Bharat Biotech gets regulator nod for Phase-3 trial of nasal vaccine

NEW DELHI: Hyderabad-based drug maker Bharat Biotech has got regulatory approval to start Phase-3 clinical trials to test its intranasal Covid vaccine as booster dose (third dose) on people who have received both doses of Covaxin, an official source said.
Separately, the drug regulator also gave permission to the pharmaceutical company to conduct Phase-3 clinical trial to compare the immunogenicity and safety of the intranasal vaccine candidate with Covaxin, which has also been developed and manufactured by Bharat Biotech.
This trial would be conducted in nine sites, including AIIMS Delhi and Patna. The development assumes significance because once the nasal vaccine gets final approval for use, it has the potential to massively ramp up vaccination against Covid as it is likely to be far more affordable, easy to administer and not require clinical setting or healthcare workers for administration of doses.
At present, over 23 crore doses of Covaxin have been administered, accounting for 14% of the total nearly 165 crore doses given across the country.
The Drugs Controller General of India (DCGI) gave a ‘No Objection Certificate’ to the Hyderabad-based vaccine maker on Thursday allowing it to conduct randomised Phase 3 multi-centric clinical trials with the intranasal vaccine candidate as a third shot to those who have received two doses of Covid vaccines.