Hyderabad-based Bharat Biotech said in a statement on Friday that it has completed the final Phase-3 analysis for Covaxin. Citing pre-print data from “India’s largest efficacy trial”, the manufacturer claimed that an overall efficacy of 77.8% against Covid-19 patients has been found in Covaxin.
The data, however, is yet to be peer-reviewed.
Elaborating 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 variant in India, it said.
COVAXIN® Proven SAFE in India’s Largest Efficacy Trial. Final Phase-3 Pre-Print Data Published on https://t.co/JJh9n3aB6V pic.twitter.com/AhnEg56vFN
— BharatBiotech (@BharatBiotech) July 2, 2021
Against asymptomatic Covid-19 patients, Covaxin provides an efficacy of 63.6%, Bharat Biotech said at the conclusion of its Phase-3 efficacy trial.
The third phase of the trial was reportedly conducted across 25 hospitals in India as trial sites. The large-scale final analysis deployed a double-blind, randomised, multi-centre 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 25,798 volunteers from the age group of 18 to 98 years, the report 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.
Earlier, Bharat Biotech’s US partner Ocugen had reported similar findings regarding Covaxin, adding that adverse events reported in the study were low. Only 12.4% of the subjects experienced commonly known side-effects, it said. Both adverse events and severe adverse events reported in the vaccine group were found at similar rates to the placebo group, the company added.