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Persons with end stage kidney disease (ESKD) on dialysis are at high risk for severe COVID-19 disease. In September 2023, 2023–2024 COVID-19 vaccination was recommended in the United States for all persons aged ≥6 months. Due to possible immune dysfunction, advanced age, and high prevalence of additional underlying conditions, including immunocompromising conditions, among individuals with ESKD, reduced vaccine effectiveness (VE) is a concern. Understanding effectiveness of 2023–2024 COVID-19 vaccine among persons with ESKD can inform COVID-19 vaccine recommendations for this population. A retrospective cohort investigation was conducted among Medicare fee-for-service beneficiaries aged ≥18 years with ESKD receiving dialysis using Medicare enrollment and claims records. Follow-up began on September 17, 2023, and continued until the earliest occurrence of claim for a COVID-19–associated outcome, other censoring event, or end of follow-up. A marginal structural Cox model was used to estimate VE (calculated as [1 – hazard ratio]*100 %), interpreted as the benefit of 2023–2024 COVID-19 vaccination compared with no 2023–2024 vaccine dose. VE was estimated by presence of additional immunocompromising conditions, age group, and time since vaccination. During September 17, 2023 – April 13, 2024, 17,749/112,250 (16 %) Medicare beneficiaries aged ≥18 years with ESKD without additional immunocompromising conditions received a 2023–2024 COVID-19 vaccine dose, with a maximum 209 days of follow-up since vaccination. During the follow-up period 6539 medically attended COVID-19 events, including 3605 COVID-19-associated hospitalizations, 789 COVID-19-associated deaths, and 896 COVID-19-associated thromboembolic events, were recorded. VE against COVID-19-associated hospitalization was 55 % (95 % confidence interval [CI]: 42 % - 65 %) at 7–59 days after vaccination and 47 % (95 % CI: 35 % – 57 %) at ≥60 days after vaccination. VE against COVID-19-associated death was 71 % (95 % CI: 46 % - 84 %) at 7–59 days after vaccination and 51 % (95 % CI: 24 % – 69 %) ≥60 days after vaccination. VE against COVID-19-associated thromboembolic events was 44 % (95 % CI, 24 %, 59 %). The 2023–2024 COVID-19 vaccines provided protection against COVID-19-associated hospitalization, death, and thromboembolic events among adults with ESKD. These data support the recommendation that adults with ESKD receive the updated COVID-19 vaccine. •End stage kidney disease (ESKD) is associated with increased risk of severe COVID-19.•Uptake of 2023–2024 COVID-19 vaccination among adults with ESKD was low.•COVID-19 vaccination was effective against severe COVID-19 among adults with ESKD.•COVD-19 vaccine effectiveness among adults with ESKD waned with more time since vaccination.

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. 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. 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. 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.

•No increased GBS risk following 2017–2018 influenza vaccinations.•Increased GBS risk with adjuvanted vaccine, not statistically significant after adjustment.•Benefits of influenza vaccines heavily outweigh this potential risk. The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services have been actively monitoring the risk of Guillain-Barré syndrome (GBS) following influenza vaccination among Fee-for-Service (FFS) Medicare beneficiaries every season since 2008. We present our evaluation of the GBS risk following influenza vaccinations during the 2017–2018 season. We implemented a multilayered approach to active safety surveillance that included near real-time surveillance early in the season, comparing GBS rates post-vaccination during the 2017–2018 season with rates from five prior seasons using the Updating Sequential Probability Ratio Test (USPRT), and end-of-season self-controlled risk interval (SCRI) analyses. We identified approximately 16 million influenza vaccinations. The near real-time surveillance did not signal for a potential 2.5-fold increased GBS risk either in days 8–21 or 1–42 post-influenza vaccination. In the SCRI analyses, we did not detect statistically significant increased GBS risks among influenza-vaccinated Medicare beneficiaries ≥65 years for either the 8–21 or 1–42-day risk windows for all seasonal vaccines combined, high-dose vaccine, or standard-dose vaccines; we did detect an increased GBS risk in days 8–21 post-vaccination for individuals vaccinated with the adjuvanted vaccine (OR: 3.75; 95% CI: 1.01, 13.96), although this finding was not statistically significant after multiplicity adjustment (p = 0.146). Our multilayered surveillance approach—which allows for early detection of elevated GBS risk and provides reliable end-of-season SCRI estimates of effect size—did not identify an increased GBS risk following 2017–2018 influenza vaccinations. The slightly increased GBS risk with the adjuvanted vaccine, which was not statistically significant following multiplicity adjustment, is consistent with the package inserts of all U.S.-licensed influenza vaccines, which warn of a potential low increased GBS risk. The benefits of influenza vaccines in preventing morbidity and mortality heavily outweigh this potential risk.

•Assessed background incidence rate of 17 AESI in 6 administrative claims databases.•Background rates varied by database and demographic characteristics.•Rates of most AESI increased with age and were higher among males.•AMI (Medicare) and anaphylaxis (all databases) rates showed seasonality.•AESI rates fluctuated in 2020, but most returned to 2019 levels after May 2020. The U.S. Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative conducts active surveillance of adverse events of special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) of AESI are comparators to evaluate safety. We estimated IRs of 17 AESI in six administrative claims databases from January 1, 2019, to December 11, 2020: Medicare claims for adults ≥ 65 years and commercial claims (Blue Health Intelligence®, CVS Health, HealthCore Integrated Research Database, IBM® MarketScan® Commercial Database, Optum pre-adjudicated claims) for adults < 65 years. IRs were estimated by sex, age, race/ethnicity (Medicare), and nursing home residency (Medicare) in 2019 and for specific periods in 2020. The study included >100 million enrollees annually. In 2019, rates of most AESI increased with age. However, compared with commercially insured adults, Medicare enrollees had lower IRs of anaphylaxis (11 vs 12–19 per 100,000 person-years), appendicitis (80 vs 117–155), and narcolepsy (38 vs 41–53). Rates were higher in males than females for most AESI across databases and varied by race/ethnicity and nursing home status (Medicare). Acute myocardial infarction (Medicare) and anaphylaxis (all databases) IRs varied by season. IRs of most AESI were lower during March–May 2020 compared with March–May 2019 but returned to pre-pandemic levels after May 2020. However, rates of Bell’s palsy, Guillain-Barré syndrome, narcolepsy, and hemorrhagic/non-hemorrhagic stroke remained lower in multiple databases after May 2020, whereas some AESI (e.g., disseminated intravascular coagulation) exhibited higher rates after May 2020 compared with 2019. AESI background rates varied by database and demographics and fluctuated in March–December 2020, but most returned to pre-pandemic levels after May 2020. It is critical to standardize demographics and consider seasonal and other trends when comparing historical rates with post-vaccination AESI rates in the same database to evaluate COVID-19 vaccine safety.

•Annual TTS IRs were similar between Jan-Dec 2019 and Jan-Oct 2020.•Common site TTS IRs increased with age and were higher among males.•Unusual site TTS IRs were higher in males than females.•Unusual site TTS IRs increased with age for adults aged 18–64 years.•For adults aged ≥ 65 years, unusual site TTS IRs decreased with age. 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. 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). 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. TTS IRs were generally similar across years, higher for males, and increased with age. These rates may contribute to surveillance of post-vaccination TTS.

