Early launch date in step with globally acceptable norms for fast tracking COVID-19 vaccine

ICMR

Many medical experts have expressed apprehensions about the August 15 deadline for the vaccine being developed by Bharat Biotech-ICMR. Experts say that clinical trials is a long drawn process and setting early deadlines would dent India’s reputation of conducting, promoting and monitoring high-quality medical research built over decades.

Today the ICMR has clarified 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.

Two days back a letter issued by ICMR director-general Dr. Balram Bhargava to 12 hospitals in 10 states said that subject enrolment for the vaccine developed by Bharat Biotech, in collaboration with the National Institute of Virology, should be completed by July 7 as the government is looking to launch it for the public by Independence Day.

ICMR has clarified 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.

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Citing more examples of fast tracked approvals. ICMR has 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 aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay.

 

 

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