Won't impact India's Covid-19 vaccine plan: Centre on Covaxin EUA rejection

New Delhi - Approvals from the WHO are expected over the next three to four months.

By Web Report

Published: Sat 12 Jun 2021, 9:28 AM

While the US Food and Drug Administration reommended that Covaxin producers apply for full authorisation instead of emergency use authorisation (EUA), India’s Covid task force is confident that publication of crucial phase-3 trial data detailing the efficacy of the vaccine developed by the Indian Council of Medical Research and Bharat Biotech will be done over the next few weeks.

Dr V.K. Paul, who heads the task force, said publication of the data in a peer-reviewed journal would go beyond the information submitted to the Central Drugs Standard Control Organisation and also reveal findings from follow-ups of the clinical trial.

Referring to the US decision, he said it would not have any regulatory impact in India. “Every country’s regulatory system is different, although some aspects could be the same,” said Paul. “Countries have their own parameters and we respect them. Our regulator takes decisions in the same way; the scientific system takes decisions in the same manner. The scientific framework is the same, however, nuancing is based on the context…they have taken a decision, we respect the decision.”

Approvals from the WHO are expected over the next three to four months. He said there was a lot of data on the safety of Covaxin. “We have so much data on their phase 3 trial that has been screened by them, seen by our regulator,” said the top government official. “I am told that their phase 3 publication could come anytime in the next 7-8 days. This will be beyond what has been shared with the Drugs Controller General of India, when they received the licensure; the follow-up (data) will go into a peer-reviewed journal. It will be done objectively.”

Covaxin accounts for 12 per cent of total vaccines administered in India.