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Oxford Pauses Massive COVID-19 Vaccine Trials Following Safety Issue

2020-09-08T23:57:14.976Z


AstraZeneca, the pharmacist that makes the vaccine, announced the pause while reviewing the occurrence of "a potentially unexplained disease" in a volunteer. Temporary pauses are not unusual in large clinical studies and help ensure safety.


The pharmaceutical company AstraZeneca announced on Tuesday that it

temporarily halted clinical studies of the experimental vaccine against coronavirus

that it is developing in conjunction with the University of Oxford, in the United Kingdom, after the appearance of "a potentially inexplicable disease" in one of the volunteers.

"Our standard review process required a pause to allow the safety data to be reviewed," the company said in a statement. "This is a routine action to take whenever there is a potentially unexplained illness in one of the trials, while investigating, which ensures the integrity of the studies.

Temporary pauses are not unusual in large clinical studies

, and research on any serious or unexpected reactions is a required part of safety testing.

AstraZeneca noted that the problem may be a coincidence, as diseases of all kinds could arise in studies with thousands of people.

"We are working to expedite the review of this unique event to minimize any potential impact on the testing schedule," the company added.

"The fact that AstraZeneca has put their #COVID-19 vaccine #test on hold suggests that they are properly listening to IDMC (Internal Displacement Monitoring Center) regulators," the specialist doctor said on Twitter. Nick Mark in Pulmonology.

News of the hiatus comes on the same day that AstraZeneca and eight other drug manufacturers committed to upholding the highest ethical and scientific standards in the development of their vaccines.

This announcement was made amid concerns that President Donald Trump will pressure the U.S. Food and Drug Administration (FDA) 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.

However,

health officials have warned that public fear that a vaccine is unsafe or ineffective could be disastrous

and undermine the effort to vaccinate millions of people in the United States, where infections exceed 6 million people.

Source: telemundo

All news articles on 2020-09-08

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