New Delhi: Bharat Biotech said in a statement that it will be carrying out clinical trials in the United States to support the marketing application for Covaxin.
The US Food and Drug Administration (USFDA) had decided not to give Emergency Use Authorisation (EUA) to Bharat Biotech’s Covaxin.
The regulator also recommended Ocugen, the US partner for Bharat Biotech’s COVID-19 vaccine, to pursue Biologics License Applications (BLA) path for Covaxin.
Bharat Biotech said, “The USFDA had earlier communicated that no new emergency use authorisation would be approved for new Covid-19 vaccines… Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval.”
Meanwhile, Bharat Biotech completed three preclinical studies, which are published in Cellpress, a peer-reviewed journal. The studies on Covaxin’s Phase I and Phase II clinical trial are published by the peer-reviewed journal, The Lancet – Infectious Diseases, Bharat Biotech said.
The full data from studies on Covaxin’s neutralisation of variants are already published 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 said.