Bharat Biotech gets CDSCO green flag to conduct Covaxin trial via Intradermal route
New Delhi: In a major advancement, Hyderabad-based drugmaker Bharat Biotech has secured permission from Central Drugs Standard Control Organisation (CDSCO) to take up a separate clinical trial of its Covid-19 vaccine candidate, Covaxin, to be administered through the intradermal route ie. vaccine delivered beneath the outer layer of skin.
Covaxin is one of the first indigenous vaccine developed against COVID-19 and is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology (NIV), Pune. The Indian Council of Medical Research and Bharat Biotech were jointly working for the preclinical as well as clinical development of this vaccine. It had already received approval for phase-I and phase- II human trials by the Drug Controller General of India (DGCI).
This came following the frim's proposal to modify its trial protocol. The matter was put up in a meeting with the subject-expert committee.
"The firm presented their proposal for the conduct of phase I/II clinical trial of Corona Virus Vaccine, [BBV152D] by Intradermal (ID) route. The firm also presented their animal toxicity data generated through Intradermal/Intraperitoneal route & interim safety data from Phase I study through Intramuscular route," minutes to the committee's meeting on 13 August said.
After detailed deliberation, the committee recommended for grant of permission to conduct the Phase I/II clinical trial through ID route.
However, the committee's approval is subject to the company complying with two conditions—following up on participants for six months for clinical and antibody titer assessments, and clinical trial sites of this study should be different from the sites of the intramuscular study.
The intradermal vaccination would prove significant as it sharply reduces the dosage required for administrating the vaccine compared to giving it intramuscularly, which allows vaccination of a larger number of people with the same capacity. It would also significantly reduces the cost of the vaccine, reports Live Mint.
Presently, phase I/II clinical trial of Covaxin is being conducted on1,125 patients at 12 hospitals across the country, including All India Institute of Medical Sciences (AIIMS) Delhi and Patna, King George Hospital in Visakhapatnam, Nizam's Institute of Medical Sciences in Hyderabad and PGIMS in Rohtak. The vaccine is being tested through the intramuscular route, in other words, directly injecting it into the muscle.