Moderna’s (MRNA) COVID-19 was recommended for emergency use authorization (EAU) Thursday evening by an advisory committee to the U.S. Food and Drug Administration (FDA) in a majority vote, with just one abstention.
The vote brings the company one step closer to becoming the second authorized vaccine in the U.S. The advisory panel voted to allow use in adults 18 and older, including first-priority frontline health workers and nursing home residents.
For Moderna, the widely-expect authorization holds extra significance as it will be the first product by the company to reach market. It also adds to the validity, along with the candidate from Pfizer (PFE) and BioNTech (BNTX), for the messenger RNA platform to become a go-to for future vaccines.
In a statement Thursday, Moderna said the 20-0 vote, which is more in the affirmative than Pfizer received, lays the foundation to move forward pending the FDA authorization.
CEO Stéphane Bancel said, “We have been working with the U.S. Centers for Disease Control and Prevention and Operation Warp Speed to prepare for the distribution of (the vaccine) mRNA-1273, if the FDA chooses to grant an Emergency Use Authorization. We look forward to getting our vaccine to people in the U.S. to help address this ongoing public health emergency.”
The two-dose vaccine was shown to be 95% effective in a clinical trial setting, and it can be stored in 2 through 8 degree Celsius temperatures — giving hope the shots could have more widespread distribution than the vaccine from Pfizer and BioNTech. Operation Warp Speed officials said Moderna was able to produce more doses than Pfizer, and nearly 6 million doses will be shipped once the vaccine is authorized.
At the meeting, experts inquired about whether Moderna’s vaccine can protect against asymptomatic transmission of the virus. While results aren’t fully known and understood yet, it showed promise in preliminary analysis of reducing some transmission.
Moderna officials also took time to address some myths about mRNA, including that mRNA can change a person’s DNA.
“Our mRNA vaccine has no capacity to alter DNA,” said Melissa Moore, chief scientific officer of platform research.
“Once the mRNA has done its job, it is degraded (in the body),” she added, noting it follows a natural decay process.
The FDA’s Dr. Peter Marks said it was a momentous occasion to hold two vaccine advisory meetings just one week apart.
“This is somewhat of an historic event,” Marks said, thanking all the advisers and FDA staff for their efforts in going through large amounts of data in the past week.
Since Moderna’s review occurred after Pfizer and BioNTech’s, some comments addressed known issues and concerns.
Four reports of Bell’s palsy after injection raised alarm, though Marks previously stated the incidence is no more significant than with any other vaccine. Moderna noted that the information will be a part of its safety information distributed along with the vaccine.
Marks said the FDA intends to monitor the vaccine response closely.
Similar to Pfizer’s vaccine, Moderna’s first dose induced a strong response, spurring discussion of the possibility to reduce the vaccines to a single dose if further analysis shows the right type of durable protection.
One thing that didn’t get resolved, however, is exactly how and when placebo participants would be allowed to receive a vaccine. Experts seemed to favor phasing out individuals who are part of the CDC’s priority groups.
If crossover is allowed, Moderna chief medical officer Tal Zaks said the company has excess doses from clinical trials set to expire and go to waste if they aren’t used, providing hope for at least some participants.