What happens to the data of the Astrazeneca vaccine in the US

Astrazeneca acknowledged today that a press release about its coronavirus vaccine trial in the United States was based on data as of February 17. The post by Enrico Bucci, Ph.D. in Biochemistry and Molecular Biology, adjunct professor at Temple University in Philadelphia, author of the book " Bad Scientists "

Astrazeneca acknowledged today that a press release about its coronavirus vaccine trial in the United States was based on data as of Feb.17 and promised to release more comprehensive results within the next 48 hours, stating however that they are consistent with data since. provided here.

Why it matters: After initial support for Astrazeneca arrived yesterday from NIH, the National Institute of Allergy and Infectious Diseases (NIAID) today released an unusual statement expressing concern that AstraZeneca may have used "outdated information" which “may have provided an incomplete view of the efficacy data”.

NIAID urged the company to work with the Data and Safety Monitoring Board (DSMB), cited in today's release, to "review the effectiveness data and ensure that the most accurate and up-to-date data is made public as quickly as possible."

Please note: we are talking about efficacy, not safety, and the statements made yesterday by the DSMB itself about the absence of particular adverse reactions are not contradicted.

AstraZeneca said it “engages immediately” with the DSMB to share its primary analysis (the full data), which it said is “consistent with the interim analysis” (ie the data provided yesterday).

Earlier, Anthony Fauci, who is director of NIAID, called AstraZeneca's possible use of outdated information a "useless mistake", stressing however that "this is most likely a very good vaccine."

"If you look, the data is pretty good, but what they put in the press release wasn't completely accurate," Fauci said on ABC's Good Morning America.

“We must continue to try as hard as possible to get people to understand that what is in place are safeguards. And I think the Data and Safety Monitoring Board that found this discrepancy was an example of that safeguard, ”he continued.

“And ultimately, it will all be decided by the FDA. They will independently examine every bit of data and will not rely on any interpretation by anyone, including the company. "

Communication disaster of NIH and the company , it would seem; but Fauci, at the head of the same body that raised the problem, seems to reassure at this moment, because in his words it is probably an excellent vaccine.

( Post published on Enrico Bucci's Facebook profile )

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/che-cosa-succede-negli-usa-ai-dati-del-vaccino-astrazeneca/ on Tue, 23 Mar 2021 14:52:48 +0000.