World's Leading COVID-19 Vaccine Trial on Hold
Late-stage studies of AstraZeneca's World's Leading Covid-19 vaccine candidate are on temporary hold while the corporate investigates whether a recipient's "potentially unexplained" illness may be a side effect of the shot.
In a statement issued on Tuesday evening, the corporate said its "standard review process triggered an interruption to vaccination to permit review of safety data".
AstraZeneca didn't reveal more information about the possible side effect but called it "a potentially unexplained illness"
The health news site STAT first reported the pause in testing, saying the possible side effect occurred within the united kingdom. An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies within the US and other countries.
Late last month, AstraZeneca began recruiting 30,000 people within the US for its largest study of the vaccine. It is also testing the vaccine, developed by Oxford University, in thousands of individuals in Britain, and in smaller studies in Brazil and South Africa.
In a statement issued on Tuesday evening, the corporate said its "standard review process triggered an interruption to vaccination to permit review of safety data".
AstraZeneca didn't reveal more information about the possible side effect but called it "a potentially unexplained illness"
The health news site STAT first reported the pause in testing, saying the possible side effect occurred within the united kingdom. An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies within the US and other countries.
Late last month, AstraZeneca began recruiting 30,000 people within the US for its largest study of the vaccine. It is also testing the vaccine, developed by Oxford University, in thousands of individuals in Britain, and in smaller studies in Brazil and South Africa.
Two other vaccines are in huge, final-stage tests within 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 therefore the studies have already got recruited about two-thirds of the needed volunteers.
Temporary holds of huge medical studies aren't unusual, and investigating any serious or unexpected reaction may be a mandatory a part of safety testing. AstraZeneca acknowledged that it's possible the matter might be a coincidence; illnesses of all sorts could arise in studies of thousands of individuals.
The corporate statement said that they are working to expedite the review of the only event to attenuate any potential impact on the trial timeline.
It's likely the unexplained illness was serious enough to need hospitalization and not a light side effect like fever or muscle pain, said Deborah Fuller, a University of Washington researcher who is functioning on a special COVID-19 vaccine that has not yet started human testing.
Fuller also said This isn't something to be alarmed about, it's reassuring that the corporate is pausing the study to work out what's happening and punctiliously monitoring the health of study participants.
During the third and end of testing, researchers search for any signs of possible side effects which will have gone undetected in earlier patient research. due to their large size, the studies are considered the foremost important study phase for selecting up less common side effects and establishing safety.
The trials also assess effectiveness by tracking who gets sick and who doesn't between patients getting the vaccine and people receiving a dummy shot.
The announcement follows worries that President Donald Trump will pressure FDA to approve a vaccine before it's proven to be safe and effective.
The United States has invested billions of dollars in efforts to rapidly develop multiple vaccines against COVID-19. But public fears that a vaccine is unsafe or ineffective and might be disastrous, derailing the trouble to vaccinate many Americans.
AstraZeneca's US-traded shares fell quite 6 percent in after-hours trading following reports of the trial being paused.
Temporary holds of huge medical studies aren't unusual, and investigating any serious or unexpected reaction may be a mandatory a part of safety testing. AstraZeneca acknowledged that it's possible the matter might be a coincidence; illnesses of all sorts could arise in studies of thousands of individuals.
The corporate statement said that they are working to expedite the review of the only event to attenuate any potential impact on the trial timeline.
It's likely the unexplained illness was serious enough to need hospitalization and not a light side effect like fever or muscle pain, said Deborah Fuller, a University of Washington researcher who is functioning on a special COVID-19 vaccine that has not yet started human testing.
Fuller also said This isn't something to be alarmed about, it's reassuring that the corporate is pausing the study to work out what's happening and punctiliously monitoring the health of study participants.
During the third and end of testing, researchers search for any signs of possible side effects which will have gone undetected in earlier patient research. due to their large size, the studies are considered the foremost important study phase for selecting up less common side effects and establishing safety.
The trials also assess effectiveness by tracking who gets sick and who doesn't between patients getting the vaccine and people receiving a dummy shot.
The announcement follows worries that President Donald Trump will pressure FDA to approve a vaccine before it's proven to be safe and effective.
The United States has invested billions of dollars in efforts to rapidly develop multiple vaccines against COVID-19. But public fears that a vaccine is unsafe or ineffective and might be disastrous, derailing the trouble to vaccinate many Americans.
AstraZeneca's US-traded shares fell quite 6 percent in after-hours trading following reports of the trial being paused.