Vaccine · 2026
Safety monitoring of health outcomes following RSVPreF3 + AS01 and RSVPreF vaccination among Medicare beneficiaries aged 65 years and older in the United States, 2023-2024.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Lloyd Patricia C, Shah Purva B, Zhang Henry T, Shah Nimesh, Nair Narayan, Wan Zhiruo, Hu Mao, Clarke Tainya C, Chen Meng, Chillarige Yoganand, Anderson Steven A, Forshee Richard A
Аннотация
BACKGROUND: The United States Food and Drug Administration (FDA) conducts post-market surveillance to monitor the safety of vaccines and evaluate potential health outcomes not identified in prelicensure clinical trials or through passive surveillance systems. We evaluated the risk of prespecified health outcomes following two Respiratory Syncytial Virus (RSV) vaccines- GlaxoSmithKline AREXVY ® (RSVPreF3 + AS01) and Pfizer ABRYSVO ® (RSVPreF)-among Medicare beneficiaries aged ≥65 years. Evaluation of Guillain-Barré syndrome following RSV vaccination was reported separately.
METHODS: This self-controlled case series study compared the incidence of 11 prespecified health outcomes using Medicare administrative claims data during May 3, 2023 - July 13, 2024. Using conditional Poisson regression, incidence rate ratios (IRR) with 99% confidence intervals (CIs) were estimated to compare outcome rates between post-vaccination risk and control intervals for each vaccine separately; analyses were adjusted for seasonality and event-dependent observation time, where appropriate. Attributable risk (AR) and 99% CIs estimated the excess number of outcomes per 100,000 vaccine doses.
RESULTS: Approximately 3.82 million beneficiaries received an RSV vaccination during the study period (RSVPreF3 + AS01: 2.60 million; RSVPreF: 1.21 million). No statistically significant elevation in risk was observed for the prespecified health outcomes examined following RSV vaccination. Adjusted IRRs were not statistically significant and ranged from 0.54 (99% CI: 0.16, 1.76) for encephalomyelitis excluding acute disseminated encephalomyelitis (RSVPreF) to 5.99 (99% CI: 0.34, 106.47) for anaphylaxis (RSVPreF3 + AS01). Similarly, adjusted ARs were not statistically significant and ranged from -22.57 excess cases per 100,000 vaccine doses (99% CI: -47.38, 2.23) for atrial fibrillation (RSVPreF) to 0.77 (99% CI: -1.77, 3.32) for non-hemorrhagic stroke in 1-21-day risk interval (RSVPreF3 + AS01).
CONCLUSION: Findings from this study suggest no increased risk of these health outcomes following RSV vaccination. These results contribute to the larger U.S. federal government vaccine safety monitoring efforts and further supports regulatory decision-making regarding RSV vaccines administered to U.S. adults aged 65 years and older.
METHODS: This self-controlled case series study compared the incidence of 11 prespecified health outcomes using Medicare administrative claims data during May 3, 2023 - July 13, 2024. Using conditional Poisson regression, incidence rate ratios (IRR) with 99% confidence intervals (CIs) were estimated to compare outcome rates between post-vaccination risk and control intervals for each vaccine separately; analyses were adjusted for seasonality and event-dependent observation time, where appropriate. Attributable risk (AR) and 99% CIs estimated the excess number of outcomes per 100,000 vaccine doses.
RESULTS: Approximately 3.82 million beneficiaries received an RSV vaccination during the study period (RSVPreF3 + AS01: 2.60 million; RSVPreF: 1.21 million). No statistically significant elevation in risk was observed for the prespecified health outcomes examined following RSV vaccination. Adjusted IRRs were not statistically significant and ranged from 0.54 (99% CI: 0.16, 1.76) for encephalomyelitis excluding acute disseminated encephalomyelitis (RSVPreF) to 5.99 (99% CI: 0.34, 106.47) for anaphylaxis (RSVPreF3 + AS01). Similarly, adjusted ARs were not statistically significant and ranged from -22.57 excess cases per 100,000 vaccine doses (99% CI: -47.38, 2.23) for atrial fibrillation (RSVPreF) to 0.77 (99% CI: -1.77, 3.32) for non-hemorrhagic stroke in 1-21-day risk interval (RSVPreF3 + AS01).
CONCLUSION: Findings from this study suggest no increased risk of these health outcomes following RSV vaccination. These results contribute to the larger U.S. federal government vaccine safety monitoring efforts and further supports regulatory decision-making regarding RSV vaccines administered to U.S. adults aged 65 years and older.