FDA urged to publish follow-up studies on covid-19 vaccine safety signals

In July 2021 the US Food and Drug Administration (FDA) quietly disclosed findings of a potential increase in four types of serious adverse events in elderly people who had had Pfizer’s covid-19 vaccine: acute myocardial infarction, disseminated intravascular coagulation, immune thrombocytopenia, and pulmonary embolism.1 Little detail was provided, such as the magnitude of the increased potential risk, and no press release or other alert was sent to doctors or the public. The FDA promised it would “share further updates and information with the public as they become available.”Eighteen days later, the FDA published a study planning document (or protocol) outlining a follow-up epidemiological study intended to investigate the matter more thoroughly.2 This recondite technical document disclosed the unadjusted relative risk ratio estimates originally found for the four serious adverse events, which ranged from 42% to 91% increased risk. (Neither absolute risk increases nor confidence intervals were provided.) More than a…
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