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The phase-III or the last stage of clinical trial of the Covid-19 vaccine’Covishield’, being developed by Oxford University, also fabricated by the Serum Institute of India (SII), began today at the state-run Sassoon General Hospital in Pune, Maharashtra on Monday, a senior official said.
“We have begun the phase-III trials of the vaccine candidate. We’ll administer dose to 150 to 200 volunteers,” said Dr Muralidhar Tambe, Dean, Sassoon General Hospital, reported PTI.
“Those that are willing to volunteer for vaccination can contact on the following amounts –8550960196, 8104201267,” a statement said.
The phase II trial of Covishield was conducted at Bharti Vidyapeeth Medical College and King Edward Memorial (KEM) Hospital in Pune.
The SII has partnered with British-Swedish pharma company AstraZeneca for manufacturing the COVID-19 vaccine candidate, being developed by the University of Oxford.
Earlier this month, the SII had paused the clinical trials of this vaccine candidate in the country.
The Drugs Controller General of India (DCGI) had on September 11 led the SII to suspend any new recruitment in the phase-II and III clinical trial of the vaccine until further orders after AstraZeneca stopped the trials in different countries due to”an unexplained illness” at a participant in the research.
But on September 15, DCGI allowed the Serum Institute to resume its phase two and three clinical trials for the Covishield Vaccine following the pharma major submitted the recommendations of the Data Safety Monitoring Board (DSMB), UK and DSMB India and requested permission to restart enrolment in the field clinical trial of the vaccine.
Moreover, Serum Institute of India will start the trial of another Covid-19 vaccine candidate developed by Novavax in next month. US drug developer Novavax Inc earlier announced that it has revised its deal with world’s largest vaccine manufacturing company Serum Institute of India (SII) in order to produce 2 billion doses of Covid-19 vaccines.
In August, Novavax signed a deal with Pune-based Serum Institute to generate no less than one billion doses of its vaccine candidate for low-and middle-income countries and India.
But, as a part of this expanded agreement, Serum Institute will also manufacture the antigen part of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate.
