DCGI sends show-cause notice to Serum Institute for not pausing trial of COVID-19 vaccine

The drug regulator's move comes after AstraZeneca, which is developing the vaccine candidate against COVID-19 with researchers of Oxford University

Published: 09th September 2020 10:08 PM  |   Last Updated: 09th September 2020 11:11 PM   |  A+A-

This undated handout photo provided by Imperial College London shows a COVID-19 vaccine candidate. Scientists at Imperial College London will start immunizing people in Britain this week with their experimental coronavirus shot, becoming the latest entry into the race to find an effective vaccine.

For representational purposes (Photo | AP)

Express News Service

NEW DELHI: Serum Institute of India on Wednesday was forced to pause the phase 3 trial of a COVID-19 vaccine in India, developed by AstraZeneca and Oxford University, following a notice by the central drug regulator—after first saying that the trial will continue in the country.

The late-stage clinical trials for the vaccine have been put on hold since Tuesday in four other countries after a volunteer who had received the vaccine shot reported a serious adverse reaction in the UK.

The development has caught international attention as the investigational vaccine—based on an adenovirus which causes the common cold, is among the front runners in the global race to find a preventive intervention that may bring the pandemic to a halt.

The trial for the vaccine has been paused in the US, UK, South Africa, and Brazil but in India, SII—which has entered into the partnership with AstraZeneca, first maintained that the ongoing trial will continue.

“We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon,” the company 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.”

The company however changed its tune after the Drug Controller General of India issued a show-cause notice for not informing it AstraZeneca pausing the clinical trials in other countries and also for not submitting casualty analysis of the “reported serious adverse events”.

“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,” said SII in a statement issued late on Wednesday evening.

On Tuesday, as per reports, a participant in the UK, who had been administered the vaccine had been hospitalized after developing transverse myelitis—an inflammatory syndrome that affects the spinal cord and can be caused by viral infections.

However, it’s not clear whether the event was related to inoculation or co-incidental and will be confirmed only after a detailed review.

As per the information gathered by this newspaper, the vaccine has been administered to 100 volunteers in India as of now and the safety data is under the review of the data safety monitoring board of the trial before more volunteers are given the shots.

Experts meanwhile said that adverse reactions like the one reported from the UK in the trial “is not a bad thing at all, neither is it uncommon.”

“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.”

He added that the good thing is that there is a system in place to recognize these adverse events and address them—which will build confidence in the trials.

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