Hyderabad-based Bharat Biotech on Friday said that it has completed the final Phase-3 analysis for Covaxin, its indigenous vaccine against the coronavirus disease (Covid-19). Citing pre-print data from “India’s largest efficacy trial”, the pharmaceutical claimed that an overall efficacy of 77.8% against symptomatic Covid-19 patients has been found in Covaxin.
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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.
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Against asymptomatic Covid-19 patients, Covaxin provides an efficacy of 63.6%, Bharat Biotech said at the conclusion of its Phase-3 efficacy trial.
Here are the overall efficacy rates of Covaxin in a gist, as claimed by Bharat Biotech in its pre-print analysis.
Asymptomatic cases: 63% Covaxin efficacy
Mild, moderate, and severe cases: 78% Covaxin efficacy
Delta variant: 65% Covaxin efficacy
Severe Covid-19 cases: 93% Covaxin efficacy
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.
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. It had earlier shared the data with Indian drug regulators, however, the data regarding the multiple analyses had not been released until now.
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.
Covaxin, along with the Oxford University-Astrazeneca shot, has been used since the beginning of India’s nationwide vaccine drive against the viral disease on January 16. Russia’s Sputnik V was given emergency use authorisation (EUA) in April, while US pharmaceutical firm Moderna’s mRNA-based vaccine on Tuesday received approval to be used here.