Cambridge-based Moderna on Monday hit a “momentous milestone” as the biotech company gained full U.S. Food and Drug Administration approval for its COVID-19 vaccine, becoming the second firm to get the vax OK from the feds.
The FDA announced that it approved Moderna’s mRNA vax, which will be marketed as “Spikevax,” for the prevention of COVID in individuals 18-plus. The first COVID vax that got full FDA approval was the Pfizer vax “Comirnaty.”
The Moderna vax has been under emergency-use authorization, and it has been given to hundreds of millions of people around the world since December 2020.
The FDA’s approval of Spikevax now marks “a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock.
“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Woodcock added. “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.”
Spikevax has the same formulation as the emergency-use authorization Moderna vax, and is administered as a primary series of two doses, one month apart.
The approval of Spikevax is based on the FDA’s evaluation of safety and effectiveness data from the ongoing clinical trial that included 14,287 vaccine recipients and 14,164 placebo recipients. The data showed that Spikevax was 93% effective in preventing COVID — with 55 cases of COVID occurring in the vaccine group and 744 COVID cases in the placebo group. The vaccine was also 98% effective in preventing severe disease.
“The totality of real-world data and the full BLA (Biologics License Application) for Spikevax in the United States reaffirms the importance of vaccination against this virus,” Moderna CEO Stephane Bancel said.
“This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.,” Bancel added.
The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the EU, U.K., Israel and other countries.
The FDA’s safety analysis of Spikevax included 15,184 vaccine recipients and 15,162 placebo recipients. The most commonly reported side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, nausea, swollen lymph nodes under the arm and fever.
The feds determined that the benefits of the vax outweigh the risk of myocarditis and pericarditis in individuals 18-plus.
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