ICMR Director General Balram Bhargava's letter to 12 principal investigators instructing them to fast-track approvals to initiate clinical trials of Bharat Biotech's COVID-19 vaccine with an aim to launch by August 15, has caused a storm in the scientific community.
ICMR and Bharat Biotech are jointly working on the preclinical as well as clinical development of this vaccine.
It is not just the deadline, the tone and tenor of the letter that warned that non-compliance will be viewed very seriously, has sparked more controversy.
Vaccine experts raised serious concerns, calling the timelines unprecedented and unrealistic.
They pointed out that ICMR, in a rush to launch the vaccine, may end up compromising on safety and efficacy of the vaccine. Opposition parties wondered whether ICMR was acting as per scientific principles, or pandering to the whims of political bosses.
ICMR has issued a press release, toning down its earlier stance, saying that the DG-ICMR letter 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.
Also Read: ICMR says move to fast-track COVID-19 vaccine in accordance with global norms
"Just as red tape was not allowed to become a hindrance in the fast track approval of 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," ICMR said.
To be sure, no one is questioning the intent of ICMR to speed up the trial and cut the red tape.
45-day timeline
But setting a timeline of less than 45 days, is something many found difficult to grasp. In normal times, it takes about 5-15 years to develop a vaccine, but due to urgency given the pandemic situation, the timelines are compressed. Most companies and countries are now talking about 15-18 months, much of that time is taken to test the vaccine on humans.
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Even a 15-18-month timeline is a miracle, because it's a new virus, we have a very limited view of how long the vaccine protects us against COVID-19. We don't have definite answers how the vaccinated people would react to the next outbreak. Will the vaccine provide protection to high risk populations such as children and elderly people.
It is understandable that the government wants to give some hope to people. Announcing a launch date even before the vaccine is tested on first human for safety and efficacy, not only puts undue pressure on people working on the vaccine, but also creates a sense of false hope among public, making them complacent to throw winds to basic preventive measures such as social distancing, masking and personal hygiene.
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