Moderna COVID-19 vaccine wins over key FDA panel, setting up potential for 2nd emergency rollout

Moderna manufacturing site
If its vaccine snags an emergency nod, Moderna plans to ship out 20 million doses this month and another 80 million in the first quarter of 2021. (Moderna)

It’s not a case of déjà vu. Moderna’s COVID-19 vaccine is following the footsteps of Pfizer and BioNTech’s shot, snagging the support of an expert panel that voted in favor of emergency use Thursday afternoon.

The Vaccines and Related Biological Products Advisory Committee voted 20-0, with one abstention, that the benefits of the vaccine outweighed its risks for use in people 18 and older. Though the FDA is not bound to following the recommendations of such committees, it usually does. The result tees up an emergency use authorization for Moderna’s candidate that—if Pfizer and BioNTech’s experience is any indication—could come very soon.

The outcome was predictable, given the vaccine’s 94.5% efficacy rate and the fact that the panel had voted favorably on Pfizer and BioNTech’s vaccine a week earlier. The one panelist who did not vote yes took issue with the broad language of the voting question.

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“I abstained because I am uncomfortable with the language. In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 and older is just too broad,” said Michael Kurilla, M.D., Ph.D., director of the Division of Clinical Innovation at the National Institutes of Health’s National Center for Advancing Translational Sciences. “I’m not convinced that for all of those age groups that the benefits do outweigh the risks. I want to see it more targeted toward people at high risk of serious and life-threatening COVID-19 disease.”

Above all, Kurilla did not want the public to misconstrue the committee’s vote as recommending the vaccine for full approval.

Other panelists proposed adding language to address that concern, such as “emergency use authorization,” or “experimental vaccine,” or even adding the amount of time the vaccine, mRNA-1273, has been evaluated. But after a spirited discussion, the panel agreed to keep the original voting question.

Another concern centered on what would happen to the clinical trial if the vaccine gets an emergency nod. Its application hinges on safety and efficacy data from a placebo-controlled trial involving more than 30,000 patients. Many panelists were in favor of a blinded crossover study, in which patients randomized to receive either the vaccine or placebo would then receive the other injection at a later date. But they worried that once the vaccine was authorized, it would be unethical or unfeasible to keep people in the placebo arm.

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Arnold Monto, M.D., the acting chair of the committee, warned against comparing this 20-0 vote to the 17-4 vote the panel cast in favor of Pfizer and BioNTech’s vaccine last week. In that case, the dissenting voters did not have the chance to explain their votes at the time, but industry watchers suspected they took issue with the small number of trial participants aged 16 and 17 years old. Unlike Moderna, which is seeking an emergency nod in people 18 and older, Pfizer and BioNTech sought authorization for use in people aged 16 and older.

Early in the discussion, some panelists brought up facial paralysis, or Bell’s palsy, which affected three patients in the vaccine group and one patient in the placebo group. The FDA is looking into this side effect but “has no basis to conclude a causal relationship” between the vaccine and the paralysis, said Rachel Zhang, M.D., of the Office of Vaccines Research and Review in the FDA’s Division of Vaccines and Related Products Applications. However, side effects did not feature prominently in the panel’s discussion of the voting question.

If the vaccine snags the emergency nod, Moderna plans to ship out 20 million doses this month and another 80 million in the first quarter of 2021. And there's more where that came from. On Friday, the U.S. government tapped its option to buy 100 million additional doses of the vaccine—something it failed to do with the Pfizer/BioNTech shot—that are set for delivery in the second quarter of 2021.

The government committed to buying 100 million doses of Pfizer and BioNTech’s vaccine in a deal that included the option to purchase an extra 100 million to 500 million doses. But officials reportedly did not take Pfizer up on the offer, and the drugmaker’s initial supplies are now spoken for, thanks to a slew of purchase agreements around the globe.

Moderna is getting a little help from Lonza to ramp up production of its vaccine. Under the deal, Lonza is fleshing out manufacturing suites at two of its sites to push Moderna’s capacity up to 1 billion doses per year. But manufacturing the doses is just one piece of the puzzle. The other, of course, is getting them where they need to go.

Airlines have been gearing up to ship COVID-19 vaccines, which require ultra-cold storage containers. But Moderna’s shot could be slightly easier to handle than Pfizer’s, as it can be stored at 36 degrees to 46 degrees Fahrenheit (2 degrees to 8 degrees Celsius) for up to 30 days, and then at room temperature for up to 12 hours. In contrast, Pfizer’s vaccine must be kept at minus 94 degrees Fahrenheit (minus 70 degrees Celsius). To aid in distribution, the company designed suitcase-sized shipping containers that will keep its doses at ultra-cold temperatures for up to 10 days.