What happened
Shares of Novavax (NVAX +0.87%) were slipping 2.6% lower as of 3:25 p.m. EDT on Thursday. The decline came following a report by The Economic Times that the Indian government has requested additional data from Novavax's partner, Serum Institute of India (SII), for COVID-19 vaccine candidate NVX-CoV2373 (which is called Covovax in India).
So what
SII filed for 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 asked for data from a clinical trial of the vaccine conducted in India, according to The Economic Times article.
Image source: Getty Images.
The problem is that SII likely won't be able to submit data from the clinical studies of Covovax in India until next month. SII CEO Adar Poonawalla stated in August that his organization hoped that the COVID-19 vaccine would be launched in India in October for adults and in the first quarter of 2022 for children. That timeline will now be pushed back.
This delay isn't a huge blow for Novavax, as evidenced by the relatively small drop in the vaccine stock. The company's biggest opportunities are in developed markets including the U.S. and Europe.
Now what
Novavax expects to file for EUA for NVX-CoV2373 in the United Kingdom within the next few weeks. That filing should be quickly followed by submissions in Australia, New Zealand, and the European Union. The company remains on track to file for U.S. EUA in the fourth quarter of 2021.
