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Why Novavax Stock Slipped Today

By Keith Speights – Sep 9, 2021 at 3:52PM

Key Points

  • A report stated that the Indian government has requested additional data for Novavax's COVID-19 vaccine candidate before it can grant Emergency Use Authorization.
  • EUA for the vaccine in India was originally expected in October but will now be pushed back.
  • The delay isn't a huge blow for Novavax with the company's bigger opportunities in developed markets.

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Authorization of the company's COVID-19 vaccine in India appears to have hit a speed bump.

What happened

Shares of Novavax (NVAX -4.58%) 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. 

Coronavirus vaccine vial and syringe with needle in front of an Indian flag.

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. 

Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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