Making sure the COVID vaccine is safe

With COVID-19 vaccine near, Brown researchers to track adverse impacts in nursing home residents

Brown University

As the U.S. moves toward the highly anticipated approval of the first COVID-19 vaccines, residents of nursing homes and other long-term care facilities are likely to join health care workers as groups who will be among the earliest vaccine recipients in most states.

This week, the National Institute on Aging awarded a grant to a team of researchers based at Brown University to design a monitoring system to identify and track adverse health impacts after elderly nursing home residents receive COVID-19 vaccinations.

“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 U.S. population,” said lead investigator Vincent Mor, a professor of health services, policy and practice at Brown’s School of Public Health. 

“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.”

The new effort, a supplement to a $53.4 million IMPACT Collaboratory grant awarded to Brown and Hebrew SeniorLife in 2019, provides funding for Mor and a team of Brown researchers to work with Genesis HealthCare, one of the nation’s largest post-acute care providers with more than 350 facilities across 25 states.

The researchers will monitor the occurrence of adverse events — diagnoses, signs and symptoms that virologists, epidemiologists and clinicians believe may be associated with the vaccine — following COVID-19 vaccinations to residents in facilities affiliated with Genesis. The work is part of a U.S. Centers for Disease Control effort to establish a vaccine adverse event monitoring system for COVID-19, particularly focused on frail elderly residents who were not included in vaccine trials.

"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.”

Mor said that there is considerable evidence that the immune systems of frail older people are not as responsive as those of the younger people on whom vaccines are being tested, and that many elderly residents face multiple health challenges. For those reasons, careful monitoring of the vaccine response will be critical.

“We don't know how frail seniors will react to the vaccine, since it will roll out so quickly once distribution begins,” he said. “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.”

Since the beginning of the pandemic, researchers at Brown have worked with Genesis to examine data and uncover patterns that can be used to develop strategies to mitigate the impact of the pandemic in nursing homes. 

Mor said the early detection monitoring system will be based on electronic medical records from Genesis, updated daily and analyzed by researchers at Brown to identify adverse effects. The team will work with the Rhode Island Quality Institute — a center led by Neil Sarkar, an associate professor at Brown’s Warren Alpert Medical School and director of the Brown Center for Biomedical Informatics — to design the system.

The $273,187 award from the National Institute on Aging, a division of the National Institutes of Health, is one of multiple IMPACT Collaboratory supplemental grants supporting research related to the COVID-19 pandemic. The work is supported under award No. U54AG063546.

This story was adapted from a news release from the Brown University School of Public Health.