India made Covaxin 77.8% effective after Phase 3 trials
Covaxin also offers 65.2 percent protection against the rapidly emerging Delta variant, claims Bharat Biotech
Bharat Biotech's Covaxin is overall 77.8 percent effective against Covid, the vaccine maker said on Saturday in a statement, citing the data from the third phase of clinical trials.
In a statement, the vaccine maker said, "Efficacy analysis demonstrates Covaxin to be 77.8 percent effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group."
According to the statement, the vaccine offers 65.2 percent protection against the rapidly emerging Delta variant. It was also found to be "93.4 percent effective" against severe symptomatic COVID-19 and 63.6% effective against asymptomatic COVID-19, the company said.
Covaxin is a whole virus inactivated vaccine against SARS-CoV2, developed by Bharat Biotech in partnership with ICMR and NIV Pune.
The Phase 3 clinical trial was an event-driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India.
Twelve percent of the subjects experienced commonly known side effects and less than 0.5 per cent of subjects reported serious adverse events, Bharat Biotech said, adding that the overall rate of adverse events 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.
Chairman and Managing Director, Bharat Biotech, Krishna Ella 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. We are proud to state that Innovation from India will now be available to protect the global population."
"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," Prof. Balram Bhargava, Secretary Department of Health Research & Director General Indian Council of Medical Research, said.
Director National Institute of Virology ICMR Prof. Priya Abraham 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. 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 to every Indian”
Joint Managing Director, Bharat Biotech Suchitra Ella said, “It is a momentous day for everyone, at Bharat Biotech, as we announce the Final Phase-3 Results of COVAXIN® and its efficacy of 77.8%. We wish to thank ICMR, NIV-Pune, Virovax, DSMB and the Adjudication Committee."
Covaxin has received emergency use authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico.
The company is in discussions with WHO to obtain an emergency use listing for Covaxin. The product has been exported to several countries with additional requests for supplies being received.
Bharat Biotech is also undertaking additional clinical trials 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.