Pfizer and BioNtech begin the process of seeking full FDA approval for their Covid vaccine

Walgreens healthcare professional Luis S. Solano prepares a dose of the Pfizer-BioNTec vaccine against coronavirus disease (COVID-19) at the Victor Walchirk Apartments in Evanston, Illinois, February 22, 2021.
Kamil Krzaczynski | Reuters

Pfizer and German drugmaker BioNTech have started the process to file for full approval of its Covid-19 vaccine in the U.S., making the companies the first to seek full approval in the nation.

The Food and Drug Administration granted emergency authorization of their Covid vaccine in late December. Since then, Pfizer has distributed millions of doses to the U.S., with the goal of delivering 300 million doses by the end of July. If approved, Pfizer could market its shots directly to consumers and possibly change the pricing of its doses.

It usually takes the FDA about a year or longer to determine whether a drug is safe and effective for use in the general public. Due to the once-in-a-century pandemic, which has killed nearly 600,000 people in the United States, the FDA permitted the use of the shots under an Emergency Use Authorization.

The authorization grants conditional approval based on two months of data. It’s not the same as a Biologic License Application, which requires six months of data and secures full approval. The companies are seeking approval based on a “rolling submission,” which expedites the review process by allowing the FDA to review new data as the company gets it.

This is breaking news. Please check back for updates.

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