AstraZeneca (AZ) is planning to share the primary analysis from a US-based phase 3 trial of its COVID-19 vaccine following a statement issued by the US National Institute of Allergy and Infectious Diseases (NIAID) yesterday.
In the statement, NIAID said that the trial’s data and safety monitoring board (DSMB) had expressed concerns about the initial data from the COVID-19 vaccine trial.
According to the NIAID statement, the DSMB expressed concerns that AZ may have included outdated information from that trial, which could have provided an ‘incomplete’ image of the efficacy data.
NIAID urged AZ to engage with the DSMB to review the efficacy data and ensure the most up-to-date efficacy data is made public as soon as possible.
In response, AZ said that the data published on Monday for its vaccine were based on a pre-specified interim analysis cut-off of 17 February.
The company added that it had reviewed the preliminary assessment of the primary analysis, with the results being consistent with the interim analysis.
AZ is now completing the validation of the statistical analysis and will ‘immediately’ engage with the DSMB to share the primary analysis with the up-to-date efficacy data.
“We intend to issue results of the primary analysis within 48 hours,” said AZ.