Serum Institute of India has been asked by DCGI to revise its protocol to conduct Oxford's coronavirus vaccine Phase 2, 3 human trials in India.
Serum Institute of India (SII), who earlier sought permission to conduct Phase-2 and 3 trials of Oxford University's coronavirus vaccine in India, has been advised to resubmit a revised protocol to carry out trials for the potential coronavirus vaccine. The Central Drugs Standard Control Organisation (CDSCO) has asked SII to submit a revised protocol after its Subject Expert Committee evaluated the earlier protocol submitted by it.
Serum Institute of India has partnered with AstraZeneca which has got the license of manufacturing Oxford's coronavirus vaccine, to be called 'Covishield' in India.
"Our Subject Experts Committee reviewed the Serum Institute thoroughly and it has observed several recommendations like--assessment and statistical analysis, drop-out rate, immunity analysis etc. It is a comprehensive scientific analysis," ANI quoted a senior health ministry official as saying.
SII had entered a manufacturing partnership with the company -- AstraZeneca -- wherein the institute will manufacture and supply 1 billion doses of the vaccine.
"At present, we are working on the AstraZeneca Oxford vaccine which is undergoing phase III clinical trials. In addition to this, we will also start human trials in India in August 2020. Based on the current situation and most recent updates on the clinical trials, we are hoping that the AstraZeneca Oxford vaccine will be available towards the end of this year," Serum Institute of India CEO Adar Poonawalla had said in an earlier statement.
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