Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older
Vaccine·
- DOI
- 10.1016/j.vaccine.2022.11.069
- PMID
- 36496287
- PMCID
- PMC9712075
- OpenAlex
- W4313397443
- Study type
- Journal article
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Publication version
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Open linked preprint →Why this research matters now
The findings contribute to the safety knowledge base for COVID-19 vaccination in elderly populations and may inform decision making by government agencies, healthcare providers, and the public. FDA stated that potential benefits of COVID-19 vaccination outweigh potential risks of COVID-19 infection.
Structured evidence summary
Research question
The study examined safety outcomes following COVID-19 vaccination in elderly persons aged 65 years and older using a nationally representative early warning system.
Study design
This was a safety surveillance study using US Centers for Medicare & Medicaid Services data from December 11, 2020 through January 15, 2022. Weekly sequential testing compared observed outcome rates to historical expected rates prior to COVID-19 vaccination.
Population and setting
The study included 30,712,101 elderly persons aged 65 years and older covered by CMS, of whom 17,411,342 received a total of 34,639,937 COVID-19 vaccine doses.
Main findings
Four outcomes initially met the threshold for a statistical signal following BNT162b2 vaccination: pulmonary embolism (RR=1.54), acute myocardial infarction (RR=1.42), disseminated intravascular coagulation (RR=1.91), and immune thrombocytopenia (RR=1.44). After further evaluation, only pulmonary embolism still met the statistical threshold. No statistical signals were identified for mRNA-1273 or Ad26.COV2.S vaccines.
Public-health relevance
The findings contribute to the safety knowledge base for COVID-19 vaccination in elderly populations and may inform decision making by government agencies, healthcare providers, and the public. FDA stated that potential benefits of COVID-19 vaccination outweigh potential risks of COVID-19 infection.
Important limitations
An early warning system does not prove that vaccines cause the observed outcomes. More robust epidemiologic studies with adjustment for confounding factors, including age and nursing home residency, are needed to further evaluate the signals.
GIDS interpretation
This article is discoverable in GIDS through classifier links to COVID-19, vaccination, vaccine safety, and surveillance topics, as well as geographic coverage of the United States. The surveillance study design and focus on safety outcomes in elderly populations make it relevant to vaccine safety monitoring workflows.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 13 auditable classifier relationships to diseases, places, topics, and study design.