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Hyderabad, Jan 3 (PTI): 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. Ella said it was a proud moment for the nation and a terrific landmark in India”s scientific capability, a kickstart to the innovation ecosystem in India.
“While this vaccine addresses an unmet medical need in this pandemic, our objective is to provide global access to people who need it the most. Covaxin has generated excellent security data with strong immune responses to multiple viral proteins which persist,” he said.
On Sunday, Drug Controller General of India (DCGI) accepted Covishield and Bharat Biotech”s Covaxin for limited 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 production platform with an excellent safety history of over 300 million doses, he said.
The Phase III human clinical trials of Covaxin started mid-November, targeted to be carried out 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, together with approval 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 many unique product attributes including long term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralising capacity with heterologous SARS-CoV2 strains, thus potentially reducing or eliminating escape mutants, the statement said.
“It has also demonstrated to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. Its most crucial characteristic is the demonstrated safety profile, which is significantly lower compared to several other vaccines with published data,” it said.
The product development and clinical trial data so far has generated five publications, which have been submitted to international peer reviewed journals, four of which have been approved and will be published shortly, it said adding the publication of phase II trial data is undergoing the peer review procedure.
Telangana IT Minister K T Rama Rao tweeted:”Many Congratulations to Dr. Krishna Ella, Suchitra Ella & the Whole team of scientists @BharatBiotech on getting DCGI approval for Covaxin Hyderabad proceeds to shines on as the vaccine capital because of the pursuit of excellence of scientists & innovative entrepreneurs”.PTI VVK SS PTI PTI
