Comparative vaccine effectiveness against severe COVID-19 over time in US hospital administrative data: a case-control study

Wright, Bill; Tideman, Samuel; Diaz, George A.; French, Thomas K.; Parsons, Guilford; Robicsek, Ari

doi:10.1016/s2213-2600(22)00042-x

Cited by 57 publications

(61 citation statements)

References 28 publications

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“…Sex, age, comorbidities, and additional vaccine doses impact the risk of severe COVID-19 breakthrough illness. 10,[31][32][33] Among both PWoH and PWH, increasing age was the most significant risk factor for severe COVID-19 breakthrough illness in our study. Female PWoH had reduced risk, which has been previously documented; [34][35][36] however, female PWH had increased severe risk.…”

Section: Discussionsupporting

confidence: 49%

“…Among PWoH, several comorbidities have been associated with increased severe COVID-19 breakthrough illness risk. 32,33,39 Our findings suggest an increased risk with HTN, ESRD, and SOT. Comorbidities were prevalent among those who experienced a severe COVID-19 breakthrough illness with 90% having a diagnosis of obesity, DM, HTN or ESRD.…”

Section: Discussionmentioning

confidence: 48%

“…Among PWoH, several comorbidities have been associated with increased severe COVID-19 breakthrough illness risk. 32,33,39 Our findings suggest an increased risk with HTN, ESRD, and SOT.…”

Section: Discussionmentioning

confidence: 57%

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Analysis of severe illness after post-vaccination COVID-19 breakthrough among adults with and without HIV in the United States

Lang

Humes

Coburn

et al. 2022

Preprint

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Importance: Understanding the severity of post-vaccination COVID-19 breakthrough illness among people with HIV (PWH) can inform vaccine guidelines and risk-reduction recommendations. Objective: Estimate the rate and risk of severe breakthrough illness among vaccinated PWH and people without HIV (PWoH) who experience a breakthrough infection. Design, setting, and participants: The Corona-Infectious-Virus Epidemiology Team (CIVET-II) collaboration consists of four US longitudinal cohorts from integrated health systems and academic centers. Adults (≥18 years old), in-care, fully vaccinated by June 30, 2021 with HIV, and matched PWoH (on date fully vaccinated, age group, race/ethnicity, and sex) were the source population. Those who experienced a post-vaccination SARS-CoV-2 breakthrough infection were eligible. Severe COVID-19 breakthrough illness was defined as hospitalization due to COVID-19. Discrete time proportional hazards models estimated adjusted hazard ratios (aHR) and 95% confidence intervals ([,]) of severe breakthrough illness by HIV status adjusting for demographics, COVID-19 vaccine type, and clinical factors. The proportion of patients requiring mechanical ventilation or died was compared by HIV status. Exposure: HIV infection Outcome: Severe COVID-19 breakthrough illness, defined as hospitalization within 28 days after a breakthrough SARS-CoV-2 infection with a primary or secondary COVID-19 discharge diagnosis. Results: Among 1,241 PWH and 2,408 PWoH with breakthrough infections, the cumulative incidence of severe illness in the first 28 days was low and comparable between PWoH and PWH (7.3% vs. 6.7%, respectively, risk difference=-0.67% [-2.58%, 1.23%]). The risk of severe breakthrough illness was 59% higher in PWH with CD4 counts <350 cells/mm3 compared with PWoH (aHR=1.59 [0.99, 2.46]). In multivariable analyses among PWH, being female, older, having a cancer diagnosis, and lower CD4 count increased the risk of severe breakthrough illness, while previous COVID-19 reduced the risk. Among all patients, 10% were mechanically ventilated and 8% died, with no difference by HIV status. Conclusions and Relevance: The risk of severe COVID-19 breakthrough illness within 28 days of a breakthrough infection was low among vaccinated PWH and PWoH. However, PWH with moderate and severe immune suppression had a higher risk of severe breakthrough infection. Recommendations for additional vaccine doses and risk-reduction strategies for PWH with moderate immune suppression may be warranted.

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Section: Discussionsupporting

confidence: 49%

Section: Discussionmentioning

confidence: 48%

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Analysis of severe illness after post-vaccination COVID-19 breakthrough among adults with and without HIV in the United States

Lang

Humes

Coburn

et al. 2022

Preprint

View full text Add to dashboard Cite

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“…Some of the published studies used ICD-10 or ICD-10-CM codes to identify COVID-19 outcomes. [42][43][44] We found that the specifics of data capture and billing processes were associated with some patients having assigned COVID-19 diagnosis codes for billing for tests rather than as an indicator of active disease. Another reason for assigning the code was COVID-19 sequela, where the actual date of COVID-19 infection could have been anywhere from 6 months to a couple of weeks in the past.…”

Section: Discussionmentioning

confidence: 92%

COVID-19 vaccination effectiveness rates by week and sources of bias: a retrospective cohort study