•No influenza vaccine had excess Guillain-Barré syndrome (GBS) risk 1–42 days post-vaccination.•All seasonal influenza vaccines had GBS risk within expected range, 8–21 days post-vaccination.•The high dose influenza vaccine had GBS risk within expected range, 8–21 days post-vaccination.•Standard dose influenza vaccines had no excess GBS risk 8–21 days post-vaccination.•Difference in GBS risk after different vaccine types is hypothesis-generating. Guillain-Barré syndrome (GBS) is a serious acute demyelinating disease, an increased risk of which was found after the 1976 swine flu vaccinations. The U.S. Food and Drug Administration, in collaboration with the Centers for Medicare & Medicaid Services, has been conducting active surveillance for GBS after influenza vaccinations of Medicare Fee-For-Service beneficiaries since 2009. We conducted active surveillance for GBS claims in the 2015–2016 and 2016–2017 influenza seasons using the Updating Sequential Probability Ratio Test (USPRT) to monitor for signals of GBS risk. We performed self-controlled risk interval (SCRI) analyses at the end of both seasons, including chart confirmation in the 2015–2016 season, to estimate the odds ratio of GBS risk. We used 1–42 and 8–21 days post-vaccination as primary and secondary risk windows, respectively, and 43–84 days post-vaccination as the control window. Over 13 million beneficiaries were vaccinated in each season. USPRT found a low magnitude signal for GBS in both seasons. SCRI analyses did not find excess GBS risk following any influenza vaccine for days 1–42 post-vaccination in either season. In the 2015–2016 season, for the 8–21 day window, our chart-confirmation showed an attributable GBS risk of 0.87 (95% CI: 0.16, 1.49) and 1.68 (95% CI: 0.69, 2.41) cases per million vaccinees after all seasonal and high dose (HD) vaccines, respectively, an elevated GBS risk for beneficiaries aged ≥75 years following all seasonal vaccines (OR: 2.25; 95% CI: 1.15, 4.39) and HD vaccine (OR: 3.67, 95% CI: 1.52, 8.85), and an elevated GBS risk for males who received seasonal vaccines (OR: 2.18; 95% CI: 1.15, 4.15) and HD vaccine (OR: 3.33; 95% CI: 1.35, 8.20). The finding of elevated GBS risk with advancing age and in males is consistent with literature; however, a distinction between HD and SD was a new finding. In the 2016–17 season, for the 8–21 day window, attributed cases showed an attributable GBS risk of 0.87 (95% CI: 0.03, 1.61) and 1.11 (95% CI: 0.00, 2.01) cases per million vaccinees after all seasonal and HD vaccines, respectively. We found no excess GBS risk for standard dose vaccines in the 8–21 day window in either season. Our primary analysis finding of no excess GBS risk during both seasons was reassuring. The slightly elevated GBS risk, although in the expected range, in the 8–21 day window after all seasonal and high dose vaccines, but not after standard dose vaccines is hypothesis-generating because the difference may be due to vaccine factors such as antigen amount or strains in various seasons or due to host factors.

Introduction The use of erythropoiesis-stimulating agents (ESAs) for treatment of chemotherapy-induced anemia (CIA) has been linked to potential negative health effects. Additionally, research has identified disparities in ESA utilization for CIA treatment. This study examines (1) health disparities in ESA use and (2) whether reimbursement (Medicare National Coverage Determination [NCD]) or regulatory (Risk Evaluation and Mitigation Strategy [REMS]) policies impacted disparities. Methods In a retrospective cohort study (2006–2018) among 1,747,889 patients with cancer in the United States receiving myelosuppressive chemotherapy at age ≥ 65 years, differences in ESA use for CIA were estimated using generalized estimating equation models, adjusting for policy periods, demographic characteristics, and clinical factors extracted from Medicare claims data. Results After controlling for covariates, ESA use was higher among Black, female, and urban patients in all policy periods, but these disparities decreased significantly following the NCD. The gap continued to close through the REMS period. Disparities in ESA use across geographic regions were modest, and ESA use disparities across socioeconomic characteristics (area deprivation index or dual Medicare/Medicaid eligibility) were not observed. Conclusions Being female, Black, or an urban resident was associated with higher ESA use for CIA in older patients with cancer. Both NCD and REMS implementation helped reduce disparities. REMS release was not observed to contribute to racial, sex, and rural–urban disparities in ESA use for CIA.

COVID-19 has been associated with an increased risk for thromboembolic events, including ischemic stroke, venous thromboembolism, and myocardial infarction. Studies have reported lower rates of COVID-19-related thromboembolic events among persons who received the COVID-19 vaccine compared with persons who did not, but rigorous estimates of vaccine effectiveness (VE) in preventing COVID-19-related thromboembolic events are lacking. This analysis estimated the incremental benefit of receipt of a bivalent mRNA COVID-19 vaccine after receiving an original monovalent COVID-19 vaccine. To estimate VE of a bivalent mRNA COVID-19 dose in preventing thromboembolic events compared with original monovalent COVID-19 vaccine doses only, two retrospective cohort studies were conducted among Medicare fee-for-service enrollees during September 4, 2022-March 4, 2023. Effectiveness of a bivalent COVID-19 vaccine dose against COVID-19-related thromboembolic events compared with that of original vaccine alone was 47% (95% CI = 45%-49%) among Medicare enrollees aged ≥65 years and 51% (95% CI = 39%-60%) among adults aged ≥18 years with end stage renal disease receiving dialysis. VE was similar among Medicare beneficiaries with immunocompromise: 46% (95% CI = 42%-49%) among adults aged ≥65 years and 45% (95% CI = 24%-60%) among those aged ≥18 years with end stage renal disease. To help prevent complications of COVID-19, including thromboembolic events, adults should stay up to date with COVID-19 vaccination.