The Drugs Controller General of India on Friday gave approval to biotechnology company Bharat Biotech to conduct trials of its intranasal Covid-19 booster dose in India, reported ANI. The subject expert committee of the drug regulator had three weeks ago given its recommendation that for phase 3 trials of the intranasal dose.
The trials will be held in nine states, according to ANI.
Bharat Biotech also makes the Covaxin vaccine that is being used in India’s Covid-19 inoculation drive. The Hyderabad-based manufacturer has proposed the booster dose for those who have already received Covishield and Covaxin vaccines, reported Mint.
On Thursday, Union Health Minister Mansukh Mandaviya had said that India’s drug regulator has granted regular market approval to coronavirus vaccines Covishield and Covaxin for use in the adult population subject to certain conditions.
“The conditions include supply for programmatic settings including registration on the CoWin platform and to continue to submit safety data on a six-monthly basis,” the minister wrote in a tweet.
The lifting of the emergency use authorisation label effectively makes availability of vaccines easier and provide an opportunity for its entry into the distribution channel.
India has so far administered 1,64,70,18,108 vaccine doses, according to data on CoWin portal. As many as 69,91,33,014 people have received both the shots. Also, 1,02,90,374 booster shots have been administered.