FDA Expert Panel Favors COVID-19 Boosters Targeting Omicron BA.4, BA.5 Subvariants

The FDA's independent experts voted to include a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022.
The panel has advised manufacturers to develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component (bivalent) booster vaccine.
The agency said that the vaccine manufacturers need not change the vaccine for primary vaccination, saying "this coming year to be a transitional period when this modified booster vaccine may be introduced."
Yesterday, Pfizer Inc PFE and BioNTech SE BNTX announced a $3.2 billion contract to supply more COVID vaccine doses to the U.S., which may include adult omicron-adapted COVID-19 vaccines, subject to the FDA authorization.
The FDA said vaccine manufacturers have already reported data from trials containing modified vaccines containing an omicron BA.1 component.
Related: Pfizer/BioNTech's Updated Omicron-Based COVID-19 Shots Show Improved Response Against Variant.
The agency has asked the companies to submit these data before any potential authorization of a modified vaccine containing an omicron BA.4/5 component.
Manufacturers will also be asked to begin trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves.
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