Novavax Inc. (NASDAQ: NVAX) dropped 4.2% following a report in the Economic Times that the launch of its COVID-19 vaccine in India could take more time.
Approval of Novavax’s vaccine in India could delay
In the absence of FDA approval in the United States, India’s drug regulator has requested immunogenicity data on the vaccine candidate from the Serum Institute of India, as per the report. Production and distribution of Novavax’s COVID-19 vaccine is done through an Indian firm. The company expects to submit data from the ongoing trial next month.
Already the company has filed an Emergency Use Authorization for its vaccine in Indonesia, the Philippines, and India. The EUA filing with the US FDA is likely to come in the fourth quarter. However, Novavax continues to lag other drugmakers such as Pfizer Inc. (NYSE: PFE), Johnson & Johnson (NYSE: JNJ), and Moderna (NASDAQ: MRNA). As a result, this has had an impact on the stock, which is down 30% from a 52-week high of $331.
Given its population and the opportunity provided by its partnership with SII, India’s largest vaccine manufacturer, the country would have been a crucial market for Novavax. SII also manufactures and distributes AstraZeneca’s (NASDAQ: AZN) coronavirus vaccine, which has accounted for over 90% of the vaccines given so far in the pandemic’s second-most-affected country in the world.
The window of opportunity for Novavax closing in India
After a sluggish start, the country is currently vaccinating almost 10 million people every day, limiting the window for Novavax to leverage the market. More than half of India’s 1.3 billion population has received at least one dosage of the COVID-19 vaccine.
The company received a vote of confidence from the CDC, which said that participants in its vaccine trial could count as fully vaccinated after completing the vaccination program. But CDC said that the declaration is not approved for the vaccine yet to receive FDA authorization in the US.