Moderna Applies for Full Approval for Its Vaccine

Dejania Oliver

June 01, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

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.

Full U.S. approval will allow the vaccine to stay on the market once the U.S. is no longer in a public health emergency. It will also allow the company to begin advertising the shots on TV and other media platforms.

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

Moderna's vaccine, which requires two doses given 4 weeks apart, has been found to be more than 90% effective at protecting against coronavirus and more than 95% effective against severe disease up to 6 months after the second dose.

If the FDA grants Moderna's request, it would be the company's first-ever fully approved product.

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


The New York Times: "Moderna applies for full F.D.A. approval for its Covid vaccine," "See How Vaccinations Are Going in Your County and State."

CDC: "Covid-19 Vaccinations in the United States."

William Schaffner, medical director of the National Foundation for Infectious Diseases, Nashville.

CNBC: "Moderna applies for full FDA approval of its Covid vaccine."

News release, Moderna.