AstraZeneca coronavirus vaccine trial on hold in US as scientists probe into serious side effect in UK participant
The global trials that were temporarily paused because of unexplained illness in a participant, have resumed in the UK
Health officials and regulators in the US are “very concerned” about the possible side effect of AstraZeneca and Oxford University's potential coronavirus vaccine after a participant fell ill and are yet to decide whether or when the clinical trials should be resumed in the US, reveals a new report. An investigation has also been launched into the case by US authorities.
The AstraZeneca coronavirus vaccine trials across the world were paused temporarily because of unexplained illness in a participant. After a review, the trials were resumed in the UK following confirmation by UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) that it was safe to do so. However, officials from the National Institutes of Health (NIH) have said they are worried over a lack of information regarding what happened to the unnamed patient.
“The highest levels of NIH are very concerned. Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed. AstraZeneca need(s) to be more forthcoming with a potential complication of a vaccine, which will eventually be given to millions of people. We would like to see how we can help, but the lack of information makes it difficult to do so,” Dr Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke (NINDS), a part of the NIH, told Kaiser Health News (KHN). According to Nath, the NIH has not yet received tissue or blood samples from the UK patient who had the adverse reaction and its investigation is “in the planning stages.”
The US trials will remain suspended as the US Food and Drug Administration (FDA) investigates the potential side effect in the UK patient, said another report. Sources told Reuters that enrollment of new patients and other trial procedures in the US “were being rescheduled until at least midweek and that it was not clear how long it would take for the FDA to complete its probe.”
In the September 12 statement, which announced the reopening of the trials in the UK, AstraZeneca said that the company is committed to the safety of trial participants and the highest standards of conduct in clinical trials. “The company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably, and at no profit during this pandemic,” it stated.
AstraZeneca and the University of Oxford, as the trial sponsor, did not disclose any further medical information about the participant who fell ill. However, according to Stat, during a private conference call with investors, Pascal Soriot, executive director and chief executive officer of AstraZeneca, said that the trials were paused after a UK woman had neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis. “The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said,” stated the September 9 report. According to KHN, AstraZeneca has said the individual is no longer hospitalized.
Meanwhile, Dr Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, told KHN that the agency will review the data and possibly consult with British regulators before allowing resumption of the US study, which had just begun when the adverse reaction was reported. “Before allowing US trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the UK felt it was safe to continue, Goodman said.
"The AstraZeneca trial in the US has a separate safety board,” said the report. It adds, “FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the US trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.”
The US Department of Health and Human Service (HHS) had earlier announced up to $1.2B in support of AstraZeneca’s candidate vaccine. The agreement is to make available at least 300M doses of the vaccine for the US, with the first doses delivered as early as October 2020 and phase three clinical studies beginning this summer with approximately 30,000 volunteers in the US.