The Food and Drug Administration has fully approved Moderna’s COVID-19 mRNA vaccine, making it the second vaccine to reach that distinction following Pfizer-BioNTech’s Comirnaty, the agency announced Monday.
The drug will be marketed under the name Spikevax and is approved for the prevention of COVID-19 in individuals aged 18 years older. It has the same formulation as the emergency-use authorized Moderna COVID-19 vaccine and can be used interchangeably with it in a vaccination series, FDA said.
The Moderna and Pfizer vaccines have been a game-changer for the long-term care industry. Their initial authorization for emergency use in December 2020 led to a dramatic reduction of outbreaks after months of illness and death among residents and staff. The FDA fully approved Pfizer’s Comirnaty, also an mRNA vaccine, in September 2021.
Spikevax’s approval is based on FDA evaluation and analysis of follow-up safety and effectiveness data from an ongoing clinical trial including more than 28,000 participants, FDA reported.
“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities.”
In the same statement, acting FDA Commissioner Janet Woodcock, M.D. addressed the issue of vaccine hesitancy.
“While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” she said.
