New Delhi, Jul 6: The Indian Academy of Sciences, a Bengaluru-based body of scientists, has said the Indian Council for Medical Research's (ICMR) target to launch a coronavirus vaccine by August 15 is "unfeasible" and "unrealistic".
The IASc said while there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner.
While administrative approvals can be expedited, the "scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour", the IASc said in a statement.
In its statement, the IASc referred to the ICMR's letter which states that "it is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials".
The ICMR and Bharat Biotech India Limited, a private pharmaceutical company, are jointly developing the vaccine against the novel coronavirus -- SARS-CoV-2.
The IASc welcomes the exciting development of a candidate vaccine and wishes that the vaccine is quickly made available for public use, the statement said.
"However, as a body of scientists including many who are engaged in vaccine development IASc strongly believes that the announced timeline is unfeasible. This timeline has raised unrealistic hope and expectations in the minds of our citizens," it said.
Aiming to launch an indigenous COVID-19 vaccine by August 15, the ICMR had written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate, COVAXIN.
Experts have also cautioned against rushing the process for developing a COVID-19 vaccine and stressed that it is not in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.
The IASc said trials for a vaccine involve evaluation of safety (Phase 1 trial), efficacy and side effects at different dose levels (Phase 2 trial), and confirmation of safety and efficacy in thousands of healthy people (Phase 3 trial) before its release for public use.
Clinical trials for a candidate vaccine require participation of healthy human volunteers. Therefore, many ethical and regulatory approvals need to be obtained prior to the initiation of the trials, it added.
The IASc said the immune responses usually take several weeks to develop and relevant data should not be collected earlier.
"Moreover, data collected in one phase must be adequately analysed before the next phase can be initiated. If the data of any phase are unacceptable then the clinical trial is required to be immediately aborted," it said.
For example, if the data collected from Phase 1 of the clinical trial show that the vaccine is not adequately safe, then Phase 2 cannot be initiated and the candidate vaccine must be discarded.
For these reasons, the Indian Academy of Sciences believes that the announced timeline is "unreasonable and without precedent", the statement said.
"The Academy strongly believes that any hasty solution that may compromise rigorous scientific processes and standards will likely have long-term adverse impacts of unforeseen magnitude on citizens of India," it said.
Comments
COW Urine problem............
if anyone habit of drinking cow urine, then he start to call his father ' WHO ARE YOU? Did we meet before? '
Use less are feeding to thier children or they asked your help. Brain less fellow barking with influence of his god fathers funding.
Wait n see your days are nearing. Dhood Ka Dhood Paani Ka Paani
This baba is agent of Sangh parivar and trying to fool people. He should be grateful to Almighty God for his creation. shame on you baba. If you are a real Sadhu you should go and live in Jungle and not in 5 star hotels
costaldigest.com is anti nationilist website, ban
or go to pakistan
Joke of the mellenium
Actually its not his fault because he don't know about wife or kids
can anyone ask him to enter wedlock, then he will come to know what is kids and how much people expect.
children are gift of god, only true parent will understand, not these people who talk about nationilism & spread corruption.
Election time...Feku Baba
However you are mixing cow urine in your product now please start mixing poison also along with Cow urine in your product and see how automatically population will come down
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