Article Offers Behind-the-Scenes Look at Work of COVID-19 Vaccine Data and Safety Monitoring Board

Recently, members of the COVID-19 2019 Vaccine Data and Safety Monitoring Board (DSMB)—established by the National Institute of Allergy and Infectious Diseases—authored an article in The Journal of Infectious Diseasesoutlining the group’s mission, challenges, and procedures. Reneé H. Moore, PhD, research associate professor in the Department of Biostatistics and Bioinformatics, is a member of the DSMB and one of the article’s co-authors.

With the significant need for a fast, safe, and effective vaccine to protect against COVID-19, the United States government funded several phase 3 vaccine trials in May 2020 through Operation Warp Speed (OWS). The NIAID developed a single, 11-person DSMB to “ensure rigorous, independent, and unbiased scientific and ethical oversight” for these trials.

Experts on the board come from the United States, South Africa, and the United Kingdom and include experts in infectious disease, vaccinology, immunology, biostatistics, pharmacoepidemiology, public health, and bioethics. Moore has spent the bulk of her career either presenting to DSMBs or being a part of various DSMBs. Given her extensive experience in this space, she was a natural choice for the team, which has a two-year appointment (and may be extended according to need). 

“I’m so honored and humbled to be included with this group,” says Moore. “They are all dedicated to science and public health, but are also really great people.”

As articulated in the paper, the DSMB has met more than 25 times in the past year (with each meeting lasting between 2 and 3 hours), during which time members of the board analyze “accrual (including of important subgroups), data quality and completeness, and safety” for trials in progress.

The article further outlines the thorough review process the DSMB oversees for all OWS-funded trials, as well as content included within reviews, and the challenges encountered by the group—which include the speed and scale of these trials and the politicization of the pandemic. Despite the challenges and the vast workload divided among 11 people, the authors write, “the single DSMB approach can serve as a model for future situations in which there is an urgent need for coordinated development of multiple therapeutic or preventive interventions to address rapidly evolving public health threats.”

The article was accompanied by a commentary by Lawrence Corey, MD, commending the work of the DSMB and referencing the group as “behind the scenes heroes.”