Covaxin producer Bharat Biotech on Saturday announced that it will be carrying out clinical trials in the United States to support the marketing application for its vaccine.
Addiing that currently, data from both efficacy and safety follow-up of Covaxin’s Phase III trial is being analysed and compiled Bharat Biotech said it will make Phase III trials data from the final analysis public soon.
Bharat Biotech has shared full data of all research studies of its Covaxin- India's first indigenous COVID-19 vaccine.
As per the company officials, the complete data for Phase I and II, and partial data for Phase III trials of Covaxin have been thoroughly scrutinised by the regulators in India. In a timely approach to peer review, the company has already published as many as nine research studies on the safety and efficacy of Covaxin in five globally reputed peer-reviewed journals in a span of just twelve months.
Covaxin, a whole-virion inactivated coronavirus vaccine, has many firsts to its credit in data transparency. It is the first and only product to have published any data from human clinical trials in India.
The Centre on Friday said that Covaxin's phase-3 study will be published in the next seven to eight days. The data will be beyond what it had shared with the DCGI. It will be then peer-reviewed," Niti Aayog member (health) V.K Paul said at a briefing.
Meanwhile, the US Food and Drug Administration rejected giving emergency-use authorisation to Bharat Biotech International Ltd's COVID-19 vaccine Covaxin.
The regulator has recommended the company's US partner Ocugen Inc to instead apply for a full licence approval. The US company will now pursue submission of a biologics licence application for Covaxin, instead of an emergency-use approval, which will delay the launch of the vaccine in the country.
"The FDA provided feedback to Ocugen and recommended that it pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data," the company said in a statement.
Paul also said that the government respects the US Food and Drug Administration's decision to reject the company's emergency-use authorisation proposal for Covaxin, and added that it does not have any impact on India's vaccine programme.
"We are doing good on the regulatory front. There could be variations in scientific nuances among countries. We are satisfied with the vaccine, and it has no bearing on our programme," he said.