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Operation Warp Speed leader predicts when Johnson & Johnson will seek vaccine approval


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The top advisor of the Trump administration’s Operation Warp Speed predicted on Tuesday that Johnson & Johnson would seek approval for its single-shot COVID-19 vaccine candidate later this month — and that it could get the greenlight in February.

Dr. Moncef Slaoui said that he anticipated that the pharmaceutical giant would have enough data from its late-stage trials to apply for emergency use authorization from the Food and Drug Administration in late January.

“If [the] submission is happening at the end of January, one could project that approval of the emergency use authorization may happen somewhere in the middle of February,” Slaoui said at a press conference.

Slaoui said if the drug is approved, they could begin to distribute a number of doses that month somewhere in the “single-digit millions.”

“We are trying to make that number as close to a double-digit number [in the millions] as possible and then a larger number in March and much larger number in April,” Slaoui said.

“This is a one-shot vaccine so that is millions of individuals fully immunized,” he added.

Johnson & Johnson has a goal of manufacturing a billion vaccine doses this year
Johnson & Johnson has a goal of manufacturing a billion vaccine doses this year.
Courtesy Johnson & Johnson

The Food and Drug Administration has already approved vaccines from Pfizer and Moderna, though both involve a two-shot regimen.

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