Moderna COVID-19 vaccine given full FDA approval, according to company

'This is a momentous milestone in Moderna's history,' Stéphane Bancel, Moderna's CEO, says

Moderna has announced that the Food and Drug Administration has given full approval for its COVID-19 vaccine to administer to people ages 18 and older.

The American pharmaceutical and biotechnology company announced the approval in a press release Monday (Jan. 31).

According to Moderna, the vaccine will be marketed using the brand name “Spikevax.”

“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death. The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.,” Stéphane Bancel, Moderna’s CEO, said 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.”

Bancel added, “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.”

To gain approval, Moderna “submitted manufacturing and facilities data required by the FDA for licensure,” according to a statement. They added that the vaccine has received approval by regulators in more than 70 countries.

Before Monday, the Moderna vaccine was approved for use in people ages 18 and over under emergency use authorization. The Moderna vaccine has not been approved for use by the Centers for Disease Control and Prevention for anyone younger than 18 for emergency or regular use.

The Moderna vaccine marks the second COVID-19 vaccine to get full FDA approval. In fall 2021, the FDA gave full approval to the Pfizer vaccine.

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