The Phase-III data will be first submitted to the Central Drugs Standard Control Organisation (CDSCO) after which it will be published in peer-reviewed journals.
Restricted emergency approval by the DCGI had put Bharat Biotech’s Covaxin in the centre of a controversy.
Months after the Centre gave the approval for using Covaxin to vaccinate people in India, the government on Friday said that Covaxin’s third phase trial data will be released by June 20. The new announcement came a day after Covaxin manufacturer Bharat Biotech said that the data will be made public by July.
“Covaxin third-phase data and follow-up studies should be available in a few days,” VK Paul said during the press conference. Bharat Biotech has hinted that they will apply for full licensure of Covaxin when all the data is available to them.
It is to be noted that the Phase-III data will be first submitted to the Central Drugs Standard Control Organisation (CDSCO), after which it will be published in peer-reviewed journals.
“It is critical to understand the Phase-III data will first be submitted to CDSCO, followed by peer-reviewed journals, with a timeline of (approx) 3 months for publication, and as communicated earlier Covaxin phase 3 results full trial data will be made public during July,” said Bharat Biotech.
Earlier, the decision by the Drugs Controller General of India to give restricted emergency approval to Bharat Biotech’s Covaxin had raised questions over the transparency of the process. While the panel believed to have considered the phase-III data of Covishield’s UK trials, no such data of Phase-III trials were available for Covaxin.
Meanwhile, answering questions related to the rejection of approval to Covaxin by the US-based FDA, VK Paul said that every country has its own system and parameters. India has its own system and it has no impact on the vaccination programme underway in India. On the issue of vaccine passports and that people who took Covaxin can not go abroad, the Niti Aayog member said that there is a common understanding on the issue across the world and even WHO was supposed to make a decision, but it is still deliberating.
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