AstraZeneca has resumed its phase three clinical trials in the United Kingdom for the company’s coronavirus vaccine candidate after abruptly halting the program earlier this week over fears that a study participant living in the U.K. was reportedly experiencing negative side effects from the drug.
KEY FACTS
On Saturday, AstraZeneca announced trials were back on after the pause, which the firm said in a statement was voluntary and allowed for a safety review by independent parties and regulators worldwide.
The U.K. leg of the investigations determined it was safe to continue, according to a release, and the U.K. Medicines Health Regulatory Authority gave their blessing for the trials to resume.
The phase three trials were called off earlier this week after reports that a participant had side effects that could possibly be linked to the trial.
Astrazeneca called the pause a “routine action” when a clinical trial comes across a potentially unexplained illness in a participant that must be investigated to “maintain the integrity of the trials.”
AstraZeneca is developing the candidate alongside the University of Oxford, and has enjoyed a boost of $1 billion from the U.S. government in funding along with 400 million doses on pre-order if the vaccine turns out to be safe and effective.
CRUCIAL QUOTE
“AstraZeneca is committed to the safety of trial participants and the highest standards of conduct in clinical trials,” a Saturday statement from the firm read. “The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic.”
KEY BACKGROUND
The trial’s pause and the idea of vaccine side effects has made many uneasy. Experts say it will likely take widespread vaccination against the coronavirus to end the pandemic and for life to return to any semblance of normal. But in the U.S., the vaccine has been politicized as the presidential race heats up. U.S. President Donald Trump has promised the possibility of a successful vaccine release well before the end of the year—even before Election Day in November—while health officials, like the nation’s leading infectious disease expert Anthony Fauci say next year is more likely. Critics have accused Trump and his administration of pressuring health organizations to speed up the vaccine approval process to help Trump’s chances at reelection as polls show his opponent Democratic nominee Joe Biden with a slight leg up. Trump and health officials like Fauci and Health and Human Services Secretary Alex Azar Thursday have denied the accusations, with Azar insisting last week that “any vaccine that comes out is going to meet FDA’s gold standards for authorization or licensure. The president’s made that clear, I’ve made that clear, the FDA commissioner has made that clear.”
FURTHER READING
AstraZeneca Puts Phase 3 Vaccine Trial On Hold, Shares Drop 6% (Forbes)
-By Carlie Porterfield,Forbes Staff