NEW DELHI: The order issued by the Indian Council of Medical Research (ICMR) to 12 hospitals to prepare Covid-19 vaccine by August 15 could be the first instance of a deadline being set for a vaccine launch globally.
Several virologists, epidemiologists, and health experts this reporter spoke to compared the letter to a “military diktat.”
The letter, sent by ICMR director-general Dr. Balram Bhargava on Thursday, 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.
It also said that ethical committees of the hospitals should grant immediate permission to the trials and “non-compliance will be viewed very seriously.”
Experts said this letter could cause unprecedented dent to ICMR’s reputation of conducting, promoting and monitoring high-quality medical research built over decades.
“Science is about the pursuit of truth and researchers cannot be forced to produce biased evidence in order to please their political masters but that is exactly what this diktat is asking them to do,” said one of the country’s most well-known virologists Dr. T Jacob John who has been associated with Christian Medical College, Vellore, for long.
“It means the government agency has passed the judgment that the vaccine is safe and effective even without a single human being has got the jab yet.”
Dr. John also stressed that the move will make India a “laughing stock” worldwide.
Researcher and senior doctor at MGIMS, Wardha, Dr. S P Kalantri pointed out that vaccine development takes months to years.
“It's simply not possible to judge a vaccine in weeks as safety and efficacy of a formulation can be assessed only over a period of time,” he said. “I do not understand how the ICMR is expecting hospitals to enroll subjects within 3-4 days when there is so much concern and anxiety about the disease. It could even lead to unethical practices under enormous pressures by researchers at chosen sites.”
And it's not only independent researchers who seem worried, some of the principal investigators chosen for the project too are uncomfortable with the timeline and language in the letter.
“I found the content and language of the directive beyond bizarre,” said a principal investigator named in the letter. “There is an established scientific protocol to carry out clinical trials of drugs and vaccines—I am shocked how ICMR has side-lined its own guidelines so brazenly,” he said.
A senior virologist attached with the government said that the “pace of the development is impossible and the whole approach to research is unethical.”