After an extended delay, Novavax, Inc. (NASDAQ: NVAX) is finally making progress with its COVID-19 vaccine candidate – NVXCoV2373.
What happened: Maryland-based Novavax said it has completed its ongoing regulatory submission to the UK Medicines and Health Products Regulatory Agency for the authorization of NVXCoV2373.
All modules required for the regulatory review, including chemistry, manufacturing, monitoring data, are now complete, the company said. Regulatory Application for Conditional Marketing Authorization for NVXCoV23673 is the UK’s First Protein Vaccine Authorization Application
“This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine, built on a proven and well-understood vaccine platform that has demonstrated high efficacy against multiple strains of the coronavirus,” said Stanley Erck, CEO of Novavax.
Novavax expects to complete additional regulatory filings in key markets including Europe, Canada, Australia, New Zealand, World Health Organization and other markets around the world shortly. after submission to UK.
In the United States, Novavax plans to submit the full package to the FDA by the end of the year.
Why this is important: Novavax shares came under strong pressure at the end of October after a report suggested that the company faces issues with the purity of its vaccine candidate.
Guidelines released by the Food and Drug Administration in June 2020 require each batch of vaccine to achieve at least 90% purity, while Novavax was only able to show purity levels of around 70%, according to the report.
The report also raised the specter of a full license of the company’s vaccine only by the end of 2022.
The completion of the UK regulatory filing should allay investor skepticism about the company’s ability to complete its vaccination program.
NVAX price action: In pre-market trading, Novavax shares rose 14.8% to $ 154.97.
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