COVID-19 vaccine: Serum Institute gets DCGI nod to resume phase two, three trials

Serum Institute of India (SII) is all set to restart its phase two and three clinical trials for COVID-19 vaccine after getting d from Drugs Controller General of India (DCGI). As per reports, institute h asked permission to restart re-enrollment procedure for AstraZeneca and Oxford University COVID-19 vaccine following Data Safety Monitoring Board (DSMB) recommendations.

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COVID-19 vaccine trial to restart 

DCGI, in its letter to Serum Institute, said, "You (SII) may recommence clinical trial dated August 2, 2020, as recommended by DSMB, India as per alrey approved protocol and provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to conditions mentioned which are to be scrupulously followed such as extra care during screening, ditional information in informed consent and close monitoring for similar events during study follow-up”.

DCGI has asked Serum Institute to provide a full list of medications being giving to patients for manment of verse effects. Earlier this month, AstraZeneca vaccine trails h been put on hold after a volunteer showed serious side effects. This h caused vaccine trial to be put on hold in United States, Brazil and United Kingdom. vaccine trials have alrey restarted in UK.

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According to reports, Data Safety Monitoring Board (DSMB) allowed vaccine trials to restart but on three conditions: first, all relevant participant information must be recorded, including a revised informed consent form (ICF). Second, Serum Institute must place ditional safety monitory plans for those participating in trials and lastly, all participant contact numbers must be recorded in event of an emergency.

COVID-19 pandemic which saw its first outbreak in a wet market in Wuhan, China last year has w spre all across world. virus, named COVID-19 by World Health Organisation, has infected over 29 million people worldwide with global death toll reaching over 900,000.

(Input Credit ANI)

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