India’s apex medical research body has announced that the country should have its coronavirus vaccine ready in time for Independence Day on August 15. However, experts notwithstanding ICMR’s ambitious timeline have questioned how all three phases can be concluded within a month and a half.
By A. Ahmad
On July 3, the Indian Council of Medical Research (ICMR) announced that it would launch the indigenous COVID-19 vaccine for public use by August 15 after completion of clinical trials. India’s national broadcaster Prasar Bharati News Service tweeted about it.
The ICMR has selected 12 institutes for the clinical trial of ‘Covaxin’. In a letter to these institutes, the ICMR has said that it has partnered with Bharat Biotech International Limited (BBIL), a private biotechnology company headquartered in Hyderabad, to fast track clinical trials of indigenous COVID-19 vaccine (BBV152 COVID-vaccine).
It said that the vaccine is the first indigenous vaccine developed by India and is one of the top priority projects which is being monitored at the topmost level of the government.
Few facts from the ICMR letter:
1) ICMR has partnered with Bharat Biotech International Limited (BBIL) for clinical trials of indigenous vaccine ‘Covaxin’ for the coronavirus disease.
2) Bharat Biotech India Ltd’s COVID-19 vaccine ‘Covaxin’ has become the first candidate developed in India to receive the Drug Controller General of India’s (DCGI) approval to enter human trials.
3) The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s facility located in Genome Valley in Hyderabad.
4) The 12 institutes selected for the clinical trial are located in Visakhapatnam, Rohtak, New Delhi, Patna, Belgaum (Karnataka), Nagpur, Gorakhpur, Kattankulathur (Tamil Nadu), Hyderabad, Arya Nagar, Kanpur (Uttar Pradesh), Goa, and Bhubaneswar-based Institute of Medical Sciences and SUM Hospital.
Top health professionals of the country took to microblogging site Twitter to express their reservation.
Anant Bhan, Global Health, Biotech, and Health Policy Researcher, in a series of scathing tweets, raised a few significant questions. His tweet published on July 3 read: “Such an accelerated development pathway has not been done ever for any kind of vaccine, even for the ones being tried out in other countries.”
“For a vaccine for which pre-clinical development is still ongoing, as per the letter itself, how can clinical trial recruitment be starting on 07th July? And that the vaccine will be launched on 15th August? A vaccine trial completed in little over a month, efficacy pre-decided?” he asked.
His tweet further read: “How were the clinical trial sites mentioned in the appendix chosen–on what criteria and eligibility? From what list? Was this selection done by ICMR or by BBIL? Some of these seem to be small nursing homes/hospitals- are they the apt place to run a pandemic #vaccine trial?”
According to Bhan, even the tone of the letter read more like a threat. The letter said: “Get everything done by 7 July and start clinical trial participant recruitment. Otherwise, non-compliance will be viewed seriously?”
“By whom? By ICMR? Under what power?” he questioned through a series of tweets.
So, does this mean all these ‘institutions’ have to follow all due processes to enable this trial to be run within 5 days from the letter? Including ethics committee approvals? Is that not undue pressure on the institution and committees?
Besides, according to Bhan, the letter uses the term ‘subjects’ for clinical trial ‘participants’. The ICMR’s own ethics guidelines have moved on to use more ethically acceptable terms ‘participants’ rather than subjects. Subjects are used typically by pharma in regulatory studies. So does that mean the letter in question was written by BBIL and not ICMR?
Bhan also raised a point on the eligibility of the sites chosen for clinical trials. “How were the clinical trial sites mentioned in the appendix chosen–on what criteria? Eligibility? From what list? Was this selection done by ICMR or by BBIL? Some of these seem to be small nursing homes/hospitals- are they the apt place to run a pandemic #vaccine trial?” he asked.
Bhan emphasised that such an accelerated development pathway has not been done ever for any kind of vaccine, even for the ones being tried out in other countries. “Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to process,” read his tweet that was liked, shared, and retweeted thousands of times.
Meanwhile, Dr. Shenoy Robinson, advisor and thought leader on healthcare, MD Catex Health, and Chairperson CII Technical Committee on Health added, “How do you “fast track” vaccine development? Were we deliberately delaying vaccine development in the past? Or, will we now subvert protocols and use smart management? Even before it is developed, the vaccine is in the danger of losing credibility, unfortunately!”
However, in a sudden turn of events, the ICMR said that its letter “was meant to cut unnecessary red tape”.