SII Starts Final Phase Of Clinical Trials For Vaccine

On 21st September, 2020, the Serum Institute of India (SII), the world’s largest producer of vaccine in volumes, started the Phase-III or last and final stage of clinical trials, for the Covid-19 vaccine ‘Covishield’, at the state-run Sassoon General Hospital in Pune, Maharashtra. As per Dr. Muralidhar Tambe, Dean, Sassoon General Hospital, the dose of the vaccine will be administered to around 150 to 200 volunteers

The second phase of clinical trials was conducted at Bharti Vidyapeeth Medical College and King Edward Memorial (KEM) Hospital in Pune. SII has partnered with British-Swedish pharma company, AstraZeneca for manufacturing the COVID-19 vaccine candidate, being developed by the University of Oxford. Earlier, SII had shortlisted 17 sites in India for the Phase II clinical trials of the vaccine, where 1,600 candidates, between 18 to 55 years of age, had participated.

On September 10, the drug maker had paused the clinical trials of the Oxford COVID-19 vaccine candidate in India in the wake of AstraZeneca suspending the clinical trials in other countries. Five days later, the DGCI (Drugs Controller General of India) granted permission to resume trials, while revoking its earlier order of suspending any new recruitment for the second and third phase of trials.

COVID-19 vaccine candidate developed by the Jenner Institute, a part of the Nuffield Department of Medicine at the University of Oxford, showed a positive result in its initial trial. According to a report published in the British medical journal, The Lancet, the COVID-19 vaccine produced a dual immune response in people aged 18 to 55. The University of Oxford’s possible COVID-19 vaccine could be rolled out by the end of the year but there is no certainty, the lead developer of the vaccine.

SII will begin the trial of another COVID-19 vaccine candidate developed by US drug developer, Novavax Inc., next month. Novavax Inc has claimed to be doubling its potential COVID-19 vaccine manufacturing capacity to two billion doses annually, under an agreement with SII. As part of the expanded agreement, SII will also manufacture the antigen component of the vaccine.

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