Moderna COVID vaccine given full FDA approval

Moderna COVID-19 vaccine vial

The U.S. Food and Drug Administration (FDA) announced yesterday that the Moderna vaccine is now the second fully approved COVID-19 vaccine after Pfizer-BioNTech.

Marketed under the name Spikevax, the Moderna mRNA vaccine has been approved for use for persons aged 18 and up as prevention of COVID-19, according to a press release from the FDA. Previously, the Moderna vaccine was administered under the FDA’s emergency use authorization (EUA) program for persons aged 18 and older.

The EUA program allowed the use of Moderna’s vaccine in the fight against COVID-19 while the FDA considered full approval. The full approval of Spikevax will loosen controls on how the drug is administered and will give doctors more liberty to prescribe the vaccine. It is also expected to build public confidence in the vaccine.

“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,” said Acting FDA Commissioner Dr. Janet Woodcock.

Review based on clinical trial and actual use

“The approval of Spikevax is based on the FDA’s evaluation and analysis of follow-up safety and effectiveness data from the ongoing randomized, placebo-controlled, blinded clinical trial that supported the December 2020 EUA for the Moderna COVID-19 Vaccine and information from post-EUA experience to further inform safety and effectiveness,” the FDA said in the press release.

The formulation of Spikevax is identical to the formulation of the EUA Moderna vaccine, and it is administered in two doses, one month apart as a primary series, according to the FDA. Spikevax and the EUA Moderna vaccine can be used interchangeably as a COVID-19 vaccination series, FDA said.

“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,” a statement from Moderna said. “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.”

A panel of vaccine experts from the Centers for Disease Control (CDC) will convene Friday to consider endorsement of the Spikevax approval, and they are expected to do so, as they did with FDA approval of the Pfizer-BioNTech vaccine in August, according to The New York Times.

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