Corononavirus: More than 45 lakh people in India have been affected by the pandemic so far.
New Delhi:
The new recruitment for the University of Oxford’s Phase 2 and Phase 3 trials of the Covishield vaccine being manufactured in India by the Serum Institute of India, along with leading drugmaker AstraZeneca, should be suspended until new orders are placed, said the the country’s drug controller, DCGI.
The Comptroller General of Drugs of India (DCGI) also directed the Serum Institute of India (SII) to increase the safety check of subjects who have already been vaccinated as part of the trial and to submit the plan and report.
On Thursday, the Serum Institute, headed by Adar Poonawalla, said it would halt Phase 3 trials that were due to begin in India next week after AstraZeneca halted vaccine trials in four countries as a precaution. The trial pause by the pharmaceutical giant was linked to a UK volunteer displaying potentially adverse symptoms.
“We are reviewing the situation and stopping trials in India until AstraZeneca restarts trials,” said a statement from the Serum Institute, which was still preparing the preliminary work for the trial, including the list of volunteers.
Phase 2 of the human trials of the vaccine began in Pune, Maharashtra, on August 27. However, it is not clear how many volunteers received the dose. Phase 3 of the trials was scheduled to begin next week with 1,600 volunteers at 17 different sites.
On Wednesday, the DGCI sent a show of cause notice to the Serum Institute, questioning why it was continuing with trials in India, although it stopped elsewhere. The DCGI also questioned why it has not received a report detailing the patient’s symptoms in the UK.
The pharmaceutical firm, responding to the advisory, said there have been no safety concerns so far. “The Data Safety Monitoring Board of India (DSMB) has not noticed safety concerns of the first dose and safety data seven days after vaccination,” IBS said in its response.
The DSMB “recommended stopping study enrollment until ongoing investigations of the issues reported in the UK study are completed and the UK Data Security Monitoring Board is satisfied that it does not pose any security concerns. “said the Serum Institute in its response. .
After reviewing the response, the DGCI ordered the suspension of new recruitment for Phase 2 and Phase 3 human trials until further orders. The drug regulator had granted permission for the trials on August 2.
The World Health Organization (WHO) chief scientist said Thursday that AstraZeneca’s pause from an experimental vaccine for coronavirus after a participant’s illness is a “wake-up call.” A
“This is a wake-up call to recognize that there are ups and downs in clinical development and that we have to be prepared,” Soumya Swaminathan said in a virtual briefing from Geneva, Reuters news agency reported.
“We don’t have to get discouraged. These things happen.”
Across India, more than 45 lakh of patients have been affected by the coronavirus. Worldwide, more than 2.8 million people have contracted the virus so far.
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