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    Bharat Biotech submits Covaxin phase 3 data; DCGI panel to take it up today

    Synopsis

    Bharat Biotech will also hold a ‘pre-submission’ meeting on Wednesday with the WHO, regarding the approval for Covaxin.

    covaxin afpAFP
    Bharat Biotech has submitted phase 3 data for its indigenous Covid-19 vaccine, Covaxin, to the Drug Controller General of India (DCGI), Niti Aayog member VK Paul told ET.

    The Subject Expert Committee under the drug regulator will discuss the issue on Tuesday, a senior official said.

    “Phase 3 data has been submitted to the drug regulator over the weekend. Covaxin follow-up studies should be available, too, in peer-reviewed journals soon,” Paul said. The Hyderabad-based vaccine maker has released an interim analysis of its phase 3 data but has not yet published full trial results in an internationally recognised journal.

    Earlier this month, Bharat Biotech had said phase 3 data will first be submitted to the Central Drugs Standard Control Organisation and then to peer-reviewed journals. It also said it was conducting phase 4 trials to check the “real-world effectiveness of the vaccines” and to meet scientifically approved standards for safety and efficacy.

    The company did not respond to queries sent by ET on Monday.

    Bharat Biotech will also hold a ‘pre-submission’ meeting on Wednesday with the World Health Organization (WHO), regarding the approval for Covaxin.

    A pre-submission meeting provides an opportunity to the company to receive advice and guidance before submission of the final dossier, as well as an opportunity to meet WHO assessors who will be involved in examining their product.

    In May, Bharat Biotech said an emergency use listing (EUL) application had been submitted to WHO, with regulatory approvals expected between July and September. The EUL pathway involves a rigorous assessment of clinical trial data — as well as additional data on safety, efficacy and quality — and a risk management plan.

    An emergency approval from WHO will allow Bharat Biotech to export vaccines and enable easy international travel of Indian citizens who have been administered Covaxin.



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    ( Originally published on Jun 22, 2021 )
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