Pfizer-BioNTech files for U.S. approval of COVID-19 vaccine

Pfizer Inc and German partner BioNTech SA have filed for a full U.S. approval for their COVID-19 vaccine, which is now authorized only for emergency use, the drugmakers said on Friday.

A nod by the U.S. Food and Drug Administration (FDA) will make it the first approved COVID-19 shot and likely help ease hesitancy by raising confidence in the vaccine as an approval will be backed by longer-term data.

It would also allow the companies to market the vaccine directly to people above 16 years of age as well as help corporations and government agencies mandate vaccinations.

The Pfizer-BioNTech vaccine was the first to be authorized for emergency use in the United States in December based on two months of safety data for a 44,000-person clinical trial.

Vaccines from Moderna and Johnson & Johnson have also been cleared for emergency use since then. Moderna said on Thursday it plans to initiate submission for a U.S. approval this month.

Under an emergency use authorization (EUA), the FDA makes a product available to the public during an emergency based on the best available evidence, without waiting for all the evidence needed for a full approval or clearance. (https://bit.ly/3h9ncLy)

The FDA will set a date for a decision once the application is formally accepted for a review, Pfizer and BioNTech said.

A lack of full approval has led the anti-vaccine community to doubt COVID-19 shots authorized using the EUA process.

The distrust has weighed on U.S. rollout efforts, especially in some communities of color, but recent polls have shown that hesitancy among Black Americans has dropped.

U.S. President Joe Biden has announced a goal to vaccinate 70% of U.S. adults with at least one shot by the July 4. As of Thursday, 45% of total population have got at least a dose.

There was a lot of safety data on the vaccines and it was time to get the full approval, Ashish Jha, dean of the Brown University School of Public Health, told NBC’s “Today” show.

“For a lot of Americans, I think this is the confidence that they need to go ahead and get the shot.” (https://bit.ly/3f1VkWX)

Nearly 170 million doses of Pfizer-BioNTech’s vaccine have been delivered in the United States, with roughly 134 million shots administered as of Thursday, according to the U.S. Centers for Disease Control and Prevention.

The drugmakers had in April said their vaccine was around 91% effective in preventing COVID-19, pointing to data on more than 12,000 people fully inoculated for at least six months, positioning them to seek U.S. approval.

Pfizer and BioNTech said on Friday they would submit data to support the so-called biologic license application on a rolling basis over the next few weeks.

(Reporting by Ankur Banerjee in Bengaluru, additional reporting by Mrinalika Roy; Editing by Shinjini Ganguli and Arun Koyyur)


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