U.S. Health Officials Question AstraZeneca Vaccine Trial Results

Federal health officials said early Tuesday that results from a U.S. trial of AstraZeneca’s Covid-19 vaccine may have relied on “outdated information” that “may have provided an incomplete view of the efficacy data,” casting doubt on an announcement on Monday that had been seen as good news for the British-Swedish company as well as the global vaccination drive.

In a highly unusual statement released after midnight, the National Institute of Allergy and Infectious Diseases said that the data and safety monitoring board, an independent panel of medical experts under the National Institutes of Health that has been helping to oversee AstraZeneca’s U.S. trial, had notified government agencies and AstraZeneca late Monday that it was “concerned” by information the company had released that morning.

The institute urged AstraZeneca to work with the monitoring board “to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”

In a statement released on Tuesday morning, AstraZeneca said the interim results it announced on Monday were current as of February 17. The company said a preliminary review had found its primary analysis — the more up-to-date results that will be scrutinized by the Food and Drug Administration — to be “consistent” with the interim analysis.

The company said it would immediately share its most up-to-date efficacy data with the monitoring board and plans to issue results from the primary analysis within 48 hours.

In a news release on Monday announcing the results of the U.S. trial, the company said that the vaccine it developed with the University of Oxford was 79 percent effective against Covid-19, higher than observed in previous trials, and completely prevented the worst outcomes from the disease. The long-anticipated results were seen as encouraging global confidence in the vaccine, which was shaken this month when more than a dozen countries, mostly in Europe, temporarily suspended the shot’s use over concerns about possible rare side effects.

In recent days, the monitoring board’s analysis was delayed several times because the board had to ask for revised reports from those handling trial data on behalf of the company, according to a person familiar with the matter who was not authorized to discuss it publicly. ...

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