The U.S. government’s safety surveillance system monitoring COVID-19 vaccine adverse events is “woefully inadequate” and may be missing safety signals, according to researchers who say the U.S. Food and Drug Administration (FDA) made multiple decisions to ensure its first published analysis only identified known safety signals.
In a peer-reviewed letter published June 16 in the journal Vaccine, a team of experts revealed “major shortcomings” with the FDA’s near real-time surveillance study assessing outcomes in U.S. COVID-19 vaccine recipients.
