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.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization took the decision in a meeting called on January 19 for the approval of the phase I trial of the intranasal coronavirus vaccine being developed by Bharat Biotech in collaboration with the Washington University School of Medicine and Ocugen – a vaccine maker based in the US.
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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