Vaccine Update: FDA Approves Moderna COVID-19 Vaccine

Spikevax is now the second COVID-19 vaccine approved by regulators.

The FDA has granted approval to Moderna’s COVID-19 vaccine for patients 18 years or older.

According to a news release,1 the approved version of the vaccine, called Spikevax, is the same formulation as the version which received emergency use authorization in late-2020.

“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19,” said acting FDA Commissioner Janet Woodcock, MD, in the news release. "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. 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.”

In a separate release, Moderna CEO Stéphane Bancel touted the vaccine’s safety and effectiveness is defending against severe cases of COVID-19.

"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.," Bancel said.2

"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."

Pfizer's COVID-19 vaccine, Comirnaty, recieved FDA approval in August 2021.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may how install additional confidence to get vaccinated,” Woodcock said at the time.

This article originally appeared on Medical Economics.

References

  1. Coronavirus (COVID-19) update: FDA takes key action by approving second COVID-19 vaccine. News release. FDA. January 31, 2022. Accessed February 1, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-action-approving-second-covid-19-vaccine
  2. Moderna recieves full US FDA approval for COVID-19 vaccine Spikevax. News release. Moderna. January 31, 2022. Accessed February 1, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-Full-U.S.-FDA-Approval-for-COVID-19-Vaccine-Spikevax/default.aspx