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

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

Read: Germany Boosts Own Vaccine Makers In Race For COVID-19 Jab

COVID-19 vaccine trial to restart 

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

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

Read: Coronavirus: 'Three Vaccines At Clinical Trial Stage In India,' Says ICMR

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

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

(Input Credit ANI)

Read: Poland Seeks More Flu Vaccines Amid Shortage During Pandemic

Read: UAE Grants Emergency Use Of Chinese State-owned Sinopham's COVID-19 Vaccine