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      Characteristics and Outcomes Among Adults Aged ≥60 Years Hospitalized with Laboratory-Confirmed Respiratory Syncytial Virus — RSV-NET, 12 States, July 2022–June 2023

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      , MD 1 , , , MPH 1 , , MD 1 , , MPH 1 , 2 , , MD 3 , 4 , , MPH 5 , , MPH 6 , , DrPH 7 , 8 , 9 , , MS 10 , , MPH 11 , , MD 12 , , PhD 13 , , MPH 14 , , MD 15 , , MD 16 , , MD 17 , 18 , , MD 1 , RSV-NET Surveillance Team RSV-NET Surveillance Team, , , , , , , , , , , , ,
      Morbidity and Mortality Weekly Report
      Centers for Disease Control and Prevention

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          Summary What is already known about this topic? Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults. In June 2023, CDC recommended RSV vaccination for adults aged ≥60 years, using shared clinical decision-making and prioritizing those at highest risk for severe disease. What is added by this report? Among 1,634 patients aged ≥60 years hospitalized with RSV, 54% were aged ≥75 years, and 17% resided in long-term care facilities (LTCFs). Obesity, chronic obstructive pulmonary disease (COPD), and congestive heart failure (CHF) were common underlying conditions. What are the implications for public health practice? Clinicians and patients should consider age (particularly age ≥75 years), LTCF residence, and underlying medical conditions, including COPD and CHF, in shared decision-making regarding RSV vaccination to prevent severe RSV-associated outcomes. Abstract Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults. In May 2023, two RSV vaccines were approved for prevention of RSV lower respiratory tract disease in adults aged ≥60 years. In June 2023, CDC recommended RSV vaccination for adults aged ≥60 years, using shared clinical decision-making. Using data from the Respiratory Syncytial Virus–Associated Hospitalization Surveillance Network, a population-based hospitalization surveillance system operating in 12 states, this analysis examined characteristics (including age, underlying medical conditions, and clinical outcomes) of 3,218 adults aged ≥60 years who were hospitalized with laboratory-confirmed RSV infection during July 2022–June 2023. Among a random sample of 1,634 older adult patients with RSV-associated hospitalization, 54.1% were aged ≥75 years, and the most common underlying medical conditions were obesity, chronic obstructive pulmonary disease, congestive heart failure, and diabetes. Severe outcomes occurred in 18.5% (95% CI = 15.9%–21.2%) of hospitalized patients aged ≥60 years. Overall, 17.0% (95% CI = 14.5%–19.7%) of patients with RSV infection were admitted to an intensive care unit, 4.8% (95% CI = 3.5%–6.3%) required mechanical ventilation, and 4.7% (95% CI = 3.6%–6.1%) died; 17.2% (95% CI = 14.9%–19.8%) of all cases occurred in long-term care facility residents. These data highlight the importance of prioritizing those at highest risk for severe RSV disease and suggest that clinicians and patients consider age (particularly age ≥75 years), long-term care facility residence, and underlying medical conditions, including chronic obstructive pulmonary disease and congestive heart failure, in shared clinical decision-making when offering RSV vaccine to adults aged ≥60 years. Introduction Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults, resulting in approximately 60,000–160,000 hospitalizations and 6,000–10,000 deaths annually among adults aged ≥65 years ( 1 ). In May 2023, the Food and Drug Administration approved two RSV vaccines for prevention of RSV lower respiratory tract disease in adults aged ≥60 years.* In June 2023, CDC recommended RSV vaccination for adults aged ≥60 years using shared clinical decision-making between patient and clinicians; † adults at highest risk for severe RSV disease are most likely to benefit and should be prioritized for vaccination ( 1 ). To describe persons who experienced severe RSV disease requiring hospitalization, data from a large, geographically diverse surveillance system were analyzed to identify characteristics of adults aged ≥60 years hospitalized with laboratory-confirmed RSV infection during the 2022–23 respiratory virus season. Methods The Respiratory Syncytial Virus–Associated Hospitalization Surveillance Network (RSV-NET) § conducts population-based surveillance for RSV-associated hospitalizations in approximately 300 hospitals in 58 counties across 12 states, ¶ covering approximately 9% of the U.S. population. RSV-NET identifies residents within the network catchment area who are hospitalized with positive RSV tests results for provider-ordered reverse transcription–polymerase chain reaction (RT-PCR) or rapid antigen detection tests during their hospitalization or during the 14 days preceding admission. Because the 2022–23 RSV season started earlier than did seasons preceding the COVID-19 pandemic ( 2 ), this description of demographic characteristics of hospitalized RSV-NET patients includes those hospitalized during July 1, 2022–June 30, 2023. Using previously described methods ( 3 ), clinical data were collected by trained surveillance officers from a random sample of medical charts for adults hospitalized during October 1, 2022–April 30, 2023, and stratified by age and site. Sampled data are presented as unweighted case counts and weighted percentages that were weighted for the probability of selection and adjusted to better represent the hospitalized population of the catchment area ( 3 ). Age distributions of patients aged ≥60 years who were hospitalized and experienced severe outcomes, defined as intensive care unit (ICU) admission, mechanical ventilation, and in-hospital death, were compared with the overall age distribution of persons ≥60 years in the RSV-NET catchment area. Underlying medical conditions among hospitalized patients and those with severe outcomes were assessed and described. Data were analyzed using SAS survey procedures (version 9.4; SAS Institute). Differences were assessed using chi-square tests; p-values <0.05 were considered statistically significant. This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.