Researchers are partnering with Genesis Healthcare, the largest long-term care provider in the country, to develop an early warning system for significant adverse events related to use of SARS-COV-2 vaccines in the nursing home population.  Using nightly downloads of electronic medical record data, the team will build an updated system for identifying, flagging and highlighting changes in residents’ clinical status following receipt of COVID-19 vaccine.  A team of experts will convene to establish a set of indicators of adverse reactions to the vaccine with a specific set focused on residents with significant cognitive impairment, and a reporting scheme will be developed and put into practice within the partnering chain for real time identification of adverse events related to use of COVID vaccines in the organizations population.  The work will result in the development of an early warning system to monitor for adverse events related to the use of SARS-COV-2 vaccine in the nursing home population, with specific indicators focused on residents with dementia and/or significant cognitive impairment.

This project will establish an active post-vaccination surveillance system of a large population to track and report safety and outcomes related to SARS-CoV-2 vaccine(s).  Working jointly with CVSHealth and the Medicare & Medicaid Resource Information Center (MedRIC), the project will establish a data infrastructure to monitor the effects of COVID-19 vaccines administered to Medicare beneficiaries in CVS stores across the country.  Data transfers from the national retail pharmacy chain will be merged with Medicare data. The resulting data base will be analyzed to identify demographic, race/ethnicity, clinical (e.g., ADRD), and health care system factors associated with being vaccinated, estimate the rate of adverse events attributable to the vaccine and estimate breakthrough COVID illness among vaccinated Medicare beneficiaries.  This program provides the basis for assessing mid to long term safety and efficacy of the different vaccines being distributed for use in the elderly population in the country.

This project will create a quasi “real time” data base that can be used to monitor the rates of adverse events of
the SARS-CoV-2 vaccine in the frail, elderly and demented populations, few of whom were included in the
phase 3 vaccine trials. The resulting data base and proposed analyses will assess mid to long term safety and
efficacy of the different vaccines being distributed for use in the elderly population in the USA.