Bharat Biotech became the first Indian vaccine maker to have peer-reviewed data for its shots, after results from the company’s phase 1 trial to assess the safety and immunogenicity of Covaxin was published in The Lancet medical journal on Thursday.
Bharat Biotech’s Covaxin vaccine, which has been authorized for emergency use in the country to fight the Covid-19 pandemic, proved safe and produced an immune response in a small group of adults aged 18 to 55, The Lancet report said.
“BBV152 (Covaxin) led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted," the results said.
The vaccine, developed in collaboration with the Indian Council of Medical Research (ICMR), is currently undergoing bigger group of 25,800 persons trial, since November. Bharat Biotech said on Friday 13,000 people participating in the late-stage trial had been given the second dose.
Brazil, which has reported the highest number of deaths due to Covid-19 after the US, has also placed an order for the vaccine.
Covaxin is an inactivated vaccine that introduces dead virus into the body to trigger an immune response.
This is the first peer reviewed data for the vaccine that has come under criticism over the lack of transparency on the approval process for the shot.
The vaccine was granted emergency approval by the drugs controller general of India this month along with another vaccine, Covishield, developed by AstraZeneca and Oxford University.
