"Oxford Vaccine has ‘No Issues’ in India," says SII; But, DGCI issues 'Notice' to Them – Why?

The Serum Institute of India on Wednesday, was instructed to pause trials of the COVID-19 vaccine which was developed by the Oxford University and AstraZeneca. The Central Drug Regulator sent a notice to stop the trials after the trials were paused in several counties due to its sudden adverse reaction.

On Tuesday, one of the study participants reported a serious and adverse reaction in the United Kingdom. The patient has been hospitalised after developing very serious transverse myelitis which is an inflammatory syndrome that affects the spinal cord. Since then, the US, UK, South Africa, and Brazil paused the trials. However, India continued the trials until Wednesday.

“We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon,” SII said in a statement on Wednesday afternoon. “As far as Indian trials are concerned, it is continuing and we have faced no issues at all.”

“We are going by DCGI’s direction and so far we were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols,” added SII in a statement issued late on Wednesday evening.

Experts have said that it is not a bad thing and it is not uncommon either.

“In large randomized efficacy trials, an investigational drug or vaccine is given to a large heterogeneous population,” said virologist Dr Shahid Jameel. “Some of these people also have other underlying health conditions and may react adversely. This is exactly why we need large trials before approval,” Jameel added.