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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Abstract
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.
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.
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.
In the United States, respiratory syncytial virus (RSV) infections cause an estimated 58,000–80,000 hospitalizations among children aged 90% of tests reported ( 9 ). Surveillance years were defined based on troughs in RSV circulation. During 2017–2020 (the prepandemic period), surveillance years began in early July (epidemiologic week 27) and ended the following year in late June (week 26). Because the typical winter RSV epidemic was absent during 2020–21, and the 2021–22 epidemic began in the spring, the 2021–22 and 2022–23 surveillance years (pandemic period) were defined as early March (week 9) to late February (week 8) of the following year. § Several methods for characterizing RSV seasonality were explored (Supplementary Table 1, https://stacks.cdc.gov/view/cdc/126381) (Supplementary Table 2, https://stacks.cdc.gov/view/cdc/126380). A 3% test positivity threshold was chosen because it prospectively identified a high proportion of annual RSV detections during epidemic periods of moderate duration. The epidemic onset and offset (or end) weeks were defined, respectively, as the first and last of 2 consecutive weeks when the percentage of PCR tests positive for RSV was ≥3%. The epidemic duration was the inclusive number of weeks between onset and offset. The peak was defined as the week with the highest percentage of PCR tests positive for RSV. Epidemic onset, offset, peak, and duration were identified for each season at the national level and by U.S. Department of Health and Human Services (HHS) region. ¶ Because patterns of weekly RSV circulation in Alaska, Florida, and Hawaii are different from those in other states within their assigned regions (HHS Regions 10, 4, and 9, respectively), these states were excluded from regional analyses. State-level seasonality for Florida is reported; however, an insufficient number of laboratories in Alaska and Hawaii consistently reported PCR data to present state-level seasonality in those states. The analysis included data from laboratories that consistently conducted PCR testing.** This activity was conducted consistent with applicable federal law and CDC policy. †† During the period with weeks ending July 8, 2017–February 25, 2023, five distinct RSV epidemics occurred: three before the COVID-19 pandemic (2017–18, 2018–19, and 2019–20) and two during the pandemic (2021–22 and 2022–23). Using the 3% epidemic threshold, no seasonal RSV epidemic was observed to occur during the 2020–21 surveillance year (Figure 1). The number of tests performed increased substantially during the pandemic (Table). FIGURE 1 Percentage* of polymerase chain reaction test results positive for respiratory syncytial virus, by epidemiologic week — National Respiratory and Enteric Virus Surveillance System, United States, July 2017–February 2023 Abbreviations: PCR = polymerase chain reaction; RSV = respiratory syncytial virus. * Three-week centered moving averages of percentage of RSV-positive PCR test results nationally. The threshold for a seasonal epidemic was set at 3% RSV-positive PCR test results (not based on a moving average). The figure is a line chart showing percentage of polymerase chain reaction test results positive for respiratory syncytial virus in the United States during July 2017–February 2023. TABLE Summary of respiratory syncytial virus seasons, by U.S. Department of Health and Human Services Region* and in Florida — National Respiratory and Enteric Virus Surveillance System, July 