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ACIP Evidence to Recommendations for Use of GSK Adjuvanted RSVPreF3 Vaccine (AREXVY) in Adults Ages 60 and Older						Print
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										**Questions:**
Should vaccination with GSK RSVPreF3 vaccine (120μg antigen + AS01E adjuvant, 1 dose IM), rather than no vaccine, be recommended in persons aged ≥65 years?
Should vaccination with GSK RSVPreF3 vaccine (120μg antigen + AS01E adjuvant, 1 dose IM), rather than no vaccine, be recommended in persons aged 60–64 years?
**Population:**Persons aged ≥60 years
**Intervention:**GSK RSVPreF3 vaccine (120 μg antigen + AS01Eadjuvant, 1 dose IM)
**Comparison:**No RSV vaccine
**Outcomes:**
Respiratory Syncytial Virus (RSV) lower respiratory tract illness/disease (LRTI/LRTD)
Medically attended RSV LRTI/LRTD
Hospitalized for RSV respiratory illness
Severe RSV respiratory illness requiring supplemental O2or other respiratory support
Death due to RSV respiratory illness
Serious Adverse Events (SAEs)
Inflammatory neurologic events (e.g., Guillain-Barré syndrome)
Reactogenicity (grade ≥3)**Background:**
Respiratory Syncytial Virus (RSV) is a common respiratory virus that usually causes mild, cold-like symptoms, but can lead to severe outcomes, including hospitalization and death, especially for infants and older adults. RSV circulation is typically seasonal, starting during the fall and peaking in the winter. While RSV is well-recognized by pediatricians, there is lower awareness of RSV in adults, among both healthcare providers and the public. Among adults ≥65 years of age in the United States, RSV is estimated to cause approximately 6,000–10,000 deaths1-3, 60,000–160,000 hospitalizations4-8, and 0.9–1.4 million medical encounters5 per year.
On May 3, 2023, the Food and Drug Administration (FDA) approved GSK RSVPreF3 vaccine (AREXVY) for prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged ≥60 years.9 RSVPreF3 is a 1-dose (0.5 mL) subunit vaccine containing stabilized RSV prefusion F protein in combination with adjuvant (AS01E).9
The Advisory Committee on Immunization Practices (ACIP) Respiratory Syncytial Virus Vaccines Adult Work Group  reviewed the following data in the Evidence to Recommendations (EtR) framework. The work group’s judgements for each domain are presented here for adults aged ≥65 years, and separately, for adults aged 60–64 years.Public Health Problem
Problem
Criteria
Work Group Judgements
Evidence
Additional InformationIs the problem of public health importance?
Adults aged ≥65 years: Yes
Adults aged 60–64 years: Yes
While RSV is well-recognized by pediatricians, there is lower awareness of RSV in adults, among healthcare providers and the public. Even though it is often not recognized as a cause of illness in adults, the burden of disease in older adults is significant. Among adults ≥65 years of age in the United States, RSV is estimated to cause approximately 6,000–10,000 deaths1-3, 60,000–160,000 hospitalizations4-8and 0.9–1.4 million medical encounters per year.5Considering seasonal incidence of RSV-associated hospitalization among adults, stratified by age, incidence is substantially higher among adults aged 70-79 years and 80 years and older, compared with younger age groups. Focusing on the potential age thresholds of interest, adults aged 60-64 years and 65-69 years both experience intermediate incidence of hospitalization, compared with that in adults 70 and older and younger adults.8Over the surveillance years 2016–2020, CDC estimates that hospitalization incidence among adults 65 and older was approximately 2-fold to 3-fold higher than among adults 60–64.8
Among all adults hospitalized with RSV, a large proportion are severely ill, as measured by the proportion admitted to the ICU and the proportion who died. RSV-NET data from three seasons (i.e., 2017–2018 to 2019–2020) show that mortality was highest in those aged 65 years and older at 5%.8 However, the proportion admitted to the ICU exceeded 20%, even in younger patients aged 18–49 years and those aged 50–64 years.8 RSV-NET data reflect only patients hospitalized with lab-confirmed RSV, and more severely ill patients are more likely to be tested for RSV, so these data may overestimate the proportion with severe illness. Regardless, RSV can cause severe disease in hospitalized adults of all ages.8
Several chronic medical conditions have been associated with severe RSV disease. Adults with chronic pulmonary diseases including chronic obstructive pulmonary disease (COPD) and asthma, congestive heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease have been shown to be at increased risk of RSV-associated hospitalization.7,9-11
In addition, RSV can cause severe disease in immunocompromised persons. Recipients of hematopoietic stem cell transplantation and lung transplantation are at particularly high risk of progression to LRTD and death.12,13 Increased risk of severe illness has also been shown in patients receiving chemotherapy for hematologic or solid organ malignancy and patients on long term immunosuppression for solid organ transplantation.12,14
Residents of nursing homes and long-term care facilities have also been shown to have increased risk of severe disease15 and RSV is an important cause of respiratory illness outbreaks in these settings.15,16Benefits and Harms
Benefits and Harms
Criteria
Work Group Judgements
Evidence
Additional InformationHow substantial are the desirable anticipated effects?
