The Serum Institute of India, which is manufacturing the Oxford University’s Covishield vaccine and will hold the phase 3 clinical trials in India from next week, has been issued a showcause notice by the country’s drug controller DGCI. Trials for the vaccine were stopped in four nations as a precautionary measure after one of the recipients in the UK showed some adverse symptoms, which are yet to be linked to the vaccine.
In its notice, the Drugs Regulator General of India questioned why the Serum Institute is progressing with the trials and why it has not sent a detailed report about the patient in the UK.
The Serum Institute is currently enrolling volunteers for the phase 3 trial of the Covishield, which is being developed jointly by the Oxford University and pharma giant AstraZeneca. It was expected to test the vaccine on around 1,600 participants across 17 sites.
On Wednesday evening, the Serum Institute said, “We are going by DCGI’s direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”
In a statement earlier in the day, the Pune-based vaccine manufacturer said the Indian trials are continuing and they have faced no issues at all. The company also said they “can’t comment much on the UK trials, but they have been paused for further review”.
AstraZeneca, the British-Swedish pharma giant that’s developing the vaccine jointly with Oxford University, had said the volunteer had suffered “an unexplained illness” and such pauses in drug trials are “routine”.
An AstraZeneca spokesperson had said it is too early to determine the sick participant’s specific diagnosis, news agency Reuters had reported.
New York Times had reported that a volunteer in the UK trials was diagnosed with transverse myelitis, an inflammation of the spinal cord generally caused by infections, citing a person close to the situation that it didn’t name.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” spokeswoman Michele Meixell said in a statement. – NDTV