Indian clinical research body justifies timeline for coronavirus vaccine trials


Indian Council of Medical Research, a leading clinical research agency in the country on Saturday justified its decision to fast-track development of a potential coronavirus vaccine.

In a response to several concerns raised by health experts on the schedule for the clinical trials of the vaccine, the agency disclosed on Saturday 4th July 2020 that the schedule was in line with international standard.

“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,” ICMR said in a statement released on Saturday.

ICMR Director General Balram Bhargava said it is the agency’s plan to see that the vaccine is launched for public health use by 15th August and by 7th July patient enrolment for human trials would be commenced.

The vaccine being collaboratively developed by the ICMR and Bharat Biotech in India is one of the potential coronavirus vaccines being tested globally.

Considering the normal standards for vaccine development it usually takes years to complete but giving the emergency nature of the pandemic, the bureaucratic red tape has been skipped to fast track vaccine production.

Despite the knowledge of the protocols being relaxed, ICMR’s vaccine development timeline has received a barrage of criticism from health experts in India who entertain fear that public safety and ethics would be compromised during the trials.

The criticism came following a leaked letter from ICMR on Friday in which the agency stated the timeline for the vaccine trials.

While justifying its intent, the agency said the letter “was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.”

It was stated that the aim of the timeline is to avoid unnecessary protocols and ensure completion of the phases of the trials on time.

“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.

ICMR equally emphasized that it is in the public health interest that the agency deems it necessary to fast track clinical trials of the indigenous vaccine.

“In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine,” the statement noted.

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