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First nasal vaccine developed by Bharat Biotech gets nod for Phase 2/3 trial

Published on Aug 13, 2021 06:48 PM IST

The Phase 1 trial in healthy volunteers of age groups ranging from 18 to 60 years was well tolerated, according to the ministry of science and technology.

A health worker collects a nasal swab sample from a devotee to test for Covid-19.(AFP)
By | Edited by Kunal Gaurav, Hindustan Times, New Delhi

Amid ongoing research around the world to develop nasal sprays to help prevent coronavirus disease (Covid-19), Bharat Biotech’s intranasal vaccine has received regulatory approval for Phase 2/3 trials. The adenoviral intranasal vaccine BBV154 is the first of its kind Covid-19 jab to undergo human trials in India. The Phase 1 trial in healthy volunteers of age groups ranging from 18 to 60 years was well tolerated, according to the ministry of science and technology.

The ministry said the intranasal vaccine was found to be safe, immunogenic and well-tolerated in the preclinical toxicity studies and was able to elicit high levels of neutralizing antibodies in animal studies. It has received approval to conduct Phase 2 randomised clinical trial of “heterologus prime-boost combination of Sars-CoV-2 vaccines to evaluate the immunogenicity and safety of Covaxin with BBV154...in healthy volunteers.”

The development of Bharat Biotech’s intranasal vaccine has been supported by the department of biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC). They strategised to fast-track research and development efforts, especially for vaccine development, diagnostics, drug repurposing, therapeutics and testing.

“The department through Mission Covid Suraksha, is committed to development of safe and efficacious Covid-19 vaccines. Bharat Biotech’s BBV154 Covid Vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials,” Dr RenuSwarup, secretary, DBT said, referring to the scheme launched to accelerate Covid-19 vaccine development efforts as part of the third stimulus package announced by the Centre.

Bharat Biotech's Covaxin had demonstrated 77.8% efficacy against symptomatic Covid-19 and 93.4% against severe illness during the Phase 3 clinical trials.

India has administered nearly 53 crore doses of Covid-19 vaccines, of which Covishield, a version of AstraZeneca's Covid-19 vaccine, and Covaxin form the major part of the vaccination coverage.

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