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PAstra pharmaceutical companyZeneca formally announced Wednesday What is it The phase III trial in the UK testing a vaccine for the coronavirus that causes covid-19 has been put on hold, following a report from a serious adverse event among its participants. More details about the report have since emerged, but many unanswered questions remain as to whether this incident is actually related to the vaccine.
Tuesday night, STAT News reported that the trial was suddenly suspended due to the adverse event, although it was not immediately clear what exactly had happened. Late on Tuesday, other outlets reported that the event involved a UK woman in the treatment group believed to have developed transverse myelitis, a neurological condition characterized by inflammation of the spinal cord. In Wednesday afternoon, STAT news reported that AstraZeneca CEO Pascal Soriot told investors early in the morning that the women had been hospitalized with severe neurological symptoms, but She was already recovering and could be discharged today.
In its statement on retention, the company saire that “a standard review process has been triggered, leading to the voluntary pause of vaccination in all trials to allow an independent committee to review safety data for a single unexplained disease event that occurred in the trial of UK Phase III “.
Transverse myelitis is a weird illness It affects motor and sensory functions regulated by both halves of the spinal cord, although the symptoms associated with it are not always evenly distributed on both sides of the body. These symptoms include pain and weakness in the limbs, difficulty controlling the bowels and bladder, and sensations of numbness or tingling. Most of the time, there is no clear cause for transverse myelitis. But it has often been linked to a wide range of infectious diseases, such as Zika, West Nile, and Lyme disease.
Given what we know about the condition, it is certainly plausible that the women’s symptoms may have been caused by Astra.Zeneca vaccine, which is being developed in conjunction with the University of Oxford. But right now, it’s too early to tell. Although adverse events reported during a clinical trial are often considered synonymous with “side effects” of a treatment, the term is more limited than that. It simply means that these symptoms occurred while someone was taking the treatment: it may or may not be related to treatment. Only after additional research, usually by scientists not directly involved in conducting the research, can we more clearly link an adverse event to the drug or medical device. being tested.
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According to STAT News, this is not the first time a possible red flag has appeared during one of Astra.Zeneca trials for a coronavirus vaccine. During the investor call, Soriot revealed that a trial was suspended sometime in July, after a male participant began developing neurological symptoms. However, the man was eventually diagnosed with multiple sclerosis and his case was deemed unrelated to the vaccine, although it is unclear who did. MS has been linked to viral infection, but no virus has emerged as a clear cause. Transverse myelitis is sometimes the first sign of what is later recognized as MS.
AstraMusicca has not yet responded to a request for comment from Gizmodo on the details of the suspension of the previous clinical trial and the reported adverse event.
As demoralizing as this news may be, it is also an indication that the clinical trial process is working as expected. The fact that this possible complication was noticed almost immediately after it happened is a good sign that the researchers are keeping a close eye on the volunteers.. If this disease turns out to be related to the vaccine, that is also something that researchers working on other covid-19 vaccines, especially those that are similarly based on the use of a castrated adenovirus as a method of administering the dose of the vaccine, should keep in mind in your studies.
If this leads to the failure of the AstraZeneca vaccine, that would not be a surprise, either. Unfortunately, clinical research is rarely easy, And there is a wide margin of failure for potential treatments, even those that reach Phase III, the last stage necessary to secure approval from government agencies like the US. Food and Drug Administration. Of course, they crossed their fingers that this is not the case.
As for the woman at the center of it all, the prognosis for transverse myelitis can vary widely. People do recover to some extent in the first three months, although two-thirds still have persistent moderate to severe symptoms. The sooner someone is diagnosed and receives supportive treatment, such as steroids and physical therapy, the better their outcome. usually he thought about leaving.
