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

Moderna on Tuesday became the latest pharmaceutical company to apply to the U.S. Food and Drug Administration for full approval for its Covid-19 vaccine for use in people 18 and older. F.D.A. approval would allow the company to market the shot directly to consumers, and could also help raise public confidence in the vaccine.

Full approval could also make it easier for schools, employers, government agencies and the U.S. military, which has encountered resistance to coronavirus vaccines, to mandate vaccinations.

“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.

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

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

Last week, Moderna announced 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.

Moderna’s full approval request comes as more than 50 percent of the U.S. population has received at least one dose of a vaccine, but 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.

source: nytimes.com