Assessment of potential adverse events following the 2022-2023 seasonal influenza vaccines among U.S. adults aged 65 years and older.

BACKGROUND: While safety of influenza vaccines is well-established, some studies have suggested potential associations between influenza vaccines and certain adverse events (AEs). This study examined the safety of the 2022-2023 influenza vaccines among U.S. adults ≥ 65 years. METHODS: A self-controlled case series compared incidence rates of anaphylaxis, encephalitis/encephalomyelitis, Guillain-Barré Syndrome (GBS), and transverse myelitis following 2022-2023 seasonal influenza vaccinations (i.e., any, high-dose or adjuvanted) in risk and control intervals among Medicare beneficiaries ≥ 65 years. We used conditional Poisson regression to estimate incidence rate ratios (IRRs) and 95 % confidence intervals (CIs) adjusted for event-dependent observation time and seasonality. Analyses also accounted for uncertainty from outcome misclassification where feasible. For AEs with any statistically significant associations, we stratified results by concomitant vaccination status. RESULTS: Among 12.7 million vaccine recipients, we observed 76 anaphylaxis, 276 encephalitis/encephalomyelitis, 134 GBS and 75 transverse myelitis cases. Only rates of anaphylaxis were elevated in risk compared to control intervals. With all adjustments, an elevated, but non-statistically significant, anaphylaxis rate was observed following any (IRR: 2.40, 95% CI: 0.96-6.03), high-dose (IRR: 2.31, 95% CI: 0.67-7.91), and adjuvanted (IRR: 3.28, 95% CI: 0.71-15.08) influenza vaccination; anaphylaxis IRRs were 2.54 (95% CI: 0.49-13.05) and 1.64 (95% CI: 0.38-7.05) for persons with and without concomitant vaccination, respectively. CONCLUSIONS: Rates of encephalitis/encephalomyelitis, GBS, or transverse myelitis were not elevated following 2022-2023 seasonal influenza vaccinations among U.S. adults ≥ 65 years. There was an increased rate of anaphylaxis following influenza vaccination that may have been influenced by concomitant vaccination.

Incidence rates of thrombosis with thrombocytopenia syndrome (TTS) among adults in United States commercial and Medicare claims databases, 2017-2020.

BACKGROUND: Increased risk of thrombosis with thrombocytopenia syndrome (TTS) following adenovirus vector-based COVID-19 vaccinations has been identified in passive surveillance systems. TTS incidence rates (IRs) in the United States (U.S.) are needed to contextualize reports following COVID-19 vaccination. METHODS: We estimated annual and monthly IRs of overall TTS, common site TTS, and unusual site TTS for adults aged 18-64 years in Carelon Research and MarketScan commercial claims (2017-Oct 2020), CVS Health and Optum commercial claims (2019-Oct 2020), and adults aged ≥ 65 years using CMS Medicare claims (2019-Oct 2020); IRs were stratified by age, sex, and race/ethnicity (CMS Medicare). RESULTS: Across data sources, annual IRs for overall TTS were similar between Jan-Dec 2019 and Jan-Oct 2020. Rates were higher in Medicare (IRs: 370.72 and 365.63 per 100,000 person-years for 2019 and 2020, respectively) than commercial data sources (MarketScan IRs: 24.21 and 24.06 per 100,000 person-years; Optum IRs: 32.60 and 31.29 per 100,000 person-years; Carelon Research IRs: 24.46 and 26.16 per 100,000 person-years; CVS Health IRs: 30.31 and 30.25 per 100,000 person-years). Across years and databases, common site TTS IRs increased with age and were higher among males. Among adults aged ≥ 65 years, the common site TTS IR was highest among non-Hispanic black adults. Annual unusual site TTS IRs ranged between 2.02 and 3.04 (commercial) and 12.49 (Medicare) per 100,000 person-years for Jan-Dec 2019; IRs ranged between 1.53 and 2.67 (commercial) and 11.57 (Medicare) per 100,000 person-years for Jan-Oct 2020. Unusual site TTS IRs were higher in males and increased with age in commercial data sources; among adults aged ≥ 65 years, IRs decreased with age and were highest among non-Hispanic American Indian/Alaska native adults. CONCLUSION: TTS IRs were generally similar across years, higher for males, and increased with age. These rates may contribute to surveillance of post-vaccination TTS.

