The plan was disclosed in a letter by the Indian Council of Medical Research to 12 institutes where human trials are to be held for the vaccine, Covaxin, ordering them to secure necessary approvals from internal committees by July 7 with a warning that “non-compliance will be viewed very seriously”.
The
vaccine has been jointly developed by ICMR and Hyderabad-based Bharat
Biotech (BBIL), with the latter itself previously indicating that a
vaccine could take more time. In an interview to The New Indian Express
on Wednesday, Bharat Biotech chairman and managing director Krishna Ella
said that if clinical trials of Covaxin met safety and efficacy
standards, the vaccine could be available for mass use by early 2021.
But ICMR has other plans as evident in the do-or-die tone of its letter.
“It is envisaged to launch the vaccine for public health use latest by 15th August 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,” said the letter signed by Balram Bhargava, the director-general of ICMR.
Clinical trials include a clutch of tightly monitored inoculation among sets of volunteers to test whether a vaccine is safe and works – a process that on average has taken over 10 years. In a pandemic, this timeline can be compressed, but most experts believe that is still likely to take 12-18 months – making India’s plans on Covaxin scientifically implausible.
“I would have understood if the company had made such claims but DG-ICMR making this unscientific claim doesn’t make sense. Anyone who has even basic knowledge of how clinical trials work, would know this is completely unscientific,” said an official at one of the institutes selected for the process, asking not to be named.
Criticised for setting an unreasonable deadline that would affect safety, efficacy and quality, ICMR later suggested that it was only making an effort to put out trial data by August 15. “Request has been made to fast track the vaccine trials,” said Dr Rajnikant Srivastava, spokesperson, ICMR, in a text message. No order was issued.
Experts pointed out that even this objective seemed improbable for the August 15 deadline.
“Developing an effective vaccine is a time-consuming process. Recruitment of participants in itself can take months even if we try to expedite everything like we are doing for Covid-19. Each of the phases — one, two and three — should take at least a few months as it is not just one centre but multiple centres that are involved in conducting trials to determine safety and efficacy of a vaccine,” said Anant Bhan, a researcher in bioethics and global health.
“In one month, it is possible to determine immediate safety, tolerability and immunogenicity of a candidate vaccine. This is sufficient to determine whether the approach has some promise or not. However, promising at this stage means just that, not effectiveness in preventing infections,” said Dr Anurag Agrawal, director, CSIR- Institute of Genomics and Integrative Biology, Delhi.
Covaxin is yet to enter the clinical trials phase, a stage that 18 vaccine candidates across the world have already raced to. The earliest any of these expect to determine safety and efficacy is not until second quarter of next year.
ICMR’s position also surprised experts because data about the vaccine’s
preclinical performance has not been made public yet. “It is very
ambitious and probably unprecedented. You can’t rush science. It is one
thing to do something and another to do it properly. It is not possible
to do it properly in such a short span of time,” Bhan said.
One expert said while it usually takes four to five years, human trials can be finished in a year in the case of Covid-19. “Normally for phase 1, 2 and 3 human trials, it takes about four to five years, but this is an unprecedented situation where everyone is talking Covid so the process can be finished in about a year,” said Dr NK Mehra, ICMR chair and former head, transplants immunology and immunogenetics department, All India Institute of Medical Sciences (AIIIMS).
Another doctor at AIIMS, which is one of the institutes were the trials will be held, said: “We are waiting for the ethics committee clearance and unless I get that I cannot comment on that. I don’t know how much time it will takefor the approvals; could be 15 days or probably a month. I can’t say,” said Dr Sanjay Rai, professor, community medicine department, and one of the trial conductors.
Bharat Biotech is among seven Indian firms working on Covid-19 vaccines. It was the first to get the regulatory nod to begin phase 1 and phase 2 human trials on Monday.
A Bharat Biotech spokesperson declined to comment on the letter, but said pre-clinical studies of the vaccine showed “extensive safety and effective immune responses”..
The Sars-CoV-2 strain
that causes Covid-19 was isolated in ICMR-National Institute of Virology
(NIV), Pune, and transferred to Bharat Biotech on May 9.
https://www.hindustantimes.com
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