Shares of BioNTech (BNTX 2.24%) were jumping 10.6% higher as of 12:23 p.m. EDT on Monday. The big gain came after Pfizer (PFE -1.28%) stated that it's in discussions with the government of India about accelerating authorization of the partners' COVID-19 vaccine.
Pfizer CEO Albert Bourla stated on Monday, "We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country." Although Pfizer and BioNTech submitted the COVID-19 vaccine for Emergency Use Authorization (EUA) in India in late 2020, the Indian government's requirement of a safety study conducted in the country prompted the two drugmakers to withdraw the application in February.
However, India is now reeling from a surge in COVID-19 cases. The country indicated that it would change its authorization process for vaccines to require a local clinical trial within 30 days after approval instead of prior to approval.
The country presents a large market opportunity for Pfizer and BioNTech. However, the relatively high price tag for the companies' COVID-19 vaccine combined with its storage requirements could limit those prospects to some extent.
BioNTech is enjoying considerable success in 2021 with the biotech stock soaring more than 150% year to date after today's gain. It could still have other catalysts on the way, including the potential for its COVID-19 vaccine winning EUA in India and the possibility of securing additional large supply deals outside of the U.S.