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    Government panel recommends mixing Bharat Biotech's Covaxin and nasal vaccine in trials

    Synopsis

    The subject expert committee (SEC) under India's drug regulator gave its go-ahead to Hyderabad-based Bharat Biotech to conduct the phase 2/3 clinical trials, administering a dose each of Covaxin and the adenoviral intranasal vaccine with an interval between the two.

    Titled design - 2020-12-12T201616.039Reuters
    A government panel has recommended a trial that will involve combining the doses of Bharat Biotech's Covaxin and its nasal Covid vaccine which is undergoing clinical studies.

    The subject expert committee (SEC) under India's drug regulator gave its go-ahead to Hyderabad-based Bharat Biotech to conduct the phase 2/3 clinical trials, administering a dose each of Covaxin and the adenoviral intranasal vaccine with an interval between the two.

    "After detailed deliberation, the committee recommended grant of permission for conduct of the proposed clinical trial removing the word 'interchangeability' from the study title," said the minutes of SEC's meeting held on Thursday.

    Bharat Biotech's intranasal vaccine is the first of its kind Covid-19 vaccine to undergo trials in India.

    The company is developing a single-dose nasal Covid-19 vaccine in partnership with Washington University in St Louis, US.

    Vax

    Public health experts say a single-dose nasal vaccine would be the best choice for India. They also feel that mixing the two vaccines will be more effective, since it is expected to generate greater immune responses. Bharat Biotech chairman Krishna Ella said at the Ficci Capital Markets Conference on Thursday that the combination of the two vaccines could be a game-changer.

    Production of the nasal vaccine can be scaled up easily; the company can produce 100 million doses a month, he said. Bharat Biotech is expecting significant data from its studies on the intranasal Covid-19 vaccine in the next two-and-a-half months. As vaccination across the world has gained pace, several studies are being conducted on the mixing of vaccines.

    AstraZeneca and Pfizer vaccines have been mixed for a trial.

    In another development, Russia-developed Sputnik V has been mixed with AstraZeneca vaccine and no serious adverse events were reported. India is also conducting a study mixing Covaxin and Covishield, developed by AstraZeneca and manufactured locally by Serum Institute. While mixing of vaccine doses is gaining momentum across the world, experts have warned that this decision should not be taken by individuals, and it should only come from drug authorities.


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