Serum Institute begins Phase 2, 3 clinical trials of its COVID-19 vaccine

You're never too old to get vaccinated
You're never too old for a vaccine! Shots that are a must for adults

As COVID-19 cases continue to see a spike, there is some good news on the horizon.

Indian pharma major Serum Institute has initiated Phase 2 and 3 of clinical trials of its COVID-19 vaccine on 1600 healthy adults to evaluate its safety, efficacy and immune response. Pune-based Serum Institute has partnered with AstraZeneca for manufacturing  coronavirus vaccine candidate developed by University of Oxford.

As per Clinical Trial Registry India, the scientific title of the study says that phase 2/3 clinical trial will be observer-blind, randomised, controlled study to determine the safety and immunogenicity of Covishield (COVID-19 vaccine) in healthy Indian adults.

Serum Institute got the approval from Drugs Controller General of India (DCGI) earlier this month for the trials. The vaccine is likely to be tested on adults spread across 17 cities in the country.

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According to news agency ANI, the sites where the trials would be conducted are Andhra Medical College in Visakhapatnam, JSS Academy of Higher Education and Research in Mysore, Seth G S Medical College and KEM Hospital in Mumbai, KEM Hospital Research Centre in Vadu, B J Medical College and Sassoon General Hospital in Pune, All India Institute Of Medical Sciences in Jodhpur, Rajendra Memorial Research Institute of Medical Sciences in Patna, Institute of Community Medicine in Madras, Post Graduate Institute of Medical Education & Research (PGIMER), Bharati Vidyapeeth Deemed University Medical College and Hospital in Pune, Jehangir Hospital in Pune, AIIMS Delhi, ICMR Regional Medical Research Centre in Gorakhpur, TN Medical College & BYL Nair Hospital in Mumbai, Mahatma Gandhi Institute of Medical Sciences in Sewagram and Government Medical College Nagpur.

Of the total 1,600 eligible participants, 400 participants will be part of the immunogenicity cohort and will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Oxford/AZ-ChAdOx1 nCoV-19, respectively.

The remaining 1,200 participants from safety cohort will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Placebo, respectively.

(With ANI inputs)

 

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