Novavax to submit COVID-19 vaccine EUA request to U.S. FDA next month

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

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.

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

(Reporting by Leroy Leo in Bengaluru; Editing by Aditya Soni and Shinjini Ganguli)

  • Related Posts

    • Pharma
    • January 21, 2025
    • 84 views
    Biocon urges govt to exempt cancer, rare-disease drugs from tax in Budget

    India should eliminate tax on drugs for cancer treatment and for chronic and rare diseases, the chairperson of major drugmaker Biocon Ltd said ahead of Prime Minister Narendra Modi’s budget…

    • Pharma
    • January 21, 2025
    • 127 views
    Glenmark Pharma share rises 2% as unit launches blood clotting drug

    Glenmark Pharmaceuticals share price:Pharmaceutical major Glenmark Pharmaceuticals shares rose up to 2.23 per cent to hit an intraday high of Rs 1,537.90 per share on Tuesday, January 21, 2025. The…

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    Biocon urges govt to exempt cancer, rare-disease drugs from tax in Budget

    Biocon urges govt to exempt cancer, rare-disease drugs from tax in Budget

    Glenmark Pharma share rises 2% as unit launches blood clotting drug

    Glenmark Pharma share rises 2% as unit launches blood clotting drug

    Fire breaks out at pharmaceutical company in Andhra Pradesh, no casualty

    Fire breaks out at pharmaceutical company in Andhra Pradesh, no casualty

    Pharma body to cap prices of cigarette substitutes, seeks data

    Pharma body to cap prices of cigarette substitutes, seeks data