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COVID-19 vaccine developed by Moderna, NIH gets FDA review date
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The FDA’s vaccine advisory committee will meet on Dec. 17 to review an emergency use authorization (EUA) request for the COVID-19 vaccine candidate codeveloped by Moderna and the NIH, Moderna announced.
It will be the second such meeting in 8 days of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which will review an EUA request filed by Pfizer and BioNTech for their COVID-19 vaccine candidate on Dec. 10.
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Moderna announced the VRBPAC date at the same time it reported that preliminary data from a primary efficacy analysis showed its messenger RNA (mRNA)-based vaccine, mRNA-1273, was 94.1% efficacious overall and 100% efficacious against severe COVID-19, with no serious safety concerns identified to date.
According to a press release, the phase 3 COVE study exceeded the 2-month median follow-up following vaccination required for an EUA submission, which Moderna said it was filing Monday.
“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Moderna CEO Stéphane Bancel said in the press release. “I want to thank the thousands of participants in our phase 1, phase 2 and phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus.”
Moderna announced interim results from COVE earlier this month, which were based on the first 95 cases of COVID-19 among more than 30,000 participants. The new analysis included 196 COVID-19 cases, of which 185 occurred in the placebo group and 11 in the treatment arm. All 30 severe cases of COVID-19 occurred in the placebo arm, Moderna said.
The company announced that one participant in the placebo arm died as a result of COVID-19.
Perspective
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Peter Hotez, MD, PhD, FASTMH, FAAP
I think by the middle of next year we'll have at least a half-dozen promising COVID-19 vaccines, with possibly ours included. It may turn out that the spike protein of the SARS-CoV-2 is a relatively "soft target" in terms of the effects of inducing virus-neutralizing antibodies. So far, any vaccine that induces high levels of virus neutralizing antibodies and presumably T-cell help appears to work either in non-human primates, humans or both. And there are many ways to do this — through mRNA immunizations, adenovirus-vectored vaccines, recombinant protein vaccines, and others. An important question moving forward is in regards the durability of this protective immunity against the spike protein and whether there will be any long-term safety issues. This is why we'll need a robust system of data safety and efficacy monitoring. But the bottom line is a good one — vaccines are coming, and we just need to keep everyone alive for a few more months in order to get them vaccinated on the other side.
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