_1594052644844_1594052732451_1614776165445.jpg "Covaxin is an indigenous, inactivated vaccine that is being developed in collaboration with ICMR’s National Institute of Virology, Pune. Photo: Twitter@BharatBiotech")
Bharat Biotech on Wednesday claimed that its Covid-19 vaccine candidate Covaxin shows "significant immunogenicity against the rapidly emerging variants" of Coronavirus.
The comments come in the backdrop of the Hyderbad-based vaccine maker's announcing that Covaxin has demonstrated an interim vaccine efficacy of 81% in Phase 3 clinical trials.
The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research, the Hyderabad-based company said in a statement.
Thirty-six of the 43 cases were recorded in participants who received a placebo, compared with seven cases in people who were given the Bharat Biotech vaccine, pointing to an efficacy rate of 80.6%, the company said.
"Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today's results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants," Bharat Biotech Chairman and Managing Director Krishna Ella said.
Covaxin demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants, Ella added.
Bharat Biotech said the interim analysis of its vaccine included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups, the company said.
The trial's conduct and monitoring are as per good clinical practice guidelines and have been outsourced to IQVIA, it added.
"Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains," Bharat Biotech said.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The findings cement Bharat Biotech’s claims of the vaccine being safe and may help overcome vaccine hesitancy as India gears up to ramp Covid-19 vaccination drive.
Covaxin is one of the two Covid-19 vaccines approved for emergency use in India for its mega vaccination drive, which started on 16 January, 2021 and is now in the next phase. The other one is Serum Institute of India's locally-made Oxford-AstraZeneca’s COVID 19 vaccine, Covishield.
Covaxin has been administered to hundreds of Indian citizens already including to Prime Minister Narendra Modi, who took the first shot on Monday marking the beginning of the second phase of vacciantions in the country for elderly citizens above 60 years of age and those above 45 years of age with comorbidities.
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