2017–February 2023 † HHS region (headquarters) or state, RSV season No. of laboratories reporting No. of tests performed Onset epidemiologic week§ (mo) Peak epidemiologic week¶ (mo) Offset epidemiologic week** (mo) Epidemic duration, no. of wks†† % of annual detections in epidemic period§§ National 2017–18 130 810,977 42 (Oct) 51 (Dec) 16 (Apr) 27 96 2018–19 138 816,512 41 (Oct) 51 (Dec) 16 (Apr) 28 95 2019–20 166 999,493 42 (Oct) 51 (Dec) 12 (Mar) 23 95 2021–22 196 1,849,047 21 (May) 30 (Jul) 1 (Jan) 33 92 2022–23 221 3,160,659 24 (Jun) 44 (Nov) 3 (Jan) 32 92 Region 1 (Boston) 2017–18 9 38,902 44 (Nov) 52 (Dec) 17 (Apr) 26 97 2018–19 10 39,951 45 (Nov) 52 (Dec) 15 (Apr) 23 94 2019–20 12 53,441 44 (Nov) 52 (Dec) 12 (Mar) 21 96 2021–22 11 70,122 25 (Jun) 36 (Sep) 51 (Dec) 27 90 2022–23 10 184,128 35 (Sep) 44 (Nov) 50 (Dec) 16 81 Region 2 (New York City) 2017–18 8 52,010 43 (Oct) 1 (Jan) 13 (Mar) 23 93 2018–19 9 62,066 44 (Nov) 51 (Dec) 13 (Mar) 22 89 2019–20 13 100,384 43 (Oct) 49 (Dec) 10 (Mar) 20 90 2021–22 9 186,986 30 (Jul) 39 (Oct) 50 (Dec) 21 78 2022–23 11 286,733 38 (Sep) 45 (Nov) 51 (Dec) 14 74 Region 3 (Philadelphia) 2017–18 11 55,660 42 (Oct) 52 (Dec) 14 (Apr) 25 94 2018–19 9 46,260 43 (Oct) 49 (Dec) 13 (Mar) 23 93 2019–20 13 63,745 43 (Oct) 1 (Jan) 9 (Feb) 19 90 2021–22 16 85,062 24 (Jun) 34 (Aug) 52 (Jan) 29 92 2022–23 13 142,867 23 (Jun) 42 (Oct) 3 (Jan) 33 95 Region 4 (Atlanta) 2017–18 9 55,316 40 (Oct) 51 (Dec) 14 (Apr) 27 92 2018–19 9 59,747 38 (Sep) 52 (Dec) 13 (Mar) 28 92 2019–20 11 60,429 38 (Sep) 48 (Nov) 9 (Feb) 24 92 2021–22 11 130,818 14 (Apr) 30 (Jul) 47 (Nov) 34 86 2022–23 13 267,547 21 (May) 40 (Oct) 50 (Dec) 30 89 Region 5 (Chicago) 2017–18 33 201,222 44 (Nov) 50 (Dec) 17 (Apr) 26 95 2018–19 35 185,950 41 (Oct) 1 (Jan) 12 (Mar) 24 92 2019–20 51 273,402 42 (Oct) 51 (Dec) 11 (Mar) 22 93 2021–22 68 462,017 24 (Jun) 33 (Aug) 49 (Dec) 26 86 2022–23 81 725,015 32 (Aug) 44 (Nov) 2 (Jan) 23 90 Region 6 (Dallas) 2017–18 16 128,254 40 (Oct) 48 (Dec) 17 (Apr) 30 97 2018–19 16 123,577 40 (Oct) 47 (Nov) 13 (Mar) 26 94 2019–20 17 131,460 40 (Oct) 48 (Nov) 11 (Mar) 24 95 2021–22 22 300,954 20 (May) 28 (Jul) 1 (Jan) 34 96 2022–23 21 355,621 17 (Apr) 41 (Oct) 3 (Jan) 39 95 Region 7 (Kansas City) 2017–18 8 24,443 46 (Nov) 7 (Feb) 20 (May) 27 97 2018–19 9 32,138 46 (Nov) 52 (Dec) 18 (May) 25 97 2019–20 9 36,150 43 (Oct) 51 (Dec) 13 (Mar) 23 97 2021–22 14 120,813 21 (May) 33 (Aug) 51 (Dec) 31 91 2022–23 29 247,426 36 (Sep) 44 (Nov) 2 (Jan) 19 88 Region 8 (Denver) 2017–18 9 55,535 48 (Dec) 7 (Feb) 17 (Apr) 22 96 2018–19 9 57,877 48 (Dec) 5 (Feb) 18 (May) 23 97 2019–20 11 64,399 46 (Nov) 4 (Jan) 14 (Apr) 21 97 2021–22 10 119,298 26 (Jul) 39 (Oct) 1 (Jan) 28 92 2022–23 9 115,584 39 (Oct) 45 (Nov) 5 (Feb) 19 90 Region 9 (San Francisco) 2017–18 11 121,569 47 (Nov) 6 (Feb) 16 (Apr) 22 97 2018–19 8 108,118 48 (Dec) 6 (Feb) 17 (Apr) 22 97 2019–20 8 108,085 47 (Nov) 1 (Jan) 13 (Mar) 19 96 2021–22 9 163,200 29 (Jul) 49 (Dec) 6 (Feb) 30 98 2022–23 9 473,657 37 (Sep) 45 (Nov) 4 (Jan) 20 91 Region 10 (Seattle) 2017–18 8 56,212 47 (Nov) 4 (Jan) 15 (Apr) 21 96 2018–19 15 74,851 47 (Nov) 6 (Feb) 17 (Apr) 23 95 2019–20 13 74,837 46 (Nov) 52 (Dec) 12 (Mar) 19 95 2021–22 18 154,248 34 (Aug) 50 (Dec) 5 (Feb) 24 94 2022–23 20 228,081 39 (Oct) 45 (Nov) 5 (Feb) 19 90 Florida 2017–18 6 20,224 32 (Aug) 46 (Nov) 9 (Mar) 30 87 2018–19 7 24,390 29 (Jul) 45 (Nov) 13 (Mar) 37 91 2019–20 5 28,626 33 (Aug) 48 (Nov) 7 (Feb) 27 88 2021–22 5 43,340 12 (Mar) 23 (Jun) 49 (Dec) 38 90 2022–23 2 68,801 18 (May) 40 (Oct) 3 (Jan) 38 90 Abbreviations: HHS = U.S. Department of Health and Human Services; PCR = polymerase chain reaction; RSV = respiratory syncytial virus. * https://www.hhs.gov/about/agencies/iea/regional-offices/index.html. Patterns