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

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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Moderna applies for full F.D.A. approval for its Covid vaccine.

Moderna's coronavirus vaccine was authorized for emergency use in December.
Moderna’s coronavirus vaccine was authorized for emergency use in December.Credit…James Estrin/The New York Times
  • June 1, 2021, 11:23 a.m. ET

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,” Stephane 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.

Moderna announced last week that its vaccine appeared to be highly effective in teenagers and that it planned to apply for emergency use authorization for adolescents in June. Pfizer’s vaccine was authorized for use in 12- to 15-year-olds last month.

Both the Moderna and Pfizer vaccines require two shots spaced several weeks apart, and are built around messenger RNA, the genetic material that cells read to make proteins, to help generate antibodies to the virus.

Full approval for each of the vaccines would allow the companies to market them directly to consumers and could make it easier for schools, employers and government agencies to require them. It could also encourage the U.S. military, which has had low uptake of vaccines, to mandate vaccinations for service members.

Approval could also help raise public confidence in another vaccine, after the pace of vaccinations has dropped sharply since mid-April.

A recent poll from the Kaiser Family Foundation showed signs that some hesitant people have been persuaded: About a third of people who had planned to “wait and see” whether they would get vaccinated said that they had made vaccine appointments or planned to do so.

“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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