Moderna to Apply for Emergency FDA Approval for Its COVID-19 Vaccine

Amanda Casanova

Moderna announced they would apply on Monday for the Food and Drug Administration to approve the drugmaker’s coronavirus vaccine for emergency use.

According to the New York Times, Stéphane Bancel, the company’s chief executive, said the first injections could be administered as early as Dec. 21 if the FDA approves the vaccine.

Moderna says the vaccine is 94.1 percent effective and its study of 30,000 people has met the criteria needed to determine the vaccine’s success.

New data released this week also found that the Moderna vaccine was 100 percent effective at preventing severe diseases that could occur from the coronavirus infection. Moderna also found no serious side effects resulting from the vaccine.

Bancel said the company was “on track” to produce 20 million doses of the vaccine by the end of December. In 2021, the company estimates producing between 500 million and one billion doses.

The vaccine requires two doses, given one month apart.

Moderna’s application is the second for the FDA. On Nov. 20, Pfizer also applied for emergency use authorization. The company says it can produce up to 50 million doses by the end of December and about half of those would go to the U.S. The Pfizer vaccine also requires two doses per person.

Moderna’s application will be reviewed by FDA scientists and a final review will take place on Dec. 17. A decision could come within 24 to 72 hours after the final review.

Operation Warp Speed, the government’s program to prioritize a vaccine, have said immunizations could start within 24 hours after an FDA decision.

The vaccine is expected to be provided to the public for free.

This week, a panel of advisers to the Centers for Disease Control and Prevention will meet to discuss how to allocate the first shots of the vaccine. Experts say initial shots will likely be available to health care workers, police officers and other essential workers.

Photo courtesy: ©Getty Images/Sittithat Tangwitthayaphum

Amanda Casanova is a writer living in Dallas, Texas. She has covered news for since 2014. She has also contributed to The Houston Chronicle, U.S. News and World Report and She blogs at The Migraine Runner.