Background: Immunocompromised patients are at higher risk for severe COVID-19 outcomes
.
However, these patients were largely excluded from SARS-CoV-2 vaccine clinical trials, creating a large gap in clinical research evidence
.
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However, these patients were largely excluded from SARS-CoV-2 vaccine clinical trials, creating a large gap in clinical research evidence
.
Objective: Objective To understand the incidence and incidence rate ratio (IRR) of 2019-nCoV breakthrough infection after vaccination with SARS-CoV-2 vaccine in immunocompromised and non-immunocompromised populations
.
Design, setting, and participants: This retrospective cohort study analyzed data from the National COVID-19 Cohort Collaboration (N3C), a partner that developed a secure, central electronic medical record-based Repository that stores COVID-19 clinical data from academic medical centers across the United States
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People who had received at least one dose of the SARS-CoV-2 vaccine between December 10, 2020 and September 16, 2021 were included in the sample
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Key outcomes and measures: Vaccination, diagnosis of COVID-19, diagnosis of immune dysfunction (ie, HIV infection, multiple sclerosis, rheumatoid arthritis, solid organ transplantation and bone marrow transplantation), other complications and demographic data passed N3C data enclave access
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Breakthrough infection was defined as a COVID-19 infection contracted on or after day 14 of vaccination, using robust SE Poisson regression to assess risk after full or partial vaccination in immunocompromised or non-immunocompromised patients
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Poisson regression models were run over the study period (before or after June 20, 2021 [delta pre or post delta]), full vaccination status, pre-vaccination COVID-19 infection, demographic characteristics, geographic location, and complication burden control
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RESULTS: A total of 664 722 patients were included in the N3C sample
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The median (IQR) age of these patients was 51 (34-66) years, and they were predominantly female (n = 378 307 [56.
9%])
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Overall, the incidence of COVID-19 breakthrough infection was 5.
0‰/1000 person-months in the fully vaccinated population, but increased after the Delta variant became the dominant strain (incidence before June 20, 2021) Incidence rates after June 20, 2021 were 2.
2 [95%CI, 2.
2-2.
2] vs 7.
3 [95%CI, 7.
3-7.
4]/1000 person-months, respectively
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Complete vaccination was associated with a 28% lower risk of breakthrough infection compared with partial vaccination (adjusted IRR [AIRR], 0.
72; 95% CI, 0.
68-0.
76)
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People with breakthrough infections after full vaccination were more likely to be older adults and women
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HIV infection (AIRR, 1.
33; 95% CI, 1.
18-1.
49), rheumatoid arthritis (AIRR, 1.
20; 95% CI, 1.
09-1.
32), and solid organ transplantation (AIRR, 2.
16; 95% CI, 1.
96-2.
38) ) had a higher rate of breakthrough infections
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Conclusions and significance: This cohort study found that adequate vaccination was associated with a reduced risk of COVID-19 breakthrough infection, regardless of the patient's immune status
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Despite adequate vaccination, immunocompromised individuals are at significantly higher risk of developing a breakthrough infection with COVID-19 than those without the condition
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For immunocompromised individuals, continued use of nonpharmacological interventions (such as mask wearing) and alternative vaccine strategies (such as booster shots or immunogenicity testing) are recommended even after full vaccination
.
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Despite adequate vaccination, immunocompromised individuals are at significantly higher risk of developing a breakthrough infection with COVID-19 than those without the condition
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For immunocompromised individuals, continued use of nonpharmacological interventions (such as mask wearing) and alternative vaccine strategies (such as booster shots or immunogenicity testing) are recommended even after full vaccination
.
Original source: Sun J, Zheng Q, Madhira V, et al.
Association Between Immune Dysfunction and COVID-19 Breakthrough Infection After SARS-CoV-2 Vaccination in the US.
JAMA Intern Med 2021 Dec 28
JAMA
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