The SARS-CoV-2 pandemic has had a devastating impact upon the US population with over 12 million positive cases and some 260,000 deaths as of mid-November, 2020. In no population has the impact of this virus been more apparent than in the elderly population and those with significant medical co-morbidities. All population-based analyses conducted to date suggest that the risk of morbidity and mortality in the elderly population, relative to younger adults, increases logarithmically. Indeed, even controlling for extensive clinical characteristics in a nursing home population, advanced age has a substantial influence on COVID-19 mortality. Furthermore, a diagnosis of Alzheimer?s Disease and Related Dementias (ADRD) appear to confer excess risk of morbidity and mortality associated with COVID-19, whether in a nursing home or not. The world- wide scientific and medical enterprise has responded to the pandemic by investment in the development of numerous vaccines. Recent extremely positive preliminary results from several manufacturers indicates that vaccines will be distributed by early 2021. However, since elderly and disabled Medicare beneficiaries were under-represented in the volunteers included in randomized clinical trials, it is possible that the senescent immune system might increase their risk of vaccine-related adverse effects from the vaccine or fail to protect them as much as are younger people. Given that those with ADRD already suffer from a neurodegenerative disease, they may be at greater risk of well-established, serious neurological adverse events of vaccines such as stroke and Guillain-Barre Disease. In addition, the unknown potential for adverse events may result in high rates of incomplete vaccination among frail older adults vulnerable to SARS-CoV-2. Unsuccessful vaccination might be further exacerbated among older adults with ADRD by barriers to vaccination, such as dependence on a caregiver for transportation. Given that the success of national SARS- CoV-2 vaccination efforts depends on both vaccine efficacy and vaccine coverage, ensuring that dementia patients and those with co-morbidities receive all required doses is critical. Since society cannot wait to vaccinate this population with an effective vaccine, we must establish an active post-vaccination surveillance system of a large population to report vaccine safety Working closely with CVS, the largest pharmacy company in the country which has been designated as a major site for distribution of the SARS-CoV-2 vaccine(s), we propose to match the background and pharmacy records of some 13 million customers who are Medicare beneficiaries to Medicare data maintained by Acumen, LLC in order to build a merged CVS and Medicare claims data system, examine 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 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 provide 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.
