Covaxin, India's first indigenous vaccine against Covid-19, showed enhanced immune response without any serious side effects in the participants of phase one trial, according to results published in reputed medical journal "The Lancet Infectious Diseases" yesterday.
The study published in The Lancet assumes significance in the backdrop of reports that Bharat Biotech has sought Bangladesh's permission to conduct human trial in the country for its vaccine, reports our New Delhi correspondent.
The vaccine, codenamed "BBV152", was "well tolerated in all dose groups with no vaccine-related serious adverse events", noted the authors of The Lancet study funded by Bharat Biotech.
The same results were earlier published in the preprint server medRxiv in December.
"BBV152 led to tolerable safety outcomes and enhanced immune responses. The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events," The Lancet study said, adding the most common adverse event was pain at the injection site, followed by headache, fatigue, and fever.
Bharat Biotech Joint Managing Director Suchitra Ellia tweeted that the publication of the study in The Lancet was "an international validation of Indian innovation".
She also announced that 13,000 volunteers out of 25,800 have so far been successfully given the second dose of the vaccine in phase three human trial.
The Indian drug controller's clearance given to Covaxin which is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) in Pune, even before human trial phase was over, had raised concerns among some experts who questioned its efficacy. The most important criticism was that none of its data was made public when it was given the clearance for emergency use.
India's weeklong vaccination programme since its start on January 16 has so far used Covishield developed by Oxford University and Swedish pharma firm AstraZeneca and Covaxin with the former featuring in a major part of the inoculation drive.
India has so far vaccinated more than 12.7 lakh people against Covid-19 till 6pm local time yesterday. India aims to inoculate three crore healthcare and frontline workers in the first phase of the vaccination campaign.