Serum Institute Suspends Oxford Vaccine Trials in India Following Drug Controller Notice – The Tribune India


Aditi tandon

Tribune News Service

New Delhi, September 11

The Serum Institute of India announced Thursday the suspension of trials in India of the COVID vaccine candidate from the University of Oxford-AstraZeneca until the global suspension of the process is reversed and the trials are restarted.

The IBS led by Adar Poonawala, who is a vaccine manufacturing partner, said today: “We are reviewing the situation and halting the trials in India until AstraZeneca restarts them. We are following DCGI’s instructions and will not be able to comment further on them. You can connect with DCGI for more updates on this front. “

The SII announced the announcement of the Indian trial pause one day after the Comptroller General of Drugs of India issued a notice of demonstrative cause asking why the permits previously granted for phase 2 and 3 human trials on volunteers Indians are not suspended in light of new evidence. of severe disease in a participant of the phase 3 vaccine trial in the United Kingdom.

AstraZeneca yesterday announced the global suspension of ongoing phase 3 trials of the vaccine after a participant developed a serious neurological disease whose source is being investigated.