New Delhi: Against the backdrop of August 15 timeline issued by Indian Council of Medical Research (ICMR) to launch the indigenous COVID-19 vaccine, researchers related to Bioethics and experts have raised questions over such deadline given the fact that clinical trial needs months of research and experiment to get a vaccine.
ICMR was, however, quick to react that "it was just a letter asking the institutes to fast track the vaccine trials. The vaccine already got Drug Controller General of India's approval."
"The Director-General has sent the letter requesting to fast track the vaccine trials. We are clarifying that there was no forcible time limit given to the clinical trial institutes," said Dr Lokesh Sharma, a senior scientist in ICMR to ETV Bharat.
The ICMR letter issued by DG Dr Balram Bhargava that generated attractions said, "It is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project."
Dr Bhargava asked all 12 medical institutes and sites selected for the clinical trial, to fast track all approvals related to the initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7, 2020.
"For a vaccine for which pre-clinical development is still going on, how can clinical trial recruitment be started on July 7...A vaccine trial completed in little over a month, efficacy pre-decided?" said Dr Anant Bhan, a researcher on Bioethics.
He also raised questions over the criteria under which the 12 sites have been chosen. "Some of these seem to be small nursing homes and hospitals, are that the appropriate place to run a pandemic vaccine trial," said Dr Bhan.
It may be mentioned here that Bharat Biotech with which ICMR and NIV, Pune has jointly been developing the vaccine named "COVAXIN", had recently said that Drug Controller General of India-CDSCO granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from preclinical studies.
The preclinical studies demonstrate safety and immune response. Under the preclinical trial, scientists give the vaccine to animals such as mice or monkeys to see if it produces an immune response.
After preclinical testing, it comes phase I safety trials on a small number of people, followed by phase II expanded trial on hundreds of people split into groups such as children and elderly.
If the phase II trial passes the safety and ability test to stimulate the immune system, it comes the phase III efficacy trial where the vaccine is given to thousands of people. This trial determines whether a vaccine protects against any pandemic.
However, in a pandemic situation, a vaccine may receive emergency use authorisation before getting formal approval.
Dr Sharma said that clinical trials (Phase 1-3) need more than 60 days.
"After all the trials are over, then comes the patients' followup process which is also a lengthy process," said Dr Sharna from ICMR.
Experts said that looking into the urgency of a situation, phase I and II or phase II and III trial can be clubbed together.
Researchers around the world are developing more than 145 vaccines against the Coronavirus pandemic out of which 20 vaccines are in human trials.
Interestingly, at a time when Hyderabad based Bharat Biotech's COVAXIN became the first indigenous vaccine candidate to get the nod for the clinical trial, Ahmedabad based Zydas Cadila Healthcare also got approval from the DCGI to conduct phase I and II human trials for its vaccine "ZyCoV-D".
Officials said that the DCGI gave the approval on a fast-tracked basis.
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