AstraZeneca announced a hiatus after a volunteer experienced serious adverse effects
The news that Pharmaceutical AstraZeneca stopped trials of phase 3 of the vaccine it is developing in conjunction with the University of Oxford, fell like a bucket of cold water in a world that is waiting for the drug to face the coronavirus pandemic that has been living since the beginning of the year. But Is it bad that rehearsals have stopped?
One of the thousands of volunteers who received the experimental vaccine had severe reactions after receiving it, so according to the clinical trial safety protocol, the pharmacist paused the tests.
However, in a press release AstraZeneca explained that it is a “routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while investigating ”.
At this time scientists review the safety information on the vaccine to find possible risks. “As part of the ongoing global randomized controlled trials of the Oxford coronavirus vaccine, our standard review process took a voluntary pause in vaccination to allow review of safety dataExplains the statement. “In large trials, diseases will happen by chance, but they need to be independently reviewed to verify this carefully,” he adds.
For its part, Matt Hancock, British Health Minister, explained to the media that this situation “is not necessarily a setback” and defined it as “a challenge”. Actually “this is not the first time this has happened to an Oxford vaccine,” she added. She also stated that the pause “will not necessarily” delay the development of the vaccine, “it depends on what they find when they do the research.”
AstraZeneca emphasized its commitment to the safety of volunteers and “to the highest standards of conduct in our trials.”, so they work to “accelerate the review of the single event to minimize any potential impact on the trial schedule.”
– Rebecca Robbins (@RebeccaDRobbins) September 9, 2020
The rehearsal pause occurs just when AstraZeneca and eight other pharmaceutical companies signed a pledge that they will send their drugs “for approval or authorization of emergency use only after demonstrating safety and efficacy. through a Phase 3 clinical study that is designed and conducted to meet the requirements of expert regulatory authorities such as the FDA ”.
“We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles“They stated in a joint statement signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.