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AstraZeneca is questioned over potential use of outdated information in its COVID-19 clinical trial

The outdated information may have provided an incomplete view of the efficacy data, says Data and Safety Monitoring Board.

Susan Morse, Managing Editor

(Photo by Leon Neal/Getty Images)(Photo by Leon Neal/Getty Images)

AstraZeneca may have included outdated information from its COVID-19 vaccine clinical trial, the Data and Safety Monitoring Board said late Monday.

The outdated information may have provided an incomplete view of the efficacy data, the board said in notifying the National Institute of Allergy and Infectious Diseases, the Biomedical Advanced Research and Development Authority and AstraZeneca.

AstraZeneca is being urged to work with the Data and Safety Monitoring Board to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

On Tuesday, AstraZeneca said it would do so. 

"We will immediately engage with the independent data safety monitoring board to share our primary analysis with the most up-to-date efficacy data," the biopharmaceutical company said by statement. "We intend to issue results of the primary analysis within 48 hours."

AstraZeneca said that the numbers published Monday showing 79% vaccine efficacy were based on a pre-specified interim analysis with a data cut-off of February 17.

"We have reviewed the preliminary assessment of the primary analysis, and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis," AstraZeneca said.

Ultimately, 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, the Data and Safety Monitoring Board said.

WHY THIS MATTERS

Vaccination efforts include overcoming vaccine hesitancy.

An estimated 69% of the American public intends to get a vaccine, or has already received one, up significantly from the 60% who said they planned to get vaccinated in November, the Pew Research Center said earlier this month. 

Numbers are lower for Black Americans, but their trust is also steadily climbing. A majority, 61%, say they plan to get a COVID-19 vaccine or have already received one, up sharply from 42% who said they planned to get vaccinated in November, the report said.

The questioning of AstraZeneca's data could add a layer of skepticism to getting that particular vaccine, after several countries temporarily suspended its use following reports of blood clots in some people who were vaccinated. Independent reviews have found no increased risk of blood clots due to the vaccine.

THE LARGER TREND

On Monday, the Data and Safety Monitoring Board released a statement saying results from a large clinical trial in the United States and South America indicate that AstraZeneca's COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease and hospitalization. 

The independent board, which is overseeing the trial, identified no safety concerns related to the vaccine. 

The United Kingdom-based global biopharmaceutical company AstraZeneca developed the vaccine and led the trial as regulatory sponsor.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com