Covaxin can neutralise double mutant variant

Bharat Biotech’s indigenously developed Covid-19 vaccine Covaxin “effectively neutralises” the double mutant variant of the coronavirus detected in the latest wave of the pandemic, said the Indian Council of Medical Research (ICMR).

Phase 3 clinical trials of Covaxin by Bharat Biotech International Ltd (BBIL) and ICMR have demonstrated 100% efficacy against severe Covid-19 disease. Apart from demonstrating an overall interim clinical efficacy of 78% in the second interim analysis, Covaxin has also worked well against most variants of Covid-19, BBIL and ICMR said in a joint statement on Wednesday.

“The tireless efforts of our scientists at ICMR and BBIL have resulted in a truly effective international vaccine of the highest standards and efficacy,” said ICMR director general Balram Bhargava, also secretary, department of health research.


Excellent Safety Record: Krishna Ella
“I am also happy to note that Covaxin works well against most variants of SARS-CoV-2,” he added.

Earlier on Wednesday, ICMR had tweeted: “ICMR study shows #COVAXIN neutralises against multiple variants of SARS-CoV-2 and effectively neutralises the double mutant strain as well… ICMR-NIV has recently been successful in isolating and culturing the double mutant strain B.1.617 SARS-CoV-2 identified in certain regions of India and several other countries.”

The vaccine was approved and introduced initially through emergency use authorisation under the clinical trial mode when India launched its public immunisation programme in January.

The phase 3 study enrolled 25,800 participants of 18-98, including 10% over the age of 60, with analysis conducted 14 days after the second dose.

Covaxin was developed with seed strains received from the National Institute of Virology (NIV) and the phase 3 clinical trial was cofunded by ICMR.

“Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use,” said Krishna Ella, chairman and managing director, Bharat Biotech. “The efficacy data against severe Covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalisations and disease transmission, respectively.”

Bharat Biotech said the second interim analysis of phase 3 trials was based on accruing more than 87 symptomatic cases of Covid-19. Due to the recent surge in cases, 127 symptomatic cases were also recorded, resulting in a point estimate of vaccine efficacy of 78% against mild, moderate and severe Covid-19 disease.

“The efficacy against severe Covid-19 disease was 100%, with an impact on reduction in hospitalisations. The efficacy against asymptomatic Covid-19 infection was 70%, suggesting decreased transmission in Covaxin recipients,” said Bharat Biotech.

The Hyderabad-headquartered vaccine maker said 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. Further, the vaccine maker said, based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of Covaxin.

Bharat Biotech said several million doses of Covaxin had been supplied and administered in India and many other countries with an excellent safety record, evident by the minimal or lack of post-immunisation adverse events.

The vaccine maker said its 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.

So far more than 60 countries have evinced interest in Covaxin and some have given it emergency use authorisation, said Bharat Biotech. These include Mexico, the Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among others. EUAs are in process in the US and several European countries, it said.