NIAID Statement on AstraZeneca Vaccine

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Tuesday, March 23, 2021

NIAID Statement on AstraZeneca Vaccine


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 The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.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.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine

 

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Source: https://www.chron.com/news/article/AstraZeneca-s-U-S-coronavirus-vaccine-trial-data-16046159.php

AstraZeneca used 'outdated and potentially misleading' data that overstated effectiveness of its vaccine, panel says
Carolyn Y. Johnson, Laurie McGinley and William Booth, The Washington Post
March 23, 2021
Updated: March 23, 2021 4:49 p.m.

WASHINGTON - The long-running saga behind the coronavirus vaccine developed by the drugmaker AstraZeneca and the University of Oxford made another dramatic turn Tuesday as independent monitors took the extraordinary step of questioning the company's portrayal of its data - a move that cast into doubt the fate of the vaccine in the United States.

In a memo sent to company and government officials obtained by The Washington Post, experts who have been overseeing the vaccine trial expressed concern and disappointment that the drugmaker had presented "outdated and potentially misleading" data on its coronavirus vaccine, making the shots appear more effective than shown by fuller data.

On Monday, AstraZeneca and academic scientists trumpeted a vaccine that was 79% effective in its large U.S. clinical trial. That news release triggered concern among independent monitors who had seen more recent data, because when an additional month was taken into account, the effectiveness ranged from 69% to 75%.

The letter came from 11 leading statisticians, infectious-disease physicians and ethics experts appointed by the National Institutes of Health to review trial data for all the major coronavirus vaccines supported by the federal government. It says the company's decision to use early data that puts the vaccine in the most favorable light is a scientific misstep that could erode trust in the shot...