AstraZeneca trial participant who had adverse reaction experienced transverse myelitis, safety report shows


The woman who experienced a severe adverse reaction after receiving a COVID-19 vaccine while participating in AstraZeneca's U.K. trial had transverse myelitis, according to an internal safety report obtained by CNN.

AstraZeneca announced it had taken a "voluntary pause" of its phase 3 COVID-19 vaccine trial Sept. 9 after a previously healthy 37-year-old woman experienced an adverse reaction. The drugmaker resumed the trial in the U.K. Sept. 12 after gaining approval from the Medicines Health Regulatory Authority, the country's equivalent of the FDA, but has yet to continue the trial in the U.S.

The document says the participant "experienced confirmed transverse myelitis," a rare neurological condition in which the spinal cord becomes inflamed, and was hospitalized on Sept. 5. It also detailed the participant's symptoms, which included weakness, decreased motor functions and pain in her arms.

The report was issued to physicians running AstraZeneca's trials Sept. 11.

© Copyright ASC COMMUNICATIONS 2021. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.


Featured Whitepapers

Featured Webinars