Carefully following discussions, hopeful of WHO recognition for Covaxin soon: Harsh vardhan Shringla

Two days after World Health Organisation (WHO) sought additional clarifications for emergency use listing of Bharat Biotech’s vaccine Covaxin, Foreign Secretary Harsh Vardhan Shringla on Thursday said that the government is carefully following the discussion staking place within the health body and hoped that approval for the indigenous COVID-19 vaccine will be granted 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.

He was answering a query at a media briefing on Prime Minister Narendra Modi’s forthcoming visit to Italy and United Kingdom.

WHO said on Tuesday that additional clarifications from manufacturer are needed to conduct a final Emergency Use Listing (EUL) risk-benefit assessment for global use of India-made Covaxin.

“The Technical Advisory Group for Emergency Use Listing (TAG-EUL) expects the clarification from Bharat Biotech by end of this week and thus will reconvene for the final risk-benefit assessment on Wednesday, November 3,” WHO had said.

Shringla said TAG is a technical group and any request for emergency use authorisation (EUA) with the WHO is decided on technical considerations. “We (Goverment of India) are carefully following the discussions taking place within the health body, and we are hopeful that approval for Covaxin will be granted very soon,” he said.

Bharat Biotech had submitted its EOI (Expression of Interest) for EUL by WHO on April 19.