Delhi: 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 a vaccine by August 15, has caused a furore in the medical and scientific fraternity.
ICMR and Bharat Biotech are jointly working on the preclinical and a clinical development of the aforementioned 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.
Dr Balram Bhargava’s July 2 directive to lead researchers of several institutions chosen as test sites to complete clinical trials soon so as to have the world’s first Covid-19 vaccine ready on August 15 has dented the credibility of India’s apex medical research body that he heads, say top scientists, government officials, and public health experts, who are not buying the research’s agency argument that the letter was an effort to speed up vaccine trials.
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.
The Indian Academy of Sciences @IAScBng has put out a press release today expressing concerns on the letter issued by ICMR pic.twitter.com/BpbZakqqZ9
— Anant Bhan (@AnantBhan) July 5, 2020
45-day timeline unrealistic?
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.
The pre-clinical study has not been published.
“In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine… 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 added in the statement.
“It is good to be ambitious and aspirational but it should not be done at the cost of due diligence for ensuring the safety and efficacy of the vaccine. I would Iike to believe that it is a typographical error of saying 2020, instead of 2021. If not, the implications are serious as the proposed vaccine can only be ready by August 15 by fudging data or incomplete documentation. There is no other way,” said K Sujatha Rao, former secretary, ministry of health and family welfare.
While the vaccine trials can be fast-tracked, it still takes over a year to launch and commercialize the product, experts said. So all eyes are on August 15 to find out if the claims of India’s premier medical body falls flat or come true.
PNN/Agencies