Pune: Serum pauses Oxford vaccine trials, will wait for all-clear from DCGI

PUNE: Serum Institute of India on Thursday hit a temporary pause on human trials of the Oxford vaccine by stopping enrolment of new volunteers at 17 trial sites in the country.

SII said the pause would stay until clearance to proceed comes from the Drugs Controller General of India (DCGI).
The DCGI had on Wednesday served SII a showcause notice asking why it hadn’t informed the drug regulator of a reported adverse event in a volunteer at a trial site in the United Kingdom, which had forced pharma firm AstraZeneca to pause global trials of the vaccine.
The SII has signed a deal to manufacture the Oxford vaccine (co-developed by AstraZeneca) in India under the name Covishield.
On Wednesday, the Adar Poonawalla-led SII said, “We are currently reviewing the situation and pausing India trials till AstraZeneca restarts the trials in the UK. We are following DCGI’s instructions.”
In India, Covishield is yet to enter phase 3 of the vaccine trial. So far, 100 volunteers — 68 from Pune — have already received shots of the potential Covid vaccine. They are currently under observation.
A senior official from Indian Council of Medical Research (ICMR), which is overseeing trials of the Oxford vaccine in India, said its safety profile would continue to be evaluated among the first 100 volunteers.
“The trial sites in India will not enrol or recruit new volunteers for the vaccine test. But the ongoing work of analysing the safety data of the Oxford vaccine in vaccinated volunteers for a week will continue unhindered,” the ICMR official said.
On Tuesday, AstraZeneca paused global trials after it was reported that a UK volunteer had experienced a suspected adverse reaction. The development is now under an internal review.
While several experts told TOI that “transverse myelitis”, the side-effect reportedly exhibited by the UK volunteer, was a serious neurological condition, sources said a preliminary “causality investigation” indicated that pre-existing conditions might have led to the adverse event. The issue does not appear to be related to the vaccine, they said.
AstraZeneca has described the pause in trials as “routine action”.
On Tuesday, the pharma major said: “In large clinical trials, illnesses will happen by chance and must be independently reviewed. We will be guided by this (review) committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly.”