Oxford University’s Covishield vaccine testing had been halted due to some adverse effect seen. In order to protect the volunteers, on whom the testing will be done there was a halt in the testing process. On this basis, a showcause notice was issued to the Serum institute of India (SII). The question arose by the Oxford university was that why the SII did not inform them about the “reported serious adverse events”. Due to these effects, the UK partner AstraZeneca has to “temporarily pause” its global clinical trials of the Oxford covid vaccine candidate.
On Wednesday, the SII said that there was no explicit directive which was yet issued to pause the trials. A report of the casualty has not yet been submitted about the serious adverse event. The Drugs Controller General of India, V G Somani wants to know why permission was granted for phase 2 and 3 trials, when patient safety has not yet been established.
According to a media report, the vaccine trial caused a volunteer to show symptoms of neurological disorder which affects the spinal cord. The symptoms indicated a rare disease called transverse myelitis. Although the disease is rare, the condition of the volunteer is improving and she will soon be discharged.
It was also reported earlier that the trial had also been halted once earlier in June, when another volunteer had also developed neurological problems. The patient was later diagnosed with multiple sclerosis, the effect was not due to the vaccine.
On Wednesday, the SII said that, “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.”
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.
The Covishield vaccine has been received by a total of 100 volunteers in India. It was said that if the vaccine is certified, it will be manufactured by the SII.