Hyderabad: The subject enrollment 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.
On the direction of the Indian Council of Medical Research (ICMR), authorities at NIMS began the process to register 30-60 subjects for the trial.
Blood and swab samples of the subjects will be collected and if found fit they will be administered the first dose of the vaccine after a week.
NIMS Director Dr K. Manohar told reporters that healthy subjects will be screened and their blood and swab samples sent to ICMR-designated lab in New Delhi. After receiving the test reports, the Department of Medicine will analyse the same and issue the fitness certificates to the subjects.
The subjects would be administered two doses of the vaccine. There will be two vaccine dosage of three micrograms and six micrograms, and a placebo.
Each subject would be given the second dose of the same vaccine after 14 days.
For two days after administering the vaccine, the subjects would be monitored for two days in the ICCU at NIMS by a team of doctors, after which they would be sent home and monitored through videoconference or phone.
The phase-I clinical trial would go on for 28 days, after which the ICMR and the Drug Controller General of India (DGCI) would accord permission for Phase-II trial with more subjects.
Phase-1 would have around 375 subjects across the country and Phase-II 875.
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.
“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 vaccine is being derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune. ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine,” he wrote.
While experts raised doubts on the August 15 target, the ICMR defended it, saying its process is in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.
The research body said the Director’s letter was intended to cut red tape, without bypassing any necessary process, and speed up recruitment of participants for human trials so that these phases can be completed at the earliest.
BBIL refused to comment on ICMR’s August 15 deadline.
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.