Safety Board Wary of AstraZeneca’s COVID Vaccine Trial Data

An independent review board has cast doubt on the findings for AstraZeneca’s coronavirus vaccine candidate, saying the drugmaker’s efficacy claims may have been based on outdated data.

AstraZeneca on Monday reported that its coronavirus vaccine showed 79% efficacy against symptomatic disease and 100% efficacy against severe disease and hospitalization, citing U.S. clinical trial data.

But the National Institute of Allergy and Infectious Diseases said in a statement Tuesday that the Data and Safety Monitoring Board (DSMB) voiced its concerns about the initial data from AstraZeneca’s vaccine clinical trial, saying that the company may have included outdated information from that trial, which may have provided an incomplete view, CNN reported.

“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,” the institute said in the statement, CNN reported.

The safety board operates as an autonomous expert group of 10-15 members who specialize in vaccine development, statistics and ethics, that examines all trial data before the pharmaceutical companies, doctors managing the trials and the Food and Drug Administration. The DSMB has the power to advise a company of positive findings or halt trials for safety concerns, CNN reported.

The board also reviewed vaccine candidates from Moderna and Johnson & Johnson, both of which were ultimately granted emergency authorization by the FDA, CNN reported.

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