SII pauses trials of COVID-19 vaccine candidate Covishield in India
The company took this step after the DCGI issued a show cause notice to the company for not informing it about AstraZeneca pausing the clinical trials of the vaccine candidate in other countries
Serum Institute of India (SII) said it is pausing clinical trials of AstraZeneca-Oxford COVID-19 vaccine candidate in the country.
Earlier this week AstraZeneca had said it had paused the trials because of ”an unexplained illness” in a participant in the study.
SII’s latest announcement also comes against the backdrop of DCGI’s show-cause notice to SII for not informing it about AstraZeneca pausing the clinical trials of the Oxford vaccine candidate in other countries.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials,” SII said in a statement. The vaccine maker also said it is following instructions of the DCGI.
In the show-cause notice, DCGI V G Somani had asked SII as to 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.
(Edits by EP News Bureau)