A nurse makes syringes with the preparation of Astrazeneca in Axel Stelzner’s general practice.
Hendrik Schmidt | Image alliance via Getty Images
LONDON – A U.S. health agency on Tuesday expressed concern that AstraZeneca may have included out of date information from a clinical trial of its Covid-19 vaccine, which may cast doubt on the published efficacy results.
The Data Safety Monitoring Board “was concerned that AstraZeneca may have included out of date information from this study, which may provide an incomplete view of the efficacy data,” the US National Institute of Allergy and Infectious Diseases said in a statement.
“We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released as soon as possible.”
The NIAID is headed by the White House Chief Medical Officer, Dr. Anthony Fauci, directs and is part of the National Institutes of Health.
AstraZeneca did not immediately respond to a CNBC request for comment.
The statement comes just a day after the results of a large U.S. study showed that the coronavirus vaccine developed by AstraZeneca and Oxford University is 79% effective against symptomatic illness and 100% effective against serious illness and hospitalization.
Data from the late-stage human study was based on more than 32,000 volunteers at 88 trial centers in the United States, Peru, and Chile.
The results were welcomed as “surprisingly positive” and “good news for the global community”.
AstraZeneca said it plans to prepare the primary analysis, which will be submitted to the U.S. Food and Drug Administration for emergency approval before mid-April.
The vaccine against Oxford-AstraZeneca had been temporarily suspended in several countries after reports of blood clots in some people who had been vaccinated. However, AstraZeneca said Monday that the independent DSMB had not found an increased risk of blood clots.
Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business, told CNBC’s Squawk Box on Monday that it was “very gratifying to see that the Data Safety Monitoring Board, even with a magnifying glass, is not imbalance between the vaccinated group and the vaccinated group found. ” the placebo group. “
“That gives us a lot of confidence,” he added.