FDA Claims on COVID-19 Vaccine Safety Are Unsupported By Reliable Data—And Could Severely Hinder Vaccine Access
Author: Frank Han.
Source: Volume 27, Number 01, Winter 2026 , pp.3-4(2)
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Abstract:
Frank Han criticizes an internal FDA proposal to revise vaccine safety testing and approval procedures based on claims that mRNA COVID-19 vaccines caused multiple child deaths from myocarditis. Han argues that the agency’s memo relies largely on VAERS reports, which cannot establish causation without corroborating clinical and epidemiological data from systems such as the Vaccine Safety Datalink or PRISM. Existing research indicates that myocarditis after vaccination is rare and generally less severe than myocarditis following COVID-19 infection. Han warns that requiring large new placebo-controlled trials for updated vaccines could delay access, undermine public confidence, and hinder routine vaccine development.Keywords: Vaccine Safety; COVID-19 Vaccines; Myocarditis; FDA Regulation; Public Health Policy
Affiliations:
1: University of Illinois Chicago.