The Drugs Controller General of India (DCGI) has given vaccine manufacturer Bharat Biotech approval for conducting Phase-III clinical trials of an intranasal booster dose for those who have received both doses of Covaxin.
Only the Central Drugs Laboratory (CDL), Kasauli, certified batches shall be used in the clinical trials, which will be conducted at nine sites, including the All India Institute of Medical Sciences, New Delhi and Bihar. The Chimpanzee Adenovirus Vectored COVID-19 Vaccine (BBV154) is to be administered through an intranasal route and each single dose is 0.5 ml.
The trials will evaluate BBV154 intranasal vaccine for both the 2-dose primary schedule and booster dose schedule.
The DCGI has stated that this permission is subject to the conditions prescribed in part A of Chapter V of the New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940.
“It may kindly be noted that merely granting permission to conduct clinical trials with the vaccine does not convey or imply that, based on the clinical trial data generated with the vaccine, permission to market this vaccine in the country will automatically be granted to you,’’ it stated.
The DCGI explained that the Phase III clinical trials should be conducted as per protocol titled “A Phase III randomized open label multi-center study to compare immunogenicity and safety of BBV154 with Covaxin and to assess lot-to-lot consistency of BBV154”.
Experts have noted that an intranasal vaccine as a booster will be easier to administer in mass vaccination drives.
