Covid-19: Bharat Biotech not allowed to conduct simultaneous Phase I, II trials for nasal vaccine

Indian vaccine manufacturer Bharat Biotech has not been granted permission to carry out simultaneous Phase 1 and Phase 2 trials for its nasal coronavirus vaccine candidate, CNBC TV18 reported.

The decision has been taken by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation during a meeting held on January 19.

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The company sought approval for the trials of the vaccine that is being developed in collaboration with the Washington University School of Medicine and Ocugen — a vaccine maker based in the US.

The SEC asked Bharat Biotech to first carry out Phase 1 and submit the immunogenicity data before proceeding to the next phase of trial.

Bharat Biotech has claimed that the non-invasive, single-dose vaccine will be easier to administer and will be an eco-friendly vaccine that is efficacious in the long run.

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Krishna Ella, Chairman, Bharat Biotech, has said, as per the MoneyControl report: “An intranasal vaccine will not only be simple to administer but will also reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive.”

He added: “One drop of Bharat Biotech’s intranasal Covid-19 vaccine in each of the nostrils would be sufficient.”