** Results Among 3,218 adults aged ≥60 years with an identified RSV-associated hospitalization during July 2022–June 2023, a total of 1,738 (54.0%) were aged ≥75 years (this group constituted 29.0% of the catchment population of adults aged ≥60 years); 434 (13.5%) and 1,208 (37.5%) of RSV-associated hospitalizations occurred in persons aged 60–64 and ≥80 years, respectively. Overall, 222 (6.9%) patients were Hispanic or Latino (Hispanic), 2,159 (67.2%) patients were non-Hispanic White (White), 496 (15.4%) non-Hispanic Black or African American (Black), 228 (7.1%) non-Hispanic Asian or Pacific Islander (A/PI), 13 (0.4%) non-Hispanic American Indian or Alaska Native (AI/AN) persons, and 100 (3.2%) persons were of other or unknown race. The median patient age was 75 years (IQR = 68–84 years). The median age of White patients (77 years; IQR = 69–85 years) was significantly higher than that of patients who were Black (70 years; IQR = 65–77), Hispanic (74 years; IQR = 66–83 years), or AI/AN (72 years; IQR = 71–75 years) and was lower than that among A/PI (79 years; IQR = 71–87 years) patients (p-value <0.01 for all) (Supplementary Table 1; https://stacks.cdc.gov/view/cdc/133296). The proportion of hospitalized patients whose race was reported as Hispanic or Black decreased with increasing age (p-value <0.01); Black patients accounted for 28.2% of hospitalized patients aged 60–64 years and 8.2% of those aged ≥80 years (Supplementary Table 2; https://stacks.cdc.gov/view/cdc/133297). Among a random sample of 1,634 adults aged ≥60 years hospitalized during October 2022–April 2023 whose medical charts were reviewed, 54.1% were aged ≥75 years, and 290 (17.2%) were long-term care facility (LTCF) residents, including 175 (26.9%) of those aged ≥80 years (Table). Nearly all patients (1,553 [95%]) had SARS-CoV-2 test results available, among which 39 (2.4%) were positive; 1,587 (97.1%) had influenza testing results, among which 23 (2.2%) were positive. †† Prevalence of severe outcomes was not higher among patients with viral codetections compared with those with RSV alone detected (p>0.5). The median length of hospitalization was 4.1 days (IQR = 2.2–7.6 days). A substantial proportion (332 [18.5%; 95% CI = 15.9%–21.2%]) of patients had at least one severe outcome, including 297 (17.0%) who required ICU admission, 94 (4.8%) who required mechanical ventilation, and 98 (4.7%) who died while hospitalized. TABLE Characteristics of a random sample of patients aged ≥60 years hospitalized with laboratory-confirmed respiratory syncytial virus infection * (N = 1,634), stratified by age and site — Respiratory Syncytial Virus–Associated Hospitalization Surveillance Network, 12 states, † October 2022–April 2023 Characteristic Age group, yrs Overall 60–69 70–79 ≥80 No. Weighted %
(95% CI) No. Weighted %
(95% CI) No. Weighted %
(95% CI) No. Weighted %
(95% CI) Total, row % 1,634 100 523 32 554 34 557 34 Sex Female 975 60.5 (57.0–63.8) 311 60.7 (54.8–66.4) 317 57.5 (51.7–63.1) 347 62.8 (56.7–68.7) Male 659 39.5 (36.2–43.0) 212 39.3 (33.6–45.2) 237 42.5 (36.9–48.3) 210 37.2 (31.3–43.3) Race and ethnicity § AI/AN 7 0.3 (0.1–0.7) 3 0.5 (0.1–1.5) 4 0.5 (0.1–1.5) 0 — A/PI, NH 95 7.1 (5.2–9.5) 31 7.3 (3.6–12.8) 23 3.9 (2.3–6.2) 41 9.8 (6.1–14.6) Black or African American, NH 213 13.0 (11.0–15.2) 111 22.4 (18.0–27.4) 69 13.0 (9.6–17.0) 33 5.7 (3.5–8.7) White, NH 1,181 70.2 (67.0–73.3) 333 60.6 (54.6–66.4) 404 70.2 (64.7–75.4) 444 77.6 (72.1–82.4) Hispanic or Latino 92 6.7 (5.0–8.7) 33 7.2 (4.4–11.0) 33 9.1 (5.5–13.9) 26 4.2 (2.4–6.7) All other races¶ 5 0.4 (0.1–1.3) 1 0.1 (0.0–0.9) 2 0.3 (0.0–1.2) 2 0.7 (0.0–3.3) Unknown 41 2.3 (1.6–3.3 11 1.9 (0.8–3.6) 19 3.0 (1.7–4.9) 11 2.0 (0.9–3.9) LTCF residence** 290 17.2 (14.9–19.8) 36 5.8 (3.8–8.5) 79 16.1 (12.0–20.9) 175 26.9 (22.2–32.0) Viral codetection †† SARS-CoV-2 39 2.4 (1.5–3.6) 11 1.6 (0.7–3.1) 19 3.4 (1.7–5.9) 9 2.2 (0.8–4.9) Influenza 23 2.2 (1.2–3.8) 7 1.9 (0.4–5.0) 9 2.3 (0.6–5.7) 7 2.4 (0.8–5.5) Hospitalization outcome§§ Hospital stay, days, median (IQR) 4.1 (2.2–7.6) — 4.0 (2.0–7.4) — 4.1 (2.3–7.7) — 4.2 (2.2–7.7) — BiPAP/CPAP 339 19.8 (17.3–22.6) 116 23.3 (18.3–28.9) 131 22.6 (18.1–27.6) 92 14.8 (11.2–19.2) High-flow nasal cannula 80 4.3 (3.2–5.7) 22 3.9 (2.1–6.7) 31 5.4 (3.3–8.2) 27 3.7 (2.2–5.8) ≥1 severe outcome¶¶ 332 18.5 (15.9–21.2) 112 20.5 (16.3–25.3) 124 22.3 (17.2–28.1) 96 13.7 (10.2–17.8) ICU admission 297 17.0 (14.5–19.7) 111 20.5 (16.2–25.2) 110 20.6 (15.5–26.4) 76 11.3 (8.0–15.4) Invasive mechanical ventilation 94 4.8 (3.5–6.3) 42 6.4 (4.4–9.0) 33 4.9 (2.9–7.7) 19 3.5 (1.4–6.9) In-hospital death 98 4.7 (3.6–6.1) 22 3.0 (1.7–4.8) 39 5.8 (3.7–8.5) 37 5.2 (3.2–7.9) Underlying medical condition ≥1 underlying medical condition*** 1,584 95.5 (93.2–97.2) 501 96.3 (94.0–97.9) 540 97.2 (95.1–98.6) 543 93.5 (87.3–97.2) Chronic lung disease 813 49.2 (45.7–52.7) 290 54.4 (48.2–60.4) 292 53.9 (48.0–59.7) 231 41.2 (35.3–47.3) COPD 552 33.7 (30.5–37.0) 197 38.9 (33.1–44.8) 189 34.4 (28.9–40.4) 166 29.1 (24.0–34.6) Asthma 332 19.1 (16.6–21.8) 134 25.4 (20.4–31.0) 108 16.5 (12.9–20.7) 90 16.4 (12.3–21.2) Other††† 72 5.4 (3.8–7.3) 17 3.0 (1.6–5.1) 34 8.4 (5.0–13.1) 21 4.6 (2.4–8.0) Cardiovascular disease 1,108 67.1 (63.7–70.5) 304 55.0 (48.8–61.0) 371 67.5 (61.8–72.8) 433 76.3 (70.0–81.8) CHF§§§ 545 33.2 (30.0–36.5) 165 31.5 (26.1–37.2) 165 29.8 (24.4–35.7) 215 37.4 (31.7–43.4) CAD¶¶¶ 435 26.4 (23.5–29.5) 109 20.9 (16.3–26.3) 151 28.8 (23.7–34.4) 175 28.6 (23.6–34.1) CVA**** 253 13.7 (11.7–15.9) 55 9.6 (6.9–13.0) 90 14.0 (10.7–17.8) 108 16.7 (12.8–21.1) Immunocompromising condition 292 18.6 (16.0–21.4) 101 19.0 (14.5–24.1) 121 22.8 (18.0–28.1) 70 14.8 (10.8–19.6) Diabetes mellitus 553 32.6 (29.5–35.8) 200 38.0 (32.4–43.9) 195 32.7 (27.6–38.1) 158 28.4 (23.1–34.2) Neurologic condition 439 27.3 (24.3–30.5) 96 17.3 (13.4–21.7) 135 25.2 (20.3–30.6) 208 36.8 (31.0–42.9) Dementia†††† 183 12.4 (10.1–15.0) 7 1.0 (0.4–2.4) 40 8.5 (5.5–12.5) 136 24.5 (19.4–30.1) Other 256 14.9 (12.6–17.4) 89 16.2 (12.5–20.6) 95 16.7 (12.6–21.4) 72 12.3 (8.8–16.6) Kidney disorder 477 29.3 (26.3–32.5) 134 24.7 (19.7–30.1) 156 30.0 (24.8–35.5) 187 32.3 (26.9–38.0) Obesity 572 37.8 (34.3–41.4) 230 46.4 (40.3–52.5) 213 42.4 (36.5–48.6) 129 27.1 (21.3–33.6) Abbreviations: AI/AN = American Indian or Alaska Native; A/PI = Asian or other Pacific Islander; BiPAP/CPAP = bilevel positive airway