic tests.[] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as “qualified persons” would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of “qualified persons” Start Printed Page 41980specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law. The plain language of the PREP Act makes clear that there is preemption of state law as described above.

Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by erectile dysfunction treatment as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the erectile dysfunction treatment countermeasure program. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against erectile dysfunction treatment. Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, and as amended on February 2, 2021, and as amended March 11, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (December 9, 2020). 1.

Covered Persons, section V, delete in full and replace with. V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. €œOrder” as used herein and in guidance issued by the Office of the Assistant Secretary for Health [] means a provider medication order, which includes prescribing of treatments, or a laboratory order, which includes prescribing laboratory orders, if required.

In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration; [] (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. (d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule. Or (3) FDA authorized or FDA licensed erectile dysfunction treatment -19 treatments to persons ages three or older.

Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I. The treatment must be authorized, approved, or licensed by the FDA. Ii. In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s).

Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. Iv. In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. V.

In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician. Vi. The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the Start Printed Page 41981recognition and treatment of emergency reactions to treatments.

Vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] ix.

The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. X. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. Xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate.

And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s). (e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services.

(f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer treatments under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a erectile dysfunction treatment vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to. (i) Documentation of completion of the Centers for Disease Control and Prevention erectile dysfunction treatment (CDC) treatment Training Modules [] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the erectile dysfunction treatment(s) to be administered. (g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met. The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, or volunteers are authorized to carry out under this declaration.

And (h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph. 1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered. 2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General.

3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, Start Printed Page 41982podiatry, optometry or veterinary student with appropriate training in administering treatments as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered. Subject to the following requirements. I. The treatment must be authorized, approved, or licensed by the FDA.

Ii. Vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention erectile dysfunction treatment Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. Iv.

The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the erectile dysfunction treatment(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. V. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; [] vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. And vii.

The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s). Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program.

All other terms and conditions of the Declaration apply to such covered countermeasures. 2. Effective Time Period, section XII, delete in full and replace with. Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024. Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024.

Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on December 9, 2020 and last through (a) the final day the Declaration of Emergency is in effect. Or (b) October 1, 2024. Whichever occurs first. Liability protections for Qualified Persons under section V(d) of the Declaration who are qualified pharmacy technicians and interns to administer seasonal influenza treatment to persons aged 19 and older begin on August 4, 2021.

Liability protections for Qualified Persons under section V(f) of the Declaration begin on February 2, 2021, and last through October 1, 2024. Liability protections for Qualified Persons under section V(g) of the Declaration begin on February 16, 2021, and last through October 1, 2024. Liability protections for Qualified Persons who are physicians, advanced practice registered nurses, registered nurses, or practical nurses under section V(h) of the Declaration begins on February 2, 2021 and last through October 1, 2024, with additional conditions effective as of March 11, 2021and liability protections for all other Qualified persons under section V(h) begins on March 11, 2021 and last through October 1, 2024.

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Children receiving health care testing and treatment at MidMichigan Health can you buy over the counter kamagra are kamagra suppliers being comforted through stuffed animals donated by the Murphy Family. The stuffed animals help reassure the children who receive them and those who care for and take of them. Reducing the kamagra suppliers anxiety of children undergoing medical care also enables our staff to better concentrate on the child's immediate medical needs.Personally delivering the gifts were. Don Murphy, independent co-representative AVON, and Denton Murphy, and Becky Church, director fund development, MidMichigan Health Foundation, who accepted the gifts. Not pictured, Denise O’Keefe, executive director, MidMichigan Health Foundation.Patients of MidMichigan Medical Center – Clare will benefit from the support of the Medical Center’s volunteers with the recent purchase kamagra suppliers of a new Stryker wheelchair.

