Serum Institute To Pause Vaccine Trials In India After Drug Controller's Notice

The Serum Institute was issued a showcause by the country's drug controller DCGI yesterday, where it was questioned why it was continuing the trials in India even though it has been stopped elsewhere.

Serum Institute of India said it will stop the Phrase 3 trials that were to begin in India next week.

New Delhi:

The Serum Institute of India, which is manufacturing the coronavirus vaccine Covishield being developed by the Oxford University along with pharma major AstraZeneca, said today it would stop Phase 3 trials that were to begin in India next week. AstraZeneca stopped vaccine trials across four nations as a precautionary measure after a volunteer in the UK showed some potentially adverse symptoms.

The Serum Institute, headed by Adar Poonawalla, was issued a showcause notice by the country's drug controller DCGI yesterday, which questioned why it was continuing the trials in India though it has been stopped elsewhere. The DCGI also questioned why it has not received a report detailing the symptoms of the patient in the UK.

"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials," read a statement from the Serum Institute, which was still doing the groundwork for the trial including listing volunteers. The trials were to be held on 1,600 volunteers across 17 sites in India and were expected to begin next week.

"We are following DCGI's instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front," added the statement.

After the DCGI notice, the Serum Institute had said last evening, "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, said on Wednesday that the UK volunteer had suffered "an unexplained illness" and such pauses in drug trials were "routine".

The New York Times reported that the a person was diagnosed with transverse myelitis, an inflammation of the spinal cord generally caused by infections, citing unnamed sources.

The Serum Institute's move came amid concerns over the coming tests in India.

"I was horrified to read last night @8:15pm that Serum Institute said it was continuing with its vaccine trials. I immediately got in touch with senior govt officials & am glad the Drug Controller has since issued show-cause notice. Safety standards ARE & MUST be same world over," former Union minister Jairam Ramesh had tweeted.

The race for a vaccine has become more intense worldwide as the coronavirus pandemic rages on. India, which is the world's second worst-hit nation, has recorded close to 97,000 cases in a day, the highest daily jump so far.