The Food and Drug Administration fully approved Moderna’s mRNA COVID-19 vaccine on Monday, saying it meets its safety and manufacturing requirements.
Why it matters: Moderna’s vaccine, which will now be marketed as Spikevax, is the second coronavirus vaccine to receive full approval after the FDA approved Pfizer-BioNTech’s vaccine in August.
- Hundreds of millions of doses of Moderna’s vaccine have already been administered in the U.S. under the FDA’s emergency use authorization.
What they’re saying: “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,” acting FDA Commissioner Janet Woodcock said in a statement.
- “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,” Moderna CEO Stéphane Bancel said.
The big picture: The rise of the Omicron variant forced vaccine makers to reevaluate the effectiveness of their vaccines, which were developed based on eaarlier forms of the virus.
- Studies show that Moderna and Pfizer-BioNTech’s vaccines still overwhelmingly prevent severe disease and hospitalizations, especially when the first two doses are reinforced with a booster shot.