Moderna Applies for Full Approval for Its Vaccine By Dejania Oliver
June 2, 2021 Moderna on Tuesday became the latest drug company to apply for full FDA approval for its coronavirus vaccine to use in people 18 or older.
Last month, Pfizer applied to the FDA for approval of their vaccine in people 16 and older.
“We look forward to working with the FDA and will continue to submit data from our phase III study and complete the rolling submission,” Stéphane Bancel, Moderna’s chief executive, said in a press release.
Moderna’s vaccine was authorized for emergency use in December, which gave conditional approval of its use based on 2 months of safety data. In order to get full approval, Moderna must provide 6 months of data to prove it is safe to market the shots to consumers directly. Over 151 million doses have already been administered, according to the CDC.
The company’s application follows the move by Pfizer and BioNTech to seek full approval last month. The vaccines already have emergency use authorization in the United States.
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