Terming it “unfeasible”, the Indian Academy of Sciences (IASc) slammed the Indian Council of Medical Research (ICMR) on July 5 for its claims that an indigenous vaccine against the novel coronavirus would be launched by August 15, following completion of clinical trials.
IASc’s statement came after ICMR and Bharat Biotech India Limited, a private pharmaceutical company, said that they had “envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials”.
The two are jointly developing a vaccine against SARS-CoV-2, the virus that causes COVID-19.
The top science institute said that this timeline has “raised unrealistic hope and expectations in the minds of our citizens”.
“While there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner. These trials 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,” IASc said in a statement.
The institute added that clinical trials of a vaccine candidate requires participation of healthy human volunteers and, therefore, “many ethical and regulatory approvals need to be obtained prior to the initiation of the trials.”
While 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”, IASc 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 the people.
On July 4, ICMR issued a clarification saying the process was in accordance with globally accepted norms. The medical authority asked Bharat Biotech in an internal communication on July 2 to fast-track clinical trials of the indigenous COVID-19 vaccine.
In an official statement, ICMR Director General Balram Bhargava had stated that ICMR envisages the launch of the indigenous COVID-19 vaccine by August 15. Bharat Biotech recently got a nod for the clinical trial of its vaccine — COVAXIN.
