Malvern Company Readies for FDA Submission of COVID-19 Vaccine

Image via Anthony Quintano, Creative Commons.

Later this month, Malvern-based Ocugen will seek an emergency-use authorization from the FDA to cooperate with Bharat Biotech for the India-based company’s COVID-19 vaccine, Covaxin, writes John George for the Philadelphia Business Journal.

According to Shankar Musunuri, CEO of Ocugen, the company is also in talks with the Biomedical Advanced Research and Development Authority on a potential purchase of the vaccine by the U.S. government.

“They are supporting all the current vaccine suppliers” that have been approved for emergency use, said Musunuri.

Ocugen CEO Shankar Musunuri.

The two companies will file the application for Covaxin as soon as more data become available from the current clinical testing that can be included in the submission. The vaccine has already been approved in India.

“We’re aiming to make up to 200 million doses available this year to support the U.S. COVID-19 immunization program,” said Musunuri.

Ocugen is now in discussions with potential manufacturers in the U.S. and is planning to work with its Indian partner on the transfer of technology, provided the FDA grants approval for the vaccine. The local company will receive 45 percent of Covaxin’s sales in the U.S.

Read more about Ocugen in the Philadelphia Business Journal.

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