ALL NEWS

AstraZeneca COVID-19 vaccine study paused after one illness

Sep 9, 2020, 6:51 AM | Updated: Aug 2, 2022, 12:36 pm

FILE - This July 18, 2020, file photo, shows the AstraZeneca offices in Cambridge, England. AstraZe...

FILE - This July 18, 2020, file photo, shows the AstraZeneca offices in Cambridge, England. AstraZeneca announced Monday, Aug. 31, its vaccine candidate has entered the final testing stage in the U.S. The company said the study will involve up to 30,000 adults from various racial, ethnic and geographic groups. (AP Photo/Alastair Grant, File)

(AP Photo/Alastair Grant, File)

Late-stage studies of AstraZeneca’s COVID-19 vaccine candidate are on temporary hold while the company investigates whether a recipient’s “potentially unexplained” illness is a side effect of the shot.

In a statement issued Tuesday evening, the company said its “standard review process triggered a pause to vaccination to allow review of safety data.”

AstraZeneca didn’t reveal any information about the possible side effect except to call it “a potentially unexplained illness.” The health news site STAT first reported the pause in testing, saying the possible side effect occurred in the United Kingdom.

An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies in the U.S. and other countries. Late last month, AstraZeneca began recruiting 30,000 people in the U.S. for its largest study of the vaccine. It also is testing the vaccine, developed by Oxford University, in thousands of people in Britain, and in smaller studies in Brazil and South Africa.

Two other vaccines are in huge, final-stage tests 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 already have recruited about two-thirds of the needed volunteers.

Temporary holds of large medical studies aren’t unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing. AstraZeneca pointed out that it’s possible the problem could be a coincidence; illnesses of all sorts could arise in studies of thousands of people.

“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,” the company statement said.

It’s likely the unexplained illness was serious 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 working on a different COVID-19 vaccine that has not yet started human testing.

“This is not something to be alarmed about,” Fuller said. Instead, it’s reassuring that the company is pausing the study to figure out what’s happening and carefully monitoring the health of study participants.

Dr. Ashish Jha of Brown University said via Twitter that the significance of the interruption was unclear but that he was “still optimistic” that an effective vaccine will be found in the coming months.

“But optimism isn’t evidence,” he wrote. “Let’s let science drive this process.”

Angela Rasmussen, a virologist at Columbia University in New York, tweeted that the illness may be unrelated to the vaccine, “but the important part is that this is why we do trials before rolling out a vaccine to the general public.”

During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking 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 those receiving a dummy shot.

The development came the same day that AstraZeneca and eight other drugmakers issued an unusual pledge, vowing to uphold the highest ethical and scientific standards in developing their vaccines.

The announcement follows worries that President Donald Trump will pressure the U.S. Food and Drug Administration to approve a vaccine before it’s proven to be safe and effective.

The U.S. has invested billions of dollars in efforts to quickly develop multiple vaccines against COVID-19. But public fears that a vaccine is unsafe or ineffective could be disastrous, derailing the effort to vaccinate millions of Americans.

Representatives for the FDA did not immediately respond to requests for comment Tuesday evening.

AstraZeneca’s U.S.-traded shares fell more than 6% in after-hours trading following reports of the trial being paused.

___

Associated Press writers Matthew Perrone and Carla K. Johnson contributed to this report.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

We want to hear from you.

Have a story idea or tip? Send it to the KSL NewsRadio team here.

All News

Rep. Tyler Clancy, R-Provo, speaks about HB261 at the Capitol in Salt Lake City on Friday, Jan. 19,...

Aimee Cobabe

Lawmaker wants to increase maximum amount of time for involuntary civil commitments

Utah lawmakers are supporting a bill to increase the maximum amount of time for involuntary civil commitments.

5 hours ago

Eastyn K. Tueller, 19, is accused of going nearly 100 mph when her vehicle smashed into another veh...

Pat Reavy, KSL.COM

Intoxicated woman in fatal ’22 crash was going 98 mph in 35 mph zone, charges say

A West Valley woman accused of traveling nearly 100 mph in a 35 mph zone while driving impaired has been charged with causing a fatal crash in 2022.

5 hours ago

Shane Romano and Sami Sowers take a rest in the shade at Sunnyside Park in Salt Lake City, Tuesday,...

Mark Jackson

SLC Council considering proposal to lease section of neighborhood park to University of Utah

SLC Council is considering a proposal to lease a little over an acre of Sunnyside Park to the University of Utah for a new baseball stadium.

6 hours ago

Sandy Police Sgt. Clay Swensen, the department's public information officer, talks with member of t...

Devin Oldroyd

Sandy Police looking for missing endangered 35-year-old

The Sandy Police Department is asking the public for help locating missing and endangered 35-year-old David Galloway.

7 hours ago

crime Ballpark...

Curt Gresseth

Cop talks knocking down violent crime in Ballpark Neighborhood

Violent crime in the Ballpark Neighborhood of Salt Lake City is down. A deputy chief details how the SLCPD achieved the results.

7 hours ago

"tree work here" sign pictured on a rose park streed...

Eric Cabrera

Rose Park street losing half its trees, upsetting some residents

Residents of a Rose Park apartment complex are upset. Twenty trees on their street are set to be cut down this week.

8 hours ago

Sponsored Articles

Mother and cute toddler child in a little fancy wooden cottage, reading a book, drinking tea and en...

Visit Bear Lake

How to find the best winter lodging in Bear Lake, Utah

Winter lodging in Bear Lake can be more limited than in the summer, but with some careful planning you can easily book your next winter trip.

Happy family in winter clothing at the ski resort, winter time, watching at mountains in front of t...

Visit Bear Lake

Ski more for less: Affordable ski resorts near Bear Lake, Utah

Plan your perfect ski getaway in Bear Lake this winter, with pristine slopes, affordable tickets, and breathtaking scenery.

front of the Butch Cassidy museum with a man in a cowboy hat standing in the doorway...

Bear Lake Convention and Visitors Bureau

Looking Back: The History of Bear Lake

The history of Bear Lake is full of fascinating stories. At over 250,000 years old, the lake has seen generations of people visit its shores.

silhouette of a family looking over a lake with a bird in the top corner flying...

Bear Lake Convention and Visitors Bureau

8 Fun Activities To Do in Bear Lake Without Getting in the Water

Bear Lake offers plenty of activities for the whole family to enjoy without having to get in the water. Catch 8 of our favorite activities.

Wellsville Mountains in the spring with a pond in the foreground...

Wasatch Property Management

Advantages of Renting Over Owning a Home

Renting allows you to enjoy luxury amenities and low maintenance without the long-term commitment and responsibilities of owning a home.

Clouds over a red rock vista in Hurricane, Utah...

Wasatch Property Management

Why Southern Utah is a Retirement Paradise

Retirement in southern Utah offers plenty of cultural and recreational opportunities. Find out all that this region has to offer.

AstraZeneca COVID-19 vaccine study paused after one illness