Bharat Biotech's Covaxin shows 78% efficacy in phase-3 interim analysis
Premium- The efficacy against severe covid-19 disease was 100%, with an impact on reduction in hospitalizations, the Hyderabad-based company said
NEW DELHI : New Delhi:Bharat Biotech’s covid-19 vaccine—Covaxin—demonstrated 78% efficacy in its phase-3 interim analysis results, the company announced on Wednesday.
The efficacy against severe covid-19 disease was 100%, with an impact on reduction in hospitalizations, the Hyderabad-based company said and added that the efficacy against asymptomatic covid-19 infection was 70%, suggesting decreased transmission in Covaxin recipients.
TRENDING STORIESSee All
Premium Complete lockdown in Maharashtra: CM Uddhav Thackeray to take a final call today
1 min read . 11:06 AM IST
Premium Air India flights to and from the UK cancelled between 24th to 30th April
1 min read . 11:23 AM IST
Covaxin showed 81% efficacy in an early analysis of phase 3 trial data released earlier in March.
The second interim analysis is based on accruing more than 87 symptomatic cases of covid-19. Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% against mild, moderate, and severe covid-19 disease, the company said in a statement.
Safety and efficacy results from the final analysis will be available in June, and the final 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 between 18 and 98 years of age, including 10% over the age of 60, with analysis conducted 14 days post second dose. “Efficacy against SARS-CoV-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in emergency use. Covaxin is now a global innovator vaccine derived from research and development from India. The efficacy data against severe covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalization and disease transmission, respectively," Dr Krishna Ella, chairman and managing director, Bharat Biotech, said.
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), making it a true public-private partnership towards public health.
“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," Dr Balram Bhargava, secretary, department of health research and director general, ICMR, said.
MORE FROM THIS SECTIONSee All
Premium Premium Tablet for Covid? Trial gets delayed as cases plummet in UK
1 min read . 04:14 PM IST
Premium Premium Second wave of covid-19 may peak in May, say IIT Kanpur scientists
3 min read . 03:51 PM ISTSeveral 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 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 globally 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 globally have expressed interest in Covaxin. These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity across the whole 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. The capacity expansion has been implemented across multiple facilities in Hyderabad and Bengaluru to reach 700 million doses per year, one of the largest production capacities for inactivated viral vaccines worldwide.
Click here to read the Mint ePaperMint is now on Telegram. Join Mint channel in your Telegram and stay updated with the latest business news.