US health regulators are seeking additional data from Moderna Inc.’s coronavirus booster vaccine, as the Biden administration expects to begin a widespread booster campaign later this month with just the Pfizer Inc vaccine. .-BioNTech, say people familiar with the matter.
Moderna announced Friday that it had “completed” its submission of data to the Food and Drug Administration for authorization of reinforcements. The FDA has been looking for more data as the Moderna filing has come in, the people added.
In particular, the FDA is seeking more information on the efficacy of a 100-microgram dose, the same as the first two injections people received, not just the 50-microgram booster presented by Moderna as a potential booster, one of the officials said. persons. .
It is unclear whether the apparent stalemate will lead to a prolonged delay or will ultimately be resolved. The FDA will now look closely at Moderna’s submission. The agency has been pushing for data on a 100-microgram booster as it weighs its next steps.
The Biden administration announced that it would offer reinforcements beginning Sept. 20, but the benchmark expectation now is that it will start only with the Pfizer-BioNTech opportunity at that time, the people said. Moderna is ready to go a couple of weeks later, one of them said.
The FDA and the Department of Health and Human Services did not immediately respond to requests for comment. The White House referred the inquiries to HHS.
“We consider our presentation complete,” said Kate Cronin, a spokeswoman for Moderna. “We cannot comment on the FDA review portion and what it will entail.”
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The company announced on Friday that it had “completed” its submission, two days after saying it had submitted the initial data to the FDA.
Moderna also submitted booster dose data to the European Medicines Agency for conditional marketing approval, the company said in a statement late Friday.