Hyderabad: Bharat Biotech, manufacturer of Covaxin, said on Saturday that it would conduct clinical trials in the United States as it prepares to seek full approval for the Covid-19 vaccine in that country.
It may be recalled that the USFDA, which regulates drug approvals in the US, had declined permission for emergency use authorisation for Covaxin. Following this, Bharat Biotech said that its American partner Ocugen will follow the biologics licence application’ (BLA) process, which leads to full approval for use of a medicine.
For the BLA, data from an additional clinical trial will be required to support the marketing application submission for Covaxin.
Bharat Biotech also said that it shares data of all Covaxin research studies. While Phase I, II, and partial data for Phase III trials of Covaxin have been scrutinised by Indian regulators, it has published nine studies in 12 months on Covaxin’s safety and efficacy in peer-reviewed journals. Currently, data from both efficacy and safety follow-up of Phase III trials is being analysed; the data and final analysis will be made public soon, Bharat Biotech said.
Covaxin, a whole-virion inactivated Coronavirus vaccine, is the only Covid-19 vaccine to have efficacy data in Indian populations, the company said.
Three preclinical studies on Covaxin in laboratory animals were published in Cellpress, while studies on Phase I (to assess a vaccine’s safety, immune response and to determine right dosage) and Phase II (to assess safety and ability of the vaccine to generate an immune response) trials were published in The Lancet-Infectious Diseases, the company said.
The study on neutralization of Beta and Delta variants (B.1.351 and B.1.617.2) was published at bioRxiv, and the study on B1.1.28 variant, in the Journal of Travel Medicine, while the studies on B.1.617 variant and Alpha variant (B.1.1.7) were published at Clinical Infectious Disease, and Journal of Travel Medicine respectively, Bharat Biotech said.