Make haste, but slowly say experts as Bharat Biotech officials keep mum on ICMR's 15 Aug deadline
While the ICMR has said it is important to expedite the clinical trials for a promising indigenous vaccine in the public interest and that all other vaccine candidates across the globe have been similarly fast-tracked, scientists in one voice have cautioned against being over-optimistic
The Indian Council of Medical Research's 15 August deadline for "a usable coronavirus vaccine" coming just a handful of days after Bharat Biotech's announcement of a successful vaccine candidate 'COVAXIN' has not gone down well with medical experts who have stressed the need to adhere to the highest scientific and ethical standards and conveyed worry about the unfeasibility of such a timeline.
While the ICMR has said it is important to expedite the clinical trials for a promising indigenous vaccine in the public interest and that all other vaccine candidates across the globe have been similarly fast-tracked, scientists in one voice have cautioned against being over-optimistic while Bharat Biotech officials have, in an action that speaks louder than words, refused to comment on the ICMR's deadline.
The Hyderabad-based organisation, one of seven Indian companies involved in the indigenous production of a vaccine for the novel coronavirus, said that phase 1 and 2 clinical trials of 'COVAXIN' in COVID-19 patients will begin this month after a go-ahead from the Central Drugs Standard Control Organisation (CDSCO).”
'Unfeasible, without precedent'
On Sunday, the Indian Academy of Sciences (IASc) slammed the ICMR's letter, saying while it welcomes the exciting development of a candidate vaccine and wishes it is quickly made available for public use, it strongly believes that the deadline is unfeasible and it has raised "unrealistic hopes and expectations" in the mind of citizens.
The IASc, outlining a whole host of reasons in its press release "issued in the public interest", called the timeline unfeasible and without precedent. "The academy strongly believes that any hasty solution may compromise rigorous scientific processes and standards will likely have long-term adverse impacts of unforeseeable magnitude on the citizens of India," the statement, put out by IASc president Partha P Majumder, read.
The IASc is just the latest of the experts in the scientific community to raise concerns about the ICMR's letter and the 15 August deadline.
'Could take years'
On Saturday, hours before the ICMR attempted to walk back its earlier statement, saying its letter to investigators of the clinical trial sites was meant to "cut unnecessary red tape, without bypassing any necessary process" and speed up the recruitment of participants, WHO chief scientist Soumya Swaminathan, raising alarm bells in an interview with The Wire, warned that scientific and ethical standards could not be sacrificed in the name of speed.
Swaminathan, coincidentally the immediate predecessor of ICMR Director General Dr Balram Bhargava, told The Wire that as per her understanding, phase 1 trials of the Bharat Biotech's drug have not yet begun and that people cannot be given this vaccine by 15 August.
"Our process to develop a vaccine to fight COVID-19 is as per the globally accepted norms of fast tracking," ICMR, had said in its Saturday statement.
Swaminathan emphasised the importance of following all ethical and scientific guidelines and said the public needs to believe that the most rigorous processes have been followed. She said as per the WHO, phase 3 trials, often considered the most important in the entire process, should involve between 20,000 and 30,000 people and "could take years."
She further told The Wire 150 attempted vaccines are at the pre-clinical stage of testing, 17 to 18 are in clinical stages and one or two in phase 3. She added that a vaccine would be discovered only in early 2021 and that too "if we are lucky". She said a vaccine would be available in sufficient volume only at the end of 2021 and that who would first get it still needs to be worked out.
'Not how science works'
As per Scroll, the expected duration of the trial, according to the government’s official clinical trial registry, is one year and three months. Even doctors entrusted with conducting the trial called the timeline in the ICMR letter "unrealistic".
“I don’t think anywhere in the world has anyone ever given a date in advance for the release of a new vaccine before a clinical trial has even begun,” Amar Jesani, editor of the Indian Journal of Medical Ethics and a public health activist, told Scroll. “That is not how science works.”
Vasantha Muthuswamy, chairperson of the ethics advisory committee of the ICMR’s bioethics cell, said she had not seen Bhargava’s letter, but allowed that the timeline was far 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," she told Scroll.
Speaking to Firstpost, Dr Anant Bhan backed up Swaminathan. "We can’t compromise on the safety and the efficacy aspects," Bhan, a a researcher in global health, bioethics and health policy said. "Minimum standards around safety, efficacy and quality need to be followed. Collapsing the entire process to just 45 days is unlikely and almost impossible."
Bhan also questioned the way in which the ICMR and the Drugs Controller General of India (DCGI), which has allowed phase 1 and 2 (human) clinical trial of 'COVAXIN', are approaching the process, saying it would raise questions on the vaccine's efficacy.
“How can the clinical trial recruitment for such a vaccine be starting on 7 July and the vaccine itself launched on 15 August?" Bhan wondered in an interview with Firstpost."Are we pre-deciding the efficacy of a vaccine trial, which is completing in little over a month?”
Bhan also said it is surprising that the CDSCO allowed a clinical trial of this scale to be expedited over such a short period. “It could also be that they have permitted phases 1 and 2, and once they have the data, they have to return to the regulator for permission for phase 3. But none of this information is available for anyone to see,” Bhan pointed out.
Bhan, in a series of tweets, further said, "To my knowledge, 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."
'Letter reads like a threat'
AIIMS director Randeep Guleria, head of the clinic research group of the national taskforce on COVID-19, speaking to Indian Express, seemed taken aback. “It will be a very challenging and difficult task, considering that we have to look at both efficacy and safety of any vaccine that is introduced. Also, if we get the desired results, the other challenge is the process of mass production of the vaccine,” Guleria told Indian Express.
Virologist Shaheed Jameel minced no words, telling the newspaper that the ICMR's 15 August timeline is "ridiculous.".Jameel, chief executive of the Wellcome Trust-DBT Alliance, which funds health research in India, said he fears that the global scientific community would "laugh at us" for this.
"It should not have happened. India is a serious player in science. Who is going to trust us if we behave like this? Who is going to believe us even if we indeed come up with a good vaccine tomorrow?" Jameel added, further stating that the language in the letter reads "like a threat".
Make haste, but slowly
Virologist Upasana Ray noted while an accelerated launch or promise for launch for a vaccine against novel coronavirus deserved applause, careful consideration must also be given to whether the process is being rushed and its possible public impact. “We must rush albeit carefully. Giving this project high priority is absolutely important. However, excess pressure might not necessarily lead to a positive product for public use,” Ray, senior scientist at CSIR-IICB, Kolkata, told PTI.
"From now till 15 August, the company has just over a months' time to wrap up everything that normally a vaccine development process requires for releasing a vaccine for clinical use," she said. "How can such a sharp timeline be even decided? Where does the evidence come from that by such a short time all the essential steps will be completed? What about the safety and efficacy, the fundamental steps of any drug development? Have even the pre-clinical studies been completed? Too much rush comes with possible risks," she said.
The ICMR has responded to these concerns by pointing to its reputation and track record, saying the process is in accordance with globally accepted norms.
"ICMR is among the world’s most reputed organisations in the field of medical research and regulation and its track record of facilitating India’s globally respected and acknowledged vaccine and drug industry speaks for itself," it said in its letter. It further added that its trials would be conducted following best practices and rigour and would be reviewed, as required, by a Data Safety Monitoring Board (DSMB)."
"While issues raised in public domain from time-to-time by commentators are welcome, as they form an important part of feedback loop, the best of India's medical professionals and research scientists should not be second guessed for their professionalism or adherence to the highest scientific rigour," the statement further read. "ICMR is committed to treat the safety and interest of people of India as a topmost priority."
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