Novavax Slips on Report India Launch May Take More Time

This post was originally published on this site – Novavax stock (NASDAQ:NVAX) fell 4.2% on Thursday on a report in India’s Economic Times newspaper that the launch of the company’s Covid-19 vaccine in the country may take more time.

According to the report, in the absence of its approval in the U.S., India’s drug regulator has asked for the immunogenicity data from Serum Institute of India. The Indian company is the manufacturer and distributor of Novavax’s Covid vaccine.

While the trials are ongoing, data is likely to be submitted only by next month, the ET report said.

Novavax has filed for emergency use authorization of the vaccine in India, Indonesia and the Philippines. Filing for EUA with the U.S. Food and Drug Administrator is only expected to happen in December quarter. The company is significantly behind the likes of Moderna (NASDAQ:MRNA), Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ) and others in rolling out its Covid vaccine. That has reflected in its share price which is down around 30% from its 52-week high of $331.

India would have been a key market for the company given its population and the opportunity it had due to its tie-up with SII, the country’s largest vaccine-maker. SII also makes and distributes AstraZeneca’s (NASDAQ:AZN) Covid vaccine, accounting for more than 90% of the shots administered so far in the world’s second-most affected country due to the pandemic.

That window for Novavax may be narrowing for now as the country is now vaccinating more than 10 million people a day after a slow start. More than half have now been vaccinated with at least one dose in the 1.3-billion-people nation.