AstraZeneca on September 8 has paused the late-stage trial of one of the leading vaccine candidates. It was due to an unexplainable illness in a study participant.
According to a company spokeswoman, Michele Meixell, their standard review process was triggered. Due to which they have voluntarily put a pause on the vaccination. This was done to allow a review of safety data by an independent committee.
The study is testing a COVID-19 vaccine by AstraZeneca and the University of Oxford researchers at various sites. The sites also include the United Kingdom, where the unexplainable illness took place.
The nature of the case and time of its occurrence was not disclosed. However, according to sources, the participant will recover soon.
The US Food and Drug Administration defines the incident as an adverse event. According to them, evidence suggests a possible relationship to the drug being tested. As per reports the halt on the trial was due to ‘serious adverse reaction’.
The suspension of the trial has also an adverse impact on other AstraZeneca vaccine trials. This suspension will also effect clinical trials by other vaccine makers.
The US National Institutes of Health, which is providing funding for AstraZeneca’s trial, is not available for any comment. The shares of AstraZeneca fell more than 8% in the after-hours US trading. However, the shares of rival vaccine developers rose. Moderna Inc. was up by more than 4% and Pfizer Inc. rose by less than 1%.
Nine leading US and European vaccine developers pledged on September 8 to uphold their scientific safety. They also want to uphold the efficiency standards for their experimental vaccines despite the urgency to contain the COVID-19 pandemic.