DGCI approves for phase 3 trial of Bharat Biotech intranasal vaccine as booster

Earlier, Bharat Biotech’s covid-19 vaccine Covaxin has received approval for emergency use in Children 12 - 18 years of age

The Subject Experts Committee (SEC) of the Drug Controller General of India (DGCI) on Wednesday granted "in principle" approval to Bharat Biotech to conduct "Phase III superiority study and Phase III booster dose study" trials for its intranasal Covid vaccine.

The approval was sought by the vaccine manufacturer last week.

The SEC has asked the company to submit the protocol for booster study.

On Tuesday, the Committee held a meeting to discuss the vaccine manufacturer Bharat Biotech's application for clinical trials of its intranasal Covid vaccine as a booster.

The Hyderabad-based manufacturer had proposed the booster dose for those who have been already been innoculated with Covishield and Covaxin vaccines.

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.

There will be a gap of around six months between the second and the intranasal booster dose. The source said that the nasal booster vaccine is likely to be launched in India by March following clinical trials.

In his address to the nation on December 25, Prime Minister Narendra Modi had assured that soon the country will develop a nasal vaccine.

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