Serum Institute to Resume Oxford COVID-19 Vaccine’s Trail in India
Category: #health  By Pankaj Singh  Date: 2020-09-17
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Serum Institute to Resume Oxford COVID-19 Vaccine’s Trail in India

India’s Drugs Controller General (DCGI) has approved Pune-based Serum Institute of India (SII) to restart the clinical trial of the Oxford/AstraZeneca COVID-19 vaccine in India.

The DCGI has cancelled its previous order of suspending enrollment of any new volunteer for the Phase 2/3 clinical trial. The DCGI has requested SII to submit particulars of medication used in agreement with the protocol for the management of adverse effects.

The drug regulating body of the country has asked the Serum Institute to take extra precautions during screening, offer additional data in informed consent, and closely observe participants for any severe effects during follow-up of the study.

In the previous week pharma leader AstraZeneca and the Oxford University restarted the clinical test of its COVID-19 vaccine AZD 1222 in the UK, after the approval by the Medicines Health Regulatory Authority (MHRA) that the tests were safe.

The human test in the UK restarted several days post getting paused after a volunteer reported illness. In India, Serum Institute is steering Phase 2/3 human trials for the COVID-19 vaccine created by the University of Oxford and AstraZeneca.

Subsequently, the DCGI also directed SII to stop the tests until further notice. The DCGI had delivered a show-cause notice to SII on September 9 for not notifying it about AstraZeneca pausing clinical tests of the vaccine candidate in other countries. On September 11, the DCGI directed the SII to stop any fresh recruitment in Phase 2/3 clinical tests in till further orders.

SII submitted the approvals of the Data and Safety Monitoring Board, UK and DSMB, India, to the DCGI, asking to resume registration in the clinical tests.

According to the order delivered by the DCGI, the DSMB, UK, suggested the researchers to restart all immunization in their clinical tests, subject to certain conditions. DSMB has also suggested current the study and enrolment of the remaining volunteers in the clinical tests according to the protocol subject to some conditions.

 

Source: https://www.businesstoday.in/sectors/pharma/serum-institute-gets-nod-to-resume-clinical-trials-of-oxford-covid-19-vaccine-in-india/story/416134.html



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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