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FDA says ready to immediately approve Pfizer and Moderna boosters

But after Moderna filed a similar request on Wednesday, officials began debating whether to expedite that clearance as well, people with knowledge of the matter said.

The FDA declined to comment.

Moderna reported earlier this summer that its booster is 93% effective when given six months after the second dose, and the company has since been in close contact with the FDA regarding a possible clearance of its injection for all. the adults.

With Covid-19 cases up more than 20% in the United States over the past two weeks, some administration officials have also argued that clearing the vaccine before Thanksgiving would allow all adults to apply quickly. a booster, regardless of the vaccine they originally received.

The FDA is now expected to finalize authorization for both vaccines on Friday morning, ahead of an afternoon meeting of the Centers for Disease Control and Prevention’s vaccine advisory committee, according to people with knowledge of the matter.

Still, it’s unclear how the CDC panel will react to Moderna’s prompt authorization of the recall. The external advisers – who are responsible for recommending who should receive the vaccines – were initially only intended to consider expanded eligibility for Pfizer’s recall. The FDA’s decision could raise concerns among some advisers that they will be asked to approve the distribution of a second vaccine on a more expedited schedule than originally anticipated.

The CDC is not required to follow the panel’s advice on how vaccines should be deployed, but it has traditionally followed its recommendations.


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