According to US federal health officials, the results of a new US trial of AstraZeneca’s COVID vaccine may have used “outdated information,” in a blow to the company, which has been criticized for safety issues.
The Data and Safety Monitoring Board (DSMB) had notified the National Institute of Allergy and Infectious Diseases (NIAID) of concerns that AstraZeneca “may have given an incomplete view of the effectiveness data,” according to a statement released on Tuesday.
The NIAID said, “We encourage the company to collaborate with the DSMB to review the efficacy data and ensure that the most precise, up-to-date efficacy data is made public as soon as possible.”
The message comes just hours after AstraZeneca announced on Monday that its COVID vaccine gave strong protection in a long-awaited US study among adults of all ages. The discovery was expected to restore public confidence in the film around the world, bringing it one step closer to approval in the United States.
The vaccine was found to be 79 percent effective in preventing symptomatic COVID-19 cases in a study of 30,000 individuals, including older adults. Previous research had raised concerns about the inoculant’s effectiveness in the elderly.
There were no serious illnesses or hospitalizations among vaccinated volunteers, compared to five such cases among dummy shot participants – a small number, but consistent with findings from the United Kingdom and other nations that the vaccine protects against the disease’s worst symptoms.
Independent safety monitors for the study found no serious side effects, including no increased risk of rare blood clots, which led several countries, mainly in Europe, to suspend the vaccine’s use last week temporarily.
The company plans to submit an application to the US Food and Drug Administration (FDA) in the coming weeks, and outside advisors to the government will debate the evidence publicly before the agency takes a decision.
After a careful review of the data by independent advisory committees, the Food and Drug Administration and the Centers for Disease Control and Prevention will decide on authorization and guidelines for the use of the vaccine in the United States.
The NIAID statement did not detail its concerns, but it comes as Washington is under increasing pressure to share Astrazeneca vaccines made in the United States before the approval is finalized.
Last week, the White House announced that the US has seven million “releasable doses” of the vaccine out of a total order of 300 million. It also stated that three million doses would be “loaned” to Mexico and Canada.
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