Bharat Biotech has started running second-stage clinical trials at 12 selected sites across the country, where vaccination shots have been delivered directly into the muscles of healthy volunteers. However, according to a recent report, Bharat Biotech has proposed to conduct trials using the intradermal (ID) vaccine delivery route, which has been approved by the Subject Expert Committee (SEC), a body that comes under Central Drugs Standard Control Organisation (CDSCO). The CDSCO is the national regulatory body for Indian pharmaceuticals and medical devices, and serves as an arm of the Central Health Ministry.
According to the minutes of a meeting with the SEC, “The firm presented their proposal for conducting Phase I/II clinical trials of the coronavirus vaccine (BBV152D) by the ID route. The firm also presented its animal toxicity data generated through the intradermal/intraperitoneal route and interim safety data from Phase I study through the intramuscular route. After detailed deliberation, the committee recommended for grant of permission to conduct the phase I/II clinical trials through ID route on few conditions.”
The conditions for approval are that “participants should be followed up for six months for clinical and antibody titter assessments and clinical trial sites of this study should be different from the sites of the intramuscular study.”
Under the ID route, the vaccine is administered in the dermis, under the layer of the skin. Whether its price will be lower than the intramuscular vaccine is unclear, but it is expected to increase the number of beneficiaries.
“Intradermal vaccination translates into giving smaller doses of a vaccine to a larger number of people. It does not decrease the price of the vaccine but increases the beneficiary number. The cost per person vaccinated would decrease. But the price of the vaccine does not come down,” said Dr Lalit, a former epidemiologist at ICMR.