U.S. health agency casts doubt over AstraZeneca’s Covid vaccine trial data

A nurse draws up syringes with the preparation from Astrazeneca in Axel Stelzner’s GP practice.Hendrik Schmidt | picture alliance via Getty ImagesLONDON — A U.S. health agency on Tuesday expressed concern that AstraZeneca may have included outdated information from a clinical trial of its Covid-19 vaccine, potentially casting doubt over published efficacy results.The Data Safety Monitoring Board “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the U.S. National Institute of Allergy and Infectious Diseases said in a statement.”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 NIAID is led by White House Chief Medical Advisor Dr. Anthony Fauci and is part of the National Institutes of Health.AstraZeneca did not immediately respond to a CNBC request for comment.The statement comes just one day after the findings of a large U.S. trial showed that the coronavirus vaccine developed by AstraZeneca and the University of Oxford is 79% effective in preventing symptomatic illness and 100% effective against severe disease and hospitalization.Data from the late-stage human trial study was based on more than 32,000 volunteers across 88 trial centers in the U.S., Peru and Chile. The findings were welcomed as “surprisingly positive” and “good news for the global community.”AstraZeneca said it planned to prepare for the primary analysis to be submitted to the U.S. Food and Drug Administration for emergency use authorization before mid-April.The Oxford-AstraZeneca vaccine had been temporarily suspended in several countries after reports of blood clots in some vaccinated people. However, AstraZeneca said Monday that the independent DSMB had found no increased risk of blood clots.Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business unit, told CNBC’s “Squawk Box” on Monday that it was “very pleasing to see that even with a magnifying glass the Data Saftey Monitoring Board didn’t see any imbalance between the vaccinated group and the placebo group.””So, that gives us a lot of confidence,” he added.


Source link