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By Helen Branswell Jan. 31, 2022
The Food and Drug Administration granted full approval to Moderna’s Covid-19 vaccine on Monday, making it the country’s second fully licensed vaccine to protect against SARS-CoV-2. The approval is for use of the vaccine in people 18 years and older.
Until now the vaccine, which will be marketed under the brand name Spikevax, has been deployed under an emergency use authorization. The Pfizer and BioNTech vaccine, Comirnaty, became the first to receive full approval in August. Johnson & Johnson’s vaccine, the third in use in the United States, is still being used under an EUA.
The approval is a milestone for the Cambridge, Mass.-based Moderna; this is the first time the company has brought an approved product to market in the United States. The vaccine has already been licensed in a number of countries and jurisdictions worldwide, including Canada, Japan, the European Union, the U.K., and Israel.
“The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus,” said Stéphane Bancel, chief executive officer of Moderna, in a statement. “This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.”
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The vaccine is approved as a two-dose regimen, even though third doses, characterized as boosters, are already in use in a number of countries, including the United States. The first two doses are given on a 28-day interval, with the booster given five months or more after dose two.
Moderna continues to trail Pfizer in authorizations for teens and children; its vaccine has still not been green-lit for use in anyone under the age of 18 in the U.S. In June it applied for an extension of its EUA to cover children aged 12 to 17, but was informed by the FDA at the end of October that the agency needed more time to assess the risk of myocarditis and pericarditis following vaccination. Both the mRNA vaccines have been linked to an increased risk of the potentially harmful heart conditions.
Moderna said the FDA indicated the review would not be completed before January. The company indicated at the time that it would delay filing its application for an EUA extension to cover children 6 to 11 years of age until the FDA review of the EUA application for teens 12 to 17 has been ruled on.
Senior Writer, Infectious Disease
Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development.
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Biotech & Pharma