ICMR, India’s largest medical research organization, said Friday that it is looking to launch the world’s first Covid-19 vaccine on August 15, which generated disbelief among scientists who say the procedure requires careful testing and studies and will be reliably completed in six weeks. until the deadline.
The plan disclosed in a letter from the Indian Medical Research Council to 12 institutes where human trials will be conducted for the Covaxin vaccine, instructing them to discharge mandatory approvals from internal committees until July 7 with a warning that “the non-compliance will be taken very seriously.”
The vaccine was developed jointly through Hyderabad-based ICMR and Bharat Biotech (BBIL), the latter in the past indicates that a vaccine may take longer. In an interview with the New Indian Express on Wednesday, Bharat Biotech President and CEO Krishna Ella said that if Covaxin clinical trials meet standards of protection and efficacy, the vaccine could be available for mass use until early 2021.
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But the CIMR has plans, as evidenced by the tone of life or death of its letter.
“The vaccine is expected to be introduced for public fitness purposes until 15 August 2020 after the final touch of all clinical trials. BBIL is temporarily running towards the target, but the end result will depend on the cooperation of all clinical trial sites interested in this project,” said the letter signed by Balram Bhargava, Director General of ICMR.
Clinical trials come with a series of highly controlled inoculations between teams of volunteers to check if a vaccine is working, a procedure that takes on average more than 10 years. In a pandemic, this calendar can be compressed, but top experts estimate it will take 12 to 18 months longer, making India’s plans on Covaxin scientifically unlikely.
“I would have understood if the company had made such statements, however, DG-ICMR in making this non-scientific statement makes no sense. Anyone who has the fundamental wisdom of how clinical trial paintings would know this is absolutely impossible to verify,” one official said. one of the institutes chosen for the process, requesting to be identified.
Criticized for establishing an unreasonable time frame that would be safe, effective and quality, CIMR later warned that it was only making an effort to publish the verification knowledge until August 15. ICMR spokesperson Srivastava in a text message. No orders were issued.
Experts under pressure that even this purpose is unlikely until the August 15 deadline.
“The development of an effective vaccine is a time-time process. Recruiting consistent participants can take months, even if we review to boost just like we do for Covid-19. Each phase – one, two and 3 – deserves to be taken at least a few months because it is not only a center, but several centers that care about conducting trials on the protection and efficacy of a vaccine,” said Anant Bhan, a global bioethics and fitness researcher.
“In a month, it is imaginable to discover without delay the safety, tolerability and immunogenicity of a candidate vaccine. This is enough to determine whether the technique is promising or not. However, promising at this level only means that, not effective in infection prevention,” said Dr. Anurag Agrawal, director of the CSIR-Institute of Genomics and Integrative Biology in Delhi.
Covaxin has not yet entered the clinical trial phase, a level at which 18 vaccine applicants from around the world have already rushed. The previous one expects protection and effectiveness until the time of next year’s quarter.
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ICMR’s position also surprised experts because knowledge of the preclinical functionality of the vaccine has not yet been made public. “It’s very ambitious and probably unprecedented. You can’t rush science. It’s one thing to do anything and another to do it right. It’s not imaginable to do well in such a short time,” Bhan said.
One expert said it normally takes 4 to five years, human trials can be completed in a year in the case of Covid-19. “Normally, for phase 1, 2, and 3 human trials, it takes 4 to five years, yet it’s an unprecedented scenario in which everyone talks about Covid, so the procedure can be completed in about a year,” Dr. NK said. Mehra, president of ICMR and former director of the Department of Immunology and Immunogenetics of Transplants, Institute of Medical Sciences of India (AIIIMS).
Another aiIMS physician, who is one of the institutes where the trials will be conducted, said: “We are awaiting the approval of the ethics committee and, unless you obtain it, I comment. I do not know how long it will take for approvals; it can be only 15 days or probably a month. I can’t say, ” said Dr. Sanjay Rai, a professor in the Department of Community Medicine and one of the trial directors.
Bharat Biotech is one of seven Indian corporations using Covid-19 vaccines. It is the first to download regulatory approval to begin Phase 1 and Phase 2 human trials on Monday.
A spokesman for Bharat Biotech declined to comment on the letter, saying that preclinical studies of the vaccine have shown “extensive protection and effective immune responses.”
The Sars-CoV-2 strain that originated with Remote Covid-19 at the ICMR-National Institute of Virology (NIV), Pune, and transferred to Bharat Biotech on May 9.
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