Shringla says India following WHO's talks on Covaxin 'carefully'; approval expected soon

The government is carefully following the World Health Organization (WHO) discussions over Emergency Use Listing (EUL) for Bharat Biotech’s Covaxin, said Foreign Secretary Harsh Vardhan Shringla on Thursday, 29 October. While answering a query at a media briefing on Prime Minister Narendra Modi’s visit to Italy and the UK, Shringla said that the approval for the India-made vaccine against COVID-19 “should b given soon”. He also informed that WHO’s technical advisory group (TAG) met on 26 October and they “had a few questions” for Bharat Biotech.

“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, as per ANI.

“We (Government 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 further stated.

Foreign Secretary’s remarks on the indigenous COVID-19 vaccine come after the United Nations (UN) health agency on Tuesday said that additional clarifications from the manufacturer were required to conduct the final EUL risk-benefit assessment for global use of Covaxin. The WHO had said, “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, 3 November.”

WHO official: ‘We really trust the Indian industry’

Hailing Bharat Biotech’s swift responses to the agency’s queries,  Dr Mariangela Simao, Assistant Director-General, Access to Medicines and Health Products at WHO said that “we really trust the Indian industry”. Simao added that WHO is in touch with the manufacturer and both sides have “daily conversations and calls and meetings clarifying what additional data needs" are needed by the technical expert. 

"Let me just clarify and without wanting to mention any specific manufacturer but saying that we have assessed an Indian manufacturer earlier in the year and it took 30 days, she said, a reference to the Serum Institute of India which manufactures the AstraZeneca Covishield vaccine," said WHO official, as per PTI.

"So this is not about moving quicker with one or another vaccine. We really trust the Indian industry. India produces a different majority of vaccines in the world, high quality vaccines. We are right now at the last stage of the assessment by this external advisory group and we hope to have a final recommendation to the WHO next week. I hope that's well understood," added Simao. 

(IMAGE: PTI/Shutterstock)

(With ANI and PTI inputs)