Trials to be conducted in the United States by Bharat Biotech

To support the marketing application for COVAXIN, Bharat Biotech will be conducting clinical trials in the United States, according to Asian News International (ANI) in one of its tweets today. Currently, the analysis and compilation of data from both efficacy and safety follow-up of Covaxin’s Phase III trial are being carried out. The Phase III trials data from the final analysis public shall be made by the company.

An emergency use authorisation shall no longer be pursued for COVAXIN by the BLA which is a full approval mechanism by the FDA for drugs and vaccines,  the feedback given by FDA to Ocugen regarding the Master file.

It has been recommended to go for Biologics Licence Application (BLA) route along with additional data, nixinhopes of emergency use authorisation, by the US food and drug administration to Ocugen Inc, the US partner of Bharat Biotech, the Indian vaccine maker in a set back to the company’s COVID-19 vaccine Covaxin.

Bharat Biotech’s Covaxin is said to offer protection against the Delta (B.1.617.2) along with Beta (B.1.351) variants of SARS-CoV-2, which contributes to the occurrence of COVID-19 according to a joint study by Pune’s National Institute of Virology researchers along with those from the Indian Council of Medical Research (ICMR) and Bharat Biotech has found.

The neutralisation potential of sera was collected from 20 COVID-recovered cases along with 17 people vaccinated with two doses of Covaxin against Beta and Delta variants and thereby comparing it with the prototype D614G variant.


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