Results from a US trial of AstraZeneca’s Covid vaccine may have used “outdated information” on its efficacy, according to a US health agency. Reuters has the story.
The concerns throw into question whether the British drugmaker can seek US emergency use authorisation for the vaccine in the coming weeks as planned, and come just one day after interim data from the trial had shown better-than-expected results.
The vaccine developed with Oxford University was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data. It was also 100% effective against severe or critical forms of the disease and hospitalisation and posed no increased risk of blood clots.
The Data Safety Monitoring Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data”, the US National Institute of Allergy and Infectious Diseases (NIAID) 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,” it said, adding that the DSMB had informed AstraZeneca of its concerns.
The NIAID did not specify what outdated information AstraZeneca relied on from its trial. In Europe, the AZ Covid vaccine has been at the centre of fears relating to side effects from the jab, such as blood clots. This latest development in the US could, if found to be true, see the country refusing to grant emergency use authorisation as planned.
Worth reading in full.
Stop Press: AstraZeneca has responded to concerns over its vaccine from the DSMB, saying that the numbers it published yesterday were “pre-specified” and that more detailed information would be sent to US health officials within 48 hours.