FDA Grants Full Approval for Moderna Vaccine

WASHINGTON — The U.S. Food and Drug Administration has approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine, known as Spikevax, was approved after finding the vaccine met rigorous standards for safety, effectiveness, and manufacturing quality.

“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, in a press release.

In 2020, the FDA approved the Moderna COVID-19 vaccine for use in individuals 18 years of age or older under an emergency use authorization.

Spikevax, which uses the same formulation of the EUA Moderna COVID-19 vaccine, will be administered through a series of two doses, each a month apart.

For those 18 years of age or older, Spikevax can be used interchangeably with the EUA Moderna COVID-19 vaccine to complete a vaccine series of three doses, or it can be used to mix and match as a single booster at least five months after a completed series of a different available COVID-19 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 Woodcock.

The clinical trial to determine effectiveness and safety of Spikevax was built upon the data and information which supported the EUA for the Moderna COVID-19 vaccine.

To conduct the trial, researchers enrolled 14,287 recipients 18 years of age and older to receive the vaccine and 14,164 recipients received a placebo.

The results showed that Spikevax was 93% effective in preventing severe disease after a clinical trial, with only 55 cases of COVID-19 occurring in the vaccine group compared to 744 cases in the placebo group.

The vaccine was also found to be 98% effective in preventing severe disease.

A separate evaluation for safety was conducted involving 15,184 vaccine recipients and 15,162 placebo recipients who were 18 years of age and older. More than half of the participants were then followed for four months after the second dose.

Additionally, an extra level of surveillance was conducted pertaining to inflammation of the heart muscle and inflammation of the tissue surrounding the heart which showed that there is an increase in these risks particularly within seven days following the second dose of Spikevax.

The highest observed risk was in males ages 18 to 24 years of age, but short-term follow-up data suggests that most individuals had a resolution of symptoms.

Still, the FDA has advised not enough information about Spikevax is available to fully understand the potential long-term health outcomes.

Alexa can be reached at [email protected]