The Indian Council of Medical Research (ICMR) plans to launch the indigenous Covid-19 vaccine (BBV152 COVID vaccine) by 15 August. Twelve select institutes have been asked to fast-track approvals for clinical trials of COVAXIN. Recruitment for human clinical trials has to be completed by 7 July, and all stakeholders have been asked to treat this as top priority. Final outcome of the vaccine’s success will depend on cooperation of all clinical trial sites
The ICMR had partnered with Bharat Biotech and National Institute of Virology for manufacturing the vaccine. SARS-CoV-2 strain was isolated in NIV, Pune before being transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and made in Bharat Biotech’s High Containment BSL-3 (Bio-Safety Level 3) facility located in Genome Valley in Hyderabad.
The institutes selected for clinical trials are located in Goa, Patna, Delhi, Nagpur, Rohtak, Visakhapatnam, Belgaum, Kanpur, Kattankulathur, Gorakhpur, Arya Nagar and Hyderabad.The Drug Controller General of India (DCGI) has already granted permission to pharma major Zydus Cadila for conduction of Phase I and Phase II human clinical trials for COVID-19 vaccine.
Zydus Cadila had earlier stated that the potential vaccine displayed a strong immune response in animal studies. Produced antibodies were able to fully neutralise virus, for which it will start over 1000 human trials at many places in India.
Meanwhile, experts have raised concerns over the ICMR’s move to fast-track vaccine development and set a deadline for 15 August. “For a vaccine for which preclinical development is still ongoing, how can clinical trial recruitment be starting on July 7 and the vaccine be launched on August 15? A vaccine trial completed in little over a month, efficacy predecided?” Anant Bhan, a researcher at the Global Health, Bioethics and Health Policy, said in a series of tweets on this development.
He has also raised questions on the medical institutes that have been selected for human trials for this vaccine. “How were the clinical trial sites mentioned in the appendix chosen—on what criteria? What was their eligibility? From which list was this selection done by ICMR? Some of these institutes seem to be small nursing homes/ hospitals. Are they the apt place to run a pandemic vaccine trial?” he asked.