Bharat Biotech on Saturday released the results from the Phase 3 trials of Covaxin, claiming it demonstrated overall vaccine efficacy of 77.8 per cent against the coronavirus. The vaccine is 65.2 per cent effective against the Delta variant. The Hyderabad-based multinational biotechnology company shared the final Phase-3 data published on medRxiv, saying Covaxin has been proven ‘safe’ in India’s largest efficacy trial.
The Covaxin Phase-3 analysis, published on the medRxiv pre-print server, was reportedly conducted across 25 hospitals in India as trial sites. The large-scale final analysis deployed a double-blind, randomised, multi-center clinical trial, using a sponsor-supplied randomisation scheme where volunteers received two intramuscular doses of either the Covid-19 vaccine or a placebo — four weeks apart. It consisted of 25,800 volunteers from the age group of 18 to 98 years, the report said. Elaborating on its findings from the efficacy analysis, Bharat Biotech added that Covaxin also demonstrates 93.4% effectiveness against severe symptomatic Covid-19 cases. On the other hand, Covaxin provides 65.2% protection against the B.1.617.2 (Delta) strain, currently the most predominant Covid-19 variant in India, it said.
The vaccine was approved for emergency use in the Indian population in January, and the Hyderabad-based company had then said it would release phase III data by March. The release was since pushed back on several occasions.
