An advisory committee to the US Food and Drug Administration (FDA) has registered an overwhelmingly favorable vote for the COVID-19 vaccine co-developed by Moderna and the National Institutes of Health.
After a day-long meeting, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 20-0, with one abstention, in favor of the proposition that Moderna’s messenger RNA (mRNA) vaccine’s benefits outweighed its risks for individuals 18 years old and up.
FDA and the sponsor agreed in their presentations that overall efficacy was over 94% in a clinical trial of more than 30,000 participants, and that the safety profile seen in an interim analysis raised no red flags.
The vaccine is intended to be given in a prime-boost regimen with the two doses given 28 days apart. As with the Pfizer-BioNTech mRNA vaccine, COVID-19 vaccine rates declined among vaccine recipients after the first dose, though neither vaccine candidate is currently being studied in a single-dose regimen.
Though FDA is not required to follow the recommendations of its advisory committees, it usually does so; last week’s emergency use authorization (EUA) for the first vaccine against COVID-19 came on the day after VRBPAC gave the Pfizer-BioNTech vaccine the green light. (RELATED: FDA authorizes Pfizer-BioNTech vaccine for emergency use, Regulatory Focus 11 December 2020)…