Ocugen Files Application With FDA To Conduct Phase 3 Trials of Covaxin in US

Ocugen has partnered with Bharat Biotech to develop Covaxin for the US market.

Covaxin vaccine. Image used for representational purposes.

(Photo: FIT)

American biopharmaceutical firm Ocugen, which is partnering with Bharat Biotech to develop Covaxin for the US market, said on Wednesday, 27 October, that it has submitted an Investigational New Drug Application (IND) to the US Food and Drug Administration to conduct clinical trials.

As per a press release published by the firm, the Phase 3 trial proposed in the IND will be instrumental in establishing whether the 'immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the US'.

The trial will be conducted on people who are not yet vaccinated against COVID-19, or those who have who have already received two doses of an mRNA vaccine at least six months prior in the US.

This comes after the World Health Organization sought additional data from Bharat Biotech to consider Covaxin for its Emergency Use Listing.

The WHO had said in September that the process of assessing Bharat Biotech's vaccine is underway and a decision regarding its emergency use listing will be made in October.

Speaking on the IND, CEO of Ocugen Dr Shankar Musunuri said, "We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public."

Covaxin Approved for Travel to Oman

Meanwhile, the Embassy of India in Oman on Wednesday said that the Hyderabad-based COVID-19 vaccine has now been added to the approved list of COVID-19 vaccines that will allow travel to the country.

All passengers from India who have been vaccinated with two doses of Covaxin at least 14 days prior to the date of arrival will now be allowed to travel to Oman without quarantining.