| アブストラクト | BACKGROUND: On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system, and v-safe, a smartphone-based surveillance system. METHODS: VAERS and v-safe data from 2/27/2021 to 2/28/2022 were analyzed. Descriptive analyses included sex, age, race/ethnicity, seriousness, AEs of special interest (AESIs), and cause of death. For prespecified AESIs, reporting rates were calculated using the total number of doses of Ad26.COV2.S administered. For myopericarditis, observed-to-expected (O/E) analysis was performed based on the number verified cases, vaccine administration data, and published background rates. Proportions of v-safe participants reporting local and systemic reactions, as well as health impacts, were calculated. RESULTS: During the analytic period, 17,018,042 doses of Ad26.COV2.S were administered in the United States, and VAERS received 67,995 reports of AEs after Ad26.COV2.S vaccination. Most AEs (59,750; 87.9 %) were non-serious and were similar to those observed during clinical trials. Serious AEs included COVID-19 disease, coagulopathy (including thrombosis with thrombocytopenia syndrome; TTS), myocardial infarction, Bell's Palsy, and Guillain-Barre syndrome (GBS). Among AESIs, reporting rates per million doses of Ad26.COV2.S administered ranged from 0.06 for multisystem inflammatory syndrome in children to 263.43 for COVID-19 disease. O/E analysis revealed elevated reporting rate ratios (RRs) for myopericarditis; among adults ages 18-64 years, the RR was 3.19 (95 % CI 2.00, 4.83) within 7 days and 1.79 (95 % CI 1.26, 2.46) within 21 days of vaccination. Of 416,384 Ad26.COV2.S recipients enrolled into v-safe, 60.9 % reported local symptoms (e.g. injection site pain) and 75.9 % reported systemic symptoms (e.g., fatigue, headache). One-third of participants (141,334; 33.9 %) reported a health impact, but only 1.4 % sought medical care. CONCLUSION: Our review confirmed previously established safety risks for TTS and GBS and identified a potential safety concern for myocarditis. |
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| 投稿者 | Woo, Emily Jane; Gee, Julianne; Marquez, Paige; Baggs, James; Abara, Winston E; McNeil, Michael M; Dimova, Rositsa B; Su, John R |
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| 組織名 | Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation;and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver;Spring, MD 20903, United States. Electronic address: jane.woo@fda.hhs.gov.;Immunization Safety Office, Division of Healthcare Quality Promotion, National;Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control;and Prevention, 1825 Century Center Blvd, Atlanta, GA 303239, United States.;Epidemiology Research and Innovations Branch, Division of Healthcare Quality;Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers;for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333, United;States.;Spring, MD 20903, United States. |
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