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AstraZeneca’s vaccine trial results may have included outdated info, U.S. officials say

Vial of AstraZeneca COVID-19 vaccine

Results from a U.S. trial of AstraZeneca’s COVID-19 vaccine may have included “outdated information” that could mean the company provided an incomplete view of efficacy data, federal health officials said early Tuesday.

AstraZeneca said in a statement that the data it released Monday included cases up to Feb. 17, as the study rules specified, and that it was continuing to analyze cases that have occurred since then. The company said a preliminary analysis of data that have continued to roll in was consistent with what it had already reported. It promised an update within 48 hours.

AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that could help rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S

In the study of 30,000 people, the vaccine was 79% effective at preventing symptomatic cases of COVID-19, including in adults over 65. There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received placebos — a small number, but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease.

AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that led numerous countries to briefly suspend vaccinations last week.

But just hours after those encouraging results were reported, the U.S. National Institute of Allergy and Infectious Diseases issued an unusual statement. The agency said the Data and Safety Monitoring Board “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.

Astra Zeneca vaccine waits for injection at the homeless accommodation YMCA in Romford, east London, Wednesday, Feb. 3, 2021. The British health service NHS England have started to vaccinate homeless 'vulnerable' people. In a study carried out but the Oxford University, the Astra Zeneca vaccine has been shown to stop also the transmission of the virus.(AP Photo/Frank Augstein)

“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 statement said.

In previous vaccine trials, as in this one, cases continued to accrue even as companies began to release their data. But the AstraZeneca circumstance is unusual in drawing the concern of the data monitoring board

The Food and Drug Administration reviews the most up-to-date trial findings when it assesses vaccines.

AstraZeneca aims to file an application with the FDA in the coming weeks for emergency-use authorization of the vaccine, and the government’s outside advisors will publicly debate the evidence before the agency makes a decision.

Authorization and guidelines for use of the vaccine in the United States will be determined by the FDA and the Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.

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