JOIN USICMR's vaccine rush raises eyebrows
In a controversial move, the Indian Council of Medical Research (ICMR) said it wants to squeeze the long-drawn process of vaccine development into 40 days, eyeing an Independence Day public launch of the first indigenous vaccine against Covid-19.
The decision has not only come under serious criticism from independent scientists and public health experts but has even made the vaccine's manufacturer – Hyderabad-based Bharat Biotech – uncomfortable, as the company refused to put a deadline on the vaccine's commercial launch in the absence of even preliminary human trial data.
A day after the company announced receiving the DCGI approval for phase-I and phase-II clinical trials of Covaxin, the apex council wrote to 12 hospitals chosen for the trial asking them to set a July 7 deadline for enrollment of participants for the phase-I trials to check the safety of the vaccine while reminding them to accord “highest priority” to the project that was being monitored at the “topmost level in government”.
“It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials,” Bhargava said in the letter dated July 2.
But Bharat Biotech Chairman and Managing Director Krishna Ella was non-committal on any launch date for the vaccine.
“I cannot commit now on when the trial would start and when we would receive the results,” Ella told DH.
Health experts scoffed at the “deadline-oriented” clinical trials, wondering whether the efficacy of the vaccine was pre-decided.
“For a vaccine for which pre-clinical development is still ongoing, as per the letter itself, how can clinical trial recruitment be starting on July 7? And that the vaccine will be launched on August 15? A vaccine trial completed in little over a month, efficacy pre-decided,” said Anant Bhan, former President of the International Association of Bioethics.
For comparison, the indigenous rotavirus vaccine — also manufactured by Bharat Biotech — took three decades to come to the market after the strain was isolated at the All India Institute of Medical Sciences in the mid-1980s.
“It is not possible for human safety, immunogenicity and efficacy studies on a new vaccine to be completed in four weeks. If the aim is to give the people of India a safe and efficacious vaccine, ICMR should reconsider its directive,” a senior biologist who doesn't want to be identified told DH.
According to the Clinical Trials Registry-India, the Phase-I and Phase-II clinical trials of the Covaxin will be carried out on 1,125 participants across 12 hospitals that include AIIMS in Delhi and Patna, and the Nizam’s Institute of Medical Sciences in Hyderabad.