Ocugen expects to sell 100 million doses of India’s Covaxin in US this year

by Justine Coleman - 03/15/21 3:52 PM ET

Biopharmaceutical company Ocugen Inc. expects to sell 100 million doses of India’s Covaxin coronavirus vaccine in the U.S. this year, the CEO said Monday.

The Pennsylvania-based firm’s CEO, Shankar Musunuri, told Reuters that Ocugen plans to start Covaxin vaccinations in the second quarter of 2021. Under the plan, the first doses of India’s state-backed vaccine would be imported as Ocugen ramps up production in the U.S.

Ocugen is aiming to request an emergency use authorization from the Food and Drug Administration (FDA) next month. So far, the FDA has approved vaccines from Pfizer and BioNTech, Moderna, and Johnson & Johnson for emergency use in the U.S.

Musunuri told Reuters that the FDA is “fine with the way the interim analysis is being done.” The CEO’s comments come after Bharat Biotech International and the Indian Council of Medical Research determined the two-dose vaccine was 81 percent effective in a study released earlier this month.

Ocugen, which will have the U.S. rights to the vaccine, could direct its vaccinations to children, as India approved in January its usage for all people over the age of 12, Musunuri said. The Pfizer-BioNTech vaccine has been approved for those 16 and older, while the Moderna and Johnson & Johnson vaccines have been approved for those at least 18 years old.

Some experts suspect Covaxin could be more effective against variants since it combats the whole body of a virus instead of the “spike-protein” tip, Reuters noted.

Under a contract that Ocugen and Bharat Biotech are finalizing, Bharat Biotech will send its technology to Ocugen for it to manage U.S. development and regulatory approval, and Bharat Biotech will receive 55 percent of the overall profit.

The U.S. has administered more than 109 million doses of the COVID-19 vaccines currently available, including more than 54.6 million from Pfizer and BioNTech, more than 52.8 million from Moderna and more than 1.4 million from Johnson & Johnson, according to the Centers for Disease Control and Prevention.