The recently developed vaccine by AstraZeneca for novel coronavirus has been suspended for further trials after it showed unexplained symptoms by its recipient.
Thus, the Phase III study of AstraZeneca and University of Oxford’s COVID-19 vaccine candidate is kept on hold for the time being. In the meanwhile, the pharmaceutical company is on its investigation as to whether a recipient’s illness is a side effect of the shot or unrelated, the pharma giant announced on September 9th 2020, Wednesday.
AstraZenca clarified that the pause is a voluntary, routine action that occurs whenever there is a potentially unexplained illness during a clinical trial. To maintain the integrity of a trial, any illness must be investigated before reopening, if that is the ultimate outcome.
The unexplained illness occurred in the UK and was isolated to a single event. Best case scenario: the participant experienced an illness event unrelated to the vaccine or COVID-19, and the trial will be restarted shortly. Worst case scenario: the illness is a side effect of the vaccine, severe enough to halt testing altogether.
AZD122 expanded into a Phase III clinical trial at the end of August after interim results from Phase I/II trial showed the vaccine produced antibodies in around 90% of participants with no severe adverse events reported. Mild to moderate side effects, such as fever, headache, and muscles ache was prevalent in 60% of the recipients; though were resolved before the end of the trial.
The multi-site Phase III trials aims to enroll 30,000 volunteers at 80 sites across the US AstraZeneca is also testing the vaccine in thousands of volunteers in the UK, Brazil and South Africa. The pharmaceutical giant recently received $1.2 billion in funding for 300 million doses as part of Operation Warp Speed, a multi-agency effort to fast-track coronavirus vaccines.
The trial pause comes just a day after nine pharmaceutical CEOs came together to sign a historic pledge to “uphold the integrity of the scientific process” as the companies work toward a potential COVID-19 vaccine. AstraZenca’s Soriot signed the pledge, in addition to the CEOs of BioNTech, GlaxoSmithKline, Johnson & Johnson, Moderna, Novavax, Merck, Pfizer and Sanofi.
