On Tuesday, Moderna became the youngest pharmaceutical company to apply to the US Food and Drug Administration for full approval of its Covid-19 vaccine for use in people aged 18 and over. FDA approval would allow the company to commercialize the shot directly to consumers and could also help build public confidence in the vaccine.
Full approval could also make it easier for schools, employers, government agencies, and the U.S. military that has encountered resistance to coronavirus vaccines to require vaccinations.
“We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the ongoing filing,” said Stéphane Bancel, CEO of Moderna, in a statement.
Last month, Pfizer and BioNTech filed with the agency for full approval of their vaccine for use in people aged 16 and over.
Moderna’s emergency vaccine was approved in December and more than 151 million doses had been administered in the United States by Sunday, according to the Centers for Disease Control and Prevention.
Last week, Moderna announced that its vaccine appears to be highly effective in teenagers and plans to apply for an emergency permit for teenagers in June. Pfizer’s vaccine was approved for use in 12 to 15 year olds last month.
Both the Moderna and Pfizer vaccines require two vaccinations several weeks apart and are based on messenger RNA, the genetic material that cells read out to make proteins to raise antibodies against the virus.
Moderna’s full regulatory filing comes as more than 50 percent of the US population received at least one dose of a vaccine, but the pace of vaccinations has slowed significantly since mid-April. A recent survey by the Kaiser Family Foundation showed signs that some hesitant people were being persuaded: About a third of those who had planned to “wait and see” whether they would get vaccinated said they had made vaccination appointments or were going to do so.
“I think there are a lot of people on the fence who are worried that things are moving too fast and about possible side effects,” said Dr. William Schaffner, National Foundation for Infectious Diseases medical director and vaccine expert. “But those concerns are allayed as they see more of their friends and acquaintances celebrating their vaccination.”
Jan Hoffman contributed to the coverage.