pressure/continuous positive airway pressure; CAD = coronary artery disease; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; CVA = cerebrovascular accident; ICU = intensive care unit; LTCF = long-term care facility; NH = non-Hispanic. * Data are from a weighted sample of hospitalized adults with completed medical record abstractions. Sample sizes presented are unweighted with weighted percentages. † Includes persons admitted to a hospital with an admission date during October 1, 2022–April 30, 2023. Selected counties in California, Colorado, Connecticut, Georgia, Maryland, Michigan, Minnesota, New Mexico, New York, Oregon, Tennessee, and Utah. § If ethnicity was unknown, NH ethnicity was assumed. ¶ Includes NH persons reported as other or multiple races. ** LTCF residents include hospitalized adults who were identified as residents of a nursing home or skilled nursing facility, rehabilitation facility, assisted living or residential care, long-term acute care hospital, group or retirement home, or other LTCF upon hospital admission. A free-text field for other types of residences was examined; patients with an LTCF-type residence were also categorized as LTCF residents. †† Results reported among adults who received testing (as opposed to all hospitalized adults). Because of testing practices, denominators differed among the viral respiratory pathogens based on type of test results available: SARS-CoV-2 = 95% (1,553) and influenza (influenza A, influenza B, and flu [not subtyped]) = 97% (1,587). Among 375 (24.2%) patients who received testing for other viruses, 15 additional viruses were detected: nine rhinoviruses, four seasonal coronaviruses, and two parainfluenza viruses. §§ Hospitalization outcomes are not mutually exclusive categories, and patients can be included in more than one category. ¶¶ Severe outcome is defined as requiring ICU admission or mechanical ventilation or experiencing in-hospital death. *** Defined as one or more of the following: chronic lung disease, including asthma; chronic metabolic disease including diabetes mellitus; blood disorder or hemoglobinopathy; cardiovascular disease; neurologic disorder; immunocompromising condition; renal disease; gastrointestinal or liver disease; rheumatologic, autoimmune, or inflammatory condition; obesity; feeding tube dependency; and wheelchair dependency. ††† Other chronic lung diseases include interstitial lung disease, pulmonary fibrosis, restrictive lung disease, sarcoidosis, asbestosis, and chronic respiratory failure including oxygen dependence. §§§ CHF includes cardiomyopathy, heart failure with preserved ejection fraction, and heart failure with reduced ejection fraction. ¶¶¶ CAD includes history of coronary artery bypass graft and myocardial infarction. **** CVA includes history of stroke or transient ischemic attack. †††† Dementia includes Alzheimer disease and other types of dementia. Almost all sampled patients (1,584; 95.5%) had at least one underlying medical condition, most commonly obesity (37.8%), chronic obstructive pulmonary disease (COPD) (33.7%), congestive heart failure (CHF) (33.2%), and diabetes mellitus (32.6%); 18.6% had an immunocompromising condition (Table) (Figure 1). The following underlying conditions were significantly more prevalent in patients with severe outcomes than in those without severe outcomes: COPD (40.0% versus 32.0%; p = 0.047), other chronic lung diseases excluding COPD and asthma (9.1% versus 4.4%; p = 0.04), and CHF (41.2% versus 31.4%; p = 0.01). FIGURE 1 Underlying medical conditions* , † among patients hospitalized with laboratory-confirmed respiratory syncytial virus infection § — Respiratory Syncytial Virus–Associated Hospitalization Surveillance Network, 12 states, ¶ October 2022–April 2023 Abbreviation: COPD = chronic obstructive pulmonary disease. * With 95% CIs indicated by error bars. † Congestive heart failure includes cardiomyopathy; coronary artery disease includes history of coronary artery bypass graft and myocardial infarction; cerebrovascular accident includes history of stroke or transient ischemic attack; dementia includes Alzheimer disease and other types of dementia. § Data are from a weighted sample of hospitalized adults with completed medical record abstractions. Sample sizes presented are unweighted with weighted percentages. ¶ Select counties in California, Colorado, Connecticut, Georgia, Maryland, Michigan, Minnesota, New Mexico, New York, Oregon, Tennessee, and Utah. Figure is a bar graph indicating underlying medical conditions among U.S. patients in 12 states hospitalized with laboratory-confirmed respiratory syncytial virus infection during October 2022–April 2023, based on data from the Respiratory Syncytial Virus–Associated Hospitalization Surveillance Network. Whereas adults aged 75–79 years and ≥80 years accounted for 12.4% and 16.2% of the catchment area populations, respectively (Figure 2), they accounted for 16.0% (95% CI = 13.5%–18.8%) and 38.1% (95% CI = 34.7%–41.7%) of hospitalizations, 21.2% (95% CI = 13.2%–31.3%) and 25.5% (95% CI = 18.6%–33.5%) of ICU admissions, and 25.6% (95% CI = 14.8%–39%) and 42.1% (95% CI = 29.1%–55.9%) of in-hospital deaths, respectively. Orders to not resuscitate or intubate were in place for 321 (20%) patients, including 211 (35%) patients aged ≥80 years. FIGURE 2 Age distribution* among persons aged ≥60 years residing in the surveillance network catchment area † and among laboratory-confirmed respiratory syncytial virus–associated hospitalizations, intensive care unit admissions, and in-hospital deaths — Respiratory Syncytial Virus–Associated Hospitalization Surveillance Network, 12 states, October 2022–April 2023 Abbreviations: ICU = intensive care unit; RSV = respiratory syncytial virus; RSV-NET = Respiratory Syncytial Virus–Associated Hospitalization Surveillance Network. * With 95% CIs indicated by error bars. † The RSV catchment area includes select counties in California, Colorado, Connecticut, Georgia, Maryland, Michigan, Minnesota, New Mexico, New York, Oregon, Tennessee, and Utah. RSV-associated hospitalizations among RSV-NET catchment area residents have hospital admission dates from October 1, 2022 through April 30, 2023. Those with severe RSV disease might be more likely to receive RSV testing; therefore, these