The emergency use approval for Covaxin is "a giant leap for innovation and novel product development" in India and the "goal is to provide global access to populations that need it the most", Bharat Biotech chairman and managing director Dr Krishna Ella has said.
In a release issued after DCGI nod to the indigenous COVID-19 vaccine Covaxin for restricted use in emergency situations on Sunday, Dr Ella said it is 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 added.
Dr Ella said that the development of Covaxin is a public-private partnership between Indian Council of Medical Research (ICMR) ICMR, Pune's National Institute of Virology (NIV), and Bharat Biotech. He thanked ICMR Director-General Dr Balram Bhargava for his "visionary leadership" in the project.
The company said 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".
"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," the release said.
The company said that 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."
"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 release said.
It said that 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.
The release said that publication of phase II trial data is undergoing the peer review process, and as part of the company's regulatory guidelines, all data has been submitted to the DCGI and Central Drugs Standards Control Orgzation (CDSCO).
( With inputs from ANI )
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