Moderna's COVID-19 Vaccine, Spikevax, Receives FDA Approval

Moderna's COVID-19 vaccine has now been given full approval by the US Food and Drug Administration (FDA), according to a press statement released January 31.

The vaccine, which received emergency use authorization (EUA) in December 2020, will now be known as Spikevax and has been approved for people aged 18 and up, the FDA statement said.

"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," acting FDA Commissioner Janet Woodcock, MD, said in the statement. "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."

Pfizer-BioNTech's COVID-19 vaccine was the first to receive full FDA approval in August 2021. There's no significant reason why it took so much longer for the Moderna vaccine to receive full FDA approval, William Schaffner, MD, an infectious disease specialist and professor at the Vanderbilt University School of Medicine, tells Health, explaining that Moderna has always been slightly behind Pfizer-BioNTech in the vaccine timeline. "From the beginning, Pfizer has been a step or two ahead of Moderna with the COVID-19 vaccine, and that includes full licensure approval," Dr. Schaffner says. "Somebody has got to be first and somebody has to be second—it's no more than that."

There are many steps involved in the FDA approval process. First, the agency evaluated preclinical and clinical data Moderna submitted in what's known as a biologics license application (BLA). Next, the FDA made sure the vaccine met its safety and effectiveness criteria for approval. Then the agency analyzed follow-up safety and effectiveness data from ongoing randomized, placebo-controlled, blinded clinical trials of the vaccine, per the statement.

These included analyses of data from 14,287 vaccine recipients and 14,164 placebo recipients 18 years of age and older. This data, which was gathered before the Omicron variant appeared, showed that Spikevax was 93% effective in preventing COVID-19, with 55 cases of COVID-19 occurring in the vaccine group and 744 COVID-19 cases in the placebo group. The data also showed that the vaccine was 98% effective in preventing severe disease.

In addition to analyzing data to determine the effectiveness of the Moderna vaccine, the FDA likely scrutinized data on instances of myocarditis, a type of heart inflammation linked to the vaccine, before making a final decision, Dr. Schaffner says. "This is a rare side effect and it's transient, but it has been a concern," he explains. "It occurs more frequently with Moderna than Pfizer. I wouldn't be surprised if it took a little longer for the FDA to look at the safety data for this reason."

Here, you'll find answers to all your questions about what the FDA approval of Spikevax means for you.

What does this mean if I already got the Moderna vaccine?

The FDA-approved vaccine is the exact same Moderna COVID-19 vaccine that had previously been operating under an EUA, Thomas Russo, MD, professor and Chief of Infectious Disease at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo in New York, tells Health. "If you've already gotten your primary Moderna series, it doesn't change anything," he says. In short: The vaccine you previously received has since been approved by the FDA.

Dr. Russo adds that there are only two main differences between the EUA and FDA-approved statuses. One is that some companies and organizations may feel more comfortable mandating the vaccine for employees now that it's officially approved. The other is that Moderna can now legally advertise its vaccine.

What other vaccines have been approved?

In August 2021, the Pfizer-BioNTech COVID-19 vaccine received full FDA approval. That vaccine took on the name Comirnaty and is approved for people aged 16 and up.

With Moderna's approval, only the Johnson & Johnson COVID-19 vaccine is still operating under an EUA for its primary series.

Worth noting: Both the Pfizer-BioNTech and Moderna booster shots are available under an EUA—they have not yet been fully FDA-approved. The Pfizer-BioNTech vaccine is also operating under an EUA for its primary vaccination series in people under the age of 16.

What does this mean in terms of fighting the COVID-19 pandemic?

Experts are hopeful that full approval of the Moderna vaccine will encourage unvaccinated Americans to get the shot, but they're not overly optimistic. "For those people who have avoided getting a vaccine that was only available through EUA, this should be the impetus to get vaccinated," infectious disease expert Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, tells Health. "However, the Pfizer vaccine has been FDA approved for some time and it didn't really change vaccine uptake dramatically. It's increasingly the case that the unvaccinated are choosing to remain that way." Dr. Russo agrees: "I don't think this is going to move the dial much in terms of more people getting vaccinated."

Still, Dr. Schaffner says, an EUA is now one less excuse people can use to remain unvaccinated, thus prolonging the pandemic. "There are still some people who will hide behind the notion that this is an 'experimental vaccine,'" he says. "That's now taken off the table."

The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.