Dataset Information

COVID-19 Vaccination Breakthrough Infections in a Real-World Setting: Using Community Reporters to Evaluate Vaccine Effectiveness.

ABSTRACT:

Purpose

Coronavirus disease 2019 (COVID-19) has highlighted the need for new methods of pharmacovigilance. Here, we use adult community volunteers to obtain systematic information on vaccine effectiveness and the nature and severity of breakthrough infections.

Methods

Between December 15, 2020 and September 16, 2021, 11,826 unpaid community-based volunteers reported the following information to an on-line registry: COVID-19 test results, vaccination (Pfizer, Moderna, or Johnson & Johnson) and COVID-19 symptoms. COVID-19 infections were described based on vaccination status at the time of infection: 1) fully vaccinated, 2) partially vaccinated (received first of two-dose vaccines or were <14 days post-final dose), or 3) unvaccinated.

Results

Among 8554 participants who received any COVID-19 vaccine, COVID-19 infections were reported by 74 (1.0%) of those who were fully vaccinated and 198 (2.3%) of those who were partially vaccinated at the time of infection. Among the 74 participants who reported a breakthrough infection after full vaccination, the median time from vaccination to reported positive test result was 104.5 days (interquartile range: 77-135 days), with no difference among vaccine manufacturers. One quarter (25.7%) of breakthrough infections in the fully vaccinated cases were asymptomatic and most (>97%) fully vaccinated participants reported no symptoms or only mild symptoms compared to 89.3% of the unvaccinated cases. Only 1.4% of fully vaccinated participants reported experiencing at least 3 moderate-to-severe symptoms compared to 7.8% in the unvaccinated.

Conclusion

Person-generated health data, also referred to as patient-reported outcomes, is a useful approach for quantifying breakthrough infections and their severity and for comparing vaccines.

Trial registration

Clinicaltrials.gov NCT04368065, EU PAS Register EUPAS36240.

SUBMITTER: Reynolds MW

PROVIDER: S-EPMC9451035 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

COVID-19 Vaccination Breakthrough Infections in a Real-World Setting: Using Community Reporters to Evaluate Vaccine Effectiveness.

Reynolds Matthew W MW Xie Yiqiong Y Knuth Kendall B KB Mack Christina D CD Brinkley Emma E Toovey Stephen S Dreyer Nancy A NA

Infection and drug resistance 20220903

<h4>Purpose</h4>Coronavirus disease 2019 (COVID-19) has highlighted the need for new methods of pharmacovigilance. Here, we use adult community volunteers to obtain systematic information on vaccine effectiveness and the nature and severity of breakthrough infections.<h4>Methods</h4>Between December 15, 2020 and September 16, 2021, 11,826 unpaid community-based volunteers reported the following information to an on-line registry: COVID-19 test results, vaccination (Pfizer, Moderna, or Johnson & ...[more]

PMID: 36090603

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Project description:BackgroundThis exploratory study compares self-reported COVID-19 vaccine side effects and breakthrough infections in people who described themselves as having diabetes with those who did not identify as having diabetes.ObjectiveThe study uses person-reported data to evaluate differences in the perception of COVID-19 vaccine side effects between adults with diabetes and those who did not report having diabetes.MethodsThis is a retrospective cohort study conducted using data provided online by adults aged 18 years and older residing in the United States. The participants who voluntarily self-enrolled between March 19, 2021, and July 16, 2022, in the IQVIA COVID-19 Active Research Experience project reported clinical and demographic information, COVID-19 vaccination, whether they had experienced any side effects, test-confirmed infections, and consented to linkage with prescription claims. No distinction was made for this study to differentiate prediabetes or type 1 and type 2 diabetes nor to verify reports of positive COVID-19 tests. Person-reported medication use was validated using pharmacy claims and a subset of the linked data was used for a sensitivity analysis of medication effects. Multivariate logistic regression was used to estimate the adjusted odds ratios of vaccine side effects or breakthrough infections by diabetic status, adjusting for age, gender, education, race, ethnicity (Hispanic or Latino), BMI, smoker, receipt of an influenza vaccine, vaccine manufacturer, and all medical conditions. Evaluations of diabetes medication-specific vaccine side effects are illustrated graphically to support the examination of the magnitude of side effect differences for various medications and combinations of medications used to manage diabetes.ResultsPeople with diabetes (n=724) reported experiencing fewer side effects within 2 weeks of vaccination for COVID-19 than those without diabetes (n=6417; mean 2.7, SD 2.0 vs mean 3.1, SD 2.0). The adjusted risk of having a specific side effect or any side effect was lower among those with diabetes, with significant reductions in fatigue and headache but no differences in breakthrough infections over participants' maximum follow-up time. Diabetes medication use did not consistently affect the risk of specific side effects, either using self-reported medication use or using only diabetes medications that were confirmed by pharmacy health insurance claims for people who also reported having diabetes.ConclusionsPeople with diabetes reported fewer vaccine side effects than participants not reporting having diabetes, with a similar risk of breakthrough infection.Trial registrationClinicalTrials.gov NCT04368065; https://clinicaltrials.gov/study/NCT04368065.

