FDA Panel Recommends Moderna ’s COVID-19 Vaccine, the Second To Receive Such Approval in the U.S.

In an overwhelming 20 to zero vote, with one abstention, the U.S. Food and Drug Administration’s vaccine advisory committee recommended that the agency authorize the second COVID-19 vaccine for emergency use in the country. The FDA will now decide whether or not to take the committee’s advice; last week, the agency did follow the committee’s lead in authorizing for emergency use the Pfizer-BioNTech vaccine on Dec. 11. This second vaccine, mRNA-1273, made by Massachusetts-based biotech Moderna, uses the same technology as the Pfizer-BioNTech vaccine and in trials showed similar efficacy in protecting against COVID-19 disease. During a day-long meeting on Dec. 17, Moderna executives presented data from the company’s Phase 3 study of the vaccine, which involved more than 30,000 people and included participants from a number of groups at higher risk of COVID-19, like those over age 65; people from certain racial and ethnic groups; and those with underlying health conditions. The results showed that the vaccine was 94.1% effective in protecting against COVID-19 disease, and was 100% effective in protecting people from severe COVID-19, defined as requiring hospitalization or supplemental oxygen support. In the study, 30 people developed severe disease—and all 30 had received the placebo shot, not the vaccine. The FDA’s decision could come quickly; last week the agency issued an emergency use authorization (EUA) for the Pfizer-BioNTech vaccine a ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news