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NEW DELHI : Bharat Biotech’s Covaxin has a 78% efficacy rate against the coronavirus, according to an early analysis of phase 3 clinical trials. But more importantly, the covid-19 vaccine was found to be effective against some of the fast-spreading variants that are infecting millions of Indians.

The effectiveness of the vaccine against severe covid disease was 100%, the Hyderabad-based company claimed, suggesting that people receiving the vaccine will not develop severe symptoms or require hospitalization.

Covaxin showed 81% efficacy during a previous analysis of phase 3 trial data released in early March. The second interim analysis is based on results from 87 symptomatic cases of covid-19, the company said in a statement.

Safety and efficacy results from the final analysis will be available in June, and the report will be submitted to a peer-reviewed publication. Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of Covaxin.

The phase 3 study enrolled 25,800 participants in the age group of 18-98 years. Around 10% of the subjects were older than 60. The analysis was conducted 14 days after the second dose was administered. “Efficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in emergency use. The efficacy data against severe covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalizations and disease transmission, respectively," said Dr Krishna Ella, chairman and managing director, Bharat Biotech.

Covaxin was developed with seed strains received from the National Institute of Virology (NIV), and the phase 3 clinical trial was co-funded by the Indian Council of Medical Research (ICMR).

“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," said Dr Balram Bhargava, secretary, department of health research, and director-general, ICMR.

Several million doses of Covaxin have been supplied and administered in India and several other countries, with an excellent safety record, evident by the minimal or lack of adverse events post-immunization. Covaxin was approved and introduced initially through an emergency use authorization under the clinical trial mode, resulting in robust safety data in real-life conditions.

The company’s efforts to further develop Covaxin continues, with clinical trials planned in India and outside to evaluate its safety and immunogenicity in younger age groups, the impact of booster doses, and protection against SARS-CoV-2 variants, Bharat Biotech said.

More than 60 countries have expressed interest in Covaxin and were highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity across the entire SARS-CoV-2 virus. Emergency use authorizations have been received from several countries. The company’s development efforts have been published in six peer-reviewed journals, with additional publications in process.

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