NEW YORK: Late-stage studies of AstraZeneca’s Covid-19 vaccine candidate are temporarily on hold while the company investigates whether a recipient’s “potentially unexplained” illness is a side effect of the injection.
In a statement issued Tuesday night, the company said its “standard review process caused a pause in vaccination to allow for review of safety data.”
AstraZeneca did not disclose any information about the possible side effect, except to call it “a potentially unexplained illness.”
Health news site STAT first reported the pause in testing, saying the possible side effect occurred in the UK. An AstraZeneca spokesperson confirmed the pause in vaccination coverage studies in the United States and other countries.
Late last month, AstraZeneca began recruiting 30,000 people in the US for its largest study of the vaccine. She is also testing the vaccine, developed by the University of Oxford, in thousands of people in Britain and in smaller studies in Brazil and South Africa.
Two other vaccines are in huge end-stage trials in the United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech. Those two vaccines work differently than AstraZeneca’s, and the studies have already recruited about two-thirds of the volunteers needed.
Temporary holds from large medical studies are not unusual, and the investigation of any serious or unexpected reactions is a mandatory part of safety testing. AstraZeneca noted that the problem may be a coincidence; diseases of all kinds could arise in studies of thousands of people.
“We are working to accelerate the review of the single event to minimize any potential impact on the testing schedule,” the company statement said.
The unexplained illness was 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 working on a different COVID-19 vaccine that has not yet been released. human trials started. .
“This is not something to be alarmed about,” Fuller said. Instead, it’s reassuring that the company is pausing the study to find out what’s going on and carefully monitoring the health of the study participants.
Dr. Ashish Jha of Brown University said via Twitter that the meaning of the disruption was unclear, but that he was “still optimistic” that an effective vaccine will be found in the coming months.
“But optimism is not a test,” he wrote. “Let science drive this process.”
Angela Rasmussen, a virologist at Columbia University in New York, tweeted that the disease may not be related to the vaccine, “but the important part is that this is why we test before releasing a vaccine to the general public.”
During the third and final stage of the trial, researchers look for any signs of possible side effects that have not been detected in previous research with patients. Due to their large size, studies are considered the most important study phase to detect less common side effects and establish safety.
Trials also assess effectiveness by tracking who gets sick and who doesn’t among patients receiving the vaccine and those receiving a sham injection.
The development came on the same day that AstraZeneca and eight other drug manufacturers issued an unusual commitment, promising to uphold the highest ethical and scientific standards in the development of their vaccines.
The announcement follows concerns that President Donald Trump will pressure the US Food and Drug Administration to approve a vaccine before it is shown to be safe and effective.
The United States has invested billions of dollars in efforts to rapidly develop multiple COVID-19 vaccines. But public fear that a vaccine is unsafe or ineffective could be disastrous and derail the effort to vaccinate millions of Americans.
Representatives for the FDA did not immediately respond to requests for comment Tuesday night.
AstraZeneca’s US-listed shares fell more than 6 percent in after-hours trading after reports that testing had stopped.
In a statement issued Tuesday night, the company said its “standard review process caused a pause in vaccination to allow for review of safety data.”
AstraZeneca did not disclose any information about the possible side effect, except to call it “a potentially unexplained illness.”
Health news site STAT first reported the pause in testing, saying the possible side effect occurred in the UK. An AstraZeneca spokesperson confirmed the pause in vaccination coverage studies in the United States and other countries.
Late last month, AstraZeneca began recruiting 30,000 people in the US for its largest study of the vaccine. She is also testing the vaccine, developed by the University of Oxford, in thousands of people in Britain and in smaller studies in Brazil and South Africa.
Two other vaccines are in huge end-stage trials in the United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech. Those two vaccines work differently than AstraZeneca’s, and the studies have already recruited about two-thirds of the volunteers needed.
Temporary holds from large medical studies are not unusual, and the investigation of any serious or unexpected reactions is a mandatory part of safety testing. AstraZeneca noted that the problem may be a coincidence; diseases of all kinds could arise in studies of thousands of people.
“We are working to accelerate the review of the single event to minimize any potential impact on the testing schedule,” the company statement said.
The unexplained illness was 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 working on a different COVID-19 vaccine that has not yet been released. human trials started. .
“This is not something to be alarmed about,” Fuller said. Instead, it’s reassuring that the company is pausing the study to find out what’s going on and carefully monitoring the health of the study participants.
Dr. Ashish Jha of Brown University said via Twitter that the meaning of the disruption was unclear, but that he was “still optimistic” that an effective vaccine will be found in the coming months.
“But optimism is not a test,” he wrote. “Let science drive this process.”
Angela Rasmussen, a virologist at Columbia University in New York, tweeted that the disease may not be related to the vaccine, “but the important part is that this is why we test before releasing a vaccine to the general public.”
During the third and final stage of the trial, researchers look for any signs of possible side effects that have not been detected in previous research with patients. Due to their large size, studies are considered the most important study phase to detect less common side effects and establish safety.
Trials also assess effectiveness by tracking who gets sick and who doesn’t among patients receiving the vaccine and those receiving a sham injection.
The development came on the same day that AstraZeneca and eight other drug manufacturers issued an unusual commitment, promising to uphold the highest ethical and scientific standards in the development of their vaccines.
The announcement follows concerns that President Donald Trump will pressure the US Food and Drug Administration to approve a vaccine before it is shown to be safe and effective.
The United States has invested billions of dollars in efforts to rapidly develop multiple COVID-19 vaccines. But public fear that a vaccine is unsafe or ineffective could be disastrous and derail the effort to vaccinate millions of Americans.
Representatives for the FDA did not immediately respond to requests for comment Tuesday night.
AstraZeneca’s US-listed shares fell more than 6 percent in after-hours trading after reports that testing had stopped.
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