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Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents
Barbara H Bardenheier1, Stefan Gravenstein2, Carolyn Blackman3
1Brown University School of Public Health, Providence, RI, USA.
Background:
The devastating impact of the SARS-CoV-2 pandemic prompted the development and emergency use authorization of two mRNA vaccines in early 2020. Vaccine trials excluded nursing home (NH) residents, limiting adverse event data that directly apply to this population.
Methods:
To prospectively monitor for potential adverse events associated with vaccination, we used Electronic Health Record (EHR) data from Genesis HealthCare, the largest NH provider in the United States. EHR data on vaccinations and pre-specified adverse events were updated daily and monitored for signal detection among residents of 147 facilities who received the first dose of vaccine between December 18, 2020 and January 3, 2021. For comparison, unvaccinated residents during the same time period were included from 137 facilities that started vaccinating at least 15 days after the vaccinating-facilities.
Results:
As of January 3, 2021, 8553 NH residents had received one dose of SARS-CoV-2 vaccine and by February 20, 2021, 8371 residents had received their second dose of vaccine; 11,072 were included in the unvaccinated comparator group. No significant associations were noted for neurologic outcomes, anaphylaxis, or cardiac events.
Conclusions:
No major safety problems were detected following the first or second dose of the vaccine to prevent COVID-19 in the study cohort from December 18, 2020 through March 7, 2021.
Insights
The COVID-19 mRNA vaccines showed no major safety issues in nursing home residents. This study monitored over 8,000 vaccinated individuals, finding no significant adverse events like neurological or cardiac issues.
Area of Science:
- Gerontology
- Vaccinology
- Public Health
Background:
- The COVID-19 pandemic necessitated rapid mRNA vaccine development.
- Nursing home residents were excluded from initial vaccine trials, creating a data gap for this vulnerable population.
Purpose of the Study:
- To prospectively monitor for adverse events following COVID-19 vaccination in US nursing home residents.
- To assess the safety of mRNA vaccines in a large, real-world cohort of elderly individuals residing in long-term care facilities.
Main Methods:
- Utilized Electronic Health Record (EHR) data from Genesis HealthCare, a major US nursing home provider.
- Monitored daily vaccination data and pre-specified adverse events in 147 facilities.
- Included an unvaccinated comparator group from 137 facilities for safety analysis.
Main Results:
- Over 8,500 nursing home residents received at least one dose of the COVID-19 mRNA vaccine.
- No significant associations were found between vaccination and neurologic, anaphylactic, or cardiac events.
- Safety monitoring included data up to March 7, 2021, covering both first and second vaccine doses.
Conclusions:
- The study found no major safety concerns associated with the first or second doses of the COVID-19 mRNA vaccine in nursing home residents.
- These findings support the safety profile of mRNA vaccines in a high-risk elderly population.
- Real-world data collection is crucial for understanding vaccine safety in diverse demographic groups.
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