Covaxin shots show 78% interim efficacy, 100% in severe cases, say Bharat & ICMR

VAX SHOWS EFFICACY, CAN REDUCE INFECTION

Covaxin shots show 78% interim efficacy, 100% in severe cases, say Bharat & ICMR

Hyderabad:22.04.2021

Indigenous Covid-19 vaccine Covaxin has shown an overall interim clinical efficacy of 78% in fighting Covid-19. It has also shown 100% efficacy against severe Covid-19 disease, its developers Bharat Biotech and Indian Council of Medical Research (ICMR) said on Wednesday, reports Swati Bharadwaj.

“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,” they said in a joint statement. “The efficacy against severe Covid-19 disease was 100%, with an impact on reduction in hospitalisations. The efficacy against asymptomatic infection was 70%, suggesting decreased transmission in Covaxin recipients,” they added. Though the second interim analysis was planned to be conducted once 87 participants got infected, a higher number – 127 cases – was recorded among the Covaxin trial participants due to the surge in cases because of the second wave and the interim efficacy data was calculated on this basis. The final analysis of the safety and efficacy results will be available in June after which the final report will be submitted to a peer-reviewed publication, they added.

Prof Balram Bhargava, secretary of the department of health research and director general of ICMR, said the 78% efficacy in the second interim analysis as well as the findings that Covaxin works well against most variants of SARS-CoV-2 consolidates the position of the indigenous vaccine in the global vaccine landscape.

Terming Covaxin as a global innovator vaccine derived from R&D conducted in India, Bharat Biotech chairman & managing director Dr Krishna Ella said Covaxin had demonstrated an excellent safety record in human clinical trials and during emergency use.

“The efficacy data against severe Covid-19 and asymptomatic infections is highly significant as this helps reduce hospitalisation and disease transmission, respectively,” he said. The developers of the desi vaccine also said that following the achievement of the success criteria, those who received placebo shots during the trial have now become eligible to receive two doses of Covaxin.

In the first week of March, the Covaxin developers had declared an interim efficacy of nearly 81% based on the first interim analysis of Phase 3 trials data after 43 cases of Covid-19 were reported among the trial participants. Of these 43 infected volunteers, only 7 had received the two Covaxin shots while the remaining 36 had all received a placebo shot.

In the phase 3 study, 25,800 participants between the ages of 18-98 years were enrolled, including 10% participants over the age of 60.