Serum Institute to Begin Phase 2 Vaccine Trial in India - What's Special About This? - Experts Share 'Details'!

As the country is working towards the production of COVID-19 vaccine, the Serum Institute of India (SII) is all set to begin its phase II/III clinical trials today.

The SII has partnered with British-Swedish pharma company AstraZeneca for manufacturing the COVID-19 vaccine candidate that has been developed by the University of Oxford.

Sharing details about the vaccine, SII is the world’s largest vaccine manufacturer produced and sold globally. As per Hindustan Times report, according to the Clinical Trials Registry of India, 17 sites have been selected to conduct the phase II/III trials, other factors like observer-blind, randomized, controlled study, to check the safety and immune response of the vaccine candidate among healthy Indian adults will be taken into considerations. 

Reports also suggest that there would be around 1,600 adults, above 18 years of age, who are expected to be recruited for the trials across India. Dr Prasad Kulkarni will be the principal investigator for SII and spearhead the process, HT further reported. 

Earlier in the month, India’s drugs controller gave approval to SII for conducting phase II and III clinical trials of the vaccine candidate in the country. 

In a statement issued on Sunday (August 23) , 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," the statement added.