India
Serum Institute gets notice after AstraZeneca halts coronavirus vaccine trial
Drug Controller General of India (DCGI) sent a notice to the Serum Institute of India (SII) asking why trials for the coronavirus vaccine candidate, developed by the University of Oxford, were not halted even when UK-based pharma giant AstraZeneca had stopped the process after a volunteer fell ill. SII responded that it will abide by directions but it hasn't been asked to stop trials, just yet.
Context: After volunteer had a reaction, late-stage trial was paused
In an unwelcome development, AstraZeneca disclosed on Tuesday that it was pausing late-stage trial after a UK-based volunteer had an "adverse reaction." The company said such incidents aren't entirely uncommon in large-scale trials while adding that it was taking steps to mitigate the impact on the vaccine timeline. The vaccine, termed as a frontrunner in the global race, was found to be effective earlier.
Volunteer who fell ill was a woman, had neurological symptoms
While initially, extensive details about the illness weren't revealed, AstraZeneca's CEO Pascal Soriot told investors that the volunteer who took ill was a woman. She had "neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis," StatNews reported. Soriot also said that though the diagnosis hasn't been confirmed, the woman was recovering and could be discharged soon.
Despite global halt, SII continued the process
After the illness was reported, AstraZeneca stopped trials globally, but its India partner SII decided against it. On Wednesday, the Pune-based firm said it will not change the process and declared that it hasn't faced any issues. SII also said it "can't comment on the UK trials," adding that the trials were "paused for further review." By evening, SII had gotten a notice.
Why didn't you inform about trials being paused, asked DCGI
In the show-cause notice, Director Dr. VG Somani asked SII why permission to conduct trials in India shall not be suspended until the UK candidate's safety is determined. According to PTI, DCGI was also critical of the fact that SII didn't inform about global trials being paused. DCGI said SII didn't submit "casualty analysis of the reported serious adverse event" either.
SII was asked to explain why permission shouldn't be suspended
"[We] give you an opportunity to show cause as provided under rule 30 of the New Drugs and Clinical Trials Rules, 2019, why the permission granted to you August 2 shall not be suspended till patient safety is established, (sic)" the notice added.
Will follow instructions, said SII after notice
After the notice gained public attention, SII said it was willing to abide by all guidelines. "If DCGI (Drug Controller General of India) has any safety concerns, we will follow their instructions and abide by the standard protocols," the world's largest vaccine manufacturer told ET. Notably, SII started trials in India last month and plans to conduct tests across 17 sites.