Project description:ImportanceLittle is known about COVID vaccine breakthrough infections and their risk factors.ObjectiveTo identify risk factors associated with COVID-19 breakthrough infections among vaccinated individuals and to reassess the effectiveness of COVID-19 vaccination against severe outcomes using real-world data.Design setting and participantsWe conducted a series of observational retrospective analyses using the electronic health records (EHRs) of Columbia University Irving Medical Center/New York Presbyterian (CUIMC/NYP) up to September 21, 2021. New York adult residence with PCR test records were included in this analysis.Main outcomes and measuresPoisson regression was used to assess the association between breakthrough infection rate in vaccinated individuals and multiple risk factors - including vaccine brand, demographics, and underlying conditions - while adjusting for calendar month, prior number of visits and observational days. Logistic regression was used to assess the association between vaccine administration and infection rate by comparing a vaccinated cohort to a historically matched cohort in the pre-vaccinated period. Infection incident rate was also compared between vaccinated individuals and longitudinally matched unvaccinated individuals. Cox regression was used to estimate the association of the vaccine and COVID-19 associated severe outcomes by comparing breakthrough cohort and two matched unvaccinated infection cohorts.ResultsIndividuals vaccinated with Pfizer/BNT162b2 (IRR against Moderna/mRNA-1273 [95% CI]: 1.66 [1.17 - 2.35]); were male (1.47 [1.11 - 1.94%]); and had compromised immune systems (1.48 [1.09 - 2.00]) were at the highest risk for breakthrough infections. Vaccinated individuals had a significant lower infection rate among all subgroups. An increased incidence rate was found in both vaccines over the time. Among individuals infected with COVID-19, vaccination significantly reduced the risk of death (adj. HR: 0.20 [0.08 - 0.49]).Conclusion and relevanceWhile we found both mRNA vaccines were effective, Moderna/mRNA-1273 had a lower incidence rate of breakthrough infections. Both vaccines had increased incidence rates over the time. Immunocompromised individuals were among the highest risk groups experiencing breakthrough infections. Given the rapidly changing nature of the SARS-CoV-2, continued monitoring and a generalizable analysis pipeline are warranted to inform quick updates on vaccine effectiveness in real time.Key pointsQuestion: What risk factors contribute to COVID-19 breakthrough infections among mRNA vaccinated individuals? How do clinical outcomes differ between vaccinated but still SARS-CoV-2 infected individuals and non-vaccinated, infected individuals?Findings: This retrospective study uses CUIMC/NYP EHR data up to September 21, 2021. Individuals who were vaccinated with Pfizer/BNT162b2, male, and had compromised immune systems had significantly higher incidence rate ratios of breakthrough infections. Comparing demographically matched pre-vaccinated and unvaccinated individuals, vaccinated individuals had a lower incidence rate of SARS-CoV-2 infection among all subgroups.Meaning: Leveraging real-world EHR data provides insight on who may optimally benefit from a booster COVID-19 vaccination.

Dataset Information

COVID-19 Vaccination Breakthrough Infections in a Real-World Setting: Using Community Reporters to Evaluate Vaccine Effectiveness.

Purpose

Methods

Results

Conclusion

Trial registration

Publications

COVID-19 Vaccination Breakthrough Infections in a Real-World Setting: Using Community Reporters to Evaluate Vaccine Effectiveness.

Similar Datasets

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