Serum Institute halts human trial of Oxford made vaccine in India after a volunteer suffers illness

Serum Institute of India (SII) on Thursday said it’s pausing clinical trials of AstraZeneca Oxford COVID-19 vaccine candidate within the country.
Earlier in the week , AstraZeneca said it had paused the trials due to ‘an unexplained illness’ during a participant within the study.

However, SII on Wednesday said it had been continuing with the trials and had not faced any issues.

SII’s latest announcement also comes against the backdrop of the central drug regulator DCGI issuing a 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 things and pausing India trials till AstraZeneca restarts the trials,” SII said during a statement.

The Pune-based vaccine maker also said it’s following instructions of the Drugs Controller General of India (DCGI), it added.

In the show-cause notice, DCGI V G Somani had asked SII on why the permission granted for conducting phase 2 and three clinical trials of the vaccine candidate within the country be not suspended till patient safety is established.