USA rejects application for Covaxin, recommends for further testing

Kabilan Kempraj -

Washington,

The US Food and Drug Administration has cancelled an Indian-made Covaxin Vaccine in the United States, after it applied for emergency use. US recommends to conduct further testing.

Covaxin is India's first, made in India vaccine. It was developed jointly by Bharat Biotech, Hyderabad and Medical Research Council of India. The US based firm Ocugen has contracted with Bharat Biotech to use the vaccine in the United States. Ocugen had applied to the US Food and Drug Administration (FDA) for permission to use Covaxin for emergency use across United States. But the submitted application was rejected by the FDA. However, FDA recommends to apply for full approval with additional information and data.

In this scenario, Ocugen CEO, Dr. Shankar Musunuri said, "FDA has recommended to apply for full approval along with biological license application. Thus we will conduct additional tests and re-apply to FDA." We are committed to bring Covaxin across United States, he said.

Ocugen owns the exclusive rights from Bharat Biotech to sell Covaxin in Canada. It is already in negotiation with the Canada's Department of Health for approval to sell Covaxin across Canada. According to the commercial contract, in a month's time Ocugen has agreed to pay Rs 73 crores to Bharat Biotech, after the launch of Covaxin.

Location: United States

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