After the US Food and Drug Administration (FDA) declined to grant emergency use authorization to Bharat Biotech and "recommended" its US partner, Ocugen Inc, to go for Biologics Licence Application (BLA) route with additional data, the Indian vaccine maker on Friday said it was pursuing the FDA advice and full approval, when granted to COVAXIN, would be the first for any Indian vaccine maker.
Bharat Biotech said, "With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States. The USFDA had earlier communicated that no new EUA’s will be approved for covid vaccines. All applications have to follow the biological license application process, with is the standard process for vaccines."
"Data from an additional clinical trial will be required to support the marketing application submission for Covaxin. Covaxin has received EUA’s from 14 countries with more than 50 countries in the process. No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. When approved, it will be a Great Leap Forward for vaccines Innovation and manufacturing from India," they added.
COVAXIN has made a massive leap into the global market as it announced that it has obtained the Emergency Use Authorization (EUA) in 14 countries with more to follow. The EUA obtained in 14 countries which means that COVAXIN could soon begin circulation in these countries. The Hyderabad-based pharma company last month had said that regulatory approval for its COVID-19 vaccine, developed in partnership with the ICMR, is under process in over 50 countries overall including Brazil, Hungary, and others. Till now, COVAXIN is yet to secure entry to WHO Emergency Use Listing of COVID vaccines.
As far as India is concerned, COVAXIN phase 3 full trial results will be made public in July, Bharat Biotech informed on Wednesday. "It is critical to understand and further emphasize the phase-3 data will first be submitted to Central Drugs Standard Control (CDSCO) followed by peer-reviewed journals, with a timeline of 3 months for publication, and as communicated earlier COVAXIN phase 3 results full trial data will be made public during July. Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for COVAXIN," Bharat Biotech informed ANI.