Data safety monitoring board has not reported any safety concerns related to vaccine
Homegrown vaccine maker Bharat Biotech’s Covid-19 vaccine, Covaxin, demonstrated an overall 77.8% efficacy against the disease in the largest Covid Phase III clinical trials carried out in the country.
Covaxin has also demonstrated 65.2% protection against the Delta variant. It was 93.4% effective against severe symptomatic Covid-19 while protection against asymptomatic Covid-19 was at 63.6%.
The company announced safety and efficacy analysis data from Phase III clinical trials of Covaxin on Saturday. Covaxin was developed by BB with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune. Covaxin was well tolerated and the data safety monitoring board has not reported any safety concerns related to the vaccine. The overall rate of adverse events in Covaxin was lower than that seen in other Covid-19 vaccines with less than 0.5% of the subjects experiencing serious adverse events. Bharat Biotech has so far not sought indemnity for Covaxin from the government.
Krishna Ella , CMD, Bharat Biotech, said this was the largest clinical trial done in the developing world world and was next only to the US and UK with 25,800 subjects, 26 sites and one lakh RTPCR used on volunteers with a staff of 1,129. The 93% efficacy against severe disease resulted in reduction of hospitalisation, and in case of asmyptomatic Covid-19 disease, it limited infection and transmission, Ella said.
Balram Bhargava, secretary, department of health research, and director general, ICMR, said Covaxin worked well against all variant strains of SARS-CoV-2 (Delta, Kappa, Alpha, Beta, Zeta and Gamma). Bhargava said they had delivered a vaccine of the highest international standards that would not only benefit Indians but also protect the global community against the deadly virus. The making of this vaccine entirely on Indian soil was a matter of great pride to every Indian, Priya Abraham, director, NIV, said.
Suchitra Ella, joint managing director, Bharat Biotech, highlighted the fact that they worked through the pandemic, lockdowns, unprecedented number of physical challenges, stress and continuous operations to complete the clinical trials in a year. Bharat Biotech is now conducting additional clinical trials to establish safety and efficacy in children in the 2-18 year age group. A clinical trial to determine the safety and immunogenicity of a booster dose is also in process.
Covaxin has received emergency use authorisations in 16 countries and is in discussions with WHO to obtain emergency use listing.
BB expects to have capacity to make one billion doses by end of 2021. The country has till date administered 4.20 crore doses of Covaxin.