Bharat Biotech gets SEC approval for phase 3 clinical trials of nasal vaccine as a booster shot
As India stares at the third wave of the COVID-19 pandemic, Bharat Biotech has received a nod from the Drugs Controller General of India (DCGI) to commence a phase 3 clinical trial for its intranasal Covid vaccine BBV154. The approval was sought by the vaccine manufacturer last week.
The nasal booster vaccine is likely to be launched in India by March following clinical trials. As against injectable vaccines, the intranasal vaccine is claimed to be easy to administer during mass inoculation campaigns.
Bharat Biotech had proposed the booster dose for those who have been already been inoculated with Covishield and Covaxin vaccines.
On Wednesday, the Subject Experts Committee (SEC) of the DGCI granted “in principle” approval to Bharat Biotech to conduct “Phase 3 superiority study and Phase 3 booster dose study” trials for its intranasal Covid vaccine. The SEC has asked the company to submit the protocol for booster study.
The Committee held a meeting on Tuesday, to discuss the vaccine manufacturer Bharat Biotech’s application for clinical trials of its intranasal Covid vaccine as a booster.
According to a source, Bharat Biotech aims to conduct clinical trials on 5,000 healthy subjects: half or 2,500 individuals who have received Covishield and another 2,500 who have been administered Covaxin.
The source said there will be a gap of around six months between the second and the intranasal booster dose.
[With Inputs from IANS]
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