Serum Institute pauses vaccine trials in India after DCGI notice

New Delhi: Serum Institute of India (SII) on Thursday said it is pausing clinical trials of AstraZeneca Oxford COVID-19 vaccine candidate in the country.

Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study.

However, SII on Wednesday said it was 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 the situation and pausing India trials till AstraZeneca restarts the trials," SII said in a statement.

The Pune-based vaccine maker also said it is following instructions of the Drugs Controller General of India (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.

SII is sponsoring mid-and late-stage human clinical trials for the vaccine candidate in India. The candidate, named Covishield in India, was administered to the first set of volunteers on August 26.

AstraZeneca said it had "voluntarily paused vaccination" in its ongoing global trials to "allow review of safety data by an independent committee" after the event triggered its standard review process.

One of the conditions for SII to conduct the trials in India had been that clinical data generated in India would be considered along with data from trials conducted by Oxford-AstraZeneca, the notice issued by DCGI Dr VG Somani on Wednesday had stated.

Before this show-cause notice, SII's spokesperson had said earlier on Wednesday that, as far as Indian trials were concerned, "it is continuing and we have faced no issues at all".

The Pune firm, the world's largest manufacturer of vaccines, has been contracted by AstraZeneca and the University of Oxford to manufacture the vaccine for low- and middle-income countries.

Meanwhile, according to reports, AstraZeneca Plc Chief Executive Officer Pascal Soriot said the Coronavirus vaccine the company is developing with the University of Oxford could still be ready before the end of the year after pausing its trials due to a possible serious neurological problem in one patient.

Speaking at an online conference on Thursday, Soriot sought to reassure investors after the company and its partner confirmed earlier this week that they had temporarily stopped giving patients the experimental shot.

The trial was halted after a person in the UK who was participating in it got sick, triggering a review of safety data. Though such interruptions are common in vaccine studies, the drug-maker and its boss are facing questions about what exactly caused the issue and whether it could be related to the shot.