A week after supporting the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), an FDA advisory committee endorsed the mRNA-1273 vaccine from Moderna (NSDQ:MRNA). A total of 20 panel members voted in favor of the vaccine, and one member abstained.
After releasing an upbeat assessment of the vaccine earlier this week, FDA is likely to grant emergency use authorization of the vaccine on Friday for adults 18 and older.
FDA has notified Moderna “that it will rapidly work toward finalization and issuance of an emergency use authorization,” according to FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” the two said in a statement.
The Moderna vaccine has less-stringent storage requirements than the Pfizer vaccine. It is stable up to 30 days when held at a refrigerator temperature of 2–8°C. By contrast, the Pfizer vaccine must be generally held between –80 and –60 °C and shielded from light before it is ready to use.
The vaccine can also be shipped in smaller batches than the Pfizer vaccine, making it easier to distribute in rural areas.
Earlier this year, Moderna committed to shipping 20 million vaccine doses by the end of 2020 and 500 million to 1 billion doses in 2021.
The vaccine received a single abstention because Dr. Michael Kurilla, the director of clinical innovation at the National Center for Advancing Translational Sciences, had a “serious reservations” about the broad recommendation to give the vaccine to adults 18 or older. That statement could sound like “full approval” under a Biologics License Application. “Many of the media reports from last week and this week talk about this panel’ approving this vaccine’ or ‘recommending this vaccine for approval,’” he said. “We even heard today during the open public hearing session several medical professionals talking about ‘approving’ [the vaccine].”
“A blanket statement for individuals 18 years and older is far too broad,” Kurilla said, adding he would have felt more comfortable if the question referred to mRNA-1273 as an “experimental” vaccine.
Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, took issue with that conclusion. “You can’t qualify things as being experimental because you can always say that about any medical product,” he said. “When the HPV vaccine came out, we could say: ‘Well, we think that it’s OK seven years because that’s what we have data for.”
Gen. Gustave Perna, who is overseeing the Operation Warp Speed effort to distribute COVID-19 vaccines, expects to ship 6 million doses of the Moderna vaccine in the week following EUA.
Filed Under: clinical trials, Drug Discovery, Infectious Disease