Share
Late-stage studies of AstraZeneca’s COVID-19 vaccine candidate are on temporary hold while the company investigates if a report of a patient with a serious side effect is linked to 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 news site STAT first reported the pause in testing, saying the possible side effect occurred in the United Kingdom.
Vaccine Trial Expected to Involve 30,000 People
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.
Drugmakers Issue Unusual Safety Pledge
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.
RELATED TOPICS:
Clovis, Sanger, Madera, and Bass Lake Will Light the Sky With Fireworks Shows Tonight
2 days ago
Oil Dips Ahead of Expected OPEC+ Output Increase
2 days ago
613 Killed at Gaza Aid Distribution Sites, Near Humanitarian Covoys, Says UN
2 days ago
Fresno County Authorities Investigating Suspicious Death of Transient Man
2 days ago
Israeli Military Kills 20 in Gaza as Trump Awaits Hamas Reply to Truce Proposal
2 days ago
Valley Crime Stoppers’ Most Wanted Person of the Day: Rachelle Maria Blanco
2 days ago
Russia Pounds Kyiv With Largest Drone Attack, Hours After Trump-Putin Call
2 days ago
How Trump’s ‘Big, Beautiful Bill’ Will Make China Great Again
1 day ago
Categories

How Trump’s ‘Big, Beautiful Bill’ Will Make China Great Again

What’s Caitlin Clark Worth to the WNBA? A Lot More Than Her $78,066 Salary.

Trump to Sign Tax-Cut and Spending Bill in July 4 Ceremony

Clovis, Sanger, Madera, and Bass Lake Will Light the Sky With Fireworks Shows Tonight

Oil Dips Ahead of Expected OPEC+ Output Increase

613 Killed at Gaza Aid Distribution Sites, Near Humanitarian Covoys, Says UN

Fresno County Authorities Investigating Suspicious Death of Transient Man
