Pfizer Asks for COVID-19 Booster Shot Approval, FDA Rejects Plan

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On Friday, the Food and Drug Administration (FDA) discussed whether people would need COVID-19 booster shots or not.

The meeting comes as people are divided over the use of booster shots. 

The FDA rejected the plan, which Pfizer-BioNTech proposed, saying that the Administration needed more data.

Earlier, on September 15, the FDA said that COVID-19 vaccines “still afford protection against severe COVID-19 disease and death in the United States.”

On Wednesday, the FDA published a document where the agency said that it "has not independently reviewed or verified the underlying data or their conclusions." 

The document, published on the agency's website, did not take a side for or against the Pfizer  (PFE) - Get Pfizer Inc. Report booster shots.

On the same day, the agency also published new data from Pfizer where the company was putting a case for the need for COVID-19 booster shots.

Related: Pfizer Makes Case for Vaccine Booster in FDA Presentation 

Pfizer said that vaccine protection may wane approximately after six months following the second dose.

"Recent data from Israel and the United States in the context of the delta variant of concern predominant circulation suggest that vaccine protection against Covid-19 infection wanes approximately 6 to 8 months following the second dose," said Pfizer, in its presentation. “A recent Israel MoH study also confirmed that a third (booster) dose of BNT162b2 restored very high levels of protection against COVID-19 even in a period when Delta was the dominant strain." 

In August, the FDA authorized booster shots of Moderna  (MRNA) - Get Moderna, Inc. Report and Pfizer for immunocompromised individuals.

However, the Biden administration announced that it’s offering booster shots for all Americans starting September 20, pending FDA authorization.

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