Bharat Biotech International Limited has received approval from the Central Drugs Standard Control Organisation (CDSCO) to conduct a separate clinical trial of its COVID-19 vaccine 'Covaxin' through intradermal route, which is just under the skin. Currently, the vaccine is being tested through intramuscular route, where it is injected directly into the muscle.
"The firm presented their proposal for conduct of phase I/II clinical trial of CoronaVirus Vaccine by intradermal (ID) route. The firm also presented their animal toxicity data generated through intradermal route and interim safety data from phase I study through intramuscular route," as per the minutes of a 13 August meeting which have been uploaded on the website of the CDSCO.
After detailed deliberation, the committee has recommended for grant of permission to conduct the Phase I and II clinical trial through ID route, as per the report.
The CDSCO is an arm of health ministry that regulates the quality of drugs and vaccines in the country. Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of drugs, conduct of clinical trials, grant of licenses of vaccine and laying down the standards for them.
The approval, however, is subject to condition that participants should be "followed up for six months" for clinical and antibody titer assessments. Besides, Bharat Biotech has been asked to develop separate clinical trial sites for this study from the existing sites of the intramuscular study.
Last month, Bharat Biotech started clinical trials for India's first Indigenous COVID-19 vaccine, Covaxin, on 1,125 patients at 12 hospitals across the country including All India Institute of Medical Sciences. The vaccine is being developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), Pune.
The ongoing trial of Covaxin will be conducted on over 1,100 people in two phases. For the first phase of clinical trials, the company plans to enroll 375 participants to test COVID-19 vaccine candidate. Based on the first trial's results, it has a plan to enroll 750 people in the second phase of trial.
The indigenous, inactivated vaccine is being developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India. The company is yet to announce when it will launch the vaccine, though Bharat Biotech's CMD Krishna Ella had said that to ensure safety and efficacy it would not expedite the vaccine with short-cuts.
Meanwhile, Serum Institute's 'Covishield' is likely to be launched in the first week of December. The government has given the company a 'special manufacturing priority license' and fast-tracked the trial protocol processes to get the trials completed in 58 days. The trial among 1,600 volunteers at 17 centres, each with about 100 volunteers, started on Aug 22.
By Chitranjan Kumar
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