August 15 target for Kovid-19 vaccine launch ible unforgivable ‘: Indian Academy of Sciences

August 15 target for Kovid-19 vaccine launch ible unforgivable ‘: Indian Academy of Sciences

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New Delhi: The Indian Academy of Sciences, an organization of scientists from Bengaluru, has called the Indian Council for Medical Research (ICMR) the goal of launching a coronavirus vaccine by 15 August as “unqualified” and “unrealistic”.
The IASC stated that there is an undeniable urgent need, requiring scientifically executed clinical trials in a phased manner for vaccine development for use in humans.
Although administrative approval can be expedited, “scientific processes of experimentation and data collection have a natural time period that cannot be taken in haste without compromising standards of scientific rigor”, the IASc said in a statement.
In its statement, the IASc referred to ICMR’s letter stating that “it is envisaged to launch the vaccine for the latest public health use by 15 August 2020 after completion of all clinical trials”.
Private pharmaceutical company ICMR and Bharat Biotech India Ltd. are jointly developing the vaccine against the novel coronavirus – SARS-CoV-2.
The statement said the IASc welcomes the exciting development of the candidate’s vaccine and wants the vaccine to be available for public use soon.
“However, as a body of scientists – many people who are engaged in vaccine development – IASc strongly believes that the announced timeline is inevitable. This time has raised unrealistic hopes and expectations in the minds of our citizens,” it said.
Aiming to launch an indigenous Kovid-19 vaccine by 15 August, ICMR wrote to select medical institutions and hospitals to fast-track clinical trial approval for the vaccine candidate, COVAXIN.
Experts have cautioned against starting the process of developing a Kovid-19 vaccine and emphasized that this pandemic is not in line with globally accepted criteria to fast-track vaccine development for potential diseases.
The IASc stated that testing for a vaccine included safety at various dose levels (Phase 2 trials) (Phase 1 trials), evaluation of efficacy and side effects, and safety in thousands of healthy people (Phase 3 trials) before its release. And confirmation of efficacy. For public use.
A candidate vaccine requires the participation of healthy human volunteers in clinical trials. Therefore, there is a need to obtain several ethical and regulatory approvals that precede the beginning of trials.
The IASC stated that it usually takes several weeks for immune responses to develop and relevant data should not be collected first.
He added, “In addition, the data collected at one stage should be adequately analyzed so that the next phase can be initiated. If the data at any stage is inadmissible then the need to end the clinical trial immediately Is, “it said.
For example, if data collected from Phase I of a clinical trial indicate that the vaccine is not sufficiently safe, Phase 2 cannot be initiated and the candidate’s vaccine should be dropped.
For these reasons, the Indian Academy of Sciences believes the announced timeline is “unreasonable and without precedent”, the statement said.
“The Academy strongly believes that any hasty solution that can compromise rigorous scientific procedures and standards will have long-term adverse effects on citizens of India of unprecedented magnitude.”

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