Adults aged ≥65 years: Moderate
Adults aged 60–64 years: Small to Moderate
The body of evidence included in GRADE regarding efficacy of GSK RSVPreF3 vaccine consisted of data from one randomized, double-blind, placebo-controlled phase 3 clinical trial conducted in 17 countries in which 24,973 immunocompetent participants aged ≥60 years were enrolled and randomized 1:1 to receive either one dose of vaccine (intervention group, 120 μg preF with AS01E) or placebo (control group).1 Considering follow-up time from two RSV seasons (2021-2022 and 2022-2023), vaccine efficacy was 74.6% (95% CI = 62.1%–83.5%) in preventing RSV LRTD and was 77.5% (95% CI = 57.9%–89.0%) in preventing medically-attended RSV LRTD.
Efficacy estimates were independently calculated by CDC using counts of events >14 days after injection and total person-time available from the GSK pivotal phase 3 trial (Efficacy=1 – incidence rate ratio x 100%). CDC method of efficacy estimation differed from manufacturer (manufacturer used a Poisson model with adjustment by covariates including season and participant age and region). When adjusted by participant age and region only, the manufacturer estimates efficacy of a single dose against RSV LRTD over two seasons to be 74.5% (97.5% CI: 60.0, 84.5) and against medically attended LRTD over two seasons to be 77.5% (95% CI: 57.9, 89.0). When also adjusted by season, the manufacturer estimates efficacy of a single dose against RSV LRTD over two seasons to be 67.2 % (97.5% CI: 48.2, 80.0) and against medically attended RSV LRTD over two seasons to be 73.1 % (95% CI: 49.4, 86.9).
The clinical trial was underpowered to estimate efficacy in the subset of adults aged ≥75 years and adults classified as frail. The clinical trial was also underpowered to estimate efficacy against hospitalization due to RSV respiratory illness, severe RSV respiratory illness requiring respiratory support, and death due to RSV respiratory illness.
The results of a modeling analysis of potential RSV-attributable illnesses prevented derived from a cost effectiveness analysis performed by the University of Michigan, showed that approximately 23,000 outpatient visits, 2,300 hospitalizations and 120 deaths in adults aged 65 years and older could be prevented in one RSV season, per 1 million vaccinations with GSK RSVPreF3 administered.2 The potential benefit is smaller for adults aged 60–64 years (approximately 18,000 outpatient visits, 890 hospitalizations, and 35 deaths prevented in one RSV season, per 1 million vaccinations with GSK RSVPreF3 administered) primarily because there is less existing RSV disease in that age group at baseline.2The limited number of events of RSV associated hospitalization, severe disease, and death observed in the trials may have been partially due to limited enrollment of those at highest risk of RSV disease. The 2021-2022 RSV season was also disrupted by the COVID-19 pandemic and had lower than average RSV burden.How substantial are the undesirable anticipated effects?
Adults aged ≥65 years: Small
Adults aged 60–64 years: Small
Evidence included in GRADE regarding safety of RSVPreF3 consisted of data from two randomized, double-blind, placebo-controlled clinical trials, including the same phase 3 clinical trial and a phase 1/2 formulation selection clinical trial.1,3 For both RCTs, safety data were considered from follow-up time after a first dose of the vaccine, but excluded follow-up time after a second dose, as only a recommendation for a single dose was being considered. The pooled relative risk of serious adverse events, a critical outcome, was 1.02 (95% CI = 0.91–1.15). The pooled relative risk for severe reactogenicity events was 4.10 (95% CI = 1.99–8.45).
