The pause on AstraZeneca coronavirus vaccine trials in India as well as other countries has shown that this vaccine can't be developed in haste, Kiran Mazumdar Shaw, Chairperson and MD, Biocon, has said. She added that the actual safer vaccine may be looked at for approval only in March or April next year.
"This is the reality check that everyone has been talking about in the medical and scientific world. People need to understand that vaccine trials have to be carefully conducted and every serious adverse has to be investigated while the trial is going on because this is actually being inoculated on healthy people. So, that is why we have to be very careful," Shaw told The Economic Times.
On Wednesday, AstraZeneca announced that it had "voluntarily paused" a randomised clinical trial of its coronavirus vaccine in what it called a routine action after a volunteer developed an "unexplained" illness. The company, which has partnered with the University of Oxford for the vaccine, is a frontrunner in the global race for a COVID-19 vaccine.
"As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," an AstraZeneca spokesperson said.
In India, Serum Institute of India, one of the partners of University of Oxford, also decided to pause the trials being conducted across 17 sites till AstraZeneca restarts the trial process.
Following a show-cause notice from the Drug Controller General of India (DCGI) on Wednesday, the Serum Institute of India said it is following the DCGI's instructions on this. "We are following DCGI's instructions...we are reviewing the situation and pausing India trials till AstraZeneca restarts the trials," it said.
Director-General of Health Services notice pulled the SII for not informing the central licencing authority regarding pausing of clinical trial by AstraZeneca. Meanwhile, Biocon in July had also received the DGCI approval to market Itolizumab injection solution for curing cytokine release syndrome in moderate to severe acute respiratory distress syndrome patients, which is triggered by coronavirus.
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