Bharat Biotech says Covaxin has shown 78% efficacy against mild to severe Covid-19 symptoms

Bharat Biotech said safety and efficacy results from the final analysis will be available in June

Covaxin has showed overall clinical efficacy of 78 per cent and 100 per cent efficacy against severe Covid-19 infections, Bharat Biotech International Limited and the Indian Council of Medical Research have together announced on Wednesday quoting the second interim analysis from Phase-3 trials.

The vaccine, part of the ongoing vaccination drive in the country, is stated by Prof Balram Bhargava, Secretary of the central government's department of health research and Director General, ICMR as “working well against most variants of SARS-CoV-2.” – the Covid-19 causing virus.

The current surge in positive cases, especially, in states like Maharashtra is believed to have been caused by variants like B.1.167 which carries double mutations.

Also Read | Covaxin neutralises double mutant strain: ICMR study

Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78 per cent against mild, moderate, and severe Covid-19 cases, BBIL and ICMR said in a joint statement on Wednesday.

“The efficacy against severe Covid-19 cases is 100 per cent, with an impact on reduction in hospitalisations. The efficacy against asymptomatic Covid-19 infection is 70 per cent, suggesting decreased transmission in Covaxin recipients.”

The testimony comes at a time when the nation is gripped under the Covid-19 second wave with about three lakh daily cases being recorded lately. The medical infrastructure is reeling under the pressure of the spiraling cases of virulent infection. Patients' woes are compounded by the shortage of drugs and oxygen.

Also Read | Bharat Biotech scales up Covaxin production to 700 million doses annually

The present estimates of Covaxin's efficacy are based on the second interim analysis from the Phase-3 trials of the indigenous vaccine conducted on 25,800 participants between 18-98 years of age, including 10 per cent over the age of 60, from November to February.

In its first interim analysis results declared in the first week of March, BBIL claimed that Covaxin was demonstrating 81 per cent efficacy in preventing Covid-19 infection. Safety and efficacy results from the final analysis will be available in June, and reports would be submitted to a peer-reviewed publication.

Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, said that the second interim analysis results have established Covaxin's efficacy against SARS-Cov-2. “Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. It is now a global innovator vaccine derived from India's Research & Development. The efficacy data against severe Covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalisations and disease transmission".

Covaxin, manufactured by Hyderabad-based BBIL, was developed with seed strains received from the ICMR's National Institute of Virology at Pune. The Phase 3 clinical trial was co-funded by ICMR, in a public, private partnership.

“The tireless efforts of scientists at ICMR and BBIL have 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,” Prof Bhargava said.

Bharat Biotech has on Tuesday said that it has “implemented capacity expansion across multiple facilities in Hyderabad and Bangalore to reach 700 million doses production annually,” without disclosing its current output. BBIL had last year pegged its Covid-19 vaccine manufacturing capacity at 200 million doses per year.