of weekly RSV circulation in Alaska, Florida, and Hawaii are distinct from other states within their assigned regions (HHS regions 10, 4, and 9, respectively); therefore, these states were excluded from regional analyses. State-level seasonality for Florida is reported; however, there are an insufficient number of laboratories consistently reporting RSV PCR data to present state-level seasonality in Alaska and Hawaii. † Because the typical seasonal RSV epidemic was notably absent during the 2020–21 surveillance year, data from this surveillance year are not shown. Surveillance years were defined based on troughs in RSV circulation. During 2017–2020, surveillance years began in epidemiologic week 27 (early July) and ended the following year in epidemiologic week 26 (late June). During the COVID-19 pandemic (2021–22 and 2022–23), surveillance years began in epidemiologic week 9 (early March) and ended the following year in epidemiologic week 8 (late February). § The epidemic onset was defined as the first of 2 consecutive weeks when the percentage of PCR tests positive for RSV was ≥3%. ¶ The epidemic peak was defined as the week with the highest percentage of PCR tests positive for RSV. ** The epidemic offset was defined as the last of 2 consecutive weeks when the percentage of PCR tests positive for RSV was ≥3%. †† The epidemic duration was the inclusive number of weeks between onset and offset. §§ Annual percentage of detections in the epidemic period was defined as the proportion of all detections during a surveillance year that occurred during the epidemic period. Nationally, RSV epidemics during the 3 surveillance years preceding the COVID-19 pandemic (2017–2020) began in October, peaked in December, and lasted a median of 27 weeks before the offset during March–April (Table). In contrast, the 2021–22 epidemic began 21 weeks earlier (May), peaked in July, and lasted 33 weeks until January 2022, although the peak percentage of RSV-positive PCR results (15%) was comparable with that during prepandemic seasons (Figure 1). During the 2022–23 surveillance year, onset occurred in June, the proportion of positive PCR results peaked in November, and the peak was higher (19%) than that during prepandemic seasons (range = 13%–16%). The epidemic lasted 32 weeks until the offset occurred in January. In both the prepandemic and pandemic periods, RSV epidemics began earliest in Florida and the Southeast and later in regions further north and west (Figure 2). During the Florida prepandemic seasons, the median onset occurred in August, the peak occurred in November, and the epidemic continued until March (median duration = 30 weeks) (Table) (Supplementary Figure, https://stacks.cdc.gov/view/cdc/126382). In the 10 HHS regions (excluding Alaska, Florida, and Hawaii), the median onset ranged from September in Region 4 to December in Region 8. The median epidemic peaks ranged from November in Region 6 to February in Regions 8 and 9. Median offsets ranged from March in Region 5 to May in Region 7; offsets occurred 2–6 weeks earlier during the 2019–20 surveillance year (i.e., when the COVID-19 pandemic began) compared with the preceding 2 surveillance years. The shortest epidemic periods occurred in Region 10 (median = 21 weeks), and the longest occurred in Region 4 (median = 27 weeks). FIGURE 2 Respiratory syncytial virus epidemic onsets* in U.S. Department of Health and Human Services Regions 1–10† and in Florida — National Respiratory and Enteric Virus Surveillance System, United States, July 2017–February 2023§ Abbreviations: FL = Florida; RSV = respiratory syncytial virus. * The epidemic onset was defined as the first of 2 consecutive weeks of a surveillance year when the