Hyderabad-based Bharat Biotech has claimed that India's first indigenous COVID-19 vaccine, COVAXIN has demonstrated 77.8 per cent effectiveness against SARS-CoV-2.
The data from the phase-3 clinical trial of COVAXIN that was released on Saturday also showed that Covaxin has an efficacy of 65.2 per cent against the B.1.617.2 Delta variant.
It also noted that the vaccine provides 93.4% effective against severe symptomatic COVID-19.
"Efficacy analysis demonstrates Covaxin to be 77.8 per cent effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. Efficacy analysis demonstrates Covaxin to be 93.4 per cent effective against severe symptomatic COVID-19," the company said.
As per the company, 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 per cent of subjects feeling serious adverse events.
"Efficacy data demonstrates 63.6 per cent protection against asymptomatic COVID-19. Efficacy data demonstrates 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant", Bharat Biotech said.
Hyderabad-based vaccine manufacturer claimed Covaxin was well tolerated and the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine, adding, "The overall rate of adverse events observed in Covaxin was lower than that seen in other COVID-19 vaccines. Bharat Biotech has so far not sought indemnity for Covaxin from the governments."
"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 global populations," said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.
Bharat Biotech also added that its commitment to continuous improvement of Covaxin is well underway with 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. Several research activities are being carried out to study variants of concern and to assess their suitability for follow up booster doses", the company said.?
It claims Covaxin has been evaluated through neutralising antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma).?
The vaccine was co-developed by ICMR and Bharat Biotech.
Director General of ICMR, Balram Bhargava 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 per cent in India's largest COVID phase 3 clinical trial thus far.
Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of highest international standards."
He further said 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.