Covaxin has been found to be 77.8% effective against symptomatic Covid-19 infections, Bharat Biotech said on Saturday as it announced the safety and efficacy analysis data from Phase III clinical trials of its vaccine developed in partnership with Indian Council of Medical Research and Pune’s National Institute of Virology (ICMR-NIV).
Besides, the vaccine has shown higher efficacy — of 93.4% — against severe Covid, researchers at ICMR-NIV said. The efficacy, safety and immunogenicity of Covaxin (BBV152) were assessed in a study carried out in 25 centres across the country.
According to data published on preprint server medRxiv, the trial — said to be India’s largest Covid phase 3 clinical trial so far — was conducted between November 16, 2020 and Jan 7, 2021 among 25,798 participants who were randomised to BBV152 or placebo groups; 24,419 received two doses of BBV152 or placebo in an interval of four weeks.
The data showed 130 cases of symptomatic infections in a case-driven analysis of 16,973 participants, who were followed up with two weeks after the second dose. Of these 130 cases, 24 infections occurred in the vaccine group and 106 among placebo recipients, resulting in an overall vaccine efficacy of 77.8 per cent.
Researchers said a higher efficacy against severe Covid-19 indicates that cases, which require hospitalisation and have threatened to overwhelm healthcare facilities, will be markedly decreased among fully vaccinated populations.
Researchers also obtained consent to test the vaccine against the variants of concern that had emerged while the clinical trial was underway. A total of 79 variants were reported from 16,973 samples, 18 in the vaccine and 61 in the placebo group. Among 50 Delta (B.1.617.2) positive cases, 13 and 37 participants were in the vaccine and placebo arms respectively, resulting in vaccine efficacy of 65.2%. Efficacy against the Kappa (B.1.617.1) variant was 90.1%.
“The safety profile of COVAXIN is now well established based on inactivated vaccine technology, and in large part due to the extensive 20-year safety track record of Bharat Biotech’s vero cell manufacturing platform,” Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech International Limited (BBIL), said in a statement issued on Saturday.
“The successful safety and efficacy readouts of COVAXIN…establish the ability of India and developing-world countries to focus towards innovation and novel product development. We are proud to state that innovation from India will now be available to protect global populations,” he said.
Professor (Dr) Balram Bhargava, Secretary, Department of Health Research, and Director General of ICMR, said: “I am delighted to note that COVAXIN, developed by ICMR and BBIL under an effective public private partnership, has demonstrated an overall efficacy of 77.8%…Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of highest international standards. COVAXIN will not only benefit the Indian citizens but would also immensely contribute to protect the global community against the deadly SARS-CoV-2 virus. I am also pleased to see that COVAXIN® works well against all variant strains of SARS-CoV-2. The successful development of COVAXIN has consolidated the position of Indian academia and industry in the global arena.”
Professor (Dr) Priya Abraham, Director, National Institute of Virology, said, “The overall efficacy of 77.8% following the phase III clinical trial of COVAXIN® is wonderful news. ICMR-NIV and BBIL have had very fruitful interactions during this exhilarating journey.”
Dr Pragya Yadav, NIV senior scientist and one of the researchers, said, “Sera from COVAXIN recipients have also been evaluated against viral variants detected in India i.e., the Alpha, Beta, Zeta, Kappa and Delta.”
The making of this vaccine entirely on Indian soil is a matter of great pride for every Indian, said Abraham.
Covaxin has received emergency use authorization (EUA) in 16 countries so far, with EUAs in process in 50 countries. The company is also in discussions with the World Health Organization (WHO) to obtain Emergency Use Listing for Covaxin.
Bharat Biotech has established Covaxin manufacturing facilities at four places in India and is eyeing further expansion to reach an annual capacity of 1 billion doses by the end of 2021.
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