Ocugen Inc plans to sell 100 million doses of India’s state-backed COVID-19 vaccine in the United States this year, the United State firm’s chief executive Shankar Musunuri told Reuters on Monday.
Musunuri said Ocugen, a Pennsylvania-based biopharmaceutical firm, was aiming to launch the Indian-developed vaccine in the United States in the second quarter of 2021, initially with imported shots before beginning production there.
The United States has already authorised COVID-19 vaccines developed by Pfizer/BioNTech, Moderna and Johnson & Johnson for emergency use.
India’s two-dose COVAXIN has been found to be 81% effective in an interim analysis of late-stage trial data on some 26,000 people in India, its developers Bharat Biotech and the state-run Indian Council of Medical Research said this month.
Bharat Biotech says as many as 40 countries are interested in COVAXIN and it has already sought emergency approvals in Brazil and the Philippines. Cracking the U.S. market would be a significant milestone for the company and India’s vaccine industry, which is the world’s largest.
Musunuri said Ocugen had held initial talks with the U.S. Food and Drug Administration and planned to seek emergency use authorisation in April.
“They’re fine with the way the interim analysis is being done,” Musunuri said, adding that Ocugen had “a regulatory path” to take the process forward.
Musunuri said COVAXIN had the potential to work against COVID-19 variants and Ocugen could initially focus on children as it was likely to be safe for those over the age of 12, while shots produced by other drug makers targeted adults.
Pfizer’s vaccine has been authorised for emergency use in the United States for individuals 16 years and older, with the other two given authorisation for emergency use in people 18 years and above.