India’s premier medical research agency the Indian Council of Medical Research (ICMR) wants to launch its COVID-19 vaccine ‘Covaxin’ by August 15 in partnership with Bharat Biotech International Limited.
The institutes have been asked by the ICMR to step up clinical trials as it is a “priority project” monitored at the topmost level of the government. A dozen institutes have been selected for clinical trials of the indigenous COVID-19 vaccine (BBV152 COVID vaccine), the government’s top medical research body has said. “The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.
The ICMR talked about plans to launch the vaccine for public health use by August 15, Independence Day. Experts have questioned the deadline, since the clinical trial is yet to begin.
ICMR director general Balaram Bhargava strictly advised all stakeholders to ensure human volunteer enrollment is initiated no later than July 7, ‘in view of public health emergency’ and the ‘urgency to launch the vaccine’.
The final outcome will depend on the cooperation of all clinical trial sites involved in this project, the ICMR told the institutes, advising them to speed up approvals related to clinical trials and ensure that subjects are enrolled starting this week.
Bharti Biotech’s application for clinical trial, reveals that the estimated duration of the trial is one year and three months. The sample size of the study is 1,125 people between 12 and 65 years. Out of the 12 institutes picked BY ICMR, seven are yet to establish an “Ethics Committee” to oversee the trial.
While ICMR has refused to comment on its letter, Satyajit Mohapatra, who is in charge of the clinical trial in SRM Hospital and Research Centre, Tamil Nadu: “ICMR has given a timeframe for completion of Phase 1 of the trial by August. Phase 2 of the study will start after completion of Phase 1, followed by Phase 3.”
The Phase 1 is planned for completion in 28 days, which would meet the August 15 deadline. It is not clear how the vaccine can be made available for public use with just the results of the first phase.
Worldwide, scientists are racing to produce a vaccine for the deadly virus that has infected over 10 million, including 600,000 in India, and caused more than 500,000 deaths.
No vaccine has yet been approved for commercial use against COVID-19. More than a dozen possible vaccines from over 100 being developed globally are being tested on humans. Some have shown potential in early-stage trials.
Industry experts say this could be only an aspirational target and directive to speed up the trials, than a realistic move to get the vaccine launched within one and a half months. “Nowhere in the world has a vaccine or drug launched within two months of approval for clinical trials and it is impossible even if the vaccine is successful,” said a top level R&D scientist with a Mumbai-based drug company.