PURPOSE: Despite widely available safety information for the COVID-19 vaccines, vaccine hesitancy remains a challenge. In some cases, vaccine hesitancy may be related to concerns about the number of reports of death to the Vaccine Adverse Event Reporting System (VAERS). We aimed to provide information and context about reports of death to VAERS following COVID-19 vaccination.
METHODS: This is a descriptive study evaluating reporting rates for VAERS death reports for COVID-19 vaccine recipients in the United States between December 14, 2020, and November 17, 2021. Reporting rates were calculated as death events per million persons vaccinated and compared to expected all-cause (background) death rates.
RESULTS: 9201 death events were reported for COVID-19 vaccine recipients aged 5 years and older (or age unknown). Reporting rates for death events increased with increasing age, and males generally had higher reporting rates than females. For death events within 7 days and 42 days of vaccination, respectively, observed reporting rates were lower than the expected all-cause death rates. Reporting rates for Ad26.COV2.S vaccine were generally higher than for mRNA COVID-19 vaccines, but still lower than the expected all-cause death rates. Limitations of VAERS data include potential reporting bias, missing or inaccurate information, lack of a control group, and reported diagnoses, including deaths, are not causally verified diagnoses.
CONCLUSIONS: Reporting rates for death events were lower than the all-cause death rates expected in the general population. Trends in reporting rates reflected known trends in background death rates. These findings do not suggest an association between vaccination and overall increased mortality.
|ジャーナル名||Pharmacoepidemiology and drug safety|
|投稿者||Day, Brendan; Menschik, David; Thompson, Deborah; Jankosky, Christopher; Su, John; Moro, Pedro; Zinderman, Craig; Welsh, Kerry; Dimova, Rositsa B; Nair, Narayan|
|組織名||Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation;and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.;Immunization Safety Office, National Center for Emerging and Zoonotic Infectious;Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.|