The U.S. FDA is reportedly expanding its probe into a serious illness arising in the COVID-19 vaccine study from AstraZeneca (NYSE:AZN).
This news, reported by Reuters, follows last week’s statement from U.S. Health and Human Services Dept. Secretary Alex Azar that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based company in collaboration with Oxford University.
In September, AstraZeneca voluntarily paused the U.S. trial after a standard review process was triggered so an independent committee could review safety data surrounding an unexplained illness that occurred in the UK Phase III trial for the AZD1222 vaccine candidate. The UK trial has since resumed, but the U.S. study remains on hold.
According to the Reuters report, that illness was believed to be a rare spinal inflammatory disorder known as transverse myelitis. The expanded investigation will reportedly observe data from earlier trials of similar vaccines developed by the same scientists.
The broadened investigation increases the possibility that the vaccine candidate could be delayed, with requested data expected to arrive this week, which would be followed by analysis from the FDA, Reuters reported. A source told the outlet that the FDA’s probe is not necessarily related to a belief that safety issues are related to the vaccines, but rather an indication that the administration is “being thorough.”
Oxford did not respond to Reuters’ request for comment, while the FDA declined to offer comment to the outlet on an experimental project.
In an emailed statement to MassDevice, an AstraZeneca spokesperson wrote:
“A standard review process triggered a voluntary pause to vaccination across all global AZD1222 trials on September 6 to allow review of safety data by an independent committee of a single event of an unexplained illness in one of the participants. Upon review of the independent committee’s recommendations, health authorities in the UK, Brazil and South Africa have confirmed trials in these countries are safe to resume.
“Regulators in each individual country determine when trials can start and they do this in their own time frame. We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial.”
The FDA did not responded to an additional request for comment from MassDevice.
AstraZeneca was one of nine companies whose CEOs signed a pledge last month which vowed to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first COVID-19 vaccines. The company has received $1.2 billion in government funding to develop the vaccine and deliver 300 million doses for the U.S.
This story was updated with a statement from AstraZeneca and may be updated further.
