Late-stage studies of a possible COVID-19 vaccine are on temporary hold while the company investigates whether a report of a patient with a serious side effect is linked to the shot.
On Tuesday night, AstraZeneca said its “standard review procedure has caused a pause in vaccination to allow review of protection data. “
AstraZeneca didn’t reveal any information about the possible side effect except to call it “a potentially unexplained illness.” The news site STAT first reported the pause in testing, saying the possible side effect occurred in the United Kingdom.
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 mammoth testing in the United States, one manufactured through Moderna and the other through Pfizer and Germany’s BioNTech. These two AstraZeneca vaccine paints and studies have already recruited about two-thirds of the volunteers needed.
Temporary suspensions from primary medical studies are not unusual, and investigation of severe 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.
The unexplained illness is most likely serious enough to require hospitalization and not a mild side effect, such as fever or muscle pain, said Deborah Fuller, a researcher at the University of Washington working on another 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.
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 its giant size, studies are considered the most important analysis phase to determine the less common side effects and the safety of the building.
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 to the highest moral and clinical criteria in their vaccine progression.
The announcement follows fears that US President Donald Trump will pressure the US Food and Drug Administration to approve a vaccine before it is shown 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 can simply be disastrous and derail efforts to vaccinate millions of Americans.
FDA officials did not respond to requests for comment Tuesday night.
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