COVAXIN VACCINE TO BE TESTED BY “INJECTING INTO SKIN”, NOT MUSCLE: ‘FASTER RECOVERY’ EXPECTED – REPORT

Bharat Biotech’s COVID-19 vaccine Covaxin is under clinical trials at 12 different sites in India. Volunteers are being closely monitored in order to understand the vaccine and its possible repercussions if any, in a heterogeneous group of people. However, the company is now considering a new method of conducting trials.

Along with the country’s top health research centre, the Indian Council of Medical Research (ICMR), Bharat Biotech has been testing Covaxin on healthy volunteers by administering the vaccine shots directly into the muscles. But, in a recent proposal the company intends to begin “Intradermal vaccine delivery route” also known as the ID route which has been approved by Central Drugs Standard Control Organisation and Subject Expert Committee, along with the valuable inputs of ICMR.

If the ID technique is to be used, then the shot will be given on one of the layers of the skin, rather than being injected into the muscles. This is expected to trigger better a immune response with a very minimal dosage of the drug.

“This method could help in dose-sparing. So you could potentially increase the number of people you are able to vaccinate with the same amount of vaccine. This can also decrease the per injection cost, which is relevant from a public health perspective,” said Anant Bhan, a researcher in global health, and former president of International Association of Bioethics.

“The firm presented their proposal for conduct of phase I/II clinical trial of Coronavirus Vaccine by Intradermal route. The firm also presented their animal toxicity data generated through intradermal route and interim safety data from phase I study through intramuscular route,” according to CDSCO.

In response to this the SEC noted, “After detailed deliberation, the committee recommended for grant of permission to conduct the phase I/II clinical trials through ID route.” However, the SEC did provide two conditions, on being a regular check up being conducted on all the volunteers for a period of six months and has also ordered the company to choose new sites for beginning clinical trials.