The news that the pharmaceutical AstraZeneca stopped trials of phase 3 of the vaccine that 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 pandemic of coronavirus 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 have received the experimental vaccine had severe reactions after receiving it, so according to the safety protocol of clinical trials, the pharmacist paused in the tests.
However, in a press release AstraZeneca explained that this is a “routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while it is being investigated.”
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 data,” the statement explains. “In large trials, diseases will happen by chance, but they need to be independently reviewed to verify this carefully,” he adds.
For his 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 their commitment to the safety of volunteers and “to the highest standards of conduct in our trials,” so they work to “expedite the review of the single event to minimize any potential impact on the trial schedule.”
The trial pause occurs just as AstraZeneca and eight other pharmaceutical companies signed a pledge stating that they will send their drugs “for approval or authorization for emergency use only after demonstrating safety and efficacy through a Phase 3 clinical study that It is designed and built 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 AstraZeneca CEOs. , BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.