American health officials raised concerns Tuesday that AstraZeneca’s coronavirus vaccine data may have relied on “outdated information” that resulted in an “incomplete view” of its overall efficiency.
Less than 24 hours earlier, AstraZeneca said that its vaccine, developed in partnership with Oxford University, was 79% effective against the virus and posed no safety concerns. The company also said that it would apply for emergency use authorization from the Food and Drug Administration, potentially giving the U.S. a fourth vaccine.
In the statement, the National Institute of Allergy and Infectious Diseases said that “it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.”
“The [Data and Safety Monitoring Board] expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficiency data,” the NAIAD added.
The U.S. trial temporarily paused last year after unexplained illnesses arose from some participants. Many European countries that had approved and begun administering AstraZeneca’s vaccine paused its rollout this month after concerns of blood clots arose. (RELATED: Public Health Experts Call For US To Share AstraZeneca Doses)
In a statement responding to the NAIAD, AstraZeneca said that its data were “based on a pre-specified interim analysis” through Feb. 17.
“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis,” the company said. “We are now completing the validation of the statistical analysis.”
AstraZeneca added that that analysis would be released within 48 hours.
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