Late-stage studies of AstraZeneca’s COVID-19 candidate vaccine are temporarily on hold while the company examines whether a recipient’s “potentially unexplained” illness is a side effect of the vaccine.
In a statement released Tuesday evening, the company said its “standard review procedure caused a pause in vaccination to allow review of protection data. “
AstraZeneca has not disclosed any data on the look effect imaginable unless it calls it “a potentially unexplained disease. ” Health news site STAT first reported the discontinuation of testing, saying that the look effect imaginable had occurred in the UK.
A spokesperson for AstraZeneca showed that the vaccine discontinuation covers studies in the United States and other countries. Late last month, AstraZeneca began recruiting an additional 30,000 people in the United States for its largest vaccine study. It is also testing the vaccine, developed through the University of Oxford, on thousands of other people in Britain and in smaller studies in Brazil and South Africa.
Two other vaccines are in the last stages of gigantic testing in the United States, one made through Moderna Inc. and the other through Pfizer and the German company BioNTech. These two AstraZeneca vaccine paints and studies have already recruited about two-thirds of the volunteers needed.
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Temporary suspensions from primary medical studies are not unusual, and investigation of any serious or unforeseen reactions is a required component of protective testing. AstraZeneca noted that the challenge is conceivably a coincidence; Ailments of all kinds can occur in studies of thousands of people.
“We are racing to accelerate the review of the singles occasion to minimize any possible effect on the testing schedule,” the company said.
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The unexplained illness is most likely serious enough to require hospitalization and not a mild side effect like fever or muscle pain, said Deborah Fuller, a researcher at the University of Washington who is administering some other COVID vaccine. 19 that has not yet begun human testing.
“It’s nothing to be alarmed about,” Fuller said. Instead, it is reassuring that the company is putting the exam on hold to perceive what is happening and painstakingly tracking the aptitude of the exam participants.
Dr. Ashish Jha of Brown University said via Twitter that the significance of the halt is not yet clear and that he is “still optimistic” that an effective vaccine will be discovered in the coming months.
“But optimism is a test,” he wrote. “Let science lead this process. “
Angela Rasmussen, a virologist at Columbia University in New York, tweeted that the disease could not possibly be related to the vaccine, “but more importantly, this is why we are testing before implementing a vaccine for the general public. ” .
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During the third and final level of testing, researchers look for any symptoms of imaginable side effects that have not been detected in previous studies in patients. Due to their giant size, studies are considered the most important phase of analysis to detect less common side effects and create safety.
Trials also assess efficacy by tracking who is in poor health and who is not among patients receiving the vaccine and those receiving a sham injection.
The progression came on the same day that AstraZeneca and 8 other drug manufacturers issued a pledge, committing themselves to the highest moral and clinical standards in their vaccine progression.
The announcement follows fears that President Donald Trump will pressure the U. S. Food and Drug Administration to approve a vaccine before it is found to be effective.
The United States has invested billions of dollars in efforts to expand various vaccines that oppose COVID-19. But public fears that a vaccine is unsafe or useless could simply be disastrous and derail the vaccination efforts of millions of Americans.
FDA officials did not respond to requests for comment Tuesday night.
AstraZeneca shares listed in the US fell more than 6% after business hours following reports of the trial stay.
Associated Press editors Matthew Perrone and Carla K. Johnson contributed to this article.
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