Novavax Sees U.K. Vaccine Approval First; in Talks With FDA
(Bloomberg) -- 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.”
The FDA issued guidance last year that said drugmakers could submit data from trials outside the U.S. to support an emergency-use application, but that they should consult with the regulator on the information they wish to include.
If regulators review Novavax’s full data and conclude the vaccine is safe and effective, it would give the world another highly potent shot alongside those from Pfizer Inc., Moderna Inc., and AstraZeneca Plc. Novavax is already working on reformulating its product to be more effective against new strains like the one in South Africa, which also proved more challenging in a trial of Johnson & Johnson’s vaccine.
The company is also conducting a big trial of its vaccine in the U.S. and said on Thursday that it had enrolled 16,000 out of a projected 30,000 people so far. The trial could yield results by March or April, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said at a New York Press Club event on Friday.
Shares of Gaithersburg, Maryland-based Novavax, which is also developing vaccines for other respiratory illnesses, surged as much as 76% in New York trading.
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