From FiercePharma.com…..
As late-stage trials progress—or not—COVID-19 vaccine timelines have grown clearer. And here’s another data point—Moderna, a leading player, doesn’t expect to be ready to file for an emergency use authorization until late November, its CEO said this week.
Speaking at a Financial Times event, Moderna CEO Stéphane Bancel said it’ll be November 25 at the earliest before the company can seek an emergency nod. Under guidelines Moderna worked out with the agency, the biotech will compile two-month safety data for at least half of trial participants who have received their second doses.
