India’s highest medical research body ICMR on Friday said it is attempting to launch the world’s first Covid-19 vaccine on August 15, which scientists say triggers mistrust for painstaking tests and analysis in the process And should not be completed reliably in six weeks. For the time limit.
The plan was revealed by the Indian Council of Medical Research in a letter to 12 institutions where human testing for the vaccine is to be done, Kovaxin, with a warning ordering them to secure the necessary approvals from internal committees by 7 July That non-compliance will be viewed very seriously ”.
The vaccine has been developed jointly by ICMR and Hyderabad-based Bharat Biotech (BBIL), the latter having already indicated that a vaccine may take longer. In an interview to The New Indian Express on Wednesday, Bharat Biotech President and Managing Director Krishna Ella said that if the clinical trials of covaxin met the safety and efficacy standards, the vaccine would continue to be of mass use by early 2021 Can be available.
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.
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.
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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.
