FDA Panel Approves Experimental Use Authorization Application For Moderna COVID-19 Booster Shots In 3 Populations
NEW YORK (CBSNewYork) -- The Food and Drug Administration on Thursday approved emergency use of a third dose of the Moderna COVID-19 vaccine, for certain groups of Americans.
The agency's advisory committee considered extensive data on the safety and effectiveness of the Moderna mRNA vaccine for experimental use authorization. That authorization has already been granted for limited recipient groups to the Pfizer vaccine last month.
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Interestingly, Moderna's application for a booster shot is for 50 micrograms, half the dose given in their original two-dose protocol, CBS2's Dr. Max Gomez reported.
Some committee members suggested that given that Moderna's original two-dose vaccine protocol appears to still strongly protect against severe disease, approving a booster may not be needed.
In any case, the specific Moderna booster question voted on Thursday by the advisory committee was for the following populations, at least six months after completing their original two-dose series:
- Individuals 65 years of age and older
- Individuals 18 through 64 years of age at high risk of severe COVID-19
- Individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-COV-2 puts them at high risk of serious complications of COVID-19, including severe COVID-19
The 19 members of the committee unanimously voted to approve the Moderna EUA application for all three populations.
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The panel's recommendation now goes to Acting FDA Commissioner Dr. Janet Woodcock for likely approval. It would then go to a Centers for Disease Control advisory committee for review and recommendation to Dr. Rachel Walensky, the agency's commissioner, who can approve or modify guidance for which groups should actually receive Moderna booster shots.
It's complicated but expected to be completed with a couple of weeks.
