FDA Review Reaffirms Moderna Coronavirus Vaccine’s Safety, Efficacy

The FDA released data Tuesday reaffirming that Moderna’s coronavirus vaccine is safe and effective in preventing severe cases in adults.

The release is a sign that the vaccine is likely to be granted emergency use from the FDA in the coming days, public health officials said, a critical step in ensuring that millions of Americans can be vaccinated as soon as possible. The FDA released similar data regarding Pfizer’s vaccine just days before it was given emergency approval as well.

The data released Tuesday not only reaffirmed the Moderna vaccine’s safety in combatting the coronavirus, but confirmed its 94.1% efficacy rate among its clinical trial of approximately 30,000 people.

Though completely safe, common side effects from the vaccine include temporary fever, head and muscle ache and fatigue, the agency said in its release.

The coming approval process is expected to mirror that of the Pfizer coronavirus vaccine last week. The FDA’s vaccine advisory panel will meet Thursday and vote whether to recommend the vaccine for emergency authorization, one week after they did the same for Pfizer’s vaccine. Moderna’s shot could be approved as early as Friday, people familiar with the timeline told The New York Times.

U.S. officials said Monday that the company is prepared to ship 6 million doses once approval is granted, more than double the amount of doses that Pfizer began to ship this past weekend.

Pfizer’s vaccine also began administration Monday in states across the country as the United States surpassed 300,000 coronavirus-related deaths.