On Tuesday, pharmaceutical giant AstraZeneca announced it was temporarily pausing its global phase three trials of its possible coronavirus vaccine after one participant suffered an unexplained illness.
What We Know:
- The vaccine “candidate” was developed by AstraZeneca, along with Oxford University, and is currently being tested in large-scale human trials in the United Kingdom, the United States, Brazil, and South Africa. All of those trials have currently been put on hold to allow scientists time to scrutinize the data as well as determine if the possible adverse reaction was related to the drug.
- “As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” a spokesperson for AstraZeneca said. “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
- AstraZeneca did not provide details on the symptoms the participant with the adverse reaction had experienced or when the trials are expected to resume. The spokesperson shared that the review was being expedited in the hopes that it would not cause any major delays.
- An individual familiar with the situation, who spoke on the condition of anonymity, told the New York Times that the participant who experienced the suspected adverse reaction had been enrolled in a Phase 2/3 trial based in the United Kingdom. They also shared that the participant had received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, it is still unknown whether this diagnosis was directly linked to AstraZeneca’s vaccine. AstraZeneca declined to comment on the location of the participant and did not confirm the diagnosis of transverse myelitis.
- Dr. Jeff Pothoff, the chief quality officer of the University of Wisconsin Health, where one of the trials is being conducted, received the potential vaccine Wednesday, telling reporters that it is not unusual for trials like this to be paused at one point or another. “We don’t know much more at this point. All these groups like AstraZeneca, have incredible attention to safety so if there is any whisper or wisp of something that would’ve gone wrong, or sometimes it’s just related to regulatory issues,” Pothoff said. “They would stop the trial temporarily while they figure something out.”
- The Oxford University’s vaccine team did confirm that this is the second time the trial has been paused due to a possible adverse effect. Earlier this summer, a different participant showed unexplained symptoms, triggering the same mandatory halt. At that time, Oxford announced that after the review, it diagnosed the individual with an illness deemed unrelated to the vaccine. The trial then quickly resumed.
“The company puts science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts. We will be guided by this committee as to when the trials could restart so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.” AstraZeneca CEO Pascal Soriot said in a statement.
- This Oxford/AstraZeneca vaccine is considered to be the leading candidate in the world race to develop an effective COVID-19 vaccine. This vaccine candidate is currently on phase three trials in the U.K., Brazil, and South Africa and there was no evidence in the earlier phases that the drug caused serious reactions. Other vaccine candidates in phase three trials are being developed by Pfizer/BioNtech and Moderna. On Tuesday, the CEOs of nine drugmakers, including AstraZeneca, released a joint statement vowing not to release any vaccine unless proven safe by rigorous testing.
As of now, it is unclear when a vaccine for the coronavirus will be available. President Trump has claimed a vaccine could be ready as early as November, but health experts say that timeline is highly unlikely.