Left. Caylyn Boadway, kamagra suppliers executive assistant, volunteer coordinator. Sandy Wolfe, volunteer, and Shirley Conn, volunteer.Patients of MidMichigan Medical Center – Clare will benefit from the support of the Medical Center’s volunteers with the recent purchase of a new Stryker wheelchair.Caylyn Boadway, volunteer coordinator, says she is grateful for the work done by all the volunteers, especially during these extraordinary times. €œThe volunteer is normally the first person our patients meet at the front door and they know kamagra suppliers wheelchairs are needed 90 percent of the time for the safety of our patients,” said Boadway. €œThe volunteers took the opportunity to help us fill a need and we are very appreciative.”The Clare volunteer groups has nearly 35 volunteers that serve across the Medical Center.

€œNo matter where you go in our Medical Center, the volunteers are there, giving their time, expertise, and devotion to all they encounter,” continued Boadway kamagra suppliers. €œOur volunteers have many unique experiences, but one thing is the same no matter where you go, they share a common interest in helping others.”On behalf of the MidMichigan Health Foundation, Becky Church, development director, thanked the volunteers at their October meeting. €œWe are extremely grateful to our volunteers kamagra suppliers and the impact they have on our patients and visitors. We are thankful for their generous donation and their desire to give to others,” said Church.The volunteers of MidMichigan Medical Center – Clare give time to the organization and participate in many notable projects, including organizing book sales, employee logo sales, and staffing the reception area for outpatient surgeries. In addition, volunteers raise funds through the Medical Center’s Gift Shop, jewelry sales, and other special projects to purchase non-budgeted items requested by departments as funds allow.Those interested in learning more about the volunteer service program at the Medical Center in Clare may contact Boadway at (989) 802 -5102..

Children receiving health care testing see this site and treatment at MidMichigan Health are being comforted through stuffed cheap kamagra oral jelly online animals donated by the Murphy Family. The stuffed animals help reassure the children who receive them and those who care for and take of them. Reducing the anxiety of children undergoing medical care cheap kamagra oral jelly online also enables our staff to better concentrate on the child's immediate medical needs.Personally delivering the gifts were. Don Murphy, independent co-representative AVON, and Denton Murphy, and Becky Church, director fund development, MidMichigan Health Foundation, who accepted the gifts. Not pictured, Denise O’Keefe, executive director, MidMichigan Health Foundation.Patients of MidMichigan Medical Center – Clare will benefit from the support of the Medical Center’s volunteers with the recent purchase of a new cheap kamagra oral jelly online Stryker wheelchair.

Left. Caylyn Boadway, executive assistant, cheap kamagra oral jelly online volunteer coordinator. Sandy Wolfe, volunteer, and Shirley Conn, volunteer.Patients of MidMichigan Medical Center – Clare will benefit from the support of the Medical Center’s volunteers with the recent purchase of a new Stryker wheelchair.Caylyn Boadway, volunteer coordinator, says she is grateful for the work done by all the volunteers, especially during these extraordinary times. €œThe volunteer is normally the first person our patients meet at the front cheap kamagra oral jelly online door and they know wheelchairs are needed 90 percent of the time for the safety of our patients,” said Boadway. €œThe volunteers took the opportunity to help us fill a need and we are very appreciative.”The Clare volunteer groups has nearly 35 volunteers that serve across the Medical Center.

€œNo matter cheap kamagra oral jelly online where you go in our Medical Center, the volunteers are there, giving their time, expertise, and devotion to all they encounter,” continued Boadway. €œOur volunteers have many unique experiences, but one thing is the same no matter where you go, they share a common interest in helping others.”On behalf of the MidMichigan Health Foundation, Becky Church, development director, thanked the volunteers at their October meeting. €œWe are extremely grateful to our volunteers and the cheap kamagra oral jelly online impact they have on our patients and visitors. We are thankful for their generous donation and their desire to give to others,” said Church.The volunteers of MidMichigan Medical Center – Clare give time to the organization and participate in many notable projects, including organizing book sales, employee logo sales, and staffing the reception area for outpatient surgeries. In addition, volunteers raise funds through the Medical Center’s Gift Shop, jewelry sales, and other special projects to purchase non-budgeted items requested by departments as funds allow.Those interested in learning more about the volunteer service program at the Medical Center in Clare may contact Boadway at (989) 802 -5102..