Moderna’s COVID-19 vaccine, Spikevax, receives FDA’s full approval

Moderna’s COVID-19 vaccine, Spikevax, has been
approved by the US Food and Drug Administration for inoculating people ages 18
and older. Releases from FDA and Moderna confirmed the news. However, the vaccine
is not approved for use in younger individuals.

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Moderna’s is the second COVID-19 vaccine to
receive full approval from the FDA. Pfizer’s COVID-19 vaccine, Comirnaty, was
approved for use in people age 16 and older in August. The Pfizer vaccine is
also approved for use in individuals ages 5 to 15.

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“This is a momentous milestone in
Moderna’s history as it is our first product to achieve licensure in the
U.S.,” Moderna CEO Stéphane Bancel said in the release. “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. We are grateful to the U.S. FDA for their thorough review of our
application. We are humbled by the role that Spikevax is playing to help end
this pandemic.”

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Dr Janet Woodcock, the FDA’s acting
commissioner, termed the approval a “significant step” in the fight
against Covid-19.

“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 said in a statement. “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.”

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The two-dose vaccine has been available in
the US under FDA emergency use authorization since December 18, 2020. Since
then, more than 204 million doses of Moderna’s Covid-19 vaccine have been
administered in the US, accounting for about 38% of all doses administered,
according to data from the US Centers for Disease Control and Prevention.