Bharat Biotech's American partner for the Covid-19 vaccine, Ocugen, announced on 27 October that it had submitted an Investigational New Drug Application (IND) to the United States Food and Drug Administration (FDA) to conduct clinical trials.
Ocugen, the Malvern, Pennsylvania-based company, is seeking permission to test the Covid-19 vaccine, Covaxin, on several hundred Americans.
The biotechnology company which has been developing gene therapies to treat eye disorders rose 1.9 per cent in premarket trading in the United States.
However, the latest news from the American company comes at a time when reports revealed that the World Health Organization (WHO) requested more information from Bharat Biotech to assess Covaxin for Emergency Use Listing (EUL)—the UN agency was supposed to take a decision on 26 October.
According to a press release by the American company, the Phase 3 trial, proposed in the IND, is intended to determine 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 United States “who either have not been vaccinated for Covid-19 or who already received two doses of an mRNA vaccine at least six months earlier”.
Dr Shankar Musunuri, chairman of the board, chief executive officer, and co-founder of Ocugen 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.”
“We are hopeful that the study conducted under the IND if allowed to proceed, will help demonstrate that the data from India will apply to the US population,” he added.
If the trial is approved, Ocugen's Phase 3 immuno-bridging study, OCU-002, would seek to enrol hundreds of healthy adults in the United States. The subjects will be randomly assigned to either two doses of Covaxin or a placebo, 28 days apart.
As reported previously, Ocugen has already applied to Health Canada for regulatory authorisation to use Covaxin in that country.
Covaxin In The United States
While the Indian vaccine is already being used in 17 nations, the United States may prove to be a difficult market to break into.
Covaxin uses the inactivated-virus technique, unlike mRNA shots from Moderna and Pfizer-BioNTech. Covaxin's efficacy has been closer to 78 per cent in trials. While American mRNA jabs are over 90 per cent effective.
But it is believed that some Americans may choose a vaccine that uses a more traditional method rather than mRNA or the viral vector that drives Johnson & Johnson's single-dose Covid-19 vaccine.
It is because some vaccine sceptics have complained that the new immunisation procedures were developed too quickly—which has been one of the most used arguments by many anti-vaxxers since the rollout in the United States.
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