FDA Authorizes Updated COVID-19 Boosters Despite Lack of Clinical Data
U.S. drug regulators on Aug. 31 authorized COVID-19 vaccine booster shots despite no clinical trial data being available for the updated formulations.
The U.S. Food and Drug Administration (FDA) granted emergency use authorization to Moderna and Pfizer for their updated boosters.
The original vaccines were based on components of the Wuhan strain of the virus that causes COVID-19. The updated shots contain components of the Wuhan strain and of the BA.4 and BA.5 subvariants of the Omicron variant.
BA.5 is the subvariant currently dominant in the United States.
“The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Dr. Robert Califf, the FDA’s commissioner, said that the agency was strongly encouraging people to get an updated booster if they’re eligible “to provide better protection against currently circulating variants.”
The authorizations came just eight days after Moderna requested authorization, and nine days after Pfizer requested authorization.
The shots can be administered as little as two months after the second shot of a primary series, or after the most recent booster, according to the FDA. That’s down from five months. The updated Moderna shot is available to those 18 and older; Pfizer’s is available to those as young as 12. For those age groups, the booster with the old formulation is no longer available. However, the primary series will still use the old formulation.
Paucity of Data
Much of the data underpinning the requests for authorization were for a different formulation, a combined Wuhan–BA.1 formulation. BA.1 is another subvariant of the Omicron variant. BA.1 has not been dominant in the United States for months.
A phase 2/phase 3 study for Moderna’s Wuhan–BA.1 bivalent vaccine showed that
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