IMPACT Collaboratory Principal Investigator Vincent Mor, PhD will lead a new supplement to the IMPACT funding to study adverse events in nursing home residents who receive the COVID-19 vaccination in real time.
The award to Brown University will be used to design an adverse event monitoring system to identify adverse health impacts after receipt of COVID-19 vaccination by elderly nursing home residents. While there are currently four vaccines in Phase 3 trials in the US, the vaccine trials have rarely included frail, aged subjects with multiple morbidities. For these reasons, and because there is considerable evidence that the immune systems of frail older people are not as responsive as those of the younger people on which vaccines are being tested, careful monitoring of their response to the vaccine will be required. Once a vaccine is approved, it is expected that frail older persons living in congregate settings are in the top priority group for distribution.
This new effort, provides funding for the School to work with Genesis HealthCare (Genesis), one of the nation’s largest post-acute care providers with more than 350 facilities across 25 states. Brown will monitor the occurrence of adverse events following nursing home residents’ receipt of a COVID-19 vaccine in facilities affiliated with Genesis. Since the beginning of the pandemic, Brown and Genesis have been working together to study data and uncover patterns that can be used to develop informed strategies to mitigate the impact of the pandemic in nursing homes.
Mor, lead investigator and professor of health service, policy and practice in the School of Public Health, said “Nursing home residents constitute about 40% of all deaths due to COVID in the nation, but make up less than one half of one percent of the US population. Residents are in desperate need of protection from the virus but no one as sick as a nursing home resident was enrolled in any of the vaccine trials.”
This work is part of the Centers for Disease Control’s effort to establish Vaccine Adverse Event Monitoring Systems, particularly focused on the frail elderly who were not included in the vaccine trials.
Mor added that “We don’t know how frail seniors will react to the vaccine and it will roll out quickly once distribution begins. Under normal circumstances, we would not know until most residents have been vaccinated if the rate of adverse events is higher than expected. Therefore, the ‘real time’ adverse event monitoring system we are establishing cooperatively with the CDC and Genesis is unique and critically important to understand how frail seniors will respond to the vaccines.”
Additional local collaborations in this work include the Rhode Island Quality Institute led by Dr. Neil Sarkar, Ph.D., president and chief executive officer, and associate professor of medical science at the Warren Alpert Medical School of Brown University.
The work is supported by the National Institute on Aging of the National Institutes of Health under Award No. U54AG063546. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Modified from the Brown University School of Public Health announcement. Read the full text here.