The outcome of inflammatory neurologic events was unable to be evaluated because there were no events in the studies included in GRADE. However, one case of Guillain Barré syndrome (GBS) was recorded in a recipient of the investigational vaccine in an open label trial without a placebo arm.  Additionally, two cases of acute disseminated encephalomyelitis (ADEM) were observed in a coadministration trial. Both cases occurred in South Africa after concurrent vaccination with both the GSK RSVPreF3 vaccine and standard dose seasonal influenza vaccine. 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. For one of the ADEM cases, the investigator revised the diagnosis to hypoglycemia and dementia in June 2023. The events from these trials were not included in GRADE due to lack of an unvaccinated comparator group. Across all clinical trials, there was a total of three cases of inflammatory neurologic events among approximately 18,000 investigational vaccine recipients.1,2
Inflammatory neurologic events were defined as Guillain-Barre syndrome (including variants thereof), chronic inflammatory demyelinating polyneuropathy, and acute central nervous system inflammation (e.g., transverse myelitis, acute disseminated encephalomyelitis). Although understood to be different clinical entities, they were considered together due to Work Group concern for a potentially shared inflammatory pathophysiology.Do the desirable effects outweigh the undesirable effects?
Adults aged ≥ 65 years: Favors intervention
Adults aged 60–64 years: No majority opinion. Judgement split: Favors intervention/ Favors comparison/ Unclear
The Work Group majority opinion was that the desirable effects of vaccination with RSVPreF3 outweigh the undesirable effects in adults 65 and older. However, there was a minority opinion among work group members that the balance of desirable and undesirable effects was unclear. These work group members were concerned about the unknown risk of inflammatory neurologic events, such as GBS, and that the benefits of vaccination may not consistently outweigh the potential risk.
For adults 60–64, there was no clear majority in the Work Group opinion.  The Work Group was divided between favoring vaccination, favoring no vaccination, and the balance being unclear due to the smaller potential benefit in this age group when compared to adults aged ≥65 and concern about the unknown risk of inflammatory neurologic events.
There was also concern that the trials were underpowered to demonstrate efficacy in adults at highest risk due to limited enrollment of frail persons, persons of advanced age, and persons residing in long-term care facilities.What is the overall certainty of this evidence for the critical outcomes?
Moderate
The GSK RSVPreF3 vaccine likely reduces RSV LRTD and medically attended RSV LRTD, both critical outcomes, with moderate evidence. The evidence for the important outcomes of hospitalization for RSV respiratory illness and severe RSV respiratory illness requiring oxygen/respiratory support was rated as very low. The vaccine results in little to no difference in serious adverse events (critical outcome, high certainty), when all organ classes are considered. The vaccine increases severe reactogenicity events with high certainty (important). There were insufficient data to evaluate the outcomes of death due to RSV respiratory illness and inflammatory neurologic events (both important). The overall certainty of evidence was considered moderate.1,2Below is a table with additional clinical details on each of the three inflammatory neurologic events reported within 42 days after vaccination with RSVPreF3 in clinical trials:
Inflammatory neurologic events reported within 42 days after vaccination with respiratory syncytial virus RSVPreF3 vaccine in clinical trials
Participant age
Country
Reported as
Onset
Trial
Work group case review78 years
Japan
GBSa, Brighton Collaborationb level 3
9 days post-vaccination
Open-label phase 3 trial without a placebo control, evaluating the immunogenicity of different revaccination intervals
Likely GBSa71 years
South Africa
ADEMc, fatal
*In June of 2023 site investigator updated reported diagnoses to hypoglycemia & dementia
7 days post-vaccination
Randomized, blinded co-administration study with standard dose seasonal influenza vaccine. Case occurred in the simultaneous administration arm of the study.
ADEMc cannot be ruled out, however, other diagnoses appear more likely71 years
South Africa
ADEMc
22 days post-vaccination
Randomized, blinded co-administration study with standard dose seasonal influenza vaccine. Case occurred in the simultaneous administration arm of the study.
ADEMc cannot be ruled out, however, other diagnoses appear more likely
aGBS = Guillain Barre syndromeb https://brightoncollaboration.us/guillain-barre-and-miller-fisher-syndromes-case-definition-companion-guide/c ADEM = acute disseminated encephalomyelitisValues
Values
Criteria
Work Group Judgements
Evidence
Additional InformationDoes the target population feel that the desirable effects are large relative to undesirable effects?
Adults 60 and older: Yes/Probably yes
A survey, developed by CDC in collaboration with the University of Iowa and the RAND corporation, was designed to assess vaccination intentions for a hypothetical RSV vaccine among U.S. adults aged 60 years and older. Overall, 68% of respondents said they ‘definitely’ or ‘probably’ would choose to get vaccinated if a safe and effective FDA-approved RSV vaccine was available. Additionally, 77% said they ‘definitely’ or ‘probably’ would get an RSV vaccine if it were recommended by a healthcare provider.1
The data collection period was December 23–31, 2022 and the final sample consisted of 586 respondents, with a completion rate of 98.7%.1The Work Group consensus was that older adults feel or probably feel that the desirable effects of RSV vaccination are large relative to the undesirable effects.Is there important uncertainty about or variability in how much people value the main outcomes?
