Serum pauses COVID-19 vaccine trial in India
SII said it was pausing clinical trials of AstraZeneca Oxford COVID-19 vaccine candidate in India until AstraZeneca restarts the trials.
Vaccine maker Serum Institute of India (SII) on Thursday announced suspension of COVID-19 vaccine trials in India.
AstraZeneca had said earlier this week that it had paused the clinical trials because of 'an unexplained illness' in a participant in the study. In view of it, SII said it was pausing clinical trials of AstraZeneca Oxford COVID-19 vaccine candidate in India until AstraZeneca restarts the trials.
"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials… we are following DCGI instructions," the Pune-based vaccine maker said in a statement.
The Drugs Controller General of India (DCGI) had issued a show-cause notice to SII for not informing it about AstraZeneca pausing the clinical trials of the Oxford vaccine candidate in other countries earlier in the week.
DCGI V G Somani had asked SII in the notice why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established, according to reports.