Bharat Biotech announced today that the Phase 3 trials of its COVID-19 vaccine known as Covaxin, India’s indigenous vaccine, demonstrated an almost 81% efficacy rate. The Phase 3 trials, made up of 25,800 subjects, were the largest ever clinical trials conducted in India in partnership with the Indian Council of Medical Research.
The data from the Phase 3 trials reveals that vaccines and placebos were given to the subjects in a 1:1 ratio and that the vaccine was well tolerated by the subjects receiving it, the company said. “Trials will continue to the final analysis of 130 confirmed cases in order to gather more data and evaluate the efficacy of the vaccine”, the company further added.
“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants,” Bharat Biotech head Krishna Ella said.
The efficacy rate of the vaccine was determined through a first interim analysis of 43 cases of COVID-19. 36 of these cases belonged to the placebo group of the vaccine trial, meaning that out of the individuals given the vaccine, 7 contracted COVID-19, resulting in the estimate of 80.6% efficacy rate. Covaxin is one of the two vaccines approved by the Indian Government to be included in the Government vaccination drive, of which the first phase commenced on 16th January. However, Covaxin is India’s only indigenous COVID-19 vaccine.
A National Institute of Virology analysis claims that the Covaxin can potentially neutralize more effective and virulent strains of COVID-19 like the U.K. Strain. “Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralise the UK variant strains and other heterologous strains”, the company stated.
“Bharat Biotech expects to share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. 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 company statement read.
Bharat Biotech expects to supply its Covaxin to other countries, with at least 40 countries expressing interest in it. Recently, Bharat Biotech confirmed that the company has signed an agreement with Brazil for the supply of 20 million doses of Covaxin.