data could potentially overestimate the proportion of severe outcomes among hospitalized patients. Figure is a bar graph indicating the age distribution among U.S. persons aged ≥60 years residing in the Respiratory Syncytial Virus–Associated Hospitalization Surveillance Network catchment area and among these persons’ laboratory-confirmed respiratory syncytial virus–associated hospitalizations, intensive care unit admissions, and in-hospital deaths in 12 states during October 2022–April 2023. Discussion During July 2022–June 2023, RSV-associated hospitalizations among adults aged ≥60 years in a large population-based surveillance system occurred predominantly among those aged ≥75 years (54%); many (17.2%) of these patients resided in long-term care facilities. The median age of hospitalized AI/AN, Black, and Hispanic patients was lower than that of hospitalized White patients. Viral coinfections reported in RSV-NET were infrequent, despite comprehensive testing for SARS-CoV-2 and influenza, indicating that RSV alone caused substantial morbidity and mortality in this population. Most patients hospitalized with RSV had underlying medical conditions, notably CHF and COPD, which were associated with severe outcomes. Severe outcomes were common, with 17.0% of hospitalized patients requiring ICU admission and nearly 5% dying during their hospitalization. CDC recommends RSV vaccination for adults aged ≥60 years using shared clinical decision-making, which may consider a patient’s individual risk for severe disease ( 1 ). Adults aged ≥75 years were overrepresented among older adult RSV-NET hospitalizations, consistent with previous studies demonstrating increased RSV hospitalization rates with increasing age ( 4 , 5 ). However, the median age of hospitalized older adults who were AI/AN, Black, and Hispanic patients was lower than that for White patients, such that persons in these three groups accounted for a larger proportion of RSV-NET hospitalizations among the younger age groups. This finding likely reflects different age distributions, as well as life expectancy, within the catchment population, as well as potentially higher risk for hospitalization at younger ages resulting from racial and ethnic disparities in underlying medical conditions, access to medical care, and socioeconomic status ( 6 – 8 ). The prevalence of underlying medical conditions among hospitalized patients was high, including CHF and COPD, both of which were disproportionately associated with severe outcomes in this analysis. Both CHF and COPD have been previously associated with increased RSV hospitalization rates ( 4 , 5 ). One study indicated that older adults with COPD (aged ≥65 years) and CHF (aged 60–79 years) had RSV hospitalization rates that were 3.5–13.4 times and 5.9–7.6 times higher, respectively, than rates among those without those conditions ( 5 ). The large proportion of LTCF residents among RSV-NET hospitalizations is also consistent with published literature demonstrating this population’s vulnerability to institutional outbreaks and hospitalization ( 9 ). Limitations The findings in this report are subject to at least three limitations. First, RSV-associated hospitalizations might have been missed because of test availability or clinician testing practices that limit RSV testing among hospitalized adults. Second, and conversely, severely ill patients might have been more likely to undergo RSV testing, potentially overestimating the proportion of severe outcomes among hospitalized patients. Finally, because RSV-NET covers 9% of the U.S. population, these findings might not be nationally generalizable. Implications for Public Health Practice RSV causes substantial morbidity and mortality in adults aged ≥60 years; these findings suggest that advanced age (particularly ≥75 years), LTCF residence, and the presence of underlying medical conditions, including COPD and CHF, might be risk factors for clinicians and patients to consider in shared decision-making regarding RSV vaccination. It is important that special attention be paid to equitable access to vaccines for AI/AN, Black, and Hispanic adults, who were hospitalized for RSV at younger ages than were White adults.

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          Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association

          BACKGROUND: The American Heart Association, in conjunction with the National Institutes of Health, annually reports the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, diet, and weight) and health factors (cholesterol, blood pressure, and glucose control) that contribute to cardiovascular health. The Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, congenital heart disease, rhythm disorders, subclinical atherosclerosis, coronary heart disease, heart failure, valvular disease, venous disease, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs). METHODS: The American Heart Association, through its Epidemiology and Prevention Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States to provide the most current information available in the annual Statistical Update with review of published literature through the year before writing. The 2023 Statistical Update is the product of a full year’s worth of effort in 2022 by dedicated volunteer clinicians and scientists, committed government professionals, and American Heart Association staff members. The American Heart Association strives to further understand and help heal health problems inflicted by structural racism, a public health crisis that can significantly damage physical and mental health and perpetuate disparities in access to health care, education, income, housing, and several other factors vital to healthy lives. This year’s edition includes additional COVID-19 (coronavirus disease 2019) publications, as well as data on the monitoring and benefits of cardiovascular health in the population, with an enhanced focus on health equity across several key domains. RESULTS: Each of the chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics. CONCLUSIONS: The Statistical Update represents a critical resource for the lay public, policymakers, media professionals, clinicians, health care administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.
