Advanced studies of AstraZeneca’s COVID-19 candidate vaccine are temporarily discontinued while the company examines whether a recipient’s “potentially unexplained” disease is a side effect of the vaccine.
In a statement released Tuesday night, the company said its “standard review procedure had caused a pause in vaccination to allow review of protection data. “
AstraZeneca did not reveal any facts about the imaginable side effects, unless she calls it “a potentially unexplained disease. “Health news site STAT first reported the pause in testing, saying that the imaginable side effect had occurred in the UK.
A spokesperson for AstraZeneca showed that the vaccination break covers studies in the United States and other countries. Late last month, AstraZeneca began recruiting another 30,000 people in the United States for its largest vaccine study. It also tests the vaccine, developed through the University of Oxford. , in thousands of others in Britain, and in smaller studios in Brazil and South Africa.
Two other vaccines are in the latter stages of major testing in the United States, one manufactured through Moderna Inc. and the other through Pfizer and The German BioNTech. These two vaccine paintings of those of AstraZeneca, and studies have already recruited about two-thirds of the necessary volunteers.
Temporary suspensions of primary medical studies are not unusual, and research into any serious or unforeseen reaction is a mandatory component of protective testing. AstraZeneca is under pressure that the challenge is possibly a coincidence; diseases of all kinds can occur in studies of thousands of people.
“We are running to speed up the review of the bachelor occasion to minimize any possible effect on the test schedule,” the company said.
The unexplained disease is likely to be severe enough to require hospitalization and not a mild side effect such as fever or muscle pain, said Deborah Fuller, a university of Washington researcher who is administering another COVID-19 vaccine that has not yet begun testing in humans.
“It’s nothing to be alarmed about,” Fuller said. Instead, it is comforting for the company to fail the exam in order to perceive what is happening and conscientiously monitor the aptitude of the exam participants.
Dr. Ashish Jha of Brown University said via Twitter that the scope of the outage is not yet transparent and that he is “always optimistic” that an effective vaccine would 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 would possibly not be vaccine-related, “but the most part is that we do trials before deploying a vaccine to the general public. “
During the third and final level of testing, researchers look for any symptoms of imaginable side effects that may not have been found in previous research with patients. effects of the less unusual aspect and identifies safety.
Trials also evaluate efficacy by monitoring who is in poor health and who is not among patients receiving the vaccine and those receiving a simulated injection.
The progression came on the same day that AstraZeneca and 8 other drug brands made a commitment, pleding to meet the highest moral and clinical criteria in the progression of their vaccines.
The announcement follows fears that President Donald Trump will put pressure on the U. S. Food and Drug Administration to pass a vaccine before it becomes effective.
The United States has invested billions of dollars in efforts to expand several vaccines that oppose COVID-19, but the public fears that a vaccine is uncertain or useless may simply be disastrous and derail the immunization efforts of millions of Americans.
FDA officials did not respond to requests for comment Tuesday night.
AstraZeneca’s US-traded shares are not the only shares in the United States. But it’s not the first time More than 6% fell after trading hours following reports of one of the tests.
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Associated Press editors Matthew Perrone and Carla K. Johnson contributed to this report.
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The Associated Press Department of Health and Science is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is for all content only.