percentage of PCR tests positive for RSV was ≥3%. Median epidemic onset weeks were calculated for the three RSV epidemics that occurred before the COVID-19 pandemic (2017–18, 2018–19, and 2019–20). † https://www.hhs.gov/about/agencies/iea/regional-offices/index.html. Patterns of weekly RSV circulation in Alaska, Florida, and Hawaii are distinct from other states within their assigned regions; therefore, these states were excluded from regional analyses. State-level seasonality for Florida is reported; however, there are an insufficient number of laboratories consistently reporting polymerase chain reaction testing data to present state-level seasonality in Alaska and Hawaii. § Surveillance years were defined based on troughs in RSV circulation. During 2017–2020, surveillance years began in epidemiologic week 27 (early July) and ended the following year in epidemiologic week 26 (late June). The aberrant 2020–21 surveillance year was defined as week 27 through week 8 (late February) inclusive. During the COVID-19 pandemic (2021–22 and 2022–23), surveillance years began in epidemiologic week 9 (early March) and ended the following year in epidemiologic week 8. The figure is a set of three maps showing respiratory syncytial virus epidemic onsets, by U.S. Department of Health and Human Services Regions 1–10 and in Florida, in the United States, during July 2017–February 2023 according to the National Respiratory and Enteric Virus Surveillance System. During the 2021–22 (pandemic) surveillance year, epidemic onsets across the 10 HHS regions and Florida occurred a median of 20 weeks earlier (range = 13–25 weeks) than the median onsets during the prepandemic period (range = March [Florida] to August [Region 10]). Epidemic peaks also occurred earlier than they did during the prepandemic years, ranging from July in Region 6 to December in Region 10. Offsets ranged from November (Region 4) to February (Region 9), which is when prepandemic peaks typically occurred. During the 2021–22 surveillance year, the epidemic durations were a median of 6 weeks longer than the median durations of prepandemic RSV epidemics (range = 21 weeks [Region 2] to 38 weeks [Florida]). During the 2022–23 season, early epidemic onsets (April–June) were observed in Florida and HHS Regions 3, 4, and 6, but the percentage of RSV-positive PCR test results levelled off before increasing again in September (Figure 1) (Table). In other regions, epidemics began between August and October. Seasons peaked from October in Region 4 to November in regions further north and west (Regions 2, 8, 9, and 10). Epidemics ended between December and February. Discussion In the United States, disruption of the seasonal circulation of RSV was observed during the COVID-19 pandemic as nonpharmaceutical interventions (e.g., school closures and masking) reduced respiratory virus transmission and led to an accumulation of susceptible persons resulting in large epidemics with atypical seasonality ( 10 ). After the implementation of nonpharmaceutical interventions in March 2020, the 2019–20 RSV epidemic ended earlier than the previous two epidemics. During 2020, RSV circulated at historically low levels. In 2021, RSV circulation began earlier (in late spring), when nonpharmaceutical interventions eased, and continued longer than it did during prepandemic years, although the percentage of RSV-positive PCR tests at the peak was comparable to those during prepandemic years. The 2022–23 epidemic began later than the 2021–22 epidemic but earlier than prepandemic epidemics, suggesting a reversion toward prepandemic seasonality with winter peaks. The peak percentage of positive RSV test results was higher than those in previous years, suggesting higher intensity