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            Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023

            Summary What is already known about this topic? Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults. In May 2023, the Food and Drug Administration approved the first two vaccines for prevention of RSV lower respiratory tract disease (LRTD) for use in adults aged ≥60 years. What is added by this report? For both vaccine products, vaccination with a single RSV vaccine dose demonstrated moderate to high efficacy in preventing symptomatic RSV-associated LRTD among adults aged ≥60 years. On June 21, 2023, the Advisory Committee on Immunization Practices recommended that persons aged ≥60 years may receive a single dose of RSV vaccine, using shared clinical decision-making. What are the implications for public health practice? RSV vaccination might prevent substantial morbidity in older adults at risk for severe RSV disease; postmarketing surveillance for safety and effectiveness will direct future guidance. Abstract Respiratory syncytial virus (RSV) is a cause of severe respiratory illness in older adults. In May 2023, the Food and Drug Administration approved the first vaccines for prevention of RSV-associated lower respiratory tract disease in adults aged ≥60 years. Since May 2022, the Advisory Committee on Immunization Practices (ACIP) Respiratory Syncytial Virus Vaccines Adult Work Group met at least monthly to review available evidence regarding the safety, immunogenicity, and efficacy of these vaccines among adults aged ≥60 years. On June 21, 2023, ACIP voted to recommend that adults aged ≥60 years may receive a single dose of an RSV vaccine, using shared clinical decision-making. This report summarizes the body of evidence considered for this recommendation and provides clinical guidance for the use of RSV vaccines in adults aged ≥60 years. RSV vaccines have demonstrated moderate to high efficacy in preventing RSV-associated lower respiratory tract disease and have the potential to prevent substantial morbidity and mortality among older adults; postmarketing surveillance will direct future guidance. Introduction In the United States, respiratory syncytial virus (RSV) causes seasonal epidemics of respiratory illness. Although the COVID-19 pandemic interrupted seasonal RSV circulation, the timing and number of incident cases of the 2022–23 fall and winter epidemic suggested a likely gradual return to prepandemic seasonality ( 1 ). Each season, RSV causes substantial morbidity and mortality in older adults, including lower respiratory tract disease (LRTD), hospitalization, and death. Incidence estimates vary widely and are affected by undertesting and potentially low sensitivity of standard diagnostic testing among adults ( 2 – 5 ). Most adult RSV disease cases occur among older adults with an estimated 60,000–160,000 hospitalizations and 6,000–10,000 deaths annually among adults aged ≥65 years ( 5 – 10 ). Adults with certain medical conditions, including chronic obstructive pulmonary disease, asthma, congestive heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease, are at increased risk for RSV-associated hospitalization ( 11 – 13 ), as are residents of long-term care facilities ( 14 ), and persons who are frail* or of advanced age (incidence of RSV-associated hospitalization among adults increases with age, with the highest rates among those aged ≥75 years) ( 6 , 15 ). RSV can also cause severe disease in persons with compromised immunity, including recipients of hematopoietic stem cell transplantation and patients taking immunosuppressive medications (e.g., for solid organ transplantation, cancer treatment, or other conditions) ( 16 , 17 ). In May 2023, the Food and Drug Administration (FDA) approved the first vaccines for prevention of RSV-associated LRTD in adults aged ≥60 years. RSVPreF3 (Arexvy, GSK) is a 1-dose (0.5 mL) adjuvanted (AS01E) recombinant stabilized prefusion F protein (preF) vaccine ( 18 ). RSVpreF (Abrysvo, Pfizer) is a 1-dose (0.5 mL) recombinant stabilized preF vaccine ( 19 ). Methods Since May 2022, CDC’s Advisory Committee on Immunization Practices (ACIP) RSV Vaccines Adult Work Group (Work Group) met at least monthly to review available evidence regarding the safety, immunogenicity, and efficacy of the GSK and Pfizer RSV vaccines among adults aged ≥60 years. A systematic review of published and unpublished evidence of the efficacy and safety of these vaccines among persons aged ≥60 years was conducted. The body of evidence consisted of one phase 3 randomized controlled trial and one combined phase 1 and 2 (phase 1/2) randomized controlled trial for each vaccine. The Work Group used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to independently determine the certainty of evidence for outcomes related to each vaccine, rated on a scale of high to very low certainty. † In evaluating safety, the Work Group defined inflammatory neurologic events as cases of Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy, and acute central nervous system inflammation (e.g., transverse myelitis or acute disseminated encephalomyelitis [ADEM]) occurring within 42 days after vaccination. The Work Group then employed the Evidence to Recommendation Framework to guide its deliberations on recommendation for RSV vaccination, reviewing data on the public health problem, benefits and harms, value to the target population, acceptability to key stakeholders, feasibility, resource use, and equity. § Work Group conclusions regarding evidence for the use of RSV vaccines among adults aged ≥60 years were presented to ACIP at public meetings on February 23 and June 21, 2023 ( 10 , 15 ). Vaccine Efficacy and Safety GSK Vaccine Evaluated efficacy evidence for the GSK RSV vaccine consisted of data from one ongoing randomized, double-blind, placebo-controlled phase 3 clinical trial conducted in 17 countries and including 24,973 immunocompetent participants aged ≥60 years randomized 1:1 to receive 1 dose of vaccine (intervention group, 120 μg preF protein with AS01E adjuvant) or saline placebo (control group) ( 20 ). Efficacy findings were based on analyses of data collected during May 2021–March 2023, which included two complete RSV seasons for Northern Hemisphere participants and one complete RSV season for Southern Hemisphere participants. Efficacy analyses for season one spanned May 2021–April 2022, while efficacy analyses for season two spanned August 2022–March 2023; exact study-defined season dates were site-dependent. Mean time from vaccination to end of efficacy follow-up across both seasons was approximately 15 months per participant. The efficacy of 1 dose of the GSK vaccine in preventing symptomatic, laboratory-confirmed RSV-associated LRTD ¶ was 82.6% (96.95% CI = 57.9%–94.1%) during the first RSV season and 56.1% (95% CI = 28.2%–74.4%) during the second season (Table 1).** Efficacy of 1 dose over two seasons was 74.5% (97.5% CI = 60.0%–84.5%) in preventing RSV-associated LRTD and 77.5% (95% CI = 57.9%–89.0%) in preventing medically attended RSV-associated LRTD. †† The study was not powered to estimate efficacy against hospitalization (intervention group = one event; control group = five events), severe RSV illness requiring respiratory support (intervention group = one event; control group = five events), §§ or death (no events). ¶¶ TABLE 1 Efficacy of 1 dose of GSK respiratory syncytial virus RSVpreF3 vaccine against respiratory syncytial virus–associated disease among adults aged ≥60 years — multiple countries, 2021–2023 Efficacy evaluation period Vaccine efficacy against outcome* RSV-associated LRTD† RSV-associated medically attended LRTD§ Season 1¶ 82.6 (57.9–94.1)** 87.5 (58.9–97.6)†† Season 2§§ 56.1 (28.2–74.4)†† —¶¶ Combined seasons 1 and 2 (interim)*** 74.5 (60.0–84.5)††† 77.5 (57.9–89.0)†† Abbreviations: LRTD = lower respiratory tract disease; RSV = respiratory syncytial virus. * Manufacturer-calculated efficacy. Includes events >14 days after injection and person-time available from the manufacturer’s pivotal phase 3 trial. Estimates adjusted for participant age and region. † LRTD defined as two or more lower respiratory symptoms (new or increased sputum, cough, and dyspnea) or signs (new or increased