(Bloomberg) – A new Covid-19 vaccine from Novavax Inc. is likely to get its first approval in the UK, and the company is discussing with U.S. regulators whether test data from other countries could be part of the injection review. , Official CEO Stan Erck said.
The company announced late on Thursday that the vaccine was effective in large trials in the United Kingdom and South Africa, although its protective power appeared to be reduced in South Africa, where a worrying mutation is prevalent. Novavax is still recruiting patients for a trial in the United States and Mexico, but the U.S. Food and Drug Administration could consider authorizing the vaccine based on results from abroad, Erck said in an interview with Bloomberg Television.
“We look forward to being able to take this data packet to the FDA and have them evaluate our vaccine based on UK data, while we conduct a phase 3 study in the United States,” said Erck. “We are talking to them. We don’t have a definitive answer yet. “
The FDA issued guidelines last year that drug manufacturers could send test data outside the United States to support an emergency use request, but that they should consult with the regulator about the information they want to include.
If regulators review Novavax’s complete data and conclude that the vaccine is safe and effective, it would give the world another highly potent injection, along with those from Pfizer Inc., Moderna Inc. and AstraZeneca Plc. Novavax is already working on the redesign of its product to be more effective against new strains like South Africa, which was also more challenging in a test with the Johnson & Johnson vaccine.
The company is also conducting a major test of its vaccine in the United States and said on Thursday that it has enrolled 16,000 of the 30,000 people projected so far. The test could yield results in March or April, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, at an event at the New York Press Club on Friday.
The shares of Novavax, based in Gaithersburg, Maryland, which is also developing vaccines for other respiratory diseases, have risen up to 76% in the New York market.
(Updates with more details on FDA submissions in the fourth paragraph)
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