Giant leap for India's innovation: Bharat Biotech MD on vaccine conditional nod

Bharat Biotech Chairman and MD Dr Krishna Ella expressed happiness after Covaxin got the DCGI's nod for restricted emergency use in India. He said that the approval of Covaxin for emergency use is a giant leap for innovation and novel product development.

Hyderabad: After Drug Controller General of India (DCGI) announced that Bharat Biotech's 'Covaxin' has been approved for "restricted use in emergency situation", company's Chairman and Managing Director Dr Krishna Ella expressed delight over the approval. Ella said that DCGI's approval will boost the development of new products and Covaxin has been designed to withstand vital proteins.

Bharat Biotech today said it has generated excellent safety data with robust immune responses to multiple viral proteins that persist and their goal is to provide global access to populations that need it the most.

Speaking to ETV Bharat, Ella said, "Covaxin produced strong immune responses. The Covaxin experiment is the largest of all we have done so far. Ours is the biggest experiment in the vaccination experiments on humans in the country. The third phase of experiments was launched in November last year. We have taken 23,000 volunteers for the third phase of experiments. The spirit of volunteers gives India and the world a great moral strength. Our aim is to provide Covaxin vaccine to all countries."

He added, "The approval of Covaxin for emergency use is a giant leap for innovation and novel product development in India. It was a proud moment for the nation and a great milestone in India''s scientific capability, a kickstart to the innovation ecosystem in India.

"While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist," he said.

Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, he said.

The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in "26,000" volunteers across India, this is India''s first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India, he said.

Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals, Ella said.

This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech''s BSL-3 (Bio-Safety Level 3) bio-containment facility.

The evaluation of Covaxin has resulted in several unique product characteristics including long term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad-spectrum neutralising capability with heterologous SARS-CoV2 strains, thus potentially reducing or eliminating escape mutants, the statement said.

"It has also shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and rapid antibody response to future infections. Its most critical characteristic is the demonstrated safety profile, which is significantly lower than several other vaccines with published data," it said.

The product development and clinical trial data thus far has generated five publications, which have been submitted to international peer-reviewed journals, four of which have been accepted and will be published soon, it said adding the publication of phase II trial data is undergoing the peer review process.

Telangana IT Minister KT Rama Rao tweeted: "Many Congratulations to Dr Krishna Ella, Suchitra Ella & the entire team of scientists @BharatBiotech on getting DCGI approval for Covaxin Hyderabad continues to shines on as the vaccine capital because of the pursuit of excellence of scientists & innovative entrepreneurs"

With PTI inputs