On Friday, March 19, the NIH Collaboratory Rethinking Clinical Trials Grand Rounds featured Emily O’Brien, PhD, FAHA of the Duke Clinical Research Institute (DCRI) and Robert M. Califf, MD, MACC of Verily Life Sciences and Google Health, discussing the PCORI-funded HERO program, the impact of the COVID-19 pandemic on healthcare workers, and other topics in a conversation moderated by DCRI Vice Dean and Executive Director Adrian Hernandez, MD, MHS.
Vaccine Availability and Willingness
O’Brien, Principal Investigator of the HERO Registry and Assistant Professor in Duke’s Department of Population Health Sciences, talked about the good news of increasing availability of safe and efficacious vaccines here in the US and abroad. Results from polling of HERO Registry members reveal increased vaccine willingness after news of emergency use authorization (EUA) by the U.S. Food and Drug Association (FDA). Vaccine deliberation has played out differently in different groups. Some people take a wait and see approach — not outright rejecting the vaccine, but waiting until more information is available. This approach is more common in younger adults and Blacks and least common in older people.
No vaccine is effective if people don’t take them. Education of and engagement with the public on vaccine accessibility, misinformation, and early results will be important to increase vaccine confidence. Recruiting celebrities and local champions to enhance messaging about vaccines might be more effective than direct appeals from White House officials.
Post-market Monitoring
Califf noted the importance of post-marketing data collection for the available COVID-19 vaccines, mentioning the HERO-TOGETHER observational study as a key way to gather that information.
Post-marketing monitoring is an essential part of the vaccine life cycle, especially in EUA situations, where the FDA is charged with weighing potential vs demonstrated benefits and risks. Califf also emphasized that with several variants of SARS-CoV-2, the virus that causes COVID-19, circulating worldwide, it will be important to keep track of people post-vaccination. Post-vaccination monitoring is also critical in evaluating vaccine use in groups such as women who are pregnant and breastfeeding that were not included in the clinical trial population.
Califf encouraged any person who works in a health care setting to become a member of the HERO Registry, and those who have received or planning to get a vaccine to enroll in HERO-TOGETHER. “The goal is to create a community, to gather and share as much information as possible,” Califf said, calling on HERO members to invite their colleagues to join.
And coming soon, HERO Registry members’ families and “pods” will be able to join the Registry. These are family members or other people who live in the same household or with whom HERO members have regular household contact. This expansion is a direct result of listening to HERO participants’ feedback. “At first, healthcare workers were concerned with how they should disinfect themselves and their clothes when they got home from work, and now their questions surround burnout and the psychosocial impacts of their work on themselves and their family members,” said O’Brien. “Opening enrollment to healthcare workers’ ‘pods’ will help the HERO Registry answer those vital questions.”
The HERO research program is uniquely positioned to better understand changes in distress experiences over time and to conduct sub-studies on various issues. The HERO Registry will continue to monitor changes in healthcare worker well-being during the pandemic.
If you are already a member of the HERO Registry, thank you! Healthcare workers who are not HERO members but are eager to participate in research opportunities to help us understand the impact of COVID-19 on frontline workers can join here.