Govt. panel allows Bharat Biotech to test administration of Covaxin through skin

New Delhi: A subject-expert committee at the Central Drugs Standard Control Organisation has given an approval to Bharat Biotech International Ltd to conduct a separate trial for administrating ‘Covaxin’, its covid-19 vaccine candidate, through intradermal route, that is just under the skin, as against the intramuscular route in the current trial.

A company needs to obtain Drug Controller General of India V.G. Somani’s approval to modify its trial protocol. While the DCGI usually accepts the committee’s decisions, Mint could not ascertain whether Somani has approved Bharat Biotech’s proposal.

“The firm presented their proposal for conduct of phase I/II clinical trial of Corona Virus Vaccine, by Intradermal (ID) route... After detailed deliberation, the committee recommended for grant of permission to conduct the Phase I/II clinical trial through ID route," minutes to the committee’s meeting on 13 August said.

The committee’s approval, however, 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.

Covaxin is a wholly-inactivated vaccine candidate that was jointly developed by Bharat Biotech and Indian Council of Medical Research’s National Institute of Virology in Pune.

Bharat Biotech is currently conducting a phase I/II clinical trial of Covaxin on 1,125 patients at 12 hospitals across the country, including All India Institute of Medical Sciences in New Delhi and Patna, King George Hospital in Visakhapatnam, Nizam’s Institute of Medical Sciences in Hyderabad and PGIMS in Rohtak.

The move to conduct a trial intradermal vaccination is 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 also significantly reduces the cost of the vaccine.

For example, in the case of anti-rabies vaccine, intradermal vaccination reduces volume of vaccine used by 60-80%, is less costly and has potential to mitigate vaccine shortages, according to a WHO document.