We are pleased to announce that the AstraZeneca COVID-19 Vaccine Trial is poised to resume in the coming days. We feel compelled to let you know about why the trial pause occurred and the pertinent findings. We promised transparency and thus are providing the information that we know to date. We must also add that following an extensive and exhaustive review of the case that led to the trial pause, we feel confident that this vaccine trial is moving forward safely. For those enrolled in the trial, we will continue to be vigilant in following your progress to ensure the vaccine’s efficacy and your safety. Oxford and AstraZeneca have since combined forces and their vaccine is one and the same. The trial is now referred to as the Oxford Vaccine Trial.
What is a trial pause? All clinical protocols are designed to have “stopping criteria” if certain safety events occur that would require a pause in recruitment or dosing. This was the case for the Oxford study. This pause should be considered as evidence that the safety protection system put in place to ensure safety of participants is working. Normally, healthy people fall ill for a multitude of reasons, and therefore illnesses such as this when testing many thousands of subjects are to be expected.
What triggered the trial pause? A single participant in the Oxford trial was found to have developed neurologic symptoms (numbness in feet) after a second injection. The participant was hospitalized for observation and the symptoms completely resolved. Every participant in the trial (over 20,000 world-wide) is followed very closely and thus, in this case the symptoms were discovered very early. This single event (one out of 20,000 participants) was unusual enough to pause the trial in every country.
What happens during the pause? During the pause, independent regulatory committees review data from the study. Regulators in each individual country then determine when trials can restart, and they do this in their own time frame. Companies provide the information to the regulators to enable them to make this determination. Many countries, including the United Kingdom where the illness occurred, restarted the trial following their own independent safety assessments. The US employs the strictest safety oversight in the world and out of an abundance of caution, asked for information on all 20,000 participants for review by the Food and Drug Administration (FDA) and an independent safety commission made up of experts in the field who were not involved with the trial, the Data Safety Monitoring Board (DSMB). Read more (pdf) …
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