Novavax Sees U.K. Vaccine Approval First; in Talks With FDA

A new Covid-19 vaccine from Novavax Inc. is likely to get its first approval in the U.K., and the company is discussing with U.S. regulators whether trial data from other countries could be part of the shot’s review, Chief Executive Officer Stan Erck said. The company announced late Thursday that the vaccine was effective in big trials in the U.K. and South Africa, though its protective power appeared to be reduced in South Africa, where a worrisome mutation is prevalent. Novavax is still recruiting patients for a trial in the U.S. and Mexico, but the U.S. Food and Drug Administration could consider authorizing the vaccine based on the results from abroad, Erck said in an interview on Bloomberg Television. “We are hoping we can take that data package to the FDA and have them evaluate our vaccine based on the U.K. data while we are running a phase 3 trial in the U.S.,” Erck said. “We are talking to them. We don’t have a definitive answer yet.”