Mangat, Halinder S;
Musah, Anwar;
Luedtke, Susanne;
Syed, Akheel A;
Maramattom, Boby V;
Maruthanal, Joel;
Bosman, Arnold;
(2022)
Analyses of reported severe adverse events after immunization with SARS-CoV-2 vaccines in the United States: One year on.
Frontiers in Public Health
, 10
10.3389/fpubh.2022.972464.
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Abstract
OBJECTIVE: To analyze rates of reported severe adverse events after immunization (sAEFI) attributed to SARS-CoV-2 vaccines in the United States (US) using safety surveillance data. METHODS: Observational study of sAEFI reported to the vaccine adverse events reporting system (VAERS) between December 13, 2020, to December 13, 2021, and attributed to SARS-CoV-2 vaccination programs across all US states and territories. All sAEFI in conjunction with mRNA (BNT-162b2 or mRNA-1273) or adenovector (Ad26.COV2.S) vaccines were included. The 28-day crude cumulative rates for reported emergency department (ED) visits and sAEFI viz. hospitalizations, life-threatening events and deaths following SARS-CoV-2 vaccination were calculated. Incidence rate ratios (IRRs) of reported sAEFI were compared between mRNA and adenovector vaccines using generalized Poisson regression models. RESULTS: During the study period, 485 million SARS-CoV-2 vaccines doses were administered nationwide, and 88,626 sAEFI reported in VAERS. The 28-day crude cumulative reporting rates per 100,000 doses were 14.97 (95% confidence interval, 14.86–18.38) for ED visits, 5.32 (5.26–5.39) for hospitalizations, 1.72 (1.68–1.76) for life-threatening events, and 1.08 (1.05–1.11) for deaths. Females had two-fold rates for any reported AEFI compared to males, but lower adjusted IRRs for sAEFI. Cumulative rates per dose for reported sAEFI attributed to adenovector vaccine were 2–3-fold higher, and adjusted IRRs 1.5-fold higher than mRNA vaccines. CONCLUSIONS: Overall cumulative rates for reported sAEFI following SARS-CoV-2 vaccination in the US over 1 year were very low; single-dose adenovector vaccine had 1.5-fold higher adjusted rates for reported sAEFI, which may however equate with multiple-doses mRNA vaccine regimens. These data indicate absence of high risks of sAEFI following SARS-CoV-2 vaccines and support safety equipoise between mRNA and adenovector vaccines. Public health messaging of these data is critical to overcome heuristic biases. Furthermore, these data may support ongoing adenovector vaccine use, especially in low- and middle-income countries due to affordability, logistical and cold chain challenges.
| Type: | Article |
|---|---|
| Title: | Analyses of reported severe adverse events after immunization with SARS-CoV-2 vaccines in the United States: One year on |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.3389/fpubh.2022.972464 |
| Publisher version: | https://doi.org/10.3389/fpubh.2022.972464 |
| Language: | English |
| Additional information: | © 2022 Mangat, Musah, Luedtke, Syed, Maramattom, Maruthanal, Bosman and Kostkova. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
| Keywords: | COVID-19 vaccination adenovector, mRNA, severe adverse events following immunization, BNT-162b2 vaccine, mRNA-1273 vaccine, Ad26.COV2.S |
| UCL classification: | UCL > Provost and Vice Provost Offices > UCL SLASH > Faculty of S&HS UCL > Provost and Vice Provost Offices > UCL SLASH > Faculty of S&HS > Dept of Geography UCL > Provost and Vice Provost Offices > UCL SLASH UCL |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10157354 |
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