Jun 1, 2021 - Health

Moderna applies for full FDA approval of COVID-19 vaccine

Orion Rummler

A woman receives a shot of the Moderna coronavirus vaccine by a soldier in Army fatigues — Maryland National Guard Brigadier General Janeen Birckhead visits with a woman as she receives her Moderna coronavirus vaccine from Specialist James Truong (L) on May 21 in Wheaton, Maryland. Photo: Chip Somodevilla/Getty Images

Moderna is seeking full approval from the Food and Drug Administration for its coronavirus vaccine, the company announced Tuesday.

The big picture: Obtaining a Biologics License Application (BLA) from the FDA requires at least six months of data, unlike the two months of data required for emergency use authorization from the agency.

Moderna's vaccine was found by the FDA to be safe and "highly effective" in preventing cases of COVID-19 in adults, as well as adolescents between the ages of 12 and 17. The vaccine is deemed safe and effective for pregnant women, according to a pre-print study in the American Journal of Obstetrics & Gynecology.
Pfizer and BioNTech began the process of applying for full FDA approval of their COVID-19 vaccine for people 16 and older early last month.

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Moderna applies for full FDA approval of COVID-19 vaccine

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