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COVID Vaccination Trial

Debora Dunbar, MSN, CRNP, ANP-BC, GNu’90 and Eileen Donaghy, MSN, CRNP, GNu’99 have been instrumental in COVID-19 vaccine trials at Penn Medicine.

Dunbar and Donaghy were engaged primarily in HIV prevention research at Penn Prevention Research Division but rapidly pivoted to COVID-19 last spring; the division enrolled trial participants for Sanofi, Moderna, and Jannsen/Johnson & Johnson vaccines. The Moderna phase III trial was the first, a trial that Dunbar spearheaded and ran, as she says, “soup to nuts.” She rapidly expanded research staff and put together a team to enroll 129 trial participants—the greatest number of patients ever enrolled in such a short period of time for a Penn vaccine study. Additionally, a home-visit nurse role was developed for participants who might be exposed to COVID-19—a necessity with the pandemic in play. The Sanofi phase I trial, with Donaghy as Project Manager, played on Dunbar’s advance work to enroll up to 40 participants in only a two-day window. Donaghy says, “Working on these trials is like nothing I ever imagined I might do.”

Despite the Moderna and Janssen/ Johnson & Johnson vaccines FDA approvals, they and the Sanofi trials continue. Of the approved vaccines, Dunbar notes, “We know they work, but we don’t know if they work or how well they work against every single COVID-19 variant. One big question to be answered is how durable is the effect of these vaccines.” In addition to the expanded staff, Dunbar and Donaghy brought in a team of Penn Nursing undergraduate students to help with the trials.