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On Monday, Moderna Inc (NASDAQ: MRNA) said its COVID-19 vaccine received full approval from the U.S. drug regulators for people 18 and older, making it the second to be fully licensed for use in the nation.
The full licensure by the U.S. Food and Drug Administration (FDA) will allow Moderna to market its vaccine directly to consumers, bolstering the shot’s use as a weapon against the coronavirus.
The vaccine, which will now be marketed by the brand name Spikevax, had previously been available to adults in the U.S. under an emergency use authorization (EUA).
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Moderna shares jumped nearly 6% to $168.88 in the early trading in New York.
Shares of Pfizer Inc (NYSE: PFE), whose COVID-19 vaccine, Comirnaty, received FDA approval and was the only vaccine commercially available in the U.S. since August, dropped over 3.5% after the news.
Seeking authorization
“This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.,” said Moderna CEO Stéphane Bancel, in a statement.
“The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved.
In December 2020, FDA gave a EUA license to Moderna’s vaccine for adults and older teenagers to combat COVID-19.
Moderna asked the agency to expand that emergency use authorization to include adolescents as young as 12 in June.
However, after four months, the drugmaker said it would delay seeking authorization for children ages 6 to 11 until regulators assess the shot’s myocarditis risk in teens. Moderna is still awaiting a decision from the FDA on whether adolescents may get the vaccine.
Worries about surging omicron cases
Earlier this month, Acting FDA Commissioner Janet Woodcock told the Senate health committee that the government needed to ensure that the police, hospital, and transportation services don’t break down as the unprecedented wave of omicron infections across the nation forces people to call out sick.
“It’s hard to process what’s happening right now, which is most people are going to get COVID,” Woodcock said.
Moreover, Bancel also hinted the same about omicron cases and warned the efficacy of boosters against COVID-19 is likely to decline over time, and people may need a fourth shot in the fall of 2022.
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