While AstraZeneca resumes clinical trials in the UK, the Indian regulator has asked Serum Institute of India (SII) to suspend recruitments for phase-2 and 3 clinical trials of the Oxford-AstraZeneca vaccine candidate and has directed the firm to increase the safety monitoring of the subjects already vaccinated as part of the trial.
In a statement, the British drug major said on Saturday that following the confirmation by the Medicines Health Regulatory Authority (MHRA), clinical trials of AZD1222 have resumed in the UK. The MHRA said that it was safe to do so, the company said.
Adar Poonawallah, CEO of SII tweeted, "As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end. Good news, @UniofOxford".
"On September 6, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume," the statement read.
It added that all trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.
Meanwhile, in an order on Friday, the drug controller general of India VG Somani directed the Pune based vaccine maker to suspend recruitments till further orders. SII is conducting trials in India for the Oxford-AstraZeneca vaccine.
Somani had issued a show cause notice to SII earlier this week asking it to explain why the permission to conduct trials should not be suspended unless patient safety is established. SII responded to the show cause notice saying that Data and Safety Monitoring Board (DSMB) noted no safety concerns from the Indian study with the first dose and seven day post vaccination data.
The DSMB has, however, recommended that the study be paused until the investigations in the serious adverse event.
In its Friday order, Somani has asked SII to increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report. The DCGI has also asked SII to DSMB UK as well as DSMB India to obtain clearance for resumption of clinical trials.