ACIP Evidence to Recommendations for Use of Nirsevimab in Children 8–19 months of age at increased risk of severe disease entering their second RSV season

Questions: Should one dose of Nirsevimab be recommended for children aged 8–19 months who are at increased risk of severe RSV disease and entering their second RSV season (200 mg)?

Population: Children aged 8–19 months who are at increased risk of severe RSV disease and entering their second RSV season

Intervention: Nirsevimab (200 mg [2 x 100 mg] injection near start of second RSV season)

Comparison: No nirsevimab prophylaxis

Outcomes:

Medically attended RSV-associated lower respiratory tract infection (LRTI)
RSV-associated LRTI with hospitalization
RSV-associated LRTI with ICU admission
RSV-associated death
All-cause medically attended LRTI
All-cause LRTI-associated hospitalization
Serious adverse events (SAEs)

Background:

RSV is the most common cause of hospitalization in U.S. infants.¹ The highest hospitalization rates are in the first months of life and risk declines with increasing age in infancy and during early childhood. During the 2017-2020 seasons prior to the COVID-19 pandemic, RSV transmission followed a consistent seasonal pattern, beginning earliest in Florida and the Southeast and peaking during December across most the U.S. However, the COVID-19 pandemic interrupted seasonal circulation of RSV and many other respiratory viruses. Following over a year of limited RSV circulation, the U.S. experienced an interseasonal RSV wave that peaked in July 2021 and continued throughout the Fall into late December. Although some limited regional interseasonal transmission occurred in Summer 2022, largely in the South- and South-Central U.S., the RSV season peaked in November and returned to off-season levels in January, suggesting that RSV circulation may be transitioning to typical winter seasonality.²

It has been estimated that each year among U.S. children aged less than 5 years, RSV is associated with 100 – 300 deaths, 58,000 – 80,000 hospitalizations, nearly 520,000 emergency department visits and approximately 1,500,000 outpatient visits.^3-7

On July 17, 2023, the U.S. Food and Drug Administration (FDA) approved the Biologics License Application of nirsevimab (Beyfortus, Sanofi and AstraZeneca) for prevention of RSV-associated LRTI in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. This webpage will focus on the Evidence to Recommendation (EtR) of the second season indication only. For EtR on the first season indication, please see: https://www.cdc.gov/vaccines/acip/recs/grade/nirsevimab-season1-rsv-infants-children-etr.html. Following FDA’s regulatory action, the ACIP met on August 3, 2023 and voted to recommend nirsevimab in young children who are at increased risk of severe RSV disease and entering their second RSV season and aged 8-19 months at the time of immunization.

Additional background information supporting the ACIP recommendation on the use of nirsevimab can be found in the relevant publication of the recommendation referenced on the ACIP website.

Public Health Problem

Public Health Problem
Criteria	Work Group Judgements	Evidence	Additional Information
Is the problem of public health importance?	Yes	Each year among U.S. children aged less than 5 years, RSV is associated with an estimated 100 – 300 deaths, 58,000 – 80,000 hospitalizations, nearly 520,000 emergency department visits, and approximately 1,500,000 outpatient visits.^1-5 The New Vaccine Surveillance Network (NVSN) incidence of RSV-associated hospitalization rates in children aged <5 years for 2016-2020 show that incidence is lower in children aged 12-23 months compared with children aged 0-5 months and 6-11 months.⁶ NVSN data show that the RSV-associated hospitalization incidence rate ratio was 6.1 for infants aged 0-2 months, 3.4 for infants aged 3-5 months and 1.9 for infants aged 6-11 months, when compared with children aged 12-23 months.⁷ The manufacturer has proposed that children up to 24 months of age who remain vulnerable to severe RSV disease, which may include but is not limited to children with chronic lung disease of prematurity (CLD), hemodynamically significant congenital heart disease (CHD), immunocompromised states, down syndrome, cystic fibrosis, neuromuscular disease, and congenital airway anomalies might warrant nirsevimab when entering their second RSV season. The Medley study, which is a phase 2/3 pharmacokinetics and safety study, included palivizumab-eligible children with hemodynamically significant CHD and CLD for the second season, but not other conditions. Palivizumab is the only product currently licensed for prevention of RSV-associated disease in the United States. The American Academy of Pediatrics has identified groups of children at risk of severe disease from RSV during their second RSV season for purposes of recommending palivizumab. Palivizumab can be considered for children with chronic lung disease if they required medical support within 6 months of the start of the second RSV season. Palivizumab can also be considered for children who are profoundly immunocompromised or have cystic fibrosis if there are manifestations of severe lung disease.⁸ To evaluate the evidence if other risk groups should be considered eligible, CDC conducted two analyses: a systematic review of literature and an analysis of MarketScan national claims database. The systematic review included any studies that compared RSV hospