Hyderabad, July 7 (IANS) The subject enrolment for Phase-I clinical trial of India’s first indigenous vaccine for COVID-19 began at Nizam’s Institute of Medical Science (NIMS) here on Tuesday.Hyderabad-based Bharat Biotech is expected to begin human trials of its COVID-19 vaccine, candidate, COVAXIN, next week. COVAXIN, which is India’s first indigenous vaccine against the novel coronavirus and has been developed by Bharat Biotech in collaboration with ICMR and NIV, Pune, will be tested on more than 1,100 people in phase 1 and 2 clinical trials.
NIMS is one of the hospitals selected by the ICMR to undertake clinical trials of Covaxin, which it is developing in partnership with Hyderabad-based Bharat Biotech International Limited (BBIL).
Meanwhile, the Ethics Committee at King George Hospital (KGH) in Visakhapatnam will hold a crucial meeting on Tuesday to finalise the preparations for the clinical trials. KGH is also one of the hospitals selected by ICMR for the trials.
In a letter to the heads of the selected institutions last week, ICMR Director General Balram Bhargava asked them to fast-track all approvals related to initiation of the clinical trials and ensure that the subject enrollment is initiated no later than July 7. On July 2, ICMR Director chief Dr Balram Bhargava wrote to 12 trial sites for the indigenous vaccine, stating that all clinical trials need to be completed by August 15. However, the August 15 target was criticised by experts who said that fast-tracking vaccine trials in four weeks could pose serious health risks. In a statement on Monday, the Indian Academy of Sciences, a Bengaluru-based body of scientists, said that while it wishes the vaccine is quickly made available for public use, the announced timeline is únfeasible’ and unrealistic’.
“It is envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target; however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” reads the letter dated July 2.
He noted that this is the first indigenous vaccine being developed by India and is one of the top priority projects that is being monitored at the topmost level of the government
The company had announced on June 29 that it had successfully developed Covaxin, India’s first vaccine candidate for COVID-19, in collaboration with the ICMR and NIV.
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine has been developed and manufactured in Bharat Biotech’s BSL-3(Bio-Safety Level 3) High Containment Facility located in Genome Valley, Hyderabad, the company said.
The Drug Controller General of India – Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.