Covaxin is showing an overall efficiency of 77.8% against Covid-19 and is 93.4% effective in severe cases of infection, said Bharat Biotech on Saturday, revealing the final Phase-3 trial results of the vaccine's safety and efficacy.
The indigenous Covid-19 vaccine is offering 63.6% security in asymptomatic cases, and is also demonstrating 65.2% protection against the Delta variant infection, the Hyderabad-based vaccine maker announced in a joint statement with Indian Council of Medical Research (ICMR) on Saturday.
“Covaxin is the first licensed SARS-CoV-2 vaccine to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing disease transmission,” Bharat Biotech said.
B.1.617.2 aka Delta, classified as a "Variant of Concern" by the World Health Organization, is reported as the coronavirus variant primarily responsible for the Covid-19 second wave in the country.
“Covaxin is working well against all variant strains of SARS-CoV-2. Covaxin's successful development has consolidated the position of Indian academia and industry in the global arena,” said Prof Balram Bhargava, Secretary, Department of Health Research & Director General, ICMR.
The much awaited Phase-3 clinical trial results were revealed exactly six months after the vaccine developed in public-private partnership was accorded the emergency use authorization by the Drugs Controller General of India on 3 January.
However, the results based on the event driven analysis of 130 symptomatic Covid-19 cases, reported at least two weeks after the 2nd dose, are yet to be peer reviewed. The study outcomes are published on preprint server MedRxiv.
Phase-3 trials of Covaxin were conducted between November 2020 and February 2021, on 25,800 volunteers across the country, in what Bharat Biotech claimed is “the largest Phase-3 efficacy trial ever conducted for any vaccine in India.”
Around 12 percent of the 34 crore Covid-19 vaccine doses administered in the country till now are Covaxin and the rest are Oxford-AstraZeneca developed and Serum Institute of India, Pune manufactured Covishield. Russian made Sputnik V, the third vaccine approved in India in April, is yet to be made available commercially.
The efficacy of Covishield was pegged at 70.42 % by the DCGI, while Sputnik V, as per an article in The Lancet, was found to be displaying 91.6 percent efficacy against Covid-19 infection.
Bharat Biotech said the overall rate of adverse events observed with Covaxin was lower than evident in other Covid-19 vaccines. “Safety analysis demonstrates adverse events reported were similar to placebo, with 12 % of subjects experiencing commonly known side effects and less than 0.5 % of subjects feeling serious adverse events”
In the second interim analysis from Phase-3 trials put out in April, Bharat Biotech and ICMR stated that Covaxin was showing overall clinical efficacy of 78 percent and 100 percent efficacy against severe Covid-19 infections.
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