No emergency nod from US looming, Covaxin to seek full approval | India News

No emergency nod from US looming, Covaxin to seek full approval |  India News

HYDERABAD: Bharat BiotechnologyUS partner Ocugen has dropped plans to apply for Emergency Use Authorization (US) for Covaxin in the US and will instead follow the Biologics License Application (BLA) route, which is a full approval, based on the recommendation of the US drug regulator. The measure will delay the rollout from Covaxin, developed locally in India, for the US market.
Noting the reasons for BLA, Bharat Biotech said: “With good herd immunity and a significant percentage of the vaccinated population, the pandemic is shrinking in the United States. Apart from this, the USFDA it had previously communicated that no new US would be approved. ”
Bharat Biotech, Ocugen will need to conduct a smaller trial in the US.
Admitting that the BLA process would extend the timelines for making Covaxin available in the US, Bharat Biotech said: “All applications must follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, additional clinical trial data will be required to support submission of the Covaxin marketing request. ”
Meanwhile, Ocugen President, CEO and Co-Founder Dr. Shankar Musunuri issued a statement saying: “Although we were close to finalizing our request to ship from the USA, we received a recommendation from the FDA to follow the path of BLA. While this will extend our timelines, we are committed to bringing Covaxin to the US. ”
Ocugen said it is in discussions with the FDA to understand the additional information required to support a BLA submission and anticipates that data will be required from an additional clinical trial.
This means that Bharat Biotech and Ocugen will have to conduct a smaller clinical trial in the US, in line with the Phase 3 study it is conducting with 4,500 volunteers in Brazil, where it recently received approval for Covaxin imports.
A spokesperson for Bharat Biotech said: “Yes, we are conducting a clinical trial in the USA.” Bharat Biotech has not yet submitted its Phase 3 efficacy data. It has only provided a provisional efficacy figure of 78% based on the second interim analysis.
Dr. Bruce Forrest, a member of Ocugen’s Vaccine Scientific Advisory Board, said that in “clinical trials to date, the emerging safety profile of Covaxin supports that it is generally well tolerated with a good safety profile.” possible thromboembolic events after the administration of more than 6.7 million doses of Covaxin in that country “.


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