In Principle Approval to test nasal COVID-19 shot as booster; Bharat Biotech gets nod from DGCI

In Principle Approval to test nasal COVID-19 shot as booster; Bharat Biotech gets nod from DGCI

BENGALURU - 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, citing that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.

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

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.

As a precautionary measure in light of rising Omicron coronavirus variant cases across the country, India approved the administration of COVID-19 booster shots on Christmas, with healthcare and frontline workers set to receive them from Jan. 10.

India's inoculation drive so far has been dominated by a domestically produced version of the AstraZeneca COVID-19 shot by Serum Institute of India and Bharat Biotech's inactivated vaccine Covaxin, both administered through injections.

On Wednesday, the country reported 58,097 new coronavirus cases, twice the number seen only four days ago, taking its total caseload to over 35 million.
-with inputs from Tribune, Reuters

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