Novavax to Submit COVID-19 Vaccine EUA Request to FDA

(Reuters) -
(REUTERS/Dado Ruvic/Illustration/File Photo)

Novavax Inc will submit a request to the Food and Drug Administration to authorize its COVID-19 vaccine this month, further delaying the submission it had expected by the end of 2021.

The company’s announcement on Friday follows submission of final data related to the vaccine’s manufacturing processes to the regulator, which is a prerequisite for the emergency use authorization application (EUA).

Novavax has had to delay its U.S. submission multiple times due to development and manufacturing setbacks. A report earlier this year said the methods Novavax used to test the efficacy of its vaccine had fallen short of regulators’ standards.

Data released in June from a late-stage U.S. trial showed the vaccine was more than 90% effective against a variety of concerning coronavirus variants, including delta.

The company has said its vaccine is effective in generating an immune response against the omicron variant, according to early data, suggesting that the existing COVID-19 vaccine can help combat the new variant.

But it will continue to develop a vaccine tailored for omicron, and expects to begin clinical studies in the first quarter of 2022.

The biotech company in 2020 received $1.6 billion from the U.S. government to cover testing and manufacturing of a potential COVID-19 shot, with the aim of delivering 100 million doses.

The two-dose, protein-based vaccine has so far got authorizations from European Union regulators and the World Health Organization.

It has also secured authorizations in India, Indonesia and the Philippines, where Novavax‘s partner Serum Institute of India will supply the vaccine.

Novavax is also awaiting approval in Japan, where its vaccine would be manufactured and distributed by Takeda Pharmaceutical.