BRIEF—US concerns on new COVID-19 Vaccine AstraZeneca data

Late Monday, the US Data and Safety Monitoring Board (DSMB) notified the NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.

March 24, 2021

The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. 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.

AstraZeneca response

Responding to these suggestions, AstraZeneca stated that rhe numbers published yesterday were based on a pre-specified interim analysis with a data cut-off of February 17.

“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis.

“We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours.”