No vaccine manufactured or developed from India has ever received emergency use authorisation or full licensure from USFDA.
NEW DELHI: Covaxin manufacturer Bharat Biotech, which is already drawing flak in India for the unusual delay in releasing its final phase 3 clinical trial results, got a fresh jolt as the US drug regulator declined emergency use authorisation (EUA) for the vaccine in that country.
Indian authorities, however, claimed the US decision will have no bearing on the nation’s Covid vaccination drive, of which Covaxin apart from Covishield is a key element. The USFDA advised Bharat Biotech’s US partner Ocugen to take the biological license applications or full approval route instead for the approval.
Putting it in context, Bharat Biotech said the USFDA has already stopped issuing EUAs, since the country now has good herd immunity and a significant percentage of its population is vaccinated. “Our US partner, Ocugen, has received a recommendation from the FDA to pursue a Biologics License Applications path for Covaxin,” the firm said. It added that for standard approval, data from an additional clinical trial will be required, extending the company’s timelines.
No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA.
“Thus, it will be a great leap forward for vaccine innovation and manufacturing from India when approved,” claimed Bharat Biotech. Covaxin has restricted use permission from 14 countries while its applications are under evaluation in more than 50 other countries. The WHO is yet to issue its EUA due to lack of data.
Phase 3 data will be out in 7-8 days, says V K Paul
Back home, the company is under fire for not publishing the results of its efficacy trials, completed earlier this year on nearly 26,000 volunteers. It had said on Wednesday that data was being analysed and will first be sent to the Central Drugs Standard Control Organisation before being submitted for publication.
In a press briefing on Friday, V K Paul, member (health), Niti Aayog, and chief of the national Covid-19 task force, however, assured it could be sooner. “I have been told that Bharat Biotech will publish phase 3 data in the next 7-8 days,” he said.
On the USFDA’s decision, he said he respected it, adding that while every country’s regulatory system might have some things in common with others, there are things and processes that are different. “Scientific framework is the same but its nuancing is as per context,” Paul said.
“All of these are scientific considerations and keeping those in mind, the nuancing might be different, especially in those countries where science is strong. Our manufacturing is strong. They have decided this, we respect it,” he added.
Source: The New Indian Express