Adults 60 and older: Important variability/Probably important variability
Among survey respondents expressing hesitancy to accept the vaccine, the primary reasons included lack of knowledge about RSV as well as long- and short-term safety concerns about the vaccine.1
The Work Group felt that there was, or probably was, important uncertainty about, or variability in, how much older adults value the main outcomes.Acceptability
Acceptability
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention acceptable to key stakehold-ers?
Adults aged ≥60 years: Yes/Probably yes
A survey of physicians, conducted February–March 2017, was administered to a national network of 930 primary care physicians who agreed to participate in surveys about vaccine policy issues. A total of 620 physicians (67%) completed the survey; and among those respondents, 317 (51%) reported caring for ≥1 adult patient with possible RSV in the preceding 12 months. A majority of physicians believed that RSV was a very important pathogen in adults of any age with an immunocompromising condition (57%) and in adults aged 65 years and older with cardiopulmonary disease (56%). By comparison, approximately one third of physicians believed that RSV was a very important pathogen in adults aged 50-64 years with cardiopulmonary disease (35%) and in adults aged 65 years and older without cardiopulmonary disease (31%).1
The Work Group felt that, generally, recommending RSV vaccines for adults aged 65 years and older, and for adults aged 60-64 years, would, or probably would, be acceptable to key stakeholders. However, the Work Group noted that a limitation of these published results was that only physicians were surveyed; and other clinicians who order or administer vaccines may have responded differently.Feasibility
Feasibility
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention feasible to implement?
Adults aged ≥60 years: Yes/Probably yes
Barriers to implementation of a novel RSV vaccine may arise from vaccine storage and handling requirements, increasing complexity of the adult vaccination schedule (including coadministration) and financial barriers.
Below are the storage and handling requirements for GSK RSVPreF3 vaccine:
Supplied as a 10-pack of single dose kits
**Reconstitution required**: single dose vial of lyophilized powder (antigen component) + single dose vial of liquid (adjuvant component)
Both components should be refrigerated (2–8°C) in original container, protected from light
After reconstitution, the product should be administered within **4 hours**, otherwise discardConsidering CDC’s current older adult routine immunization schedule, with the potential addition of a regularly scheduled COVID-19 vaccine, the immunization schedule is becoming more complex, and vaccination is not the only age- and risk-based preventive healthcare that adult clinicians must provide. If an RSV vaccine is added, clinicians will likely face competing priorities at each patient appointment. Moreover, different age cutoffs also add to the complexity. Therefore, harmonizing age recommendations with those of other older adult vaccines may improve feasibility and increase uptake. At age 65, all adults are recommended to receive pneumococcal vaccination, and there are specific influenza vaccine formulations licensed for adults aged 65 years and older.1
Coadministration concerns may be another barrier. There are limited data available on coadministration of RSV vaccines and other vaccines. If RSV vaccine needs to be administered at different visits than other adult vaccines due to safety or immunogenicity concerns, it may impact how feasible it is to add this vaccine to the adult immunization schedule.
Additionally, feasibility barriers among vaccine recipients include time and financial considerations. Older adults without health insurance coverage may experience financial hardship obtaining an RSV vaccine. Vaccines covered under Medicare Part D may require additional complexity in billing/seeking reimbursement for patients.  Financial hardship may also arise if vaccine recipients need to take time off from work to receive an RSV vaccine, or due to post-vaccination reactogenicity.
Recognizing these potential barriers, the Work Group felt that, overall, the GSK RSVpreF3 vaccine is feasible to implement among adults aged 60 years and older.Resource Use
Resource Use
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention a reasonable and efficient allocation of resources?
Adults aged ≥65 years: Probably yes
Adults aged 60–64 years: Probably no
In a CDC/University of Michigan cost-effectiveness model, vaccination was potentially cost effective. In the base case analysis in this model vaccination, an age-based recommendation for adults ≥65 years had an Incremental Cost-Effectiveness Ratio (ICER) of 167,301 $/Quality-Adjusted Life-Year (QALY). In an age-based recommendation for those 60-64 years, estimated ICER was 372,656 $/QALY.1,2 In sensitivity analyses, ICER was driven by incidence of RSV hospitalization, efficacy against hospitalization, and vaccine cost.1
The Work Group felt that RSV vaccination for older adults could be a cost-effective intervention, but there is substantial uncertainty in the net societal costs of an RSV vaccination program for older adults driven by 1) uncertainty in incidence of severe RSV illness (particularly hospitalization), 2) uncertainty in vaccine acquisition cost, and 3) uncertainty in the duration of protection from RSV vaccination.
