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Early evidence for the safety of certain COVID-19 vaccines using empirical Bayesian modeling from VAERS

von Csefalvay, C.

2021-06-13 infectious diseases
10.1101/2021.06.10.21258589 medRxiv
Show abstract

The advent of vaccines against SARS-CoV-2 ushered in an unprecedented global response to COVID-19, with the largest and most ambitious mass vaccination campaign in human history. The scale of this effort means that safety signals suggesting adverse effects may only be detectable using passive reporting. This paper examines reports to the CDC/FDAs VAERS system in the first six months of 2021, using an empirical Bayesian model with a gamma Poisson shrinker to identify potential safety signals from COVID-19 vaccines currently on the U.S. market. Based on this preliminary data, it is concluded that the COVID-19 vaccines safety significantly exceeds that of previously marketed vaccines, and other than a known risk of thrombotic events, no safety signals of concern emerge.

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