By Jonathan Springston, Editor, Relias Media
AstraZeneca reported Monday that results from the Phase III U.S. trial of its COVID-19 vaccine indicate the solution is efficacious at preventing symptomatic COVID-19. However, on Tuesday the National Institutes of Health (NIH) said it is concerned the data are outdated.
In the AstraZeneca trial, investigators recruited more than 32,000 participants: 79% white/Caucasian, 8% Black/African American, 4% Native American, 4% Asian, and 22% Hispanic. About 20% were age 65 years and older. Around 60% presented with comorbidities associated with a higher risk for progression of severe COVID-19 (e.g., cardiac disease, diabetes, or severe obesity). Researchers administered two doses of the vaccine and placebo at a four-week interval.
Researchers reported the vaccine was 79% efficacious, comparable across age and ethnicity. For those age 65 years and older, the solution was 80% efficacious. AstraZeneca reported an independent data safety monitoring board (DSMB) did not find any safety concerns about the shot.
However, the NIH says it is concerned the data presented to the DSMB are outdated, which could lead to incorrect or misleading conclusions. Indeed, AstraZeneca acknowledged its efficacy report was “based on a prespecified interim analysis,” with a cutoff of Feb. 17.
“We will immediately engage with the independent 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,” the company pledged.
Eventually, if everyone can be on the same page about the data, the FDA could issue an emergency use authorization for the AstraZeneca solution, making it the fourth U.S. COVID-19 vaccine in circulation, after Pfizer/BioNTech, Moderna, and Johnson & Johnson.
For all the Relias Media coverage of the COVID-19 pandemic, please click here.