Moderna Seeks Full F.D.A. Approval for Covid Vaccine


Moderna on Tuesday became the next pharmaceutical company to apply to the U.S. Food and Drug Administration for full approval for its coronavirus vaccine for use in people 18 and older.

Last month Pfizer and BioNTech applied to the agency for full approval of their vaccines for use in people 16 and older.

“We look forward to working with the F.D.A. and will continue to submit data from our Phase 3 study and complete the rolling submission,” Stéphane Bancel, Moderna’s chief executive, said in a statement.

Moderna’s vaccine was authorized for emergency use in December, and as of Sunday, more than 151 million doses had already been administered in the U.S., according to data from the Centers for Disease Control and Prevention.

“I think there are many people who were on the fence, who were worried about things moving too rapidly and about possible side effects,” said Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases and a vaccine expert. “But those concerns are being allayed as they see more of their friends and acquaintances celebrating getting vaccinated.”

Jan Hoffman contributed reporting.



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