The Serum Institute of India (SII) is set to begin its phase II/III clinical trials of the Oxford University-AstraZeneca Covid-19 vaccine candidate, Covishield, to check its efficacy at Pune’s Bharati Vidyapeeth Deemed University Medical College and Hospital on Tuesday.
SII is the world’s largest vaccine manufacturer by the number of doses produced and sold globally. It has entered a manufacturing partnership with AstraZeneca to produce the vaccine.
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According to the Clinical Trials Registry of India, 17 sites have been selected to conduct the phase II/III trials, observer-blind, randomized, controlled study, to check the safety and immune response of the vaccine candidate among healthy Indian adults.
Around 1,600 adults above 18 are expected to be recruited for the trials across India. Dr Prasad Kulkarni will be the principal investigator for SII and spearhead the process.
On August 3, India’s drugs controller gave approval to SII for conducting phase II and III clinical trials of the vaccine candidate in the country. The results of its phase I trial held in the UK had shown promise in generating an immune response against SARS-CoV-2, the virus that causes Covid-19.
{{/usCountry}}On August 3, India’s drugs controller gave approval to SII for conducting phase II and III clinical trials of the vaccine candidate in the country. The results of its phase I trial held in the UK had shown promise in generating an immune response against SARS-CoV-2, the virus that causes Covid-19.
{{/usCountry}}Covishield will be administered as a two-dose schedule on days 1 and 29 as 0.5 ml dose intramuscularly. Placebo will be administered as a two-dose schedule on days 1 and 29 as 0.5 ml dose intramuscularly.
The vaccine is made from a weakened version of a common cold adenovirus taken from chimps and genetically modified.
Even though confirming that the trial process has started, representatives of SII have been declining to divulge more details regarding the development.
In a statement issued on Sunday, SII said, “The phase-3 trials for the Oxford-AstraZeneca vaccine are still underway. And only once the vaccine is proven immunogenic and efficacious, SII will confirm its availability, officially. COVISHIELD will be commercialized once the trials are proven successful and all the requisite regulatory approvals are in place. …Presently, the government has granted us permission to only manufacture the vaccine and stockpile it for future use.”