U.S. COVID-19 vaccine safety surveillance results for the over 65s Vaccine Coronavirus Disease COVID Over65s medrxivpreprint US_FDA Acumen CMSGov Stanford
By Neha MathurNov 7 2022Reviewed by Danielle Ellis, B.Sc. In a recent study posted to the medRxiv* preprint server, researchers conducted near real-time safety monitoring in the United States elderly population for 14 safety outcomes weekly following the coronavirus disease 2019 vaccination. In particular, the researchers focused on safety signals following vaccination with Pfizer BioNTech , Moderna , and Janssen COVID-19 vaccines.
The US Food and Drug Administration and CMS have routinely used a safety surveillance method for influenza vaccines in the past decade. For COVID-19 surveillance, this method deployed sequential hypothesis testing prospectively as the vaccine data accumulated to detect potential safety signals during the earlier phase of surveillance. It also proved sensitive enough to quickly screen vaccine safety signals for further evaluation in robust epidemiologic studies.
The researchers compared the observed number of each outcome in the COVID-19 vaccinated population to an expected number based on the historical outcome rate in a similar COVID-19 unvaccinated population before the pandemic, adjusted for the delay in claims processing and standardized by nursing home residency status, age, gender, and ethnicity.
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