ICMR says move to fast-track COVID-19 vaccine is in accordance with global norms

India’s top health research body on Saturday said that fast tracking of clinical trials of the indigenous Covid-19 vaccine being developed by Bharat Biotech International Ltd is in accordance with the globally accepted norms.

"In the larger public health interest, it is important for ICMR to expedite clinical trials with a promising indigenous vaccine," said ICMR in a statement, a day after a letter by its Director General seeking to fast track clinical trials so that the vaccine could be launched by Aug 15 stirred a row among medical professionals and healthcare experts.

However, it said that the letter sent by DG, ICMR was meant to cut “unnecessary red tape”and ICMR was committed to treat the safety and interest of people of India as a topmost priority.

Justifying its move, ICMR further said that it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine in the larger public health interest.

“Faced with the unprecedented nature of the COVID-19 pandemic, and the consequent dislocation of the normal life, all other vaccine candidates across the globe have been similarly fast-tracked,” said ICMR in its release dated July 4.

“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, it further said.

In its letter the ICMR had also instructed the clinical trial sites to enrol the participants by July 7. While questions have been raised on an accelerated approach, ICMR said that 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.

“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 aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay,” it further added.

It said 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 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”.

Vaccine maker BBIL received the regulatory nod from the Drug Controller General of India (DCGI) to start human clinical trials for its experimental vaccine last week.