Oxford said the UK health regulator approved resuming the trials after review of the safety data triggered a pause on 6 September. It declined to disclose details about the participant’s illness.
DCGI's Dr V G Somani Friday also directed SII to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
Suspension of the trial is a routine action whenever there is a potentially unexplained illness to ensure we maintain integrity of trials, AstraZeneca says.
Oxford University and AstraZeneca tested its Covid vaccine — ChAdOx1 nCoV-19 543 — on 543 healthy adults. The results are promising. But we may need yearly booster doses.
Oxford vaccine is under Phase II/III trials in multiple countries, where many have been given the vaccine & are being followed up with — a process that consumes time, but is standard.
India should have secured greater savings by pressing Russia for prices nearer the cap while sustaining high volumes. This would have preserved strategic autonomy and served economic logic.
One such website has drawn particular scrutiny for spreading fake stories that have upset not only the Indian but also foreign defence firms by falsely attributing misinformation.
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