Covaxin’s efficacy result will help in getting WHO’s approval, says govt expert body chief
Covaxin’s recently published efficacy results will help the vaccine in getting the World Health Organisation’s (WHO) emergency approval, the chairperson of National Technical Advisory Group on Immunisation in India (NTAGI), Dr NK Arora said on Saturday.
“This will help to get the vaccine WHO emergency use listing,” Arora told news agency ANI.
India’s first indigenously developed vaccine, Covaxin, has demonstrated an efficacy of 77.8% against symptomatic Covid-19 and 93.4% against severe disease. Bharat Biotech, its manufacturer, has announced its phase 3 clinical trials, which is yet to be peer-reviewed.
“Efficacy analysis demonstrates Covaxin to be 77.8% effective against symptomatic Covid-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. Efficacy analysis demonstrates Covaxin to be 93.4% effective against severe symptomatic Covid-19,” the manufacturer said in a paper published in open access journal medRxiv.
The Phase 3 trials were carried out in 130 symptomatic Covid-19 cases, in 25 sites across the country. Based on the results collected at least two weeks after the administration of the second dose, Bharat Biotech concluded that its jab is offering 63.6% protection against asymptomatic disease, and 65.2% protection against the Sars-Cov-2, B.1.617.2 Delta variant.
The NTAGI chairman also said Covaxin’s approval from WHO will bring visibility to India since it is indigenously developed. Covaxin was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), from an isolated viral strain provided by the National Institute of Virology (NIV).
Suchitra Ella, joint managing director of Bharat Biotech, tweeted on June 30 that the company is working closely with WHO for emergency listing.
"We are working closely with the World Health Organisation for inclusion of Covaxin in its Emergency Use Listing. Approval from WHO is not expected to be a long drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past," Ella tweeted.