The Slatest

Moderna Applies for Emergency FDA Approval for Its Coronavirus Vaccine

A syringe and a bottle reading "Vaccine Covid-19" sit next to the Moderna biotech company logo.
Moderna seeks emergency FDA approval of its coronavirus vaccine. JOEL SAGET/Getty Images

Moderna announced Monday it will apply for emergency authorization from the Food and Drug Administration that could see its coronavirus vaccine ready to be administered to Americans before Christmas. The drugmaker announced the analysis of its complete data set came back over the weekend and showed the vaccine to be 94 percent effective. That confirms the company’s initial data analysis released two weeks ago. Moderna’s application comes 10 days after Pfizer and its German partner BioNTech submitted their bid for emergency use of their vaccine candidate to the FDA. There are still regulatory hurdles that each vaccine must clear, but if both are confirmed to be safe and effective, there could be enough supply to vaccinate some 20 million Americans by the end of the year.

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The Moderna vaccine, developed in conjunction with government researchers at the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, underwent a 30,000-person clinical trial that tested the vaccine against a placebo. The company said of the 30,000 participants, 196 cases of Covid-19 were detected and just 11 of those were from the group receiving the vaccine. Even more encouraging is that all 30 severe cases of the disease were found in the group receiving the placebo. Moderna also reported the vaccine to be equally effective across different demographic groups accounting for age, race, and gender.

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Moderna said it will also seek approval from regulators in Europe, the U.K., and Canada. “The FDA has pledged that before it decides to roll out any COVID-19 vaccines, its scientific advisers will publicly debate whether there’s enough evidence behind each candidate,” the Associated Press reports. “First up on Dec. 10, Pfizer and BioNTech will present data suggesting their vaccine candidate is 95% effective. Moderna said its turn at this ‘science court’ is expected exactly a week later, on Dec. 17.”

Moderna CEO Stéphane Bancel told the New York Times the company was on track to produce enough doses of the vaccine in 2021 to protect between 250 and 500 million people. “The first shots of the two vaccines are likely to go to certain groups, including health care workers, essential workers like police officers, people in other critical industries and employees and residents in nursing homes,” the New York Times reports. “On Tuesday, a panel of advisers to the Centers for Disease Control and Prevention will meet to determine how to allocate initial supplies of vaccine.”

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