FDA to Grant Covid Vaccines Full BLA Approval by Monday


The United States Food and Drug Administration, a federal agency of the Department of Health and Human Service, is likely to grant full approval to the Pfizer-BioNTech COVID-19 vaccine by Monday, several media outlets have reported.

The officials are finalizing the necessary paperwork and are currently negotiating with the company.


A green light from the FDA would make the two-shot Pfizer vaccine the first to receive full approval from the federal government, the New York Times reported.

The Pfizer vaccine has been in use in the US under an emergency authorization since December 2020. Pfizer applied for full approval three months ago. The vaccine is available to people 12 years old and above.


The health officials are hoping that a full approval from the FDA would help shed vaccine hesitancy among the Americans who have refrained from taking one as it was authorized for emergency use only.

Once it obtains the approval, Pfizer-BioNTech is also planning to ask the FDA to grant approval for a third dose as a booster shot.


The Biden administration on Wednesday said that from September 20, booster shots would be given to the fully vaccinated adults eight months after they received their second dose.

Pfizer is expected to finish submitting data that it says shows a third shot is safe and effective next week.

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