The Work Group noted that vaccination of older age groups would be more cost effective than vaccination of younger age groups.
All evidence taken into consideration, the Work Group felt that the use of GSK RSVPreF3 would probably be a reasonable and efficient allocation of resources (if recommended for adults 65 years and older), compared with no RSV vaccine. However, the Work Group felt that the use of RSVPreF3 in all adults 60-64 would probably not be a reasonable and efficient allocation of resources.Equity
Equity
Criteria
Work Group Judgements
Evidence
Additional InformationWhat would be the impact of the intervention on health equity?
Adults aged ≥65 years: probably increased/probably no impact
Adults aged 60–64 years: Probably increased
Not all persons experience the same risk of RSV disease. Incidence rates of RSV hospitalization published last year (i.e., 2022) from 3 U.S. states, show that at every age group beginning at 45 years of age, incidence was highest among adults living in low-income zip codes, and lowest among those living in high-income zip codes.1In addition to differences by income level, RSV has differing impact by race and ethnicity. As previously discussed in the Public Health Problem domain, certain chronic medical conditions increase the risk of severe RSV illness. Adults who are non-Hispanic Black, non-Hispanic American Indian or Alaska Native, and Hispanic have higher prevalence of many chronic medical conditions, including cardiovascular disease, diabetes, and asthma compared with White, non-Hispanic adults.2,3,4,5 The same is true of adults with lower income or socioeconomic status.6,7,8
In these demographic groups, chronic medical conditions are also diagnosed at earlier ages, often before age 60, increasing the risk of severe RSV disease earlier in life.9,10 In an analysis of National Health Interview Survey data from 1999 to 2018, the adjusted prevalence of multimorbidity diverges between Black individuals and White individuals beginning at age 35–39, reaching its maximum difference of approximately 10 percentage points at age 60–64.10 Among all adults hospitalized for RSV in RSV-NET 2015-2020, non-Hispanic Black, Hispanic, and non-Hispanic American Indian or Alaska Native adults were hospitalized at younger ages compared to the mean among all adults. In fact, at least 50% of the hospitalized adults in these groups would not have qualified for RSV vaccination if there had been a recommendation for adults aged 65 years and older.11
The Work Group reviewed evidence on shared clinical decision-making as a way to address equity concerns among adults 60-64 and considered whether SCDM might decrease age-based racial and ethnic health disparities. Limited evidence from prior experience with SCDM for Hepatitis B vaccine and PCV13 suggests the impact on equity of a SCDM recommendation is unclear.12,13 The Work Group also reviewed data on how providers implement SCDM: in knowledge, attitude, and practice surveys, providers were in favor of SCDM recommendations because they give more flexibility, but also felt they create confusion and require more time.14,15
Lastly, information on health insurance and vaccine access was considered. Access to a new RSV vaccine may be determined by health insurance coverage; and lack of health insurance is more common among adults younger than 65 years of age. However, this disparity is not evenly distributed in the U.S. population. American Indian or Alaska Native, non-Hispanic persons aged 55-64 years are substantially more likely to be uninsured than their age-peers in other racial and ethnic groups.16Similar to the relationship between race, ethnicity, and health insurance coverage, insurance coverage also differs by household income. The proportion of adults without health insurance is much higher among those with a household income that is 3 times below the poverty threshold than it is among those above that threshold, especially among adults below 65 years of age. The increased likelihood of being uninsured among these populations in the 60-64 year age group means that even if the vaccine is recommended, access may be unequal.16
Overall, for adults aged 65 and older, the work group felt that a recommendation for RSV vaccination would probably increase health equity, or that it would probably have no net impact (considering that the greatest disparities occur in the 60-64 age range).
