The Drugs Controller General of India (DCGI) on Friday gave permission to BharatBiotech for intranasal booster dose trials. The sources revealed earlier this month that the country is expected to get an intranasal booster vaccine in March, after timely conduction of trials, according to a report in Mint.
The Hyderabad-based firm has proposed the booster shot for those who have been already been vaccinated against COVID-19 with Covishield and Covaxin jabs.
Bharat Biotech aims to conduct clinical tests on 5,000 subjects (50 per cent vaccinated with Covishield and 50 per cent vaccinated with Covaxin). The gap between the second dose and booster dose will be six months, sources said.
Earlier in mid-December, the firm had sought permission to carry out clinical trials for its intranasal booster dose.
Meanwhile, on Thursday , India's drug regulating body has granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, as informed by Health Minister Mansukh Mandaviya.
However, the two COVID-19 vaccines will be available at shops soon though people would be able to buy them from hospitals and clinics.
"The regulator has upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions," Mandaviya said.
Soon after the approval, highly-placed sources said the two vaccines will now be available in private clinics at pre-decided MRP and people can buy those.
The market sale of the two vaccines was approved under the New Drugs and Clinical Trials Rules, 2019.
Gradually, the vaccine will be available in the market at a price lower than at what it was being sold earlier at private hospitals.
(With Agency Inputs)
