Assessment of standardized mean differences of participant characteristics (from data domains including diagnoses, medications and laboratory test results) after application of weighting showed that they are well-balanced in each analysis of incident outcomes (Supplementary Fig. During the enrollment period, the overall rate of BTI within those fully vaccinated was 10.60 (95% CI: 10.52, 10.70) per 1,000 persons at 6 months rates of breakthrough by vaccine type are presented in Supplementary Data Table 1.įor all analyses, we provide two measures of risk: (1) we estimated the adjusted HRs of a set of incident prespecified outcomes in people with BTI versus the control group and (2) we estimated the adjusted excess burden of each outcome due to BTI per 1,000 persons 6 months after a positive SARS-CoV-2 test on the basis of the difference between the estimated incidence rate in individuals with BTI and the control group. The demographic and health characteristics of the BTI and the control groups before and after weighting are presented in Supplementary Tables 1– 4. BTI participants had a positive SARS-CoV-2 test with prior record of a complete vaccination defined following Centers for Disease Control and Prevention (CDC) guidelines at 14 days after first Janssen (Johnson & Johnson)() vaccination and 14 days after second Pfizer-BioNTech (BNT162b2) or Moderna (mRNA-1273) vaccination. There were 33,940 and 4,983,491 participants in the BTI group and a contemporary control group of users of the Veterans Health Administration from 1 January 2021 to 31 October 2021 with no record of a positive SARS-CoV-2 test, respectively. Post-acute sequelae in BTI versus controls without SARS-CoV-2 infection We then undertake a comparative evaluation of the magnitude of risk in people with BTI versus those with SARS-CoV-2 infection and no prior vaccination and, separately, hospitalized people with BTI versus those hospitalized with seasonal influenza. We characterize the risks and 6-month burdens of a panel of prespecified outcomes in a cohort of people who experienced BTI after completion of vaccination in the overall cohort and by care setting of the acute phase of the disease (that is, whether people were not hospitalized, hospitalized or admitted to an intensive care unit (ICU) during the first 30 days after a positive test). Here we leverage the breadth and depth of the electronic healthcare databases of the US Department of Veterans Affairs to address the question of whether people with BTI develop post-acute sequelae. Addressing this knowledge gap is important to guide public health policy and post-acute COVID-19 care strategies. Whether people with BTI experience post-acute sequelae is not clear. Increasingly, vaccinated individuals are being diagnosed with COVID-19 as a result of breakthrough SARS-CoV-2 infection (BTI) 2, 3. The post-acute sequelae of SARS-CoV-2 infection-also referred to as Long COVID-have been characterized 1. The findings emphasize the need for continued optimization of strategies for primary prevention of BTI and will guide development of post-acute care pathways for people with BTI. Altogether, the findings suggest that vaccination before infection confers only partial protection in the post-acute phase of the disease hence, reliance on it as a sole mitigation strategy may not optimally reduce long-term health consequences of SARS-CoV-2 infection. Compared to people with SARS-CoV-2 infection who were not previously vaccinated ( n = 113,474), people with BTI exhibited lower risks of death (HR = 0.66, 95% CI: 0.58, 0.74) and incident post-acute sequelae (HR = 0.85, 95% CI: 0.82, 0.89). The results were consistent in comparisons versus the historical and vaccinated controls. At 6 months after infection, we show that, beyond the first 30 days of illness, compared to contemporary controls, people with BTI exhibited a higher risk of death (hazard ratio (HR) = 1.75, 95% confidence interval (CI): 1.59, 1.93) and incident post-acute sequelae (HR = 1.50, 95% CI: 1.46, 1.54), including cardiovascular, coagulation and hematologic, gastrointestinal, kidney, mental health, metabolic, musculoskeletal and neurologic disorders. In this study, we used the US Department of Veterans Affairs national healthcare databases to build a cohort of 33,940 individuals with BTI and several controls of people without evidence of SARS-CoV-2 infection, including contemporary ( n = 4,983,491), historical ( n = 5,785,273) and vaccinated ( n = 2,566,369) controls. The post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-also referred to as Long COVID-have been described, but whether breakthrough SARS-CoV-2 infection (BTI) in vaccinated people results in post-acute sequelae is not clear.
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