For adults 60-64 years, the Work Group considered a shared clinical decision-making recommendation and felt a recommendation for RSV vaccination would probably increase health equity by allowing access to vaccine for adults 60–64 with medical risk factors for severe RSV disease who are disproportionately from racial and ethnic groups impacted by RSV at earlier ages. However, they acknowledged that SCDM does not ensure substantially increased uptake in the target population and that health insurance may continue to be a barrier.**Work Group Interpretation Summary**
GSK’s adjuvanted RSVPreF3 vaccine demonstrated significant efficacy against lower respiratory tract disease caused by RSV among older adults over at least 2 seasons. For adults 65 years and older, the majority Work Group opinion was in favor of a universal age-based recommendation. However, there was a minority opinion not to universally recommend the vaccine at this time. Members that voted against a universal recommendation for adults 65 and older noted that the trials were underpowered to show efficacy against hospitalization and in adults at highest risk of severe RSV illness (including adults 75 and older, adults who are frail, and adults residing in long-term care facilities). Work Group members also noted uncertainty about the population-level balance of benefits and risks, considering the three inflammatory neurologic events observed in the trials. For adults 60–64, in whom overall incidence of severe RSV disease is lower, the Work Group opinion was closely divided between supporting a shared clinical decision-making recommendation that would enable access for adults in this age range with underlying conditions and other risk factors and no recommendation. Some work group members who selected no recommendation voiced support for a risk-based recommendation. Work Group members generally felt that access among adults 60-64 in some form was important to address equity issues. The Work Group stressed that for all recommendations, post-licensure surveillance for both vaccine safety and effectiveness will be critical.
Below is a table listing the pros and cons by choice of age threshold at which to recommend RSV vaccines:
The pros and cons by choice of age threshold at which to recommend RSV vaccines
Pros
ConsAge ≥65 years
Greater risk of RSV disease and therefore more favorable population-wide balance of risks and benefits of vaccination (in light of cases of inflammatory neurologic events observed)
Aligns with licensure for adjuvanted and high-dose influenza vaccines and universal pneumococcal vaccination
Lost opportunity to prevent additional disease in the 60–64 age group, who are disproportionately from racial and ethnic groups impacted by RSV at earlier agesAge ≥60 years
Potential to prevent a greater total burden of disease (e.g., number of hospitalizations)
Increases access to adults 60–64 with medical risk factors for severe RSV disease (disproportionately in racial and ethnic groups impacted by RSV at earlier ages)
Risk/benefit balance depends on the patient population that seeks and receives vaccination among those 60–64
Uninsured adults would face financial barriers obtaining vaccination (disproportionately aged 60–64 in racial, ethnic, and socioeconomic groups at greater risk)
May experience more difficulty achieving clinician adoption of the recommendation among patients 60–64
Less efficient allocation of societal resourcesBalance of consequences
**Among adults aged****≥65 years:**
The Work Group felt that the desirable consequences *probably outweigh*undesirable consequences in most settings
Is there sufficient information to move forward with a recommendation? Yes
**Among adults aged****60–64 years:**
The Work Group majority was split between the balance between desirable and undesirable consequences is *closely balanced or uncertain* and the desirable consequences *probably*outweigh undesirable consequences in most settings.
Is there sufficient information to move forward with a recommendation? Yes
**Type of recommendation, adults aged****≥65 years:**
The majority of the Work Group recommended the intervention, although there was a substantial minority opinion not to recommend the product based on currently available evidence.
**Type of recommendation, adults aged 60–64 years:**
There was no clear majority opinion. The Work Group was divided between supporting a recommendation for individual adults in this age group with shared clinical decision-making, and no recommendation in this age group.References
Background
Thompson WW, Shay DK, Weintraub E, et al. Mortality Associated with Influenza and Respiratory Syncytial Virus in the United States. JAMA. 2003;289(2):179–186. doi:10.1001/jama.289.2.179
Matias G, Taylor R, Haguinet F, et al. Estimates of Mortality Attributable to Influenza and RSV in the United States During 1997–2009 by Influenza Type or Subtype, Age, Cause of Death and Risk Status. Influenza and Other Respiratory Viruses. 2014;8(5): 507–515. doi:10.1111/irv.12258
Hansen CL, Chaves SS, Demont C, Viboud C. Mortality Associated with Influenza and Respiratory Syncytial Virus in the US, 1999–2018. JAMA Netw Open. 2022;5(2):e220527. doi:10.1001/jamanetworkopen.2022.0527
Widmer K, Zhu Y, Williams JV, et al. Rates of Hospitalizations for Respiratory Syncytial Virus, Human Metapneumovirus, and Influenza Virus in Older Adults. JID. 2012;206(1):56–62. doi:10.1093/infdis/jis309
McLaughlin JM, Khan F, Begier E, et al. Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Open Forum Infectious Diseases. 2022;9(7):1–10. doi:10.1093/ofid/ofac30
Zheng Z, Warren JL, Shapiro ED, et al. Estimated Incidence of Respiratory Hospitalizations Attributable to RSV Infections Across Age and Socioeconomic Groups. Pneumonia 2022;14(6):1–8. doi:10.1186/s41479-022-00098-
Branche AR, Saiman L, Walsh EE, et al. Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020, Clinical Infectious Diseases. 2022;74(6):1004–1011. doi:10.1093/cid/ciab595
CDC, RSV-NET data 2016–2020 (unpublished).
