Pharmaceutical company Bharat Biotech’s coronavirus vaccine Covaxin has shown 81% efficacy in the third phase of trials, the Union health ministry said in a release on Wednesday. The company said that the trials involved 25,800 subjects and claimed that it was the largest ever trial conducted in India, ANI reported.
“The interim efficacy trend of 81%, analysed as per the protocol approved by the DCGI [Drug Controller General of India], puts it at par with other global front-runner vaccines,” the health ministry said.
However, clinical trials will continue to gather more data, Bharat Biotech has said, according to NDTV. The trial results have not been made public yet.
“Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of Covaxin in additional secondary study endpoints,” the company said in a statement.
The company also said analysis from the National Institute of Virology indicated that antibodies induced by the vaccine “can neutralise the UK [United Kingdom] variant strains and other heterologous strains”, NDTV reported.
The participants included 2,433 people over the age of 60 and 4,533 with co-morbidities, according to NDTV. They were then divided into two groups, one that got the vaccine and another that was administered a placebo shot. A total of 43 people were found to have coronavirus, seven of whom were given the Covaxin shot, NDTV reported.
The first interim analysis was based on these 43 cases, the company said in its release. “An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases,” the company said. “All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication.”
The data, however, is yet to be peer-reviewed.
Meanwhile, the Indian Council of Medical Research on Wednesday said that the results were evaluated by an independent data safety and monitoring board, and showed that Covaxin was “well-tolerated and efficacious” against coronavirus across a wide range of age groups and variants in the country, ANI reported.
Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology in Pune, the vaccine was granted emergency use authorisation along with Serum Institute of India’s Covishield ahead of India’s countrywide vaccination programme that started on January 16.
However, it raised concerns among experts as the Central Drugs and Standards Committee approved it for use before completing the third phase human trials. Health authorities, including ICMR chief Balram Bhargava and Union Health Minister Harsh Vardhan, have repeatedly said the shot is “safe and immunogenic”.
In January, preliminary data of its Phase 1 trials published in The Lancet journal showed that the vaccine was well tolerated and induced enhanced immune response with neutralising antibodies among participants.
India began the second phase of its coronavirus vaccination drive on March 1. In this phase, people above 60 years of age, and those who are 45 or more and suffering from comorbidities, are now eligible for the vaccinations. This is free at government facilities, while private centres are offering it at a capped price of Rs 250 per dose.
Meanwhile, India on Wednesday reported 14,989 coronavirus cases, taking the country’s tally to 1,11,39,516, data from the health ministry showed. Deaths jumped by 98 to 1,57,346. India’s active case count stood at 1,70,126, while 1,08,12,044 people have recovered from the infection.