AstraZenecaThe National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial.

NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned after information released by the company surrounding the clinical trial for its AZD1222 vaccine may be outdated. In turn, that may have provided an incomplete view of the efficacy data, NIAID said.

“We urge the company to work with the [Data and Safety Monitoring Board (DSMB)] to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” NIAID wrote in the statement.

AstraZeneca yesterday published results from the trial, revealing that the vaccine developed in collaboration with Oxford University was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization.

Buoyed by the results, the company said it would soon use the data to pursue FDA emergency use authorization (EUA) to become the fourth approved vaccine in the U.S. It has already been approved across Europe, where issues arose surrounding potentially related blood clots and a number of European countries paused use after reports of such issues.

European medical authorities have since determined that there is little connection between the vaccine and blood clots, but noted that “the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets.”

According to the NIAID statement, the FDA and CDC will determine authorization and guidelines for AstraZeneca’s vaccine after a thorough review of the data by independent advisory committees.

 

AstraZeneca did not immediately respond to a request for comment on the NIAID statement. This story may be updated.