Food and Drug Administration. Approval letter: Arexvy. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2023. https://www.fda.gov/media/167806/downloadPublic Health Problem:
Thompson WW, Shay DK, Weintraub E, et al. Mortality Associated with Influenza and Respiratory Syncytial Virus in the United States. JAMA. 2003;289(2):179–186. doi:10.1001/jama.289.2.179
Matias G, Taylor R, Haguinet F, et al. Estimates of Mortality Attributable to Influenza and RSV in the United States During 1997–2009 by Influenza Type or Subtype, Age, Cause of Death and Risk Status. Influenza and Other Respiratory Viruses.  2014;8(5): 507–515. doi:10.1111/irv.12258
Hansen CL, Chaves SS, Demont C, Viboud C. Mortality Associated with Influenza and Respiratory Syncytial Virus in the US, 1999–2018. JAMA Netw Open. 2022;5(2):e220527. doi:10.1001/jamanetworkopen.2022.0527
Widmer K, Zhu Y, Williams JV, et al. Rates of Hospitalizations for Respiratory Syncytial Virus, Human Metapneumovirus, and Influenza Virus in Older Adults. JID. 2012;206(1):56–62. doi:10.1093/infdis/jis309
McLaughlin JM, Khan F, Begier E, et al. Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Open Forum Infectious Diseases. 2022;9(7):1–10. doi:10.1093/ofid/ofac300
Zheng Z, Warren JL, Shapiro ED, et al. Estimated Incidence of Respiratory Hospitalizations Attributable to RSV Infections Across Age and Socioeconomic Groups. Pneumonia 2022;14(6):1–8. doi:10.1186/s41479-022-00098-x
Branche AR, Saiman L, Walsh EE, et al. Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020, Clinical Infectious Diseases. 2022;74(6):1004–1011. doi:10.1093/cid/ciab595
Melgar M, Britton A. Evidence to Recommendations Framework Respiratory Syncytial Virus (RSV) in Adults. Presentation to ACIP, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/06-RSV-Adults-Melgar-508.pdf.
Wyffels V, Kariburyo F, Gavart S, Fleischhackl R, Yuce H. A Real-World Analysis of Patient Characteristics and Predictors of Hospitalization Among US Medicare Beneficiaries with Respiratory Syncytial Virus Infection. Adv Ther. 2020 Mar;37(3):1203-17.
Prasad N, Walker TA, Waite B, et al. Respiratory Syncytial Virus–Associated Hospitalizations Among Adults With Chronic Medical Conditions. Clinical Infectious Diseases. 2021;73(1): e158–e163. doi:10.1093/cid/ciaa730
Kujawski SA, Whitaker M, Ritchey MD, et al. Rates of respiratory syncytial virus (RSV)-associated hospitalization among adults with congestive heart failure—United States, 2015–2017. PLOS ONE. 2022;17(3): e0264890. doi:10.1371/journal.pone.0264890
Nam HH, Ison MG. Respiratory syncytial virus infection in adults. BMJ. 2019 Sep 10;366:l5021.
Waghmare A, Campbell AP, Xie H, Seo S, Kuypers J, Leisenring W, et al. Respiratory syncytial virus lower respiratory disease in hematopoietic cell transplant recipients: viral RNA detection in blood, antiviral treatment, and clinical outcomes. Clin Infect Dis. 2013 Dec;57(12):1731-41
Loubet P, Lenzi N, Valette M, Foulongne V, Krivine A, Houhou N, et al. Clinical characteristics and outcome of respiratory syncytial virus infection among adults hospitalized with influenza-like illness in France. Clin Microbiol Infect. 2017 Apr;23(4):253-9
Childs, A., Zullo, A.R., Joyce, N.R. *et al.* The burden of respiratory infections among older adults in long-term care: a systematic review. *BMC Geriatr* **19**, 210 (2019). https://doi.org/10.1186/s12877-019-1236-6
Goldman CR, Sieling WD, Alba LR, et al.  Severe clinical outcomes among adults hospitalized with respiratory syncytial virus infections, New York City, 2017–2019. Public Health Rep 2021; 137:929–35.Benefits and harms:
Papi A, Ison MG, Langley JM, et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. NEJM. 2023; 388:595–608 doi: 10.1056/NEJMoa2209604.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/06-RSV-Adults-Melgar-508.pdf
Leroux-Roels I, David MG, Steenackers K, et al. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial, The Journal of Infectious Diseases, Volume 227, Issue 6, 15 March 2023, Pages 761–772, https://doi.org/10.1093/infdis/jiac327Values:
CDC and University of Iowa/RAND survey, unpublished.Acceptability:
Hurley LP, Allison MA, Kim L, et al. Primary Care Physicians’ Perspectives on Respiratory Syncytial Virus (RSV) Disease in Adults and a Potential RSV Vaccine for Adults. Vaccine. 2019; 37(4): 565–570. doi:10.1016/j.vaccine.2018.12.031.Feasibility:
CDC. Adult Immunization Schedule. https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.htmlResource Use:
Hutton, D. Updated cost-effectiveness of the Pfizer and GSK vaccines (main CDC model). Presentation to ACIP. June 21, 2023. Slides: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/04-RSV-Adults-Hutton-508.pdf
Ortega-Sanchez, I. Economics of Vaccinating U.S. Adults ≥ 60 years-old against Respiratory Syncytial Virus. Presentation to ACIP. June 21, 2023. Slides: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/05-RSV-Adults-Ortega-Sanchez-508.pdfEquity:
Zheng Z, Warren JL, Shapiro ED, et al. Estimated Incidence of Respiratory Hospitalizations Attributable to RSV Infections Across Age and Socioeconomic Groups. Pneumonia. 2022;14(1):6. doi: 10.1186/s41479-022-00098-x.
