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Tribune News Service
New Delhi, August 3
Stage is set for large-scale human trials on the upcoming Oxford University-Astra Zeneca Covid-19 vaccine from this month with the Drug Controller General of India approving the Serum Institute's application for Phase 2 and 3 trials in India.
Tests cross2-crore mark
- India has by now tested
2 crore Covid samples with tests per million (TPM) reaching 14,640
-
Twenty-four states and UTs, including Haryana, Himachal Pradesh and Punjab, have TPM more than the national average
The PGI, Chandigarh, is among the 17 trial sites listed in the study, which will involve administration of vaccine to around 5,000 healthy adults. Every volunteer will be administered two doses. If the first one is administered today, the next one will be given on Day 29.
Other trial sites include AIIMS, Delhi; BJ Medical College, Pune; ICMR-Rajendra Memorial Research Institute of Medical Sciences, Patna; AIIMS, Jodhpur; Nehru Hospital, Gorakhpur; Andhra Medical College, Visakhapatnam; and JSS Academy of Higher Education and Research, Mysore.
Covishield vaccine candidate recently showed promise following Phase 1 and 2 clinical trials in the UK. No human subject presented serious adverse effects, thereby establishing vaccine safety. All volunteers tolerated the vaccine well and generated strong immune responses.
Phase 2 and 3 clinical trials on the vaccine are expected to start in India this month with CEO of Pune-based Serum Institute Adar Poonawala saying, "Phase 3 human trials will be decisive and crucial. These will show how much protection the vaccine gives against Covid-19." The Serum Institute is aiming at year-end launch of at least a few million doses of the vaccine.
from The Tribune https://ift.tt/3190eKE
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