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On Monday, Jan. 31, the Food and Drug Administration (FDA) announced that Moderna’s vaccine has been granted its full approval, joining the Pfizer shot which was authorized months ago.
The move comes after tens of millions of doses of the Moderna vaccine have already been administered across the country. It also represents Moderna’s first FDA-approved product in the US.
Officials said the FDA reviewed months of additional follow-up data submitted by Moderna to confirm the vaccine's effectiveness against COVID-19 before giving it full approval while monitoring any major side effects.
The full approval is based on clinical trial data from nearly 30,000 people, which showed the vaccine was a safe and effective protection against COVID-19, they noted.
“While hundreds of millions of doses of Moderna COVID-19 vaccines 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,” acting FDA Commissioner Janet Woodcock said in a statement.
Johnson & Johnson, the US’ third viable COVID-19 vaccination option, has not yet applied for full approval of its one-dose vaccine.
In a statement, Dr. Peter Marks, the FDA’s top vaccine regulator, said “The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.”
Moderna CEO Stephane Bancel noted that the vaccine was previously granted full approval by other federal health departments across the world.
“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,” he said. “The totality of real-world data and the full (Biologics License Application) 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 US,” Bancel added. "The full licensure of Spikevax in the US now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved.”
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