Foreign secretary Harsh Vardhan Shringla said on Thursday that the Centre was closely following discussions taking place within the World Health Organisation, as India awaits the global health body's nod for Covaxin, now delayed till at least the first week of November.
He also added that it was hoping that the WHO would okay the jab "very soon."
WHO's technical advisory group (TAG), which is a regulatory body, met Bharat Biotech officials on October 26. They had a few questions for Bharat Biotech. From what we understand, the company will submit its reply soon. According to me, once the regulatory group is satisfied with the response, the approval for Covaxin should be given soon,” Shringla said, according to news agency ANI.
He continued, “However, you should understand that the TAG a technical group. Any request for emergency use authorisation (EUA) with the WHO is made on technical considerations. We (Govt of India) are carefully following the discussions taking place within the health body, and we are hopeful that an approval for Covaxin will be granted very soon.”
The TAG, which provides recommendations to the WHO on whether a Covid-19 vaccine can be listed for approval, known technically as emergency use listing (EUL), delayed its nod to Covaxin as it felt that it needed further clarifications from the manufacturer, the Hyderabad-based Bharat Biotech, for a final EUL risk-benefit assessment. The firm is expected to submit its response by the end of the week, with TAG scheduled to meet on November 3 to discuss granting EUL.
The EUL could help India's first indigenous vaccine against Covid-19 to be recognised by a large number of countries. This would further allow Indian nationals vaccinated with Covaxin to qualify for vaccine mandates.
