AstraZeneca may have included outdated information from a clinical trial of its Covid-19 vaccine, a US health agency said on Tuesday, potentially questioning previously published positive results.
The National Institute of Allergy and Infectious Diseases said it had been informed by the trial’s Data and Safety Oversight Committee that it “was concerned about the information published by AstraZeneca on the initial data from its clinical trial. on the Covid-19 vaccine ”.
“The DSMB has expressed concern that AstraZeneca may have included outdated information from this trial, which may have provided an incomplete view of the efficacy data,” NIAID said.
He said the council had also notified its concerns to the US Biomedical Advanced Research and Development Authority and the Anglo-Swedish pharmaceutical company.
NIAID said it had urged AstraZeneca “to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is made public as quickly as possible.”
AstraZeneca and the University of Oxford did not immediately respond to a request for comment early on Tuesday.
The statement came after the results of a long wait American trial of the Oxford / AstraZeneca vaccine were released on Monday. More than 32,000 volunteers took part, mainly in the United States, but also in Chile and Peru.
The trial showed the vaccine to be 79% effective in stopping symptomatic Covid-19 and 100% effective in preventing people from becoming seriously ill.
The company said there were no safety concerns about the blood clots. Previous reports of side effects from taking the vaccine, including a rare combination of blood clots, bleeding and low platelet counts, had prompted at least 16 European countries to suspend use of the vaccine.
Most have now resumed its use, after the European Medicines Agency said it had found no link between the clotting and the vaccine. The drug watchdog left the door open to a link between the vaccine and the rarer combination of side effects, but said throughout the crisis that the vaccine’s benefits far outweighed its risks.