A day after the August 15 deadline for a COVID-19 vaccine created controversy over the safety and efficacy of the product, the ICMR got into defensive mode and said that the order to fast-track clinical trials was to cut “red tape”.
On July 2, in a letter to the 12 hospital sites, as well as Hyderabad-based Bharat Biotech, the ICMR DG, Dr Balram Bhargava had said that there were plans to launch the vaccine for public health use latest by August 15, 2020, after completion of all clinical trials. The letter asked them to recruit human participants for the trial by July 7.
Experts criticised the ICMR’s move to hasten clinical trials and pressurise research institutions to recruit participants in a short time window.
In a bid to clarify its position on the issue, the ICMR said that the letter was to ensure that trials were fast-tracked and “unnecessary red tape”, and that recruitment for participants were done without bypassing necessary procedures. It, however, did not clarify on the August 15 deadline for the vaccine.
“Just as red tape was not allowed to become a hindrance in the fast track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement,” the ICMR said in the statement.
Based on data from pre-clinical studies, the Drugs Controller General of India has given its permission to conduct phase 1 and 2 clinical trials to Bharat Biotech, the company that is working on the indigenous vaccine with the ICMR. “The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay,” the statement reads. The population-based trial is part of the final phase where vaccine efficacy is tested, before it is licensed and marketed.
The ICMR has also said that the trials would follow best practices and rigour and would be reviewed by a data safety and monitoring board, too, and international norms would be followed.
“Our trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB). While issues raised in public domain from time-to-time by commentators are welcome, as they form an important part of feedback loop, the best of India’s medical professionals and research scientists should not be second guessed for their professionalism or adherence to the highest scientific rigour.”