NEW DELHI, Oct 27: While the World Health Organization (WHO) further delayed approval for Emergency Use Listing (EUL) of Bharat Biotech-manufactured “Covaxin” Coronavirus vaccine seeking additional data, its US partner Ocugen has submitted Investigational New Drug Application (IND) to the US Food and Drug Administration to conduct its clinical trials. The WHO, which on Tuesday said it could be a matter of 24 hours before the world health body gave its approval to Covaxin, on Wednesday said its Technical Advisory Group (TAG) for Emergency Use Listing (EUL) had decided to seek additional clarifications from Hyderabad-based Bharat Biotech to conduct a final EUL risk-benefit assessment for global use of Covaxin.
In a major relief for Indians having taken “Covaxin” and want to travel to Oman, its government has now included “Covaxin” in its list of approved Covid-19 vaccines. According to a press release shared by the Indian Embassy in Oman’s capital city, Muscat, the government will allow all passengers from India who have received two doses of Covaxin at least 14 days before the estimated arrival date to travel to Oman without the need of quarantine. “All other Covid-19 related requirements/conditions, such as pre-arrival RT-PCR test shall be applicable for such passengers,” it added.
Close on the heels of the WHO seeking more clarifications, Ocugen, Bharat Biotech’s US partner for Covaxin on Wednesday said it has submitted Investigational New Drug Application (IND) to the US Food and Drug Administration to conduct clinical trials. The US firm in a press release said the Phase 3 trial, proposed in the IND, is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India was similar to that observed in a demographically representative, healthy adult population in the USA.
The US drug regulator earlier in June “recommended” Ocugen Inc, to go for Biologics Licence Application (BLA) route with additional data, instead of Emergency Use Authorisation (EUA).
The proposed trial can be to people who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier in the USA.
“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. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population, ” Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen said.
If the study is allowed to proceed, Ocugen’s Phase 3 immuno-bridging study, OCU-002, will seek to enroll several hundred healthy adults in the U.S. Subjects will be randomized to receive either two doses of Covaxin or placebo, 28 days apart. The Phase 3 study conducted in India by Ocugen’s business partner, Bharat Biotech, involved 25,798 participants receiving two doses of Covaxin or placebo, 28 days apart. Ocugen has already sought regulatory approval from Health Canada for Covaxin to be used in that country.
Covaxin is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.
However, Indians administered “Covaxin” are anxiously waiting for the WHO approval without which most of the countries treat the such passengers as “unvaccinated” requiring to undergo rigorous tests and compulsory quarantine. Oman and many other countries have allowed passengers from India who have received AstraZeneca or the Covishield vaccine without quarantine. As per reports, Oman had allowed fully-vaccinated travels from 20 countries, including India, to enter the country from September 1, exempting those with negative RT-PCR reports from quarantine.
(Manas Dasgupta)