Bharat Biotech, on January 2, welcomed the Drug Controller General of India's (DCGI) decision to grant restricted emergency use approval to its Covid-19 vaccine Covaxin. The company claimed that the vaccine has generated excellent safety data with robust immune responses even against mutants of SARS-CoV-2 virus.
“The approval of Covaxin for emergency use is a giant leap for innovation and novel product development in India. 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," Krishna Ella, the Chairman and Managing Director said.
"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," Ella added.
Bharat Biotech said 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.
"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 company said.
The Phase III human clinical trials of Coaxin began mid-November, targeted to be done in 25,800 volunteers across India, in what is considered to be India’s largest Phase III efficacy study for a COVID-19 vaccine. The company said it has completed dosing of 22,500 volunteers.
Bharat Biotech said 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 product development and clinical trial data thus far has 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. As a part of our regulatory guidelines, all data has been submitted to the DCGI and CDSCO," the company said.
Meanwhile, the Indian Council of Medical Research (ICMR) has also said that Bharat Biotech's Covaxin has advantages over other vaccines when it comes to preventing UK coronavirus strain infections.Follow our coverage of the coronavirus crisis hereICMR and @BharatBiotech collaborative a Whole Virion Inactivated Corona Virus Vaccine (#COVAXIN) is being approved for restricted use in emergency by DCGI. @MoHFW_INDIA @drharshvardhan @AshwiniKChoubey @PIB_India #ICMRFIGHTSCOVID19 #IndiaFightsCOVID19 #Unite2FightCorona pic.twitter.com/wDhAfdfdC3
— ICMR (@ICMRDELHI) January 3, 2021