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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 data on the imaginable appearance effect, unless she calls it “a potentially unexplained disease. “Health news site STAT first reported the pause in testing, saying that the imaginable-looking 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 undergoing mass last-stage testing in the United States, one manufactured through Modern Inc. ‘s Pfizer. and the German company BioNTech. These two vaccine paintings from AstraZeneca, and the studios have already recruited about two-thirds of the necessary volunteers.
Temporary suspensions of primary medical education are not unusual, and investigating any serious or unforeseen reactions is a mandatory component of protective testing. AstraZeneca noted that it is imaginable that the challenge is 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.
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 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 would possibly not be vaccine-related, “but the most part is that we do trials before launching a vaccine to the general public. “
During the third and final level of the test, researchers look for any symptoms of imaginable side effects that may not have been found in past research with patients. Due to their giant size, studies are considered the most important exploration phase for tripping. effects of the less unusual aspect and identifies safety.
Trials also evaluate efficacy by tracking who converts and who does not among patients receiving the vaccine and those receiving a dummy injection.
The progression took place on the same day that AstraZeneca and 8 other drug brands issued a commitment, pleding to meet the highest moral and clinical criteria in the progression of their vaccines.
The announcement follows fears that U. S. President Donald Trump will pressure 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 opposed to COVID-19, but public fears that a vaccine is uncertain or useless may simply be disastrous and derail efforts to vaccinate 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 They fell by more than 6% in hours following announcements of a stay of trial.
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