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What happened
Actions of Novavax (NASDAQ: NVAX) were down 2.6% as of 3:25 p.m. EDT Thursday. The drop came as a result of a report of Economic times that the Indian government has requested additional data from Novavax’s partner, Serum Institute of India (SII), for the COVID-19 vaccine candidate NVX-CoV2373 (called Covovax in India).
So what
SII applied for an Emergency Use Authorization (EUA) in India for Covovax in August. This submission was based on data from international clinical studies. An official with the country’s drug regulatory agency has requested data from a clinical trial of the vaccine in India, according to Economic times article.
Image source: Getty Images.
The problem is, SII likely won’t be able to submit clinical study data for Covovax in India until next month. SII CEO Adar Poonawalla said in August that his organization hopes the COVID-19 vaccine will be launched in India in October for adults and in the first quarter of 2022 for children. This schedule will now be postponed.
This delay is not a big blow for Novavax, as evidenced by the relatively small drop in the vaccine stock. The company’s greatest opportunities are in developed markets, particularly the United States and Europe.
Now what
Novavax plans to file an EUA application for NVX-CoV2373 in the UK in the coming weeks. This filing should be quickly followed by submissions in Australia, New Zealand and the European Union. The company remains on track to file an EUA application in the US in the fourth quarter of 2021.
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