Bharat Biotech’s COVAXIN will be evaluated as a COVID-19 vaccine candidate in the United States of America (USA), the Hyderabad-based company said in a statement on Saturday.
"Ocugen Inc., Bharat Biotech's partner for USA and Canada for its COVID-19 vaccine, announced that the US Food and Drug Administration (FDA) has lifted its clinical hold on the Company's Investigational Drug Application (IDA) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN outside United States," read the statement.
In November last year, Ocugen Inc. had said that it had submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of COVAXIN for children in the age group 2-18 years.
The submission is based on results of a Phase 2/3 paediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India, Ocugen said in a regulatory filing.
Also, Ocugen Inc. had last year announced the payment of $15 million upfront to the Indian drug maker for extending the vaccine rights to Canada.
Ocugen in a regulatory filing said it had agreed to pay another $10 million to Bharat Biotech within a month from the commercial launch of Covaxin in the North American country.
On profit sharing agreement, Bharat Biotech had said similar to the U.S. arrangement, Ocugen will retain 45 per cent of the profit from sales of Covaxin in Canada.
