HYDERABAD: Hyderabad-based vaccine manufacturer Bharat Biotech has received permission from the Central Drugs Standard Control Organisation (CDSCO) to take up clinical trials of its Covid-19 vaccine candidate, Covaxin, to be administered through the intradermal route.
While the company’s vaccine candidate is already under clinical trials at 12 centres across the country, it is being administered through the intramuscular route in which the vaccine is delivered by injection into the muscles.
Vaccine administration via the intradermal route means the vaccine will be delivered by injection into the dermis, which is the layer beneath the outer layer of skin (epidermis). According to the WHO, intradermal technique is ‘dose-sparing’, which means it consumes less vaccine than the intramuscular delivery method. It also helps in reducing the per-injection cost of vaccines and is also found to be more effective in inducing an immune response.
According to the minutes of the meeting held in New Delhi on August 13, of the Subject Expert Committee (SEC) for Covid-19 under accelerated approval process, Bharat Biotech presented its proposal for the conduct of Phase I/II clinical trials of Covaxin by intradermal (ID) route.
It also presented animal toxicity data of the vaccine candidate generated through the intradermal/intraperitoneal route along with the interim safety data from Phase I study of the vaccine through the intramuscular route.
While the SEC recommended for grant of permission to conduct clinical trials through the intradermal route, it laid down two conditions — the trial sites should be different from the sites where the present clinical trials are going on for the vaccine through the intramuscular route and that the subject should be followed up for six months for clinical and antibody titer assessments.
Hetero Drugs to conduct Phase IV trials
The CDSCO also gave permission to Hyderabad- based Hetero Drugs, along with two other pharma companies, Mylan and Cipla, to conduct the Phase IV clinical trials of their version of the Covid-19 drug, Remdesivir