New Delhi: The Drug Controller General of India (DCGI) Subject Experts Committee (SEC) has given ‘in principle' approval to Bharat Biotech for conducting a ‘Phase III superiority study & Phase III booster dose study’ for its intranasal COVID vaccine. India had approved the administration of a third ‘precaution dose’ to fully vaccinated individuals with comorbidities on December 26.
The booster shot or the ‘precaution dose’ will be administered to the frontline workers and the fully vaccinated individuals above 60 years of age with comorbidities on the doctor’s consultation. The inoculation drive for the booster shot will begin from January 10 onwards.
According to the news agency ANI, Bharat Biotech had earlier proposed clinical trials for the third dose for those vaccinated with Covishield and Covaxin. The pharma company aims to conduct clinical trials on 5,000 subjects; half vaccinated with Covishield and half with Covaxin.
The SEC has also asked the pharma giant to submit protocols for approval. According to ANI’s sources, India will get an intranasal vaccine by March. An intranasal vaccine would be easier to administer for inoculating masses.
The third dose will be administered to the designated group using the same registration ID they used for the first two doses. An individual is eligible for the third dose after six months of the second dose. The user only had to click on the comorbidities section and the papers will be verified on the vaccination spot.
Bharat Biotech, which is also a developer of Covaxin, had received emergency use authorisation for its vaccine to be administered to children between the ages of 12 and 18 years.