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ImportanceReal-world data are needed to assess incidence and factors associated with breakthrough SARS-CoV-2 infections following vaccination. ObjectiveEstimate incidence of breakthrough infections and assess associations with risk factors using self-reported data from a large NC population sample. DesignProspective observational cohort study utilizing daily online survey data to capture information about COVID-19 symptoms, testing, and vaccination status. SettingSix health care systems in North Carolina with data collected between January 15, 2021 and September 24, 2021. ParticipantsAdult study participants who reported full vaccination with a COVID-19 mRNA or J&J non-replicating viral vector vaccine (n =16,020). ExposuresPotential community exposure to SARS-CoV-2. Main Outcome and MeasuresSelf-reported breakthrough infection. ResultsSARS-CoV-2 infection after vaccination was self-reported in 1.9% of participants, with an incidence rate of 7.3 per 100,000 person-years. Younger age (45-64 vs. 18-44: HR (95% CI) = 0.65 (0.51 - 0.82); 65+ vs. 18-44: HR (95% CI) = 0.59 (0.39 - 0.90)), and vaccination with J&J Ad26.COV2.S were associated with a higher risk of breakthrough infection compared to vaccination with Pfizer BNT162b2 (Ad26.COV2.S vs. BNT162b2: HR (95% CI) = 2.23 (1.40 - 3.56)), while participants vaccinated with mRNA-1273 (mRNA-1273 vs. BNT162b2: HR (95% CI) = 0.69 (0.50 - 0.96) and those residing in urban counties experienced a lower rate of SARS-CoV-2 breakthrough infection compared with those from suburban (HR (95% CI) = 1.39 (1.01 - 1.90) or rural (HR (95% CI) = 1.57 (1.16 - 2.11) counties. There was no significant association between breakthrough infection and participant sex, race, healthcare worker status, prior COVID-19 infection, routine mask use, or overall vaccination rate in the county of residence. Conclusions and RelevanceThis NC community-based observational study showed that the proportion of the cohort who self-report breakthrough SARS-CoV-2 infections was 7.3 events per 100,000 person-years. Younger adults, those vaccinated with J&J Ad26.COV2.S, and those residing in suburban or rural counties were at higher risk of breakthrough infections and should be targeted for additional risk mitigation strategies to decrease community transmission. Trial RegistrationThe COVID-19 Community Research Partnership is listed in clinicaltrials.gov (NCT04342884). Key PointsO_ST_ABSQuestionC_ST_ABSWhat are the characteristics of those with breakthrough infections after SARS-CoV-2 vaccination in North Carolinaa FindingsIn this NC-based observational study of 16,020 participants, 1.9% self-reported a positive SARS-CoV-2 viral test at least 2 weeks following full vaccination, reflecting an event rate of 7.3 infections per 100,000 person years. Rates were higher among younger participants, participants from more rural areas in North Carolina, and those vaccinated with J&J Ad26.COV2.S. MeaningOur results show a relatively low rate of COVID-19 infection following full vaccination. Younger adults and those vaccinated with J&J Ad26.COV2.S should be targeted for additional risk mitigation strategies.
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Willingness to receive the newly developed Coronavirus Disease-2019 (COVID-19) vaccines is highly variable. To assess the receptiveness of a select sample of North Carolinians to COVID-19 vaccination, a brief survey was conducted among participants in the COVID-19 Community Research Partnership (CCRP) affiliated with five medical centers in North Carolina. A total of 20,232 CCRP participants completed a multiple choice, mini survey electronically between December 17, 2020 and January 13, 2021. Of the 20,232 survey respondents, 15,422 (76.2%) were receptive to vaccination. Vaccine receptiveness increased incrementally with age with those >70 years being the most willing to be vaccinated compared to all other age groups. Respondents with no previous COVID-19 diagnosis were more likely to accept the vaccine compared to those that have a previous COVID-19 diagnosis (76.6% vs 60.9%). Comparative analysis of gender, race/ethnicity, and residence locale revealed that women, African Americans, and suburban participants were less willing to get a COVID-19 vaccine. There was no difference in vaccine intent based on healthcare worker status. Of those unwilling to get the vaccine, 82% indicated that the reason was uncertainty about the safety and efficacy of the vaccine.
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IntroductionThe COVID-19 Community Research Partnership is a population-based longitudinal syndromic and sero-surveillance study. The study includes over 17,000 participants from six healthcare systems in North Carolina who submitted over 49,000 serology results. The purpose of this study is to use these serology data to estimate the cumulative proportion of the North Carolina population that has either been infected with SARS-CoV-2 or developed a measurable humoral response to vaccination. MethodsAdult community residents were invited to participate in the study between April 2020 and February 2021. Demographic information was collected and daily symptom screen was completed using a secure, HIPPA-compliant, online portal. A portion of participants were mailed kits containing a lateral flow assay to be used in-home to test for presence of anti-SARS-CoV-2 IgM or IgG antibodies. The cumulative proportion of participants who tested positive at least once during the study was calculated. A standard Cox proportional hazards model was constructed to illustrate the probability of seroconversion over time up to December 20, 2020 (before vaccines available). A separate analysis was performed to describe the influence of vaccines during an extended period through February 15, 2021. Results17,688 participants contributed at least one serology result. Approximately two-thirds of the population were female and almost three-quarters were between 30 and 64 years of age. The average number of serology test results submitted per participant was 3.0 ({+/-}1.9). At December 20, 2020, the overall probability of seropositivity in the CCRP population was 32.6%. At February 15, 2021 the probability among healthcare workers and non-healthcare workers was 83% and 49%, respectively. An inflection upward in the probability of seropositivity was demonstrated around the end of December, suggesting an influence of vaccinations, especially for healthcare workers. Among healthcare workers, those in the oldest age category (60+ years) were 38% less likely to have seroconverted by February 15, 2021. ConclusionsResults of this study suggest more North Carolina residents may have been infected with SARS-CoV-2 than the number of documented cases as determined by positive RNA or antigen tests. The influence of vaccinations on seropositivity among North Carolina residents is also demonstrated. Additional research is needed to fully characterize the impact of seropositivity on immunity and the ultimate course of the pandemic.