Pune hospital to resume Oxford-Serum vaccine 'COVISHIELD' Phase-3 trials next week

After receiving the Drug Controller General of India (DCGI)'s nod, Pune hospitals are set to resume Phase-3 trials of the 'Covishield' vaccine manufactured by Serum Institute of India (SII) next week. Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe said to PTI that around 150-200 volunteers will be administered with a vaccine dose. The trials were briefly paused when a volunteer in UK developed an ‘unexplained illness' during trials.

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Covishield's phase-3 trials resume

"The phase-III trial of 'Covishield' vaccine will begin at Sassoon hospital from next week. It is likely to start on Monday. Some volunteers have already come forward for the trial. Around 150 to 200 volunteers will be administered the vaccine candidate dose," he said adding, "From Saturday, the hospital started enrolling volunteers for the trial. Those who are willing to volunteer for the vaccination should contact the hospital." Under phase-II, trials were conducted at Bharti Vidyapeeth Medical College and also KEM Hospital in the city.

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DCGI allows Serum to resume trials

On September 10,  SII - the world's third-largest vaccine manufacturer, confirmed that the India trials of 'Covishield' have been paused till their UK partner AstraZeneca resumes trials. SII - which is conducting Phase-2 & 3 trials of 'Covishield' in 19 locations across India, was questioned by DCGI as to why they were continuing trials inspite of their UK trials paused as a volunteer developed an ‘unexplained illness’. As Oxford began its trials in UK after a safety review, DCGI allowed Serum to resume its trials in India.  SII's 'Covishield' is one of the three leading COVID-19 vaccine candidates currently under trial in India.     

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SII's clinical trials consist of 1,600 participants, all either being more than 18 years of age or equal to it. Apart from Pune's Bharti Vidyapeeth, B J Medical College Hospital in Pune, AIIMS Delhi, Rajendra Memorial Research Institute of Medical Sciences in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, Nehru Hospital in Gorakhpur and Andhra Medical College in Visakhapatnam have been shortlisted to hold trials. SII is in talks with the Centre for mass production, vowing to cap its vaccine price at  Rs 225/dose. 'Covishield' contains replication-deficient simian adenovirus vector ChAdOx1 containing structural surface glycoprotein (spike protein) antigens of SARS-CoV-2.

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