of circulation. Across both prepandemic and pandemic years, RSV circulation began in Florida and the Southeast and later in regions to the north and west. The consistency of this pattern could help predict the timing of future epidemics in specific regions. The findings in this report are subject to at least four limitations. First, reporting to NREVSS is voluntary, and analysis is limited to laboratories that consistently report, which might not represent local and state circulation. Second, differences in testing across regions and changes in testing practices and diagnostics over time, including increased panel testing during the COVID-19 pandemic, could have affected the baseline percentage of positive test results and trends, and thus the onset, offset, and duration of epidemics. Third, there is no standard method for characterizing seasonality; seasonal attributes vary depending on the method used. An earlier description of RSV seasonality in the United States used a more sensitive method (retrospective slope 10 §§ ) that can only be applied retrospectively and results in longer epidemic durations ( 6 , 9 ). However, the 3% RSV-positive PCR threshold used in the current analysis can be applied in near real time and identified epidemic periods that included a high concentration of detections ( 9 ). Finally, this analysis describes regional and national trends; locally available data and region-specific thresholds might better reflect circulation patterns within specific jurisdictions. Although the peak in RSV circulation during November 2022 suggests that seasonal patterns are returning to those observed in prepandemic years, it is uncertain whether this reversion will continue in the upcoming surveillance year. To monitor RSV circulation, CDC has conducted year-round surveillance using a variety of approaches including active, population-based surveillance for RSV-associated hospitalizations and outpatient visits. ¶¶ Clinicians should be aware that atypical RSV epidemics might continue and consider testing patients for multiple respiratory pathogens when indicated. With new prevention products nearing licensure, including vaccines for older adults, maternal vaccines, and long-acting RSV immunoprophylaxis for infants and children, policy makers should consider RSV seasonality when making recommendations about the timing of studies and administration of new immunization and other RSV prevention products. Summary What is already known about this topic? In the United States, the timing of seasonal respiratory syncytial virus (RSV) epidemics (October–April) was disrupted during the COVID-19 pandemic. What is added by this report? RSV circulation was historically low during 2020–21 and began earlier and continued longer during 2021–22 than during prepandemic seasons. The 2022–23 season started later than the 2021–22 season but earlier than prepandemic seasons, suggesting a return toward prepandemic seasonality. What are the implications for public health practice? Ongoing monitoring of RSV seasonality can guide the timing of immunoprophylaxis and evaluation of new immunization products. Although an eventual return to prepandemic RSV seasonality is expected, clinicians should be aware that off-season RSV circulation might continue.
Journal ID (iso-abbrev): MMWR Morb Mortal Wkly Rep
Journal ID (publisher-id): WR
Title:
Morbidity and Mortality Weekly Report
Publisher:
Centers for Disease Control and Prevention
ISSN
(Print):
0149-2195
ISSN
(Electronic):
1545-861X
Publication date
(Electronic):
06
October
2023
Publication date Collection: 06
October
2023
Volume: 72
Issue: 40
Pages: 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
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