FDA Holds Meeting to Discuss the Future of COVID-19 Vaccine Boosters
The U.S. Food and Drug Administration held a meeting on Wednesday to discuss future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for vaccines to address current and emerging variants.
The big debate of the meeting was what contingency plans should be considered if a variant emerges that is not well covered by available vaccines.
“In general, the decision around vaccine composition and the timing and availability, would not have a big impact [on] who is paying for the product,” said Robert Johnson, deputy assistant secretary and director of Medical Countermeasure Programs at the Biomedical Advanced Research and Development Authority, during the meeting.
Josh Guetzkow, a researcher from the Hebrew University of Jerusalem, also presented findings from a survey completed by the Israeli Ministry of Health asking participants about adverse events after receiving a booster shot.
The results showed participants experienced high rates of severe adverse events, including hospitalizations, Bell’s palsy, seizures, loss of consciousness and shingles.
In September, representatives from the Israeli Ministry of Health told the FDA that only 19 serious adverse events were reported to their safety monitoring system following the booster dose.
New evidence presented by Guetzkow shows that the per dose reporting rate of immunodeficiency syndromes after the third vaccine dose is 16-21 times higher than previous doses.
“Approving additional boosters without having solid answers to the questions [presented at this event] would be negligent and only serve to further erode the public’s rapidly waning trust,” said Guetzkow.
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