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As per the safety and efficacy analysis of data from the phase three clinical trials, Covaxin is `77.8 per cent effective’ against symptomatic Covid-19, according to Bharat Biotech.
The Hyderabad-based vaccine maker has concluded final analysis for Covaxin from phase three clinical trials and announced the data on Saturday.
Efficacy analysis `demonstrated’ Covaxin to be 77.8% effective against symptomatic Covid-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. It was 93.4 per cent ‘effective’ against severe symptomatic Covid and gave 63.6 per cent protection against asymptomatic Covid, the company said.
“Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant,’’ it added.
“The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever Covid vaccine trials in India establishes the ability of India and developing world countries to focus towards innovation,’’ Krishna Ella, Chairman & Managing Director, Bharat Biotech said in a release.
Balram Bhargava, Secretary Department of Health Research & Director General Indian Council of Medical Research, 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% in India’s largest Covid phase three clinical trial thus far.”
“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,’’ he said adding that the vaccine “works well against all variant strains of SARS-CoV-2.”
Safety
The safety analysis demonstrates adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events.
The vaccine was “well tolerated and the Data Safety Monitoring Board has not reported any safety concerns,” the company said, adding that the overall rate of adverse events observed in Covaxin was “lower than that seen in other Covid-19 vaccines.”
“The safety profile of Covaxin is now well established based on inactivated vaccines technology, and in large part due to the extensive 20-year safety track record of Bharat Biotech’s vero cell manufacturing platform Furthermore, Bharat Biotech has so far not sought indemnity for Covaxin from the governments,” the company said
Bharat Biotech is now continuing with additional clinical trials of Covaxin to establish safety and efficacy in children between 2-18 years of age. A clinical trial to determine the safety and immunogenicity of a booster dose is also in process. Several research activities are being carried out to study variants of concern and to assess their suitability for follow up booster doses, the release added.
Bharat Biotech has established Covaxin manufacturing at four facilities within India, further expansions are in process to reach an annualized capacity of one billion doses by the end of 2021. Technology transfer activities are in progress to companies in the United States, and other countries.
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