Evaluation of potential adverse events following COVID-19 mRNA vaccination among adults aged 65 years and older: Two self-controlled studies in the U.S.

BACKGROUND: Our near-real-time safety monitoring of 16 adverse events (AEs) following COVID-19 mRNA vaccination identified potential elevation in risk for six AEs following primary series and monovalent booster dose administration. The crude association with AEs does not imply causality. Accordingly, we conducted robust evaluation of potential associations. METHODS: We conducted two self-controlled case series studies of COVID-19 mRNA vaccines (BNT162b2 and mRNA-1273) in U.S. Medicare beneficiaries aged ≥ 65 years. Adjusted incidence rate ratio (IRRs) and 95 % confidence intervals (CIs) were estimated following primary series doses for acute myocardial infarction (AMI), pulmonary embolism (PE), immune thrombocytopenia (ITP), disseminated intravascular coagulation (DIC); and following monovalent booster doses for AMI, PE, ITP, Bell's Palsy (BP) and Myocarditis/Pericarditis (Myo/Peri). RESULTS: The primary series study included 3,360,981 individuals who received 6,388,542 primary series doses; the booster study included 6,156,100 individuals with one monovalent booster dose. The AMI IRR following BNT162b2 primary series and booster was 1.04 (95 % CI: 0.91 to 1.18) and 1.06 (95 % CI: 1.003 to 1.12), respectively; for mRNA-1273 primary series and booster, 1.01 (95 % CI: 0.82 to 1.26) and 1.05 (95 % CI: 0.998 to 1.11), respectively. The hospital inpatient PE IRR following BNT162b2 primary series and booster was 1.19 (95 % CI: 1.03 to 1.38) and 0.86 (95 % CI: 0.78 to 0.95), respectively; for mRNA-1273 primary series and booster, 1.15 (95 % CI: 0.94 to 1.41) and 0.87 (95 % CI: 0.79 to 0.96), respectively. The studies' results do not support that exposure to COVID-19 mRNA vaccines elevate the risk of ITP, DIC, Myo/Peri, and BP. CONCLUSION: We did not find an increased risk for AMI, ITP, DIC, BP, and Myo/Peri and there was not consistent evidence for PE after exposure to COVID-19 mRNA primary series or monovalent booster vaccines. These results support the favorable safety profile of COVID-19 mRNA vaccines administered in the U.S. elderly population.

Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older.

BACKGROUND: Monitoring safety outcomes following COVID-19 vaccination is critical for understanding vaccine safety especially when used in key populations such as elderly persons age 65 years and older who can benefit greatly from vaccination. We present new findings from a nationally representative early warning system that may expand the safety knowledge base to further public trust and inform decision making on vaccine safety by government agencies, healthcare providers, interested stakeholders, and the public. METHODS: We evaluated 14 outcomes of interest following COVID-19 vaccination using the US Centers for Medicare & Medicaid Services (CMS) data covering 30,712,101 elderly persons. The CMS data from December 11, 2020 through Jan 15, 2022 included 17,411,342 COVID-19 vaccinees who received a total of 34,639,937 doses. We conducted weekly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination. FINDINGS: Four outcomes met the threshold for a statistical signal following BNT162b2 vaccination including pulmonary embolism (PE; RR = 1.54), acute myocardial infarction (AMI; RR = 1.42), disseminated intravascular coagulation (DIC; RR = 1.91), and immune thrombocytopenia (ITP; RR = 1.44). After further evaluation, only the RR for PE still met the statistical threshold for a signal; however, the RRs for AMI, DIC, and ITP no longer did. No statistical signals were identified following vaccination with either the mRNA-1273 or Ad26 COV2.S vaccines. INTERPRETATION: This early warning system is the first to identify temporal associations for PE, AMI, DIC, and ITP following BNT162b2 vaccination in the elderly. Because an early warning system does not prove that the vaccines cause these outcomes, more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency, are underway to further evaluate these signals. FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.

Evaluating Survey Report of Social Security Disability Benefit Receipt Using Linked National Health Interview Survey and Social Security Administration Data.

