What happened
Monday was an up day for Novavax (NVAX 1.16%), one of the more volatile coronavirus stocks on the scene. Its shares rose by 6.5% on the back of some regulatory news in a major overseas market.
So what
On Monday morning, Novavax and manufacturer Serum Institute of India announced that an Emergency Use Authorization (EUA) submission had been filed with the South African Health Products Regulatory Agency (SAHPRA) for NVX-CoV2373, the company's coronavirus vaccine. If the EUA is approved, NVX-CoV2373 would be branded and distributed there as Covovax.
Image source: Getty Images.
The EUA application is supported by data from a pair of phase 3 clinical trials, one of which involved around 30,000 patients in the U.S. and Mexico, and a smaller U.K. study of nearly 15,000 individuals. NVX-CoV2373 did exceedingly well in both.
"Novavax and Serum Institute remain focused on delivering the COVID-19 vaccine -- built on well-understood technology -- where it is needed most," said Novavax CEO Stanley Erck. "We look forward to SAHPRA's review and, if authorized, delivering the vaccine to help South Africa control the pandemic."
Now what
South Africa was the country in which the omicron variant was first recognized, and it did experience a steep rise in new diagnoses in the weeks that followed. However, since peaking on Dec. 16, the average number of daily new infections there has declined by about 67%.
Now, South Africa adds another name to the rapidly growing list of locales where Novavax has requested regulatory approval for NVX-CoV2373. However, the biotech's vaccine is still well outpaced in the marketplace by other jabs that are well-established in major jurisdictions. These include Pfizer and BioNTech's Comirnaty, and Moderna's mRNA-1273.
