The Drug Controller General of India (DGCI) Expert Committee on the Matter Wednesday granted Bharat Biotech approval “in principle” to conduct “phase III superiority study and booster dose study” trials phase III ”for its intranasal vaccine against Covid.

Approval was requested by the vaccine manufacturer last week.

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

On Tuesday, the committee held a meeting to discuss vaccine maker Bharat Biotech’s request for clinical trials of its intranasal Covid vaccine as a booster.

The Hyderabad-based manufacturer had offered the booster dose for those who have already been inoculated with the 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 having received Covishield and 2,500 others having received Covaxin.

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

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


(Keywords: Vaccine, Coronavirus, Covid-19, Infection, Trial phase, Narendra Modi, DCGI, Booster, India)


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