Moderna Just Made a Major Announcement About Its Vaccine
The company is taking the next step in its vaccine process.
If you've gotten vaccinated in the U.S., you received one of three vaccines—Pfizer, Moderna, or Johnson & Johnson—because those are the only three COVID vaccines that have been authorized by the U.S. Food and Drug Administration (FDA) for emergency use. However, none of these vaccines have been fully approved by the FDA, with Pfizer the first to submit its application for full approval nearly a month ago. Now, another vaccine company is taking that key step: Moderna just announced that it has started its application to gain full approval from the FDA.
On June 1, Moderna said that it had begun "the rolling submission process" to apply for full approval from the FDA for its COVID vaccine in those 18 and older. The company has also requested a priority review, which asks that the FDA review and take action on its application within six months rather than the 10 months that is allocated with standard review, per CNN.
"We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine," Moderna CEO Stéphane Bancel said in a statement. "We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission."
Moderna released data April 13 that showed that its vaccine maintained at least 90 percent efficacy six months after initial vaccination. The vaccine proved to be more than 90 percent effective against all cases of COVID and more than 95 percent effective against severe COVID cases in this timeline.
This is good news for Moderna, as there is no indication that the company would be denied a BLA. The FDA says that it has the right to revoke emergency-use authorization (EUA) for any vaccine if safety or efficacy concerns arise, but it says most vaccines under EUA should meet the criteria for a BLA as long as this does not happen.
"It is expected that the data supporting the EUA, together with those that will be collected during use of vaccine under EUA, and additional data collected from ongoing trials will be sufficient to support licensure (approval) of a vaccine authorized under EUA," the FDA says.
And while the Centers for Disease Control and Prevention (CDC) reports that more than 54 million people in the U.S. have already been fully vaccinated with the Moderna vaccine, receiving a BLA will help the company long-term. According to The New York Times, full approval would allow a company to market its vaccine directly to customers, as well as make it easier for companies, government agencies, and schools to mandate vaccinations.
It also means Moderna's vaccine may be around for a long time. According to the NYT, EUAs are meant to be temporary and can be revoked once a public health emergency is over. However, any vaccine that has received full approval from the FDA can remain on the market after the pandemic ends and is no longer considered an emergency.
Moderna also just released preliminary trial data showing how well its vaccine works in adolescents. According to a May 25 report, Moderna says no cases of COVID were observed during a Phase 2/3 trial of more than 3,700 children aged 12 to 18—demonstrating a 100 percent efficacy in adolescents two weeks after the second dose. Moderna says it plans to submit data in early June to achieve emergency-use authorization of its vaccine for people in that age range.