![]() ![]() While CIs were wide for many outcomes, surveillance is ongoing. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273.Ĭonclusions and Relevance In interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. No vaccine-outcome association met the prespecified requirement for a signal. Results A total of 11 845 128 doses of mRNA vaccines (57% BNT162b2 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years 54% female individuals). For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted. For a signal, a 1-sided P < .0048 was required to keep type I error below. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Main Outcomes and Measures Incidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021.Įxposures Receipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2. Objectives To monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population.ĭesign, Setting, and Participants This study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. Importance Safety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience. ![]() ![]() Challenges in Clinical Electrocardiography.Unvaccinated concurrent comparator analyses, December 14, 2020-June 26, 2021. Confirmed myocarditis/pericarditis following mRNA vaccines compared with vaccinated comparators among individuals aged 12 – 39 years by vaccine type and dose, December 14, 2020-June 19, 2021.ĮTable 6. Medical record review of 34 confirmed myocarditis/pericarditis cases 0-21 days after mRNA vaccines within individuals aged 12-39 years, DecemJune 19, 2021.ĮTable 5. Clustering of medical record confirmed myocarditis/pericarditis cases by days since most recent dose of any mRNA vaccine among individuals 12-39 years of age.ĮTable 4. Summary of Signals during 21-day Risk Interval, from separate Dose 1, Dose 2 and Vaccine Product Analyses.ĮFigure 2. Illustration of primary analyses using vaccinated concurrent comparators and supplemental analyses using unvaccinated concurrent comparators.ĮTable 3. Diagnostic codes used to identify outcomes and adjust onset date.ĮFigure 1. ![]()
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