Phase 3 clinical trials of the Oxford coronavirus vaccine will begin this week, the Union Health Ministry had announced on Tuesday. Pune-based Serum Institute of India, manufacturer of the Oxford-AstraZeneca vaccine, has selected the sites that would undertake the clinical trials across the country.
According to sources, Phase 3 clinical trials of the Oxford vaccine is likely to begin on August 22. As per India Today TV, a hundred people would be vaccinated on the first day. The trials would begin across 20 centres, mostly in Pune, Maharashtra and Ahmedabad. AIIMS Delhi, Seth G. S. Medical College and KEM Hospital in Mumbai, TN Medical College & BYL Nair Hospital in Mumbai, Post Graduate Institute of Medical Education & Research in Chandigarh are some of the centres that would conduct the Phase 3 trials.
The Parliamentary Standing Committee on Home Affairs has been informed that the Oxford vaccine would be administered to 1,600 people in the trials. The coronavirus vaccine, Covishield, is likely to be the first candidate to be made available in India.
"Some 20 different sites and hospitals across the country have been chosen, covering five different regions that are Covid-19 hotspots. We seek to conduct trials across 11-12 hospitals in partnership with ICMR," said a spokesperson of the Serum Institute of India.
A written form of consent will have to be filled by the participants and they have to reside in the study area while also complying with the study protocol requirements. Participants will be excluded if they have acute illness with or without fever at the time of vaccine administration.
While a coronavirus vaccine is nearing production, the distribution looks like the next big question. Sources told India Today TV that people who have not been infected by the virus before are likely to be the first ones to get vaccinated. "Those who have been infected have developed antibodies against coronavirus and are not likely to fall in the priority category," they said. The sources also said that vulnerable categories could also be part of the first section to get a dose of the vaccine.
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