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of Allergy and Infectious Diseases (NIAID) released a statement late last night questioning if AstraZeneca used outdated information in the trial of its COVID-19 vaccine:
— Reuters UK (@ReutersUK) March 23, 2021
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Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the U.S. National Institute of Allergy and Infectious Diseases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 The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.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”:
“In a highly unusual statement released after midnight…”
US officials say AstraZeneca released “outdated information” when it reported a 79 percent efficacy rate for its #COVID19 vaccine. https://t.co/VGsAw1YGwN
— Jim Roberts (@nycjim) March 23, 2021
And the friction between regulators and the company is being called “so, so troubling”:
Dr. Eric Topol, a clinical trials expert at Scripps Research in San Diego, said it was “highly irregular” to see such a public display of friction between a monitoring board and a study sponsor… I’ve never seen anything like this. It’s so, so troubling.” https://t.co/GQBsOTr20k
— PERth (@mizzunky) March 23, 2021
So, what’s going on?
— tyro (@DoubleEph) March 23, 2021
AstraZeneca is seeking emergency FDA approval for the vaccine, which is now in doubt:
AstraZeneca said it will seek emergency use authorization from the FDA for its coronavirus vaccine after a U.S. clinical trial found it was 79% effective at preventing symptoms and 100% effective at preventing serious disease and hospitalization. https://t.co/2ZcmRkcjVf pic.twitter.com/jge5fwtSMV
— KPBS News (@KPBSnews) March 23, 2021