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    WHO advisory group to meet on Oct 26 to decide on Bharat Biotech’s Covaxin

    Synopsis

    WHO had earlier said that Bharat Biotech has been submitting data to it on a rolling basis and had submitted additional information on 27 September after the global health body sought more data. “The technical advisory group will meet on Oct 26th to consider EUL for Covaxin,” WHO’s chief scientist Soumya Swaminathan said.

    Covaxin_afpAFP
    WHO’s approval will allow Bharat Biotech to export the vaccine to more countries.
    WHO's technical advisory group will meet on October 26 to consider granting Emergency Use Listing (EUL) to Bharat Biotech’s Covaxin, WHO’s chief scientist Soumya Swaminathan said on Sunday.

    “WHO has been working closely with Bharat Biotech to complete the dossier,” she tweeted.

    “The technical advisory group will meet on Oct 26th to consider EUL for Covaxin,” she tweeted.

    WHO had earlier said that Bharat Biotech has been submitting data to it on a rolling basis and had submitted additional information on 27 September after the global health body sought more data.

    “WHO experts are currently reviewing this information if it addresses all questions raised, WHO assessment will be finalized next week,” it had tweeted on October 5 after the Hyderabad-based company made a presentation on the safety and efficacy data for its vaccine to the Strategic Advisory Group of Experts on Immunization (SAGE), an expert body that advises the WHO.

    In a meeting held on October 5, the company made a presentation of clinical data from Covaxin's Phase 1, 2, 3 and post-marketing studies on safety, immunogenicity, efficacy and effectiveness to the SAGE.

    “The company in its presentation has shared about the wide acceptability of the vaccine. It also informed the experts that the vaccine has been approved in 14 countries and over 70 million doses have been sent to overseas markets,” a person in the know told ET.

    The details of ongoing and planned studies on safety and effectiveness have also been submitted to the expert body, the person said.

    In addition, Bharat Biotech also shared global, regional and country-level plans for vaccine safety monitoring.

    “The decision will be taken by the WHO based on the recommendations of the SAGE,” said another person.

    WHO’s approval will allow Bharat Biotech to export the vaccine to more countries. Also, people inoculated with Covaxin will be able to travel to many countries without restrictions.

    “Our goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere,” Swaminathan further tweeted.

    The EUL pathway involves a rigorous assessment of clinical trial data as well as additional data on safety, efficacy, quality, and a risk management plan. Bharat Biotech had in June presented its Phase-3 clinical trials data, demonstrating 77.8% efficacy, to the Subject Expert Committee of India’s regulatory authority-Central Drugs Standard Control Organisation (CDSCO).


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    ( Originally published on Oct 17, 2021 )
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