Bharat Biotech pursuing full approval for Covaxin in US

The company said that no vaccine manufactured or developed in India has ever received emergency use approval or full licensure from FDA. It added, therefore, it will be a “great leap forward” for vaccine innovation and manufacturing in India if Covaxin is approved in the UN

Bharat Biotech’s American partner, Ocugen, has received a recommendation from the US Food and Drug Administration (FDA) to pursue Biologics License Applications (BLA) path, or full license, for its Covid-19 vaccine Covaxin, the Indian company said in a statement on Friday. It said the BLA path is for full approval instead of emergency use authorisation. “All applications have to follow the BLA process, which is the standard process for vaccines,” it said. The company added, therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for Covaxin. It added the process was likely to extend their overall timelines.

A health worker shows Bharat Biotech’s Covaxin. (HT file)

The company said that no vaccine manufactured or developed in India has ever received emergency use approval or full licensure from FDA. It added, therefore, it will be a “great leap forward” for vaccine innovation and manufacturing in India if Covaxin is approved in the UN.

As the Covid-19 cases have been reducing in the US because of good herd immunity and the vaccination of a significant percentage of the population, the FDA has announced no new emergency use authorisation would be approved for new vaccines.

Covaxin is one of the Covid-19 vaccines being administered under India’s immunisation programme. It has received emergency use authorisation from 14 countries. More such authorisations are under process in at least 50 other countries.

Covaxin, which has been co-developed by the Indian Council of Medical Research, is a whole virion inactivated vaccine. Inactivated vaccines contain viruses with destroyed genetic material. They cannot infect and trigger an immune response

Bharat Biotech has partnered with Ocugen for commercialisation of the Covaxin vaccine in the US. On June 3, Bharat Biotech announced that they have amended their co-development, supply, and commercialisation agreement to expand Ocugen’s exclusive territory to commercialise Covaxin to also include Canada.

In a statement earlier, Krishna Ella, chairman, and managing director, Bharat Biotech, said Covaxin has demonstrated an excellent safety record in human clinical trials and in vaccine administration under emergency use in India. “Our goal for all vaccines developed at Bharat Biotech is to provide global access. With its potential effectiveness against multiple existing and emerging variants, we believe that Covaxin is an important vaccine for everyone, including children, based on its unique yet traditional vaccine platform. We are diligently working with Ocugen to bring Covaxin to the US market and now to the Canadian market.”