AstraZeneca released a statement saying that it planned to complete and then release within 48 hours a primary analysis of the U.S. clinical trial results for its COVID-19 vaccine, according to a news release.
AstraZeneca was responding to a statement from the National institutes of Health (NIH) in which the NIH raised questions about the data that AstraZeneca released Monday about its COVID-19 vaccine. Specifically, the NIH said the Data and Safety Monitoring Board (DSMB) “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
In its response to those concerns, AstraZeneca also said, “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.” As far as the data released Monday, Astra said that the information was based on a pre-specified interim analysis with a data cutoff of February 17, 2021.
That data in question summarized results of the U.S. Phase III trial in which the company said AZD1222, its COVID-19 vaccine, demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization.
The interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomization of vaccine to placebo.