wheezing, crackles or rhonchi detected during chest auscultation, respiratory rate ≥20 respirations per minute, low or decreased oxygen saturation [ 3.9” (>100 mm). For fever, grade 3 corresponded to a temperature >102.2°F (>39°C). For all other reactions, grade 3 corresponded to reactions that prevented normal, everyday activities. Grade 4 events were not defined in these trials. §§ Defined by the Advisory Committee on Immunization Practices Respiratory Syncytial Virus Vaccines Adult Work Group as GBS (including GBS variants), chronic inflammatory demyelinating polyneuropathy, or acute central nervous system inflammation (e.g., transverse myelitis or acute disseminated encephalomyelitis) occurring ≤42 days after vaccination. ¶¶ No inflammatory neurologic events were reported in either the phase 3 or phase 1/2 trials. However, across all RSVPreF3 trials inflammatory neurologic events were reported in three of 17,922 adults vaccinated with RSVPreF3. Events included one case of GBS in an open-label phase 3 clinical trial, and two cases of acute disseminated encephalomyelitis among participants in a randomized phase 3 study of coadministration of RSVPreF3 and standard dose seasonal influenza vaccine. Relative risk could not be calculated because neither trial had a placebo-controlled comparator group. Across all GSK vaccine clinical trials in older adults, inflammatory neurologic events were reported in three of 17,922 participants within 42 days after receipt of the GSK vaccine ( 23 ). All three events occurred in trials excluded from GRADE because of lack of an unvaccinated comparator arm. The reported cases included one case of GBS in a participant aged 78 years from Japan with symptom onset 9 days postvaccination in an open-label phase 3 clinical trial and two cases of ADEM among participants in a randomized phase 3 coadministration study ( 15 , 22 ). The two ADEM cases were reported in participants aged 71 years from the same site in South Africa after concomitant receipt of the GSK vaccine and standard dose seasonal influenza vaccine; symptom onset occurred 7 and 22 days postvaccination, and one case was fatal. In both ADEM cases, the diagnosis was based on symptoms and clinical findings only; diagnostic testing (including brain imaging, cerebrospinal fluid testing, and nerve conduction studies) was not performed, leading to uncertainty in the diagnoses. The investigator in the fatal case later revised the diagnosis from ADEM to hypoglycemia and dementia ( 15 , 22 ). Pfizer Vaccine Evaluated efficacy evidence for the Pfizer vaccine consisted of data from one ongoing, randomized, double-blind, placebo-controlled phase 3 clinical trial conducted in seven countries and including 36,862 immunocompetent participants aged ≥60 years randomized 1:1 to receive 1 dose of vaccine (intervention group, 120 μg preF protein) or placebo containing the same buffer ingredients as the vaccine but without active components (control group) ( 24 ). Efficacy findings were based on analyses of data collected during August 2021–January 2023, which included one complete RSV season for Northern and Southern Hemisphere participants and a partial second season for Northern Hemisphere participants only. Efficacy analyses for season one spanned August 2021–October 2022, while efficacy analyses for season two spanned July 2022–January 2023; exact study-defined season dates were site-dependent. Mean follow-up time from vaccination to end of efficacy follow-up across both seasons, including a gap in RSV surveillance between the first and second RSV seasons, was approximately 12 months per participant. Efficacy of 1 dose of the Pfizer vaccine in preventing symptomatic, laboratory-confirmed RSV-associated LRTD ††† was 88.9% (95% CI = 53.6%–98.7%) during the first RSV season and 78.6% (95% CI = 23.2%–96.1%) during the partial second season (Table 3). §§§ Efficacy of a single dose over two seasons was 84.4% (95% CI = 59.6%–95.2%) in preventing RSV-associated LRTD and 81.0% (95% CI = 43.5%–95.2%) in preventing medically attended RSV-associated LRTD. ¶¶¶ The study was not powered to estimate efficacy against hospitalization (intervention group = one event; control group = three events), severe RSV illness requiring respiratory support (intervention group = one event; control group = one event),**** or death (no events). †††† TABLE 3 Efficacy of 1 dose of Pfizer respiratory syncytial virus RSVpreF vaccine against respiratory syncytial virus–associated disease among adults aged ≥60 years — multiple countries, 2021–2023 Efficacy evaluation period Vaccine efficacy against outcome, % (95% CI)* RSV-associated LRTD† RSV-associated medically attended LRTD§ Season 1¶ 88.9 (53.6–98.7) 84.6 (32.0–98.3) Season 2 (interim)** 78.6 (23.2–96.1) —†† Combined seasons 1 and 2 (interim)§§ 84.4 (59.6–95.2) 81.0 (43.5–95.2) Abbreviations: LRTD = lower respiratory tract disease; LRTI = lower respiratory tract illness; RSV = respiratory syncytial virus. * Manufacturer-calculated efficacy. Includes events >14 days after injection and person-time available from the manufacturer’s pivotal phase 3 trial. Estimates are unadjusted. † The RSVpreF trial had two co-primary endpoints, defined as RSV LRTI with two or more lower respiratory signs or symptoms lasting >1 day, and RSV LRTI with three or more lower respiratory signs or symptoms lasting >1 day. Lower respiratory signs and symptoms included new or worsened cough, sputum production, wheezing, shortness of breath, and tachypnea. For RSVpreF estimates in this report, LRTD refers to the RSVpreF trial endpoint of RSV LRTI with three or more lower respiratory signs or symptoms. § Medically attended RSV-associated LRTD was defined as LRTD prompting any health care visit (any outpatient or inpatient visit such as hospitalization, emergency department visit, urgent care visit, home health care services, primary care physician office visit, pulmonologist office visit, specialist office visit, other visit, or telehealth contact). Estimates were not included in per-protocol assessments. ¶ Season 1 vaccine efficacy estimates reflect efficacy against first events occurring during the first complete RSV season for Northern and Southern Hemisphere participants (August 2021–October 2022; exact study-defined season dates were site-dependent). ** Season 2 (interim) vaccine efficacy estimates reflect efficacy against first events occurring during the second complete RSV season for Northern Hemisphere participants only (July 2022–January 2023; Southern Hemisphere data not yet available). †† Interim analysis underpowered to estimate efficacy. §§ Combined season 1 and 2 (interim) vaccine efficacy estimates reflect efficacy against first events occurring any time during season 1 or season 2. The mean time from start to end of efficacy surveillance was approximately 12 months per participant. Evidence regarding safety of the Pfizer vaccine consisted of data from two randomized, double-blind, placebo-controlled clinical trials, including the same ongoing phase 3 trial ( 24 ), and a phase 1/2 trial with 91 participants aged ≥65 years who received either the vaccine formulation used in phase 3 or placebo ( 25 ). Across both clinical trials, severe reactogenicity events (grade 3 or higher local or systemic reactions recorded during days 0–7 after vaccination) occurred in 1.0% of the intervention group participants, compared with 0.7% of the control group participants (pooled RR = 1.43; 95% CI = 0.85–2.39) (Table 4). The frequency of SAEs across both trials was similar in the intervention (4.3%) and control (4.1%) groups (pooled RR = 1.04; 95% CI = 0.94–1.15). A higher number of participants in the intervention group than in the control group reported atrial fibrillation as an unsolicited event within the 30 days after injection (intervention = 10 events [ 3.9” (>100 mm) from e-diary or severe grade from adverse event case report form. For fever, grade 3 corresponded to a temperature >102°F (>38.9°C) from e-diary or severe grade from adverse event case report form. For all other reactions, grade 3 corresponded to reactions that prevented normal, everyday activities. Grade 4 event corresponded only to a fever >104°F (>40°C). §§ Defined by the Advisory Committee on Immunization Practices Work Group as GBS (including