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November 30, 2020
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The FDA Vaccine Advisory Committee will meet on December 17 to review an Emergency Use Authorization (EUA) application for the COVID-19 vaccine candidate developed by Moderna and 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 application submitted by Pfizer and BioNTech for their COVID-19 vaccine candidate on December 10.
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Moderna announced the date of the VRBPAC at the same time it reported that preliminary data from a primary efficacy analysis showed that its messenger RNA (mRNA) vaccine, mRNA-1273, was overall effective at 94, 1% and 100% effective against severe COVID-19, with no serious safety concerns identified to date.
According to a press release, the Phase 3 COVE study passed the median follow-up of 2 months following the vaccination required for an EUA presentation, which Moderna said it presented on Monday.
“We believe our vaccine will provide a powerful new tool that could change the course of this pandemic and help prevent serious illness, hospitalization and death,” Moderna CEO Stéphane Bancel he 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 the clinical trial sites who have been at the forefront of the fight against the virus.”
Moderna announced interim COVE findings earlier this month, 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 a participant in the placebo arm died from COVID-19.
Perspective
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Peter Hotez, MD, PhD, FASTMH, FAAP
I think by the middle of next year we will have at least half a dozen promising COVID-19 vaccines, with perhaps ours included. It may turn out that the SARS-CoV-2 spike protein is a “weak 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 helps T lymphocytes appears to work in both non-human primates, humans, or both. And there are many ways to do this: through mRNA immunizations, adenovirus vector vaccines, recombinant protein vaccines, and others. An important question for the future concerns the duration of this protective immunity against the spike protein and whether there will be any long-term safety concerns. This is why we will need a robust data security and effectiveness monitoring system. But the bottom line is good: vaccines are coming and we just have to keep everyone alive for a few more months to get them vaccinated on the other side.
Peter Hotez, MD, PhD, FASTMH, FAAP
Professor of pediatrics
Dean, National School of Tropical Medicine
Baylor College of Medicine
Co-director, Center for Vaccine Development
Texas Childrens Hospital
Disclosures: Hotez reports that he is an inventor of a COVID-19 vaccine technology owned by Baylor College of Medicine that was recently licensed not exclusively to a company.
COVID-19 Resource Center
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