New Delhi: Bharat Biotech mentioned in a press release that will probably be finishing up clinical trials in the United States to assist the advertising and marketing utility for Covaxin.
The US Food and Drug Administration (USFDA) had determined to not give Emergency Use Authorisation (EUA) to Bharat Biotech’s Covaxin.
The regulator additionally advisable Ocugen, the US associate for Bharat Biotech’s COVID-19 vaccine, to pursue Biologics License Applications (BLA) path for Covaxin.
Bharat Biotech mentioned, “The USFDA had earlier communicated that no new emergency use authorisation can be accepted for new Covid-19 vaccines… Our US associate, Ocugen has acquired a advice from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval.”
Meanwhile, Bharat Biotech accomplished three preclinical research, that are revealed in Cellpress, a peer-reviewed journal. The research on Covaxin’s Phase I and Phase II clinical trial are revealed by the peer-reviewed journal, The Lancet – Infectious Diseases, Bharat Biotech mentioned.
The full knowledge from research on Covaxin’s neutralisation of variants are already revealed at bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine, it added.
“Currently, data from both efficacy and safety follow-up of Covaxin’s Phase III trial is being analysed and compiled. Upholding its uncompromising commitment to integrity, the company will make Phase III trials data from the final analysis public soon,” Bharat Biotech mentioned.
(With inputs from information companies)
