SII to Suspend Recruitment for COVID Vaccine Trial For Now: DCGI
SII has also been asked to increase the safety monitoring of the subjects already vaccinated as part of the trial.
The Serum Institute of India has been directed by the Drugs Controller General of India (DCGI) to suspend any new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate until further orders, news agency PTI reported on Friday, 11 September.
SII has also been asked to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
A neurological symptom in one participant had triggered the global hold on trials, with AstraZeneca calling the halt "an abundance of caution”.
Serum Institute of India, the Indian vaccine manufacturer of the Oxford vaccine had put out a statement saying they were not pausing the trials in India.
The statement read, "We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all."
However, by the evening of 9 September, the Drugs Regulator General of India (DCGI), the apex body responsible for overseeing clinical trials, had issued a show cause notice to Serum for failing to inform them about the pausing of the trial in UK and US.
The notice stated, "In view of the above, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause... why the permission granted to you on August 2 shall not be suspended till patient safety is established."
The Latest Order
Following the show cause notice, the Pune-based firm said it is pausing the trials in India.
In the copy of the DCGI order from Friday, which has been accessed by PTI, Serum Institute’s reply is discussed, which stated that DSMB has noted no safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days post-vaccination safety data.
In its reply, SII also stated that Data and Safety Monitoring Board (DSMB) further recommended "to pause further enrolment into the study until ongoing investigations of SAE reported in the UK study is completed and the sponsor and the UK DSMB are satisfied that it doesn't pose any safety concerns".
"In the view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India, in exercise of the powers vested under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, direct to you suspend any new recruitment in the phase 2 and 3 clinical trial till further orders," the order read.
(With inputs from PTI)
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