Connect with us

Headlines of The Day

Covaxin gets nod for human clinical trials in the US

Bharat Biotech has received approval to conduct clinical trials on its Covid-19 vaccine, Covaxin, in the United States, the company said in a statement on Saturday.

“Covaxin will be evaluated as a Covid-19 vaccine candidate in the United States. Ocugen announced that the US Food and Drug Administration (FDA) has lifted its clinical hold on the company’s Investigational New Drug Application to evaluate the Covid-19 vaccine candidate, BBV152, known as Covaxin outside the US,” Bharat Biotech said.

In October 2021 Ocugen, the US partner of the Hyderabad-based vaccine maker, submitted an investigational new drug application to the FDA to conduct clinical trials. On February 2 last year, Ocugen had also announced an exclusive licensing agreement with Bharat Biotech to obtain exclusive rights to develop, manufacture and commercialise Covaxin in the US.

“We are pleased to be able to move our clinical programme for Covaxin forward, which we hope will bring us closer to offering an alternative Covid-19 vaccine,” said Dr Shankar Musunuri, chairperson of the board, chief executive officer and co-founder of Ocugen.

“We firmly believe that managing this pandemic requires more than one approach to vaccines, so we are heartened to be able to continue developing our vaccine candidate,” he said.

Ocugen has submitted a request to the FDA for the emergency use authorization of Bharat Biotech’s Covid-19 jab for paediatric use. The submission is based on results of a paediatric clinical trial conducted by Bharat Biotech in India with 526 children in the 2-18 years of age category, which bridged immunogenicity data to a large phase-3 safety and efficacy clinical trial in nearly 25,800 adults in India, Ocugen said in a regulatory filing.

With more than 200 million doses having been administered to adults outside the US, Covaxin is currently authorised under emergency use in around 20 countries, and applications for emergency use authorisation are pending in more than 60 other countries.

The World Health Organization (WHO) recently added Covaxin to its list of vaccines authorised for emergency use, and as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using Covaxin, Ocugen’s statement read on Saturday. Hindustan Times

Copyright © 2024 Medical Buyer

error: Content is protected !!