The results of a recent US trial for AstraZeneca’s Covid-19 vaccine may have used data that is no longer relevant, raising questions about accuracy, the US National Institute of Allergy and Infectious Diseases (NIAID) has said.
On Monday, the pharmaceutical giant released promising interim results from its US study, which showed its drug to have 79% efficacy in stopping symptomatic Covid-19 and to be 100% effective at preventing severe cases and hospitalization. The firm also said that the results showed that the drug does not cause blood clots.
But according to NIAID, these figures may not paint an accurate picture of the vaccine’s efficacy. The US government institute said that its independent Data Safety Monitoring Board (DSMB), which ensures data integrity and safety compliance for medical trials, had “expressed concern” that the British-Swedish pharmaceutical firm “may have included outdated information” from the trial, leading to “an incomplete view of the efficacy data.”
NIAD urged AstraZeneca to work with the DSMB to review the results and “ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
AstraZeneca responded to the allegations by clarifying that the preliminary results were based on data collected up to February 17. The pharmaceutical firm said it was working on validating its statistical analysis of the trial’s findings and that results would be released within 48 hours.
The notice could signal a major setback for the firm’s efforts to receive US emergency use authorization for its vaccine. AstraZeneca has been plagued by bad press in recent weeks, amid reports of its vaccine possibly causing blood clots. Concerns about potential adverse effects led to numerous countries halting use of the drug as a precautionary measure. AstraZeneca has denied that the drug is unsafe and some studies have concluded that there is no evidence that the vaccine can be linked to serious adverse effects.
At the same time, AstraZeneca has faced criticism for failing to meet its delivery agreement with the European Union, resulting in supply shortages as the bloc rolls out mass vaccination programs.
Even with the publication of the most recent trial data, there appears to be growing unease with the AstraZeneca jab within Europe. A poll released by YouGov on Monday revealed that only 23% of French people and 32% of Germans consider the vaccine to be safe.
Like this story? Share it with a friend!