Health experts and the medical community are in shock, with some of them even terming as “unethical” the haste being shown by the government-owned Indian Council of Medical Research (ICMR) to roll out Covaxin, a vaccine for prevention of COVID-19 before August 15, “even without its trial being started.”
Social media was also abuzz with speculation that “politics was overtaking science” and that ICMR was probably fast-tracking the vaccine so that the Prime Minister could make a grandiose announcement of an indigenous vaccine on August 15, India’s Independence Day.
The controversy began on Friday, when ICMR’s Director General, Balram Bhargava, wrote a letter to 12 hospitals participating in the trials to “fast-track all approvals”, warning that “non-compliance will be viewed very seriously. The letter highlighted that vaccine was the ‘top-most priority” of the government.
The letter clearly says that “it is envisaged to launch the vaccine for public health use by 15th August 2020 after completion of all clinical trials.”
Incidentally, Covaxin, being jointly developed ICMR and Hyderabad-based private firm, Bharat Biotech, was approved for human trial only on June 29. This means that the window for clinical trials is only about a month and a half.
Reacting to the letter, former health secretary Sujatha Rao tweeted: “Someone should brief de DG ICMR about the processes involved in coming out with a vaccine ....BB has just got the permission for phase1 & 2. will take them a good 4 months at the fastest & based on outcome phase 3. Which magic wand does ICMR have to produce it in six weeks.”
Someone should brief de DG ICMR about the processes involved in comming out with a vaccine ....BB has just got the permission for phase1 & 2.will take them a good 4 months at the fastest & based on outcome phase 3. Which magic wand does ICMR have to produce it in six weeks ?
— K Sujatha Rao (@sujakrao) July 3, 2020
Attaching Bhargava’s letter, Anant Bhan, a trained doctor and researcher, and former President, International Association of Bioethics (2017-19), in a Twitter thread questioned the medical ethics behind the rush to launch the vaccine, which is at a “pre-clinical stage.”
“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?”
Bhan further questioned what the criteria were behind choosing the clinical trial sites.
“Was this selection done by ICMR or BBIL? Some of these seem to be small nursing homes/hospitals – are they apt place to run a pandemic vaccine trial?” he said.
This is a letter which has been sent out by the ICMR DG yesterday. Now that multiple folks have confirmed genuineness, let me raise some issues with this letter on #vaccine #trials during a pandemic, in this case #COVID19
What are the ethical issues in this letter? Read on. pic.twitter.com/EaJkeaHjmV
— Anant Bhan (@AnantBhan) July 3, 2020
According to a report in ThePrint, Bharat Biotech has itself, in its submission to the Clinical Trial Registry of India, “submitted that the duration of the trial is a year and three months. The trial protocol requires follow-ups on Day 14, Day 28, Day 104 and Day 194, which means over six months.”
However, Bhargava’s letter mentions that the hospitals should try and enrol patients “no later than July 7”, implying a very short timeline for the trials to complete, something unheard of in the medical fraternity.
"I have never heard or read an announcement of a vaccine being available in the market even before its trial has started," epidemiologist Tanmay Mahapatra, told journalist Faye D’Souza in an interview.
Speaking with Scroll, Vasantha Muthuswamy, chairperson of the ethics advisory committee of the ICMR’s bioethics cell, said she had not seen Bhargava’s letter, but conceded the timelines were too short.
“By general experience, a month to decide whether to release a vaccine is a very short time,” she said. “Even if you fast-track it, it will take a minimum of one year.”
According to the appendix to Bhargava’s letter, the vaccine trials are to be conducted at 12 institutes--All India Institute of Medical Sciences in Patna and Delhi, Gillukar Multispeciality Hospital in Nagpur, Institute of Medical Sciences and SUM Hospital in Odisha, Jeevan Rekha Hospital in Belgaum, King George Hospital in Visakhapatnam, Nizam’s Institute of Medical Sciences in Hyderabad, PGIMS in Rohtak, Prakhar Hospital in Kanpur, Rana Hospital and Trauma Center in Gorakhpur, Redkar Hospital and Research Centre in Goa, and SRM Hospital & Research Centre in Tamil Nadu.
Political leaders and health activists, too, have raised ethical questions over ICMR’s letter and the criteria for selecting the hospitals.
“How can ICMR decide on vaccine launch date without regulator DCGI evaluating evidence of safety and efficacy? What liability is ICMR assuming in aggressively pushing the trial of a vaccine produced by a private company?” tweeted Sitaram Yechury, general secretary of Communist Party of India (Marxist).
Some serious questions need to be answered: #Vaccine
?How can ICMR decide on vaccine launch date without regulator DCGI evaluating evidence of safety and efficacy? What liability is ICMR assuming in aggressively pushing the trial of a vaccine produced by a private company?
— Sitaram Yechury (@SitaramYechury) July 4, 2020
Yechury goes on to question how ICMR selected the institutions which will conduct the trial? “Three of them are private institutions, including a private practitioner who has no institutional address!” he pointed out.
The question topmost among the health community and medical fraternity seems to be: Is ICMR under political pressure?
Vaccine Can’t be Expected This Year: CCMB Director
In Hyderabad, Rakesh K Mishra, Director of CSIR-Centre for Cellular and Molecular Biology, said a vaccine for COVID-19 cannot be expected before early next year as the process involves a lot of clinical trials and data testing.
Mishra said the ICMR's letter in this regard may be for internal consumption and aimed at putting pressure on hospitals to get ready for clinical human trials.
"If everything goes absolutely really like a textbook plan, then we are talking about six to eight months to think of something that now we have a vaccine. Because you have to test in large numbers. It is not like a drug that if somebody is sick you give and see if it is cured or not," Mishra told PTI when asked about the possibility of the vaccine becoming ready by August 15.