Phase III or last stage of the clinical trial of the Covid-19 ‘Covishield’ vaccine, which is being developed by the University of Oxford and manufactured by the Serum Institute of India (SII), began today at the Sassoon General Hospital, administered for the state, in Pune, Maharashtra on Monday, a senior official said.
“We have started phase III trials of the candidate vaccine. We will dose 150 to 200 volunteers,” said Dr. Muralidhar Tambe, dean of Sassoon General Hospital, PTI reported.
“Those who are willing to volunteer for vaccination can contact the following numbers: 8550960196, 8104201267,” said a statement.
The Covishield phase II trial was conducted at Bharti Vidyapeeth Medical College and King Edward Memorial (KEM) Hospital in Pune.
IBS has partnered with the British-Swedish pharmaceutical company AstraZeneca to manufacture the COVID-19 candidate vaccine, which is being developed by the University of Oxford.
Earlier this month, IBS had halted clinical trials of the candidate vaccine in the country.
The Comptroller General of Drugs of India (DCGI) had ordered the SII on September 11 to suspend any new recruitment in the phase II and III clinical trial of the vaccine until further requests after AstraZeneca halted trials in other countries due to to “an unexplained illness” in a study participant.
However, on September 15, DCGI allowed the Serum Institute to restart its phase two and three clinical trials for the Covishield vaccine after the lead pharmacist submitted recommendations from the Data Safety Monitoring Board (DSMB), UK and DSMB India. and request permission to restart enrollment in the clinical trial subject of the vaccine.
Additionally, the Serum Institute of India will begin testing another Covid-19 candidate vaccine developed by Novavax next month. American drug developer Novavax Inc previously announced that it had reviewed its agreement with the world’s largest vaccine manufacturing company, the Serum Institute of India (SII), to produce 2 billion doses of Covid-19 vaccines.
In August, Novavax signed an agreement with the Pune-based Serum Institute to produce a minimum of 1 billion doses of its candidate vaccine for low- and middle-income countries and India.
However, as part of the expanded agreement, Serum Institute will also manufacture the antigen component of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.
With PTI inputs
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