Phase 3 trial data shows Covaxin to be 77.8% effective against Covid-19
Efficacy data also demonstrates 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant, the company said in a statement while announcing its phase 3 data analysis.
Hyderabad: Bharat Biotech’s phase 3 efficacy analysis demonstrates Covaxin to be 77.8 per cent effective against while it is 93.4 per cent effective against severe symptomatic Covid-19.
Efficacy data also demonstrates 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant, the company said in a statement while announcing its phase 3 data analysis.
The phase 3 clinical trials of Covaxin, a whole virion inactivated vaccine against SARS-CoV2, developed in partnership with ICMR and NIV Pune, was an event driven analysis of 130 symptomatic Covid-19 cases, reported at least two weeks after the second dose, conducted at 25 sites across India.
Safety profile
Safety analysis demonstrates that adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects feeling serious adverse events.
Covaxin was well tolerated, and the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine, the company said.
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.
Asymptomatic cases
The company’s data further shows 63.6 per cent protection against asymptomatic Covid-19.
Bharat Biotech said that no licensed SARS-CoV-2 vaccine has reported efficacy against asymptomatic infection in a randomised controlled trial, based on qPCR testing. Covaxin is the first to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing disease transmission.
Largest trial
Dr Krishna Ella, CMD, Bharat Biotech, said, “The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever Covid vaccines trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development.”
Professor (Dr) Balram Bhargava, secretary, Department of Health Research & director general, Indian Council of Medical Research, said, Covaxin, developed by ICMR and BBIL under an effective public private partnership, has demonstrated an overall efficacy of 77.8 per cent in India’s largest Covid phase 3 clinical trial thus far.
National Institute of Virology (ICMR) director professor (Dr) Priya Abraham, said, “Sera from Covaxin recipients have also been evaluated against viral variants detected in India i.e., the Alpha, Beta, Zeta, Kappa and Delta.”
Booster doses
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.
Bharat Biotech said additional clinical trials to establish safety and efficacy in children between 2 and 18 years of age are also under way.
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