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. 2023 Jan 9;41(2):532-539.
doi: 10.1016/j.vaccine.2022.11.069. Epub 2022 Dec 1.

Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older

Hui-Lee Wong  1 , Ellen Tworkoski  2 , Cindy Ke Zhou  1 , Mao Hu  2 , Deborah Thompson  1 , Bradley Lufkin  2 , Rose Do  1 , Laurie Feinberg  2 , Yoganand Chillarige  2 , Rositsa Dimova  1 , Patricia C Lloyd  1 , Thomas MaCurdy  3 , Richard A Forshee  1 , Jeffrey A Kelman  4 , Azadeh Shoaibi  1 , Steven A Anderson  5
Affiliations

Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older

Hui-Lee Wong et al. Vaccine. .

Abstract

Background: Monitoring safety outcomes following COVID-19 vaccination is critical for understanding vaccine safety especially when used in key populations such as elderly persons age 65 years and older who can benefit greatly from vaccination. We present new findings from a nationally representative early warning system that may expand the safety knowledge base to further public trust and inform decision making on vaccine safety by government agencies, healthcare providers, interested stakeholders, and the public.

Methods: We evaluated 14 outcomes of interest following COVID-19 vaccination using the US Centers for Medicare & Medicaid Services (CMS) data covering 30,712,101 elderly persons. The CMS data from December 11, 2020 through Jan 15, 2022 included 17,411,342 COVID-19 vaccinees who received a total of 34,639,937 doses. We conducted weekly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination.

Findings: Four outcomes met the threshold for a statistical signal following BNT162b2 vaccination including pulmonary embolism (PE; RR = 1.54), acute myocardial infarction (AMI; RR = 1.42), disseminated intravascular coagulation (DIC; RR = 1.91), and immune thrombocytopenia (ITP; RR = 1.44). After further evaluation, only the RR for PE still met the statistical threshold for a signal; however, the RRs for AMI, DIC, and ITP no longer did. No statistical signals were identified following vaccination with either the mRNA-1273 or Ad26 COV2.S vaccines.

Interpretation: This early warning system is the first to identify temporal associations for PE, AMI, DIC, and ITP following BNT162b2 vaccination in the elderly. Because an early warning system does not prove that the vaccines cause these outcomes, more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency, are underway to further evaluate these signals. FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Cumulative COVID-19 Vaccine Doses, by Age and Sex, in Adults Aged 65 Years and Older in the Medicare Shared Systems Data, by Vaccine Brand, Dec 11, 2020 to January 15, 2022.
Fig. 2
Fig. 2
Distribution of Days to Diagnosis of Acute Myocardial Infarction, Pulmonary Embolism, Disseminated Intravascular Coagulation, or Immune Thrombocytopenia in 20 days after BNT162b2 Vaccination (First Dose) in Adults Aged 65 Years and Older, the Medicare Shared Systems Database.
See this image and copyright information in PMC

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