Bharat Biotech not allowed to conduct simultaneous Phase I, II trials for its intranasal COVID-19 vaccine

Bharat Biotech has claimed that the non-invasive, single-dose vaccine will be far easier to administer.

Bharat Biotech has not been allowed to conduct simultaneous phase I and phase II trials for its nasal COVID-19 vaccine candidate, reported CNBC-TV18 on January 19.

Sources say SEC did not consider the request of Bharat Biotech to conduct both Phase 1 & 2 trials simultaneously for its nasal #vaccine candidate. SEC wants co to first conduct phase 1 & submit immunogenicity data before seeking approval for phase 2 pic.twitter.com/qNg4kOpGhH

— CNBC-TV18 (@CNBCTV18Live) January 19, 2021

The SEC has reportedly refused to consider Bharat Biotech’s request and said it wants the Indian vaccine maker to first conduct the phase I trials and submit the immunogenicity data before moving on to the next stage.

Bharat Biotech has claimed that the non-invasive, single-dose vaccine will be far easier to administer and will be an eco-friendly vaccine that will work faster and last longer.

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

He had further said that “one drop of Bharat Biotech’s intranasal COVID-19 vaccine in each of the nostrils would be sufficient”.

This is the only intranasal vaccine candidate under trial in India at the moment. Preclinical testing for toxicology and immunogenicity for the BBV154 intranasal COVID-19 vaccine has already been conducted. Additionally, challenge studies have been conducted in India and the United States.

Once the vaccine is ready for rollout after getting the nod from drug regulators, Bharat Biotech will have the right to distribute it in all markets except the US, Japan, and Europe.

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