The Food and Drug Administration on Wednesday authorized Pfizer’s and Moderna’s updated COVID-19 booster shots that target the BA.4 and BA.5 omicron variants.
CDC panel clears updated Pfizer, Moderna COVID boosters targeting omicron subvariantsPUBLISHED 10:00 AM ET Aug. 31, 2022authorized Pfizer’s and Moderna’s updated COVID-19 booster shotsOn Thursday, an advisory panel for the Centers for Disease Control and Prevention also recommended the vaccines, pushing them one step closer to being offered to Americans across the country.
The CDC’s Advisory Committee on Immunization Practices, which votes on whether the agency should issue recommendations, held meetings Thursday to discuss approving the vaccines. CDC Director Dr. Rochelle Walensky will make the final call on the shots, which could come within hours of a vote by the advisers. Shots could then begin going into arms within a day.
Sánchez was ultimately the only opposing vote, saying he felt the decision “was a bit premature,” though he acknowledged the vaccines were likely to be found safe through rigorous human testing. But other panel members agreed that waiting to approve the updated vaccine until clinical data is available, which will not be until November, would prove more harmful in the long run.
Pfizer’s booster, which is manufactured in partnership with the German company BioNTech, would be available to people 12 and older, while individuals 18 and older would be eligible for Moderna’s. The FDA said it will work quickly to evaluate future data and submissions for bivalent boosters for other age groups.
“The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages,” the agency’s announcement said. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” Marks added.
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