Covaxin is Effective against Mutant Strains, says ICMR

Interim analysis of Phase-3 trial shows efficacy of 78%

Bharat Biotech has said that its Covid-19 vaccine, Covaxin, is effective against mutant strains blamed for the current surge in cases in the country.

The vaccine has demonstrated an efficacy of 78 per cent against mild, moderate and severe Covid-19 disease and 100 per cent efficacy impact on reduction in hospitalisations. The data came from an interim analysis of the vaccine’s advanced Phase-3 trials.

In a tweet, the ICMR said that the vaccine was found to be effective against the Indian-origin “double mutant” strain, besides neutralising multiple variants of SARS-CoV-2.

The company pointed out that the efficacy against asymptomatic Covid-19 infection was 70 per cent, suggesting decreased transmission in Covaxin recipients.

The Hyderabad-based vaccine company said its 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.

Phase-3 trial

The Phase-3 study enrolled 25,800 participants in the 18-98 age group, including 10 per cent over the age of 60, with analysis conducted 14 days post the second dose.

Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “The efficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and under emergency use. The efficacy data against severe Covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalisations and disease transmission, respectively.”

Balram Bhargava, Director-General of ICMR, which co-funded Phase-3 trials, said, “Covaxin has shown the efficacy of 78 per cent in the second interim analysis.” Pointing out that the vaccine reflected the highest standards and efficacy, he said, “Covaxin works well against most variants of SARS-CoV-2.”

Pricing

Bharat Biotech has not revealed its pricing plans to supply the States and the open market, after the Centre recently expanded the vaccination programme.

Recently, Ella had said that he would like to get the maximum price to recover all costs, including the ₹350-crore spent on clinical trials, in order to have money to work on vaccines for all kinds of infectious diseases. Bharat Biotech had not asked the government for any money for the trials or any advance for increasing manufacturing capacity.

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

More than 60 countries have expressed interest in Covaxin. The vaccine-maker’s capacity expansion across multiple facilities in Hyderabad and Bengaluru would help achieve 700 million doses/year, one of the largest production capacities for inactivated viral vaccines worldwide, it said.