Pfizer-BioNTech start full US FDA approval application for COVID-19 vaccine

(Shannon Stapleton, Reuters)


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WASHINGTON (Reuters) — Pfizer and German partner BioNTech said on Friday they have started an application process with the U.S. Food and Drug Administration for full approval of their COVID-19 vaccine, currently only authorized for emergency use.

If approved, the vaccine will be the first fully approved COVID-19 shot and could help ease vaccine hesitancy due to longer-term data required for an FDA approval.

The companies said they would submit data to support the so-called biologic license application, which requires longer-term follow-up data, on a rolling basis over the next few weeks.

In April, Pfizer-BioNTech said their vaccine was around 91% effective at preventing COVID-19, supported by data on more than 12,000 people fully inoculated for at least six months, positioning the duo to submit for full U.S. regulatory approval.

The companies said on Friday they have submitted nonclinical and clinical data needed to support licensure of the shot for use in individuals aged 16 and above, including updated data announced in April.

The FDA will set a goal date for a regulatory decision once the application is complete and formally accepted for review by the agency.

Under an emergency use authorization, the FDA makes a product available to the public based on the best available evidence during an emergency, without waiting for all the evidence needed for FDA approval or clearance, according to the regulator.

More than 170 million doses of Pfizer-BioNTech's vaccine have been delivered across the U.S. since it was authorized for emergency use in December.

Last month, the companies asked U.S. to allow the emergency use of their vaccine in adolescents aged 12 to 15, with the FDA set to give the nod by next week.

There are three vaccines available in the United States: Pfizer-BioNTech, Moderna and Johnson & Johnson. All have been authorized for emergency use.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Shinjini Ganguli)

© Copyright Thomson Reuters 2021

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