Tribune News Service
New Delhi, January 3
Chairman and Managing Director of Bharat Biotech Dr Krishna Ella on Sunday said the approval of COVAXIN for emergency use is a giant leap for innovation and novel product development in India.
Chief of ICMR, collaborators in COVAXIN Balram Bhargava called January 3 a “red-letter day” for Indian science and a great moment for low and middle-income nations as India readies to supply the first indigenous COVID vaccine at home and abroad.
Commenting on concerns over efficacy data for COVAXIN which is yet to undergo phase 3 trials Bhargava said: “safety has been established in interim phase 3 analysis and nearly 22,000 participants have been given the vaccine in phase 3.”
On lack of efficacy data for COVAXIN, Bhargava said: “trials are ongoing.”
Bharat Biotech called the day 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,” Ella said.
The development of COVAXIN is a public-private partnership between ICMR, NIV Pune and Bharat Biotech.
COVAXIN, the government said, showed safety, immunogenicity and efficacy in phase 2 data and safety in phase 3 data and would be specifically used for emergencies arising from UK mutant strain.
Being tested, highly purified, 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, COVAXIN platform safety is known from the past as against other COVID vaccine platforms that are newer.
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.
COVAXIN has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals.
This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world.
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 neutralizing capability with heterologous SARS-CoV2 strains, thus potentially reducing or eliminating escape mutants, the company 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.
The product development and clinical trial data thus far have generated 5 publications, which have been submitted to international peer-reviewed journals, 4 of which have been accepted and will be published soon.
The publication of phase II trial data is undergoing the peer review process.