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NIAID releases late-night statement questioning if AstraZeneca used ’outdated information’ in COVID-19 vaccine trail

The National Institute of Allergy and Infectious Diseases (NIAID) released a statement late last night questioning if AstraZeneca used outdated information in the trial of its COVID-19 vaccine:

From Reuters:

The Data Safety Monitoring Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said in a statement bit.ly/3scE3ji released after midnight in the United States.

And here’s the statement from NIAID:

“Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.”

Yes, this is “unusual”:

And the friction between regulators and the company is being called “so, so troubling”:

So, what’s going on?

AstraZeneca is seeking emergency FDA approval for the vaccine, which is now in doubt:

 

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Source: NIAID releases late-night statement questioning if AstraZeneca used ’outdated information’ in COVID-19 vaccine trail

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