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Bharat Biotech asked to conduct Phase 1 trial of intranasal covid vaccine with 75 participants

Photo: ReutersPremium
Photo: Reuters

  • Bharat Biotech had submitted data as part of its application to conduct phase 1 and 2 human trials, but the SEC asked to first conduct a phase 1 trial and only then seek clearance for phase 2 trial
  • The intranasal delivery route would be non-invasive and needle-free, and would make the vaccine ideal for children and adults without the need for trained healthcare workers

A subject expert committee (SEC) of the Indian drug regulator has asked Bharat Biotech International to conduct a phase 1 study of 75 participants to determine the safety and immunogenicity of its chimpanzee adenovirus vector-based intranasal covid-19 vaccine.

“After detailed deliberation the committee recommended that, the firm should generate Safety and Immunogenicity data in Phase-I clinical trial (75 subjects) in the proposed doses as per the protocol and submit the data for the consideration of the committee to proceed to Phase II clinical trial," minutes of the SEC meeting that happened last week showed. The minutes were made public on Monday.

Bharat Biotech had submitted animal toxicity, immunogenicity and other data as part of its application to conduct phase 1 and 2 human trials of its experimental vaccine, codenamed BBV154, but the SEC asked the company to first conduct a phase 1 trial and only then seek clearance for phase 2 trial.

According to Bharat Biotech’s website, the company anticipates the single-dose intranasal vaccine to provide broad immune response against SARS-CoV2, especially at the site where the virus infects initially—the nasal mucosa.

The intranasal delivery route would also be non-invasive and needle-free, and its ease of administration would make the vaccine ideal for children and adults without the need for trained healthcare workers.

The SEC also perused Serum Institute of India’s application for Covovax giving options for various non-covid vaccines to be used as comparators. The committee recommended that firm should conduct the bridging study for the vaccine—whose original version is being developed by US-based Novavax—with placebo or other vaccine as the comparator.

Both Bharat Biotech and Serum Institute have already received emergency authorisation from the Drugs Controller General of India V.G. Somani for their first covid-19 vaccines—Covaxin and Covishield, and both vaccines are currently being administered nationally to healthcare workers.

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