Serum Institute of India begins Phase 2/3 trials of COVID-19 vaccine
Category: #health  By Pankaj Singh  Date: 2020-08-21
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Serum Institute of India begins Phase 2/3 trials of COVID-19 vaccine

The pharmaceutical company plans to conduct clinical trials at 17 sites across the country

Serum Institute of India (SII), an Indian pharmaceutical company that develops immunobiological drugs and vaccines, has recently began the Phase II/III clinical trials to test the immune response and safety of coronavirus vaccine on Indian candidates aged between 20-50 years. Reportedly, SII has bagged approval for this trial from the Drugs Controller General of India (DCGI).

According to reliable sources, the scientific title of the Phase 2/3 clinical trials go as a randomized, observer-blind controlled study to establish the immunogenicity and safety of Covishield in healthy Indian adults. Apparently, a total of 1,600 candidates aged more than or equal to 18 years would be enrolled in this trial.

As per Clinical Trials Registry of India (CTRI), the trial will be planned for seven months and the first enrolment would be on August 24. For the record, SII is one of the world’s biggest vaccine producers in terms of the number of doses sold and produced globally. It has signed a manufacturing partnership deal with AstraZeneca to develop the Oxford-AstraZeneca vaccine.

The 17 sites in the country include JSS Academy of Higher Education and Research (Mysore), Andhra Medical College (Visakhapatnam), KEM Hospital Research Centre (Vadu), Seth G. S. Medical College and KEM Hospital (Mumbai), and B J Medical College and Sassoon General Hospital (Pune). The Ethics Committee of KEM Hospital’s Research Centre has already received the mandatory clearance for this trial, whereas the approval for the remaining 16 hospitals is still under process.

However, people with acute illnesses that have symptom of fever at the time of trial vaccine administration, or have a history of laboratory-confirmed Covid-19 result in close workplace contact or household contact would be ineligible for this trial.

Source Credit: https://www.timesnownews.com/health/article/serum-institute-initiates-phase-2-3-clinical-trials-on-1600-volunteers-for-potential-covid-19-vaccine/639771



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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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