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India’s first vaccine candidate for COVID-19 was granted permission for the human trials four days ago. On Friday, the Indian Council of Medical Research said that they want to launch the vaccine for public health use by 15th August.
Balram Bhargava, the Director-General of the council wrote on 2nd July to 12 institutions, which were participating in the trial to fast track all the approvals. He added that the participants to be tested should be registered no later than 7th July. The letter mentioned that this vaccine is at present the top priority of the government.
Covaxin, is the vaccine developed by the Hyderabad-based private company Bharat Biotech and the ICMR and has got approval for human trial on 29th June. Experts say in regard to this, that ICMR has said that it would release the vaccine in less than two months after the approval. This timeline does not sound real.
Independent experts and doctors assigned with the trials of the COVID-19 vaccine have condemned the letter. Amar Jesani, Editor of the Indian Journal of Medical Ethics and also a public health activist said that nowhere and no one in the world has ever given the date in advance for the release of a new vaccine even before a clinical trial has begun. Science doesn’t work this way.
Vasantha Muthuswamy, Chairperson of the ethics advisory committee of the ICMRs bioethics cell, said that she has not seen Balrams letter yet but the timelines given are very short. By her experience, a month is necessary to decide whether a vaccine can be released in a very short time. Even if one fast-track it, it would take at least one year.
The expected duration of the trial is one year and three months, according to the governments official clinical trials registry. Doctors and experts say that the timelines placed by the ICMR are unrealistic.
Vasudev of Lucknows King George Hospital said that the enrolment of the participants by 7th July won’t be possible in any circumstances even if they get approval from the ethics committee. He further added that the trial approved on July 7 and to give results by 15th August is not possible.
Phase 1: Phase 1 of the clinical trial is small and is used to define the safety profile.
Phase 2: In phase 2, the sample size is bigger and observes the immune responses triggered by the vaccine.
Phase 3: After phase 3 trial, a vaccine is commercially available. It has a much bigger sample size with thousands of participants.
The trial document for the Covaxin has not mentioned anything about the phase 3 trial. There seems to be some confusion in the sequence of phase 1 and 2 trial.
The head investigator from the government hospital said that till 15th August, even Phase 1 trials won’t be completed. He also added that ICMR forgot to add the year as 2021.
Source: E Times