Tsao WC, Aday AW, Almarzooq ZI, et al. Heart Disease and Stroke Statistics—2022 Update: A Report From the American Heart Association. Circulation. 2022; 145:e153–e639. doi:10.1161/cir.0000000000001052
Cheng YJ, Kanaya AM, Araneta MRG, et al. Prevalence of Diabetes by Race and Ethnicity in the United States, 2011-2016. JAMA. 2019;322(24):2389–2398. doi:10.1001/jama.2019.19365
CDC. Most Recent National Asthma Data. https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm
Bhan N, Kawachi I, Glymour MM, Subramanian SV. Time Trends in Racial and Ethnic Disparities in Asthma Prevalence in the United States From the Behavioral Risk Factor Surveillance System (BRFSS) Study (1999–2011). Am J Public Health. 2015; 105:1269-1275. doi:10.2105/ajph.2014.302172
Abdalla SM, Yu S, Galea S. Trends in Cardiovascular Disease Prevalence by Income Level in the United States. JAMA Netw Open. 2020;3(9):e2018150. doi:10.1001/jamanetworkopen.2020.18150
Hamad R, Penko J, Kazi DS, et al. Association of Low Socioeconomic Status With Premature Coronary Heart Disease in US Adults. JAMA Cardiol. 2020;5(8):899–908. doi:10.1001/jamacardio.2020.1458
Beckles GL, Chou C. Disparities in the Prevalence of Diagnosed Diabetes — United States, 1999–2002 and 2011–2014. MMWR 2016; 65(45): 1265–1269. doi:10.15585/mmwr.mm6545a4
CDC. National Health Interview Survey (NHIS) 2018: https://www.cdc.gov/nchs/nhis/shs/tables.htm
Caraballo C, Herrin J, Mahajan S, et al. Temporal Trends in Racial and Ethnic Disparities in Multimorbidity Prevalence in the United States, 1999-2018. *Am J Med*. 2022;135(9):1083-1092.e14. doi:10.1016/j.amjmed.2022.04.010
CDC RSV-NET data 2015–2020 (unpublished)
Lu PJ, Hung MC, Srivastav A, Williams WW, Harris AM. Hepatitis B Vaccination Among Adults With Diabetes Mellitus, U.S., 2018. Am J Prev Med. 2021 Nov;61(5):652-664. doi: 10.1016/j.amepre.2021.04.029. Epub 2021 Jul 20. PMID: 34294463; PMCID: PMC9077536.
National Health Interview Survey, 2019-2020. https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubs-resources/vaccination-coverage-adults-2019-2020.html
Kempe A, Lindley MC, O’Leary ST, et al. Shared Clinical Decision-Making Recommendations for Adult Immunization: What Do Physicians Think?. *J Gen Intern Med*. 2021;36(8):2283-2291. doi:10.1007/s11606-020-06456-z
Hurley LP, O’Leary ST, Kobayashi M, et al. Physician survey regarding updated PCV13 vaccine recommendations for adults ≥65 years. *J Am Geriatr Soc*. 2021;69(9):2612-2618. doi:10.1111/jgs.17274
U.S. Census Bureau, 2021 American Community Survey 1-year estimates: https://data.census.gov/tableTop of Page
							
					
							Last Reviewed:  July 20, 2023						Source: 	National Center for Immunization and Respiratory Diseases
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