Serum Institute of India to expand scope of COVID-19 vaccine trials - watsupptoday.com
Serum Institute of India to expand scope of COVID-19 vaccine trials
Posted 16 Oct 2020 12:17 PM

16-10-2020
Covid-19

Serum Institute of India which is currently conducting Phase 2 and 3 trials of the Oxford COVID-19 vaccine, has sought approval to expand the scope of vaccine trials in India. The Pune-based vaccine maker has written to the drug regulator to broaden the participant inclusion criteria to now cover older individuals, people with health conditions, those at high risk of Sars-Cov2 infection like household contacts, and those who recovered from COVID-19 infection.

Broadening the inclusion criteria will align the Indian trials of Covishield with that of the ongoing global trials and test the vaccine for high-risk individuals and real-world distribution scenarios.

The Subject Expert Committee responding to the proposal submitted on October 6th recommended approval of the amendments. It said, "After detailed deliberation, the committee recommended for approval of the proposed amendments subject to the condition that the inclusion & exclusion criteria are same as that of AstraZeneca/Oxford Trial with regard to the omission of history of COVID-19 disease in household contacts or history of COVID-19 infection or currently positive for SARS-CoV2 by RT-PCR, as it is bridging study and the same should be submitted to CDSCO."

COVID-19 vaccines are targeted for high-risk populations, such as older individuals, those with co-morbidities, healthcare workers, or household contacts of COVID positive individuals. Hence, testing the vaccine�s effectiveness in this group of people is crucial.

"There were certain cohorts in the current trial structure which are restricted to people under 60 or 65 years, now there will be no upper age limit. Senior citizens, who are actually high risk and older people with co-morbidities will be included and it makes it a fuller trial," said a senior medical doctor with expertise in vaccine trials. He didn�t wish to be named.

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