US agency questions AstraZeneca efficacy data from latest Covid-19 vaccine trial, United States News & Top Stories



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WASHINGTON (REUTERS) – British drugmaker AstraZeneca may have provided an incomplete view of efficacy data for its Covid-19 vaccine from a large-scale U.S. trial, the National Institute of US Allergies and Infectious Diseases (NIAID).

AstraZeneca said a day earlier that its Covid-19 vaccine developed with the University of Oxford is 79 percent effective in preventing symptomatic diseases in a large trial in Chile, Peru and the United States.

“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the US agency said, referring to the Data Security Monitoring Board (DSMB). Independent.

“We urge the company to work with the DSMB to review the effectiveness data and ensure that the most accurate and up-to-date effectiveness data is released as soon as possible.”

The phase three trial of the vaccine in the United States developed by AstraZeneca and the University of Oxford involved 32,449 participants, and two-thirds received the vaccine, the pharmaceutical firm said in a statement.

About 20 percent were 65 or older, and about 60 percent had health problems associated with an increased risk of severe Covid-19, such as diabetes, severe obesity, or heart disease.

Some leading European Union countries have resumed vaccines against AstraZeneca after the European Medicines Agency said last Thursday that the injection is “safe and effective” and is not linked to an increased risk of blood clots.



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