The Indian Council of Medical Research on Saturday issued a statement after health experts voiced apprehension over the medical body’s plan to launch a COVID-19 vaccine by August 15 this year, stating that the letter was sent to ‘cut unnecessary red tape’.
ICMR in a letter on July 2 had asked 12 labs and hospitals to fast-track human clinical trial approvals for the vaccine candidate ‘Covaxin,’ which is being developed in collaboration with Bharat Biotech International Limited (BBIL).
Two days later, the ICMR issued a statement that based on in-depth scrutiny of the available data from preclinical studies, the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 clinical trials.
“The letter by DG-ICMR to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants,” ICMR said. “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 medical research body added that it was important to expedite the clinical trials with a promising indigenous vaccine in the larger public health interest. The statement added that all other vaccine candidates across the globe have been similarly fast-tracked.
“ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel,” the ICMR statement said.
The statement added that the 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 the public domain from time-to-time by commentators are welcome, as they form an important part of the 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,” the statement also said.
Experts had flagged ICMR’s August 15 deadline as a ‘pipe dream’ stating that vaccine trials should not be hurried and such a deadline may impact ICMR’s reputation in the world.