New Delhi: Bharat Biotech said its Covaxin shot against Covid-19 has shown a “vaccine efficacy of 78 per cent against mild, moderate, and severe COVID-19 disease”, as it announced the results of its second interim analysis of the phase 3 clinical trial data.
“The efficacy against severe COVID-19 disease was 100%, with an impact on reduction in hospitalizations. The efficacy against asymptomatic COVID-19 infection was 70%, suggesting decreased transmission in Covaxin recipients,” the company said in a statement released Wednesday.
Covaxin was developed by the Hyderabad-based company in collaboration with the Indian Council of Medical Research (ICMR), the country’s nodal agency for medical research. It is one of two vaccines that have been deployed by Modi government in the national vaccination drive.
The final safety and efficacy results of the study, which enrolled 25,800 participants last year, will be available in June 2021 and sent to a peer-reviewed journal for publication, said the company.
“Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of Covaxin,” read the statement, which added the analysis had been “conducted 14 days post 2nd dose.”
Covaxin is made up of a whole virus that has been inactivated in order to expose the body to the virus but not its virulence.
‘Works well against variants’
ICMR chief Balram Bhargava said the “tireless efforts” of scientists at ICMR and Bharat Biotech resulted in a “truly effective international vaccine of the highest standards and efficacy”.
“I am also happy to note that Covaxin works well against most variants of SARS-CoV-2. These findings together consolidate the position of our indigenous vaccine in the global vaccine landscape,” he added in the statement.
However, data on the vaccine’s efficacy against various strains is yet to be released.
The announcement follows the results of the first interim analysis conducted in March 2021. The first interim analysis revealed an efficacy of 81 per cent, after 43 symptomatic cases were registered. Of the 43, 36 were in the placebo group while seven had been administered Covaxin.
The second interim analysis was conducted when “more than 87 symptomatic cases of Covid-19”, were found.
(Edited by Manasa Mohan)
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