FDA Reconsiders COVID Vaccine Approvals Under New Administration
Commissioner Makary cites data gaps in shift from Biden-era approach
FDA Commissioner Dr. Marty Makary announced Tuesday that the agency is reevaluating whether to approve COVID-19 vaccines for the upcoming winter season, citing insufficient data on booster effectiveness. This marks a significant shift from the Biden administration's approach, which had established a routine annual update schedule for COVID vaccines. Makary specifically mentioned a 'void of data' and indicated that many healthcare workers opted not to receive the most recent round of boosters.
The FDA's new position includes requesting additional clinical trials from vaccine manufacturers, including Novavax, whose expected April 1 approval was delayed. Makary emphasized the need for current efficacy data given the broad population immunity now present in the United States. This approach represents a departure from previous FDA protocols, where career scientific officials typically managed vaccine approvals with less direct intervention from political appointees.
KEY POINTS
- •FDA reconsidering COVID vaccine approvals
- •Shift from Biden-era vaccine policies
- •New clinical trials being requested
Makary's special assistant, Dr. Tracy Beth Høeg, has taken an active role in reviewing data sets at the agency, including involvement with Novavax's application. Høeg has also been appointed to the CDC's Advisory Committee on Immunizations, filling a position previously held by a career vaccines official from the FDA. These personnel changes align with the current administration's approach to public health policy.
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