Biopharmaceutical company Ocugen Inc. expects to sell 100 million doses of Indias Covaxin coronavirus vaccine in the U.S. this year, the CEO said Monday.
The Pennsylvania-based firms 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 Indias 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 the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines 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 CEOs 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 were designated 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 of Pfizer-BioNTech, more than 52.8 million of Moderna and more than 1.4 million of Johnson & Johnson, according to the Centers for Disease Control and Prevention.