GBS variants), chronic inflammatory demyelinating polyneuropathy, or acute central nervous system inflammation (e.g., transverse myelitis or acute disseminated encephalomyelitis) occurring ≤42 days after vaccination. ¶¶ Across all RSVpreF clinical trials, including trials other than the phase 3 and phase 1/2 trials summarized in this table, inflammatory neurologic events were reported in three of 20,255 adults ≤42 days after vaccination with RSVpreF (all in the phase 3 trial). The events included GBS, Miller Fisher syndrome (a GBS variant), and undifferentiated motor-sensory axonal polyneuropathy. Relative risk could not be calculated because no events were observed in the placebo-controlled comparator group. Across all Pfizer vaccine clinical trials among older adults, inflammatory neurologic events were reported in three of 20,255 participants within 42 days after receipt of the vaccine ( 15 , 26 , 27 ). The events included GBS in a participant aged 66 years from the United States with symptom onset 14 days postvaccination; Miller Fisher syndrome (a GBS variant) in a participant aged 66 years from Japan with symptom onset 10 days postvaccination; and undifferentiated motor-sensory axonal polyneuropathy with worsening of preexisting symptoms 21 days postvaccination in a participant aged 68 years from Argentina ( 15 , 26 , 27 ). Rationale for Recommendations Vaccination with a single dose of the GSK or Pfizer RSV vaccines demonstrated moderate to high efficacy in preventing symptomatic RSV-associated LRTD over two consecutive RSV seasons among adults aged ≥60 years. Although trials were underpowered to estimate efficacy against RSV-associated hospitalization and death, prevention of LRTD, including medically attended LRTD, suggests that vaccination might prevent considerable morbidity from RSV disease among adults aged ≥60 years. Although both vaccines were generally well-tolerated with an acceptable safety profile, six cases of inflammatory neurologic events (including GBS, ADEM, and others) were reported after RSV vaccination in clinical trials. Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events is currently unknown. Until additional evidence becomes available from postmarketing surveillance clarifying the existence of any potential risk, RSV vaccination in older adults should be targeted to those who are at highest risk for severe RSV disease and therefore most likely to benefit from vaccination. The recommendation for shared clinical decision-making is intended to allow flexibility for providers and patients to consider individual risk for RSV disease, while taking into account patient preferences. Recommendations for Use of RSV Vaccines in Older Adults On June 21, 2023, ACIP recommended that adults aged ≥60 years may receive a single dose of RSV vaccine, using shared clinical decision-making. §§§§ Clinical Guidance Shared Clinical Decision-Making for Adults Aged ≥60 years. Unlike routine and risk-based vaccine recommendations, recommendations based on shared clinical decision-making do not target all persons in a particular age group or an identifiable risk group. For RSV vaccination, the decision to vaccinate a patient should be based on a discussion between the health care provider and the patient, which might be guided by the patient’s risk for disease and their characteristics, values, and preferences; the provider’s clinical discretion; and the characteristics of the vaccine. As part of this discussion, providers and patients should consider the patient’s risk for severe RSV-associated disease. Epidemiologic evidence indicates that persons aged ≥60 years who are at highest risk for severe RSV disease and who might be most likely to benefit from vaccination include those with chronic medical conditions such as lung diseases, including chronic obstructive pulmonary disease and asthma; cardiovascular diseases such as congestive heart failure and coronary artery disease; moderate or severe immune compromise (either attributable to a medical condition or receipt of immunosuppressive medications or treatment) ¶¶¶¶ ; diabetes mellitus; neurologic or neuromuscular conditions; kidney disorders, liver disorders, and hematologic disorders; persons who are frail; persons of advanced age; and persons with other underlying conditions or factors that the provider determines might increase the risk for severe RSV-associated respiratory disease (Box). Adults aged ≥60 years who are residents of nursing homes and other long-term care facilities are also at risk for severe RSV disease. It should be noted that the numbers of persons enrolled in the trials who were frail, were of advanced age, and lived in long-term care facilities were limited, and persons with compromised immunity were excluded (some of whom might have an attenuated immune response to RSV vaccination). However, adults aged ≥60 years in these populations may receive vaccination using shared clinical decision-making given the potential for benefit. BOX Underlying medical conditions and other factors associated with increased risk for severe respiratory syncytial virus disease Chronic underlying medical conditions associated with increased risk • Lung disease (such as chronic obstructive pulmonary disease and asthma) • Cardiovascular diseases (such as congestive heart failure and coronary artery disease) • Moderate or severe immune compromise* • Diabetes mellitus • Neurologic or neuromuscular conditions • Kidney disorders • Liver disorders • Hematologic disorders • Other underlying conditions that a health care provider determines might increase the risk for severe respiratory disease Other factors associated with increased risk • Frailty † • Advanced age § • Residence in a nursing home or other long-term care facility • Other underlying factors that a health care provider determines might increase the risk for severe respiratory disease Abbreviation: RSV = respiratory syncytial virus. * A list of potentially immune compromising conditions is available at https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-who-are-immunocompromised.html. † Frailty is a multidimensional geriatric syndrome and reflects a state of increased vulnerability to adverse health outcomes. Although there is no consensus definition, one frequently used tool is the Fried frailty phenotype in which frailty is defined as a clinical syndrome with three or more of the following symptoms present: unintentional weight loss (10 lbs [4.5 kg] in the past year), self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity. § Among adults aged ≥60 years, RSV incidence increases with advancing age. Although age may be considered in determining an older adult patient’s risk for severe RSV-associated disease, there is no specific age threshold at which RSV vaccination is more strongly recommended within the age group of adults aged ≥60 years. RSV Vaccination Timing RSV vaccination is currently approved and recommended for administration as a single dose; sufficient evidence does not exist at this time to determine the need for revaccination. Optimally, vaccination should occur before the onset of the RSV season; however, typical RSV seasonality was disrupted by the COVID-19 pandemic and has not returned to prepandemic patterns. For the 2023–24 season, clinicians should offer RSV vaccination to adults aged ≥60 years using shared clinical decision-making as early as vaccine supply becomes available and should continue to offer vaccination to eligible adults who remain unvaccinated. Vaccine Administration, Including Coadministration with Other Vaccines Coadministration of RSV vaccines with other adult vaccines during the same visit is acceptable.