Ocugen Files Request with US FDA to Start Covaxin Trials in US


The company ‘Ocugen’, US partner of Bharat BioTech for the Covaxin novel corona virus vaccine said, it has submitted the application of the Investigational New Drug (IND) to the US FDA for the purpose of conducting the clinical trials, and this development comes a day after the World Health Organisation (WHO) will sought more details from the company ‘Bharat Biotech’ for the purpose of considering the company’s covid-19 vaccine known as Covaxin for the listing in the Emergency Use.

The US-based Ocugen said, the phase 3 trials of the vaccine, that has been proposed in the IND, has been designed for the purpose of establishing whether the immune response, which was experienced by the participants in a completed phase 3 trial for the efficacy of Covaxin conducted in India is similar to the data, which has been observed in a healthy, demographically representative adult population in the United States.

The US FDA has recommend the company ‘Ocugen’ for going for the Biologics Licence Application (BLA) route along with the additional data, instead of the Emergency Use Authorisation (EUA) in the country. This proposed trial can possibly beneficial to the people, who either have not been vaccinated for the novel corona virus or who had already received the two doses of an mRNA vaccine at least before six months in the United States.

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Dr. Shankar Musunuri, Chairman of the Board, CEO and Co-Founder of Ocugen said, they are now very excited for taking this step in the development of the Covaxin covid-19 vaccine, which they are now hoping will bring them more closer for introducing a different type of the corona virus vaccine to the people of the United States.


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