ARTICLE | Product Development

Moderna COVID-19 vaccine validates mRNA platform, suggests success of other vaccines

To seek FDA, EMA authorization in December after data from Phase III COVE, which includes 7K aged 65 and up, plus diverse and high-risk volunteers

November 16, 2020 12:00 PM UTC
Updated on Nov 16, 2020 at 11:18 PM UTC

Moderna is preparing to apply to FDA for emergency use authorization and to regulators in Europe and beyond for conditional approval in the coming weeks for its lead mRNA vaccine after it demonstrated 94.5% efficacy in preventing COVID-19 in an interim analysis of the Phase III COVE trial.

Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), celebrated the data, saying that it exceeded his expectations. Speaking at an NIH press briefing Monday, Fauci recalled that at the start of COVID-19 vaccine development he said that 70-75% efficacy would be satisfactory and that “something like a 95% was really aspirational. We would like to have seen it, but it was aspirational. Well, our aspirations have been met and that is really very good news.” ...