***** Available data on immunogenicity of coadministration of RSV vaccines and other vaccines are currently limited. Coadministration of RSV and seasonal influenza vaccines met noninferiority criteria for immunogenicity with the exception of the FluA/Darwin H3N2 strain when the GSK RSV vaccine was coadministered with adjuvanted quadrivalent inactivated influenza vaccine ( 28 , 29 ). RSV and influenza antibody titers were somewhat lower with coadministration; however, the clinical significance of this is unknown. Administering RSV vaccine with one or more other vaccines at the same visit might increase local or systemic reactogenicity. Data are only available for coadministration of RSV and influenza vaccines, and evidence is mixed regarding increased reactogenicity. Data are lacking on the safety of coadministration with other vaccines that might be recommended for persons in this age group, such as COVID-19 vaccines; pneumococcal vaccines; adult tetanus, diphtheria, and pertussis vaccines; and the recombinant zoster vaccine (the recombinant zoster vaccine and GSK’s RSV vaccine contains the same adjuvant). When deciding whether to coadminister other vaccines with an RSV vaccine, providers should consider whether the patient is up to date with currently recommended vaccines, the feasibility of the patient returning for additional vaccine doses, risk for acquiring vaccine-preventable disease, vaccine reactogenicity profiles, and patient preferences. Postlicensure efficacy and safety monitoring of coadministered RSV vaccines with other vaccines will further direct guidance. Precautions and Contraindications As with all vaccines, RSV vaccination should be delayed for persons experiencing moderate or severe acute illness with or without fever (precaution). RSV vaccines are contraindicated for and should not be administered to persons with a history of severe allergic reaction, such as anaphylaxis, to any component of the vaccine ( 30 , 31 ). Reporting of Vaccine Adverse Events Adverse events after vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS). Reporting is encouraged for any clinically significant adverse event even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at https://vaers.hhs.gov/index.html or by telephone at 1-800-822-7967. Future Research and Monitoring Priorities CDC will monitor adverse events, including cases of GBS, ADEM, and other inflammatory neurologic events after RSV vaccination through VAERS and the Vaccine Safety Datalink https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html). CDC will also prioritize estimating vaccine effectiveness against RSV-associated hospitalization. These data will be evaluated by CDC and ACIP as soon as they are available. According to FDA postmarketing requirements and commitments, GSK will conduct a study evaluating risk for GBS, ADEM, and atrial fibrillation after vaccination with RSVPreF3 ( 18 ). Pfizer will conduct two studies, one evaluating risk for GBS and a second evaluating risk for atrial fibrillation after vaccination with RSVpreF ( 19 ). Pfizer will also evaluate the safety and immunogenicity of a second RSVpreF dose in a subset of participants in the main phase 3 trial; GSK will evaluate safety, immunogenicity, and efficacy of RSVPreF3 revaccination as part of its main phase 3 trial.
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              The burden of respiratory infections among older adults in long-term care: a systematic review

              Background Respiratory infections among older adults in long-term care facilities (LTCFs) are a major global concern, yet a rigorous systematic synthesis of the literature on the burden of respiratory infections in the LTCF setting is lacking. To address the critical need for evidence regarding the global burden of respiratory infections in LTCFs, we assessed the burden of respiratory infections in LTCFs through a systematic review of the published literature. Methods We identified articles published between April 1964 and March 2019 through searches of PubMed (MEDLINE), EMBASE, and the Cochrane Library. Experimental and observational studies published in English that included adults aged ≥60 residing in LTCFs who were unvaccinated (to identify the natural infection burden), and that reported measures of occurrence for influenza, respiratory syncytial virus (RSV), or pneumonia were included. Disagreements about article inclusion were discussed and articles were included based on consensus. Data on study design, population, and findings were extracted from each article. Findings were synthesized qualitatively. Results A total of 1451 articles were screened for eligibility, 345 were selected for full-text review, and 26 were included. Study population mean ages ranged from 70.8 to 90.1 years. Three (12%) studies reported influenza estimates, 7 (27%) RSV, and 16 (62%) pneumonia. Eighteen (69%) studies reported incidence estimates, 7 (27%) prevalence estimates, and 1 (4%) both. Seven (27%) studies reported outbreaks. Respiratory infection incidence estimates ranged from 1.1 to 85.2% and prevalence estimates ranging from 1.4 to 55.8%. Influenza incidences ranged from 5.9 to 85.2%. RSV incidence proportions ranged from 1.1 to 13.5%. Pneumonia prevalence proportions ranged from 1.4 to 55.8% while incidence proportions ranged from 4.8 to 41.2%. Conclusions The reported incidence and prevalence estimates of respiratory infections among older LTCF residents varied widely between published studies. The wide range of estimates offers little useful guidance for decision-making to decrease respiratory infection burden. Large, well-designed epidemiologic studies are therefore still necessary to credibly quantify the burden of respiratory infections among older adults in LTCFs, which will ultimately help inform future surveillance and intervention efforts. Electronic supplementary material The online version of this article (10.1186/s12877-019-1236-6) contains supplementary material, which is available to authorized users.
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                Author and article information

                Contributors
                Journal
                MMWR Morb Mortal Wkly Rep
                MMWR Morb Mortal Wkly Rep
                WR
                Morbidity and Mortality Weekly Report
                Centers for Disease Control and Prevention
                0149-2195
                1545-861X
                06 October 2023
                06 October 2023
                : 72
                : 40
                : 1075-1082
                Affiliations
                Coronavirus and Other Respiratory Viruses Division, National Center for Immunization and Respiratory Diseases, CDC; Eagle Health Analytics, LLC., Atlanta, Georgia; California Emerging Infections Program, Oakland, California; Career Epidemiology Field Officer Program, CDC; Colorado Department of Public Health & Environment; Connecticut Emerging Infections Program, Yale School of Public Health, New Haven, Connecticut; Emory University School of Medicine, Atlanta, Georgia; Georgia Emerging Infections Program, Georgia Department of Public Health; Atlanta Veterans Affairs Medical Center, Decatur, Georgia; Maryland Department of Health; Michigan Department of Health & Human Services; Minnesota Department of Health; New Mexico Department of Health; New York State Department of Health; University of Rochester School of Medicine and Dentistry, Rochester, New York; Public Health Division, Oregon Health Authority; Vanderbilt University Medical Center, Nashville, Tennessee; Salt Lake County Health Department, Salt Lake City, Utah.
                California Emerging Infections Program
                Colorado Department of Public Health & Environment
                Connecticut Emerging Infections Program, Yale School of Public Health
                Emory University School of Medicine, Georgia Emerging Infections Program, Georgia Department of Public Health, Atlanta Veterans Affairs Medical Center
                Maryland Department of Health
                Michigan Department of Health & Human Services
                Minnesota Department of Health
                University of New Mexico Emerging Infections Program
                New York State Department of Health
                University of Rochester School of Medicine and Dentistry
                Public Health Division, Oregon Health Authority
                Vanderbilt University Medical Center
                Salt Lake County Health Department.
                Author notes
                Corresponding author: Fiona P. Havers, wja7@ 123456cdc.gov .
                Article
                mm7240a1
                10.15585/mmwr.mm7240a1
                10564327
                37796742
                c627b9dd-57a6-4e4e-ad74-50a7d497546a

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