FDA aiming to approve Pfizer vaccine by early next month

The U.S. Food and Drug Administration (FDA) is aiming to give full approval for the Pfizer and BioNTech novel coronavirus (COVID-19) vaccine by early September, the New York Times reported on Tuesday, citing “people familiar with the effort,” as its source.

President Joe Biden said last week that he expected a fully approved vaccine by early fall, though the FDA has given an unofficial deadline of Labor Day or sooner. In July, Pfizer announced it was developing a booster strategy, and in its statement said they planned to submit data to the FDA for full approval “in the near future.”

The Pfizer and BioNTech vaccine was authorized for emergency use in December 2020. Officials say full approval from the FDA may reduce fears about safety and encourage more people to get the vaccine.

The FDA said in a statement on Friday that the agency is moving quickly to review the Pfizer application.

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