Bharat Biotech has successfully developed COVAXIN™, India’s 1st vaccine candidate for COVID-19, in
collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology
(NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The
indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety
Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
The Drug Controller General of India – CDSCO, Ministry of Health & Family Welfare granted
permission to initiate Phase I & II human clinical trials after the company submitted results generated
from preclinical studies, demonstrating safety and immune response. Human clinical trials are
scheduled to start across India in July 2020.
Four days after Bharat Biotech announced that it has successfully developed COVAXIN, a vaccine candidate for COVID-19, ICMR said that it wanted to “launch the vaccine for public health use latest by 15 August”. A letter, issued by the Director General of ICMR Dr Balram Bhargava, said, “This is the first indigenous vaccine being developed by India and is one of the top priority projects which is being monitored at the topmost level of the government. The vaccine is 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. It is envisaged to launch the vaccine for public health use latest by 15 August, 2020, after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project.” The plan was disclosed in a letter by the Indian Council of Medical Research to 12 institutes where human trials are to be held for the vaccine, Covaxin, ordering them to secure necessary approvals from internal committees by July 7 with a warning that “non-compliance will be viewed very seriously”.
Dr Anant Bhan, a researcher in global health, bioethics and health policy, spoke to Firstpost about the extreme urgency of the situation. “It’s understandable for a pandemic of this scale. But we can’t compromise on the safety and the efficacy aspects. Minimum standards around safety, efficacy and quality need to be followed. Collapsing the entire process to just 45 days is unlikely, and almost impossible,” he said. The expected duration of the trial, according to the government’s official clinical trial registry, is one year and three months.
Criticised for setting an unreasonable deadline that would affect safety, efficacy and quality, ICMR later suggested that it was only making an effort to put out trial data by August 15. “Request has been made to fast track the vaccine trials,” said Dr Rajnikant Srivastava, spokesperson, ICMR, in a text message. No order was issued.
ICMR’s position also surprised experts because data about the vaccine’s preclinical performance has not been made public yet.