On Sunday, DCGI approved Covishield and Bharat Biotech''s Covaxin for restricted emergency use.
Expressing delight over the approval on restricted emergency use of its COVID-19 vaccine Covaxin, Bharat Biotech on Sunday 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.
The approval of Covaxin for emergency use is a giant leap for innovation and novel product development in India, Krishna Ella, Chairman and Managing Director of the Hyderabad-based pharmaceutical firm said in a statement.
Krishna Ella said 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.
On Sunday, Drug Controller General of India (DCGI) approved Covishield and Bharat Biotech''s Covaxin for restricted emergency use.
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, and this is India's first and only Phase III efficacy study for a COVID-19 vaccine, Krishna Ella said.
It is the largest phase III efficacy trial ever conducted for any vaccine in India, he added.
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, Krishna 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 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".
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— KTR (@KTRTRS) January 3, 2021