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Moderna’s COVID-19 vaccine obtains full FDA approval

The Food and Drug Administration approved Moderna’s COVID-19 vaccine, known as Spikevax, which was previously available to the public under emergency use authorization.

The Food and Drug Administration has approved Moderna’s COVID-19 vaccine.

To be marketed as Spikevax for the prevention of COVID-19 in individuals who are age 18 years old and older, previously the vaccine has been available to the public under emergency use authorization, or EUA.

“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. 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. “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.”

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Spikevax contains the same formulation as the emergency use authorization Moderna COVID-19 vaccine, and will be administered as a primary series of two doses, given one month apart, the company said.

Currently, Spikexav can be used interchangeably with the EUA Moderna COVID-19 vaccine, which still remains available under EUA as a two-dose primary series for individuals aged 18 years old and older, as well as a third primary series dose for those who are aged 18 years old and older and have been determined to have certain kinds of immunocompromise.

In addition, the vaccine is approved as a single booster dose for individuals aged 18 years old and older at least five months after completing a primary series of the vaccine, and as a mix and match single booster dose for those aged 18 years old and older following completion of primary vaccination with a different available COVID-19 vaccine, the company said.  

[Read More: FDA shortens interval for Moderna COVID-19 vaccine booster]

“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax. This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said. “Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.”

The approval of Spikevax is based upon the Food and Drug Administration’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, the company said.

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