Linking nationally representative population health survey data with Social Security Administration (SSA) disability program data provides a rich source of information on program recipients. Survey participant data from the 1998-2005 National Health Interview Survey (NHIS) were linked to SSA administrative records from 1997 through 2005. The goal of this study was to assess agreement between the actual benefit receipt based on the SSA administrative records and the survey report of benefit receipt in the linked NHIS and SSA file for the U.S. civilian noninstitutionalized population. This evaluation provides information on the expected accuracy of survey report of Social Security Disability Insurance (SSDI) and Supplemental Security Income (SSI) benefit receipt, including how participant characteristics may be associated with reporting misclassification. The results indicate that there is some underreporting of SSA disability benefit receipt based on the NHIS responses compared with the SSA administrative records. The analysis identified some differences between the concordant and discordant groups for selected characteristics, but there were no clear patterns among the different survey questions or the different survey participant characteristics.

Use of the National Health Interview Survey Linked to Medicaid Analytic eXtract Data to Identify Children With Medicaid-covered Births.

Objective-This report illustrates the use of National Health Interview Survey (NHIS) data linked to Medicaid Analytic eXtract (MAX) data to identify children whose births were covered by Medicaid, as indicated in MAX data, among those participating in NHIS in early childhood, and briefly describes their selected health characteristics.

Housing Assistance and Blood Lead Levels: Children in the United States, 2005-2012.

OBJECTIVES: To compare blood lead levels (BLLs) among US children aged 1 to 5 years according to receipt of federal housing assistance. METHODS: In our analyses, we used 2005 to 2012 data for National Health and Nutrition Examination Survey (NHANES) respondents that were linked to 1999 to 2014 administrative records from the US Department of Housing and Urban Development (HUD). After we restricted the analysis to children with family income-to-poverty ratios below 200%, we compared geometric mean BLLs and the prevalence of BLLs of 3 micrograms per deciliter or higher among children who were living in assisted housing at the time of their NHANES blood draw (n = 151) with data for children who did not receive housing assistance (n = 1099). RESULTS: After adjustment, children living in assisted housing had a significantly lower geometric mean BLL (1.44 µg/dL; 95% confidence interval [CI] = 1.31, 1.57) than comparable children who did not receive housing assistance (1.79 µg/dL; 95% CI = 1.59, 2.01; P < .01). The prevalence ratio for BLLs of 3 micrograms per deciliter or higher was 0.51 (95% CI = 0.33, 0.81; P < .01). CONCLUSIONS: Children aged 1 to 5 years during 2005 to 2012 who were living in HUD-assisted housing had lower BLLs than expected given their demographic, socioeconomic, and family characteristics.

Characteristics of Children in Medicaid Managed Care and Medicaid Fee-for-service, 2003-2005.

OBJECTIVES: Medicaid claims have been used to characterize utilization patterns of child Medicaid beneficiaries. However, because states are increasingly adopting Medicaid managed care plans, analyses of children enrolled in Medicaid based only on claims for fee-for-service (FFS) programs may not apply to the general Medicaid population. METHODS: The 2003-2005 National Health Interview Survey and 2003-2005 Medicaid Analytic eXtract linked files were used to examine associations between sociodemographic, health, and geographic characteristics of children aged 0-17 years and enrollment in Medicaid FFS compared with a comprehensive managed care (CMC) program. Additional analyses of age-specific health outcomes were performed on a subset of children aged 6-17 years. Chi-square tests were used to assess associations, and 95% confidence intervals are provided for point prevalence estimates. RESULTS: Higher percentages of children in CMC compared with FFS were non-Hispanic white, lived in families with income less than 100% of the federal poverty level, had excellent or very good health, lived in the Northeast and West, and lived in large central metro areas. No significant differences were observed by sex, age, and asthma diagnoses between children enrolled in CMC and FFS. Among children aged 6-17 years, higher percentages of children enrolled in FFS compared with children in CMC were diagnosed with learning disabilities or developmental delays and attention deficit hyperactivity disorder. Researchers using data from children enrolled only in Medicaid FFS programs to describe children enrolled in Medicaid should understand differences between children in CMC and FFS. Generalization of study results from FFS claims may depend on the outcomes examined.