What happened
Shares of Novavax (NVAX -0.95%) were jumping 5.2% as of 11:05 a.m. ET on Tuesday. The solid gain came after the company and its partner, Serum Institute of India (SII), announced that India granted Emergency Use Authorization (EUA) to Novavax's COVID-19 vaccine NVX-CoV2373.
So what
It makes sense that the vaccine stock experienced a boost with the authorization of NVX-CoV2373 in India. The country represents a large market opportunity for Novavax and SII, which will manufacture and market the vaccine in India under the brand name Covovax.
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Currently, only 42% of individuals in India are fully vaccinated. Covovax's efficacy and ability to be stored with standard refrigeration could make it an attractive option, especially in more remote areas of the country.
The India-authorization decision marks Novavax's fifth regulatory win in recent weeks. Novavax and SII received EUAs for the vaccine in Indonesia and the Philippines. They won Emergency Use Listing (EUL) from the World Health Organization (WHO), and the European Commission granted Conditional Market Authorization to NVX-Cov2373. Novavax also secured a second EUL from the WHO for the version of the vaccine that it will manufacture on its own.
Now what
Novavax stated in its press release announcing the Indian EUA that it expects to submit the complete regulatory package to the U.S. Food and Drug Administration (FDA) for EUA of NVX-CoV2373 by the end of this year. The company also awaits key regulatory decisions in several countries. Novavax's partner, SK bioscience, has filed for regulatory authorization of NVX-CoV2373 in South Korea. Another partner, Takeda, has submitted for approval of the vaccine in Japan.