Ostropolets

Hripcsak

2022

BMJ Open

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ObjectiveTo examine COVID-19 vaccine effectiveness over six 7-day intervals after the first dose and assess underlying bias in observational data.Design and settingRetrospective cohort study using Columbia University Irving Medical Center data linked to state and city immunisation registries.Outcomes and measuresWe used large-scale propensity score matching with up to 54 987 covariates, fitted Cox proportional hazards models and constructed Kaplan-Meier plots for two main outcomes (COVID-19 infection and COVID-19-associated hospitalisation). We conducted manual chart review of cases in week 1 in both groups along with a set of secondary analyses for other index date, outcome and population choices.ResultsThe study included 179 666 patients. We observed increasing effectiveness after the first dose of mRNA vaccines with week 6 effectiveness approximating 84% (95% CI 72% to 91%) for COVID-19 infection and 86% (95% CI 69% to 95%) for COVID-19-associated hospitalisation. When analysing unexpectedly high effectiveness in week 1, chart review revealed that vaccinated patients are less likely to seek care after vaccination and are more likely to be diagnosed with COVID-19 during the encounters for other conditions. Secondary analyses highlighted potential outcome misclassification for International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis, the influence of excluding patients with prior COVID-19 infection and anchoring in the unexposed group. Long-term vaccine effectiveness in fully vaccinated patients matched the results of the randomised trials.ConclusionsFor vaccine effectiveness studies, observational data need to be scrutinised to ensure compared groups exhibit similar health-seeking behaviour and are equally likely to be captured in the data. While we found that studies may be capable of accurately estimating long-term effectiveness despite bias in early weeks, the early week results should be reported in every study so that we may gain a better understanding of the biases. Given the difference in temporal trends of vaccine exposure and patients’ baseline characteristics, indirect comparison of vaccines may produce biased results.

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“…This constellation was also observed in a small case series of individuals with CVID by Kinoshita, although these patients developed a significant T-cell response [ 15 ]. Nevertheless, patients with humoral immunodeficiency could experience potentially severe breakthrough Covid-19 infections despite vaccination [ 26 ]. Importantly, in the majority of those cases with very low or undetectable anti-S levels, an increase was achieved with a third vaccination, in line with the finding of Barmettler et al [ 27 ].…”

Section: Discussionmentioning

confidence: 99%

Humoral response to mRNA vaccines against SARS-CoV-2 in patients with humoral immunodeficiency disease

et al. 2022

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Objectives Although mRNA-based vaccines against SARS-CoV-2 induce a robust immune response and prevent infections and hospitalizations, there are limited data on the antibody response in individuals with humoral immunodeficiency. The aim of this study was to evaluate the humoral immune response after two vaccine doses with BNT162b2 or mRNA-1273 in patients with humoral immunodeficiency disease. Methods This cross-sectional study assessed 39 individuals with hypogammaglobulinemia under immunoglobulin replacement therapy. IgG anti-SARS-CoV-2 spike protein antibodies (anti-S) were measured 4 weeks to 4 months after two doses of an mRNA vaccine against SARS-CoV-2. The proportion of patients, who developed a humoral immune response to the spike protein were evaluated and compared to 19 healthy controls. Results After vaccination with two vaccine doses, 26/39 patients (66.7%) with humoral immunodeficiency disease and all healthy controls developed anti-S. In subjects with baseline IgG <3 g/l, only 1/5 (20%) showed a humoral immune response. 10 out of 26 with CVID (38.5%) and 7/9 under immunosuppressive drugs (77.8%) developed no immune response (13 subjects with no response) compared to 0/19 in healthy controls. Subgroup analysis in patients without immunosuppressive drugs revealed lower anti-S in patients with moderate to severe humoral immunodeficiency disease: baseline IgG <3 g/l: 12.0 AU/ml (95%CI 12.0–125.0), baseline IgG 3–5 g/l: 99.9 AU/ml (95%CI 14.4–400.0), baseline IgG >5 g/l: 151.5 AU/ml (95%CI 109.0–400.0), healthy controls 250.0 AU/ml (95%CI 209.0–358.0), p = 0.007. Conclusion In most patients with mild to moderate humoral immunodeficiency we found only slightly lower anti-S antibodies compared with healthy controls after two vaccine doses with BNT162b2 and mRNA-1273. However, in patients with a decreased baseline IgG below 3 g/l and/or under immunosuppressive drugs, we found severely impaired humoral immune responses.

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Comparative vaccine effectiveness against severe COVID-19 over time in US hospital administrative data: a case-control study

Cited by 57 publications

References 28 publications

Analysis of severe illness after post-vaccination COVID-19 breakthrough among adults with and without HIV in the United States

Analysis of severe illness after post-vaccination COVID-19 breakthrough among adults with and without HIV in the United States

COVID-19 vaccination effectiveness rates by week and sources of bias: a retrospective cohort study

Humoral response to mRNA vaccines against SARS-CoV-2 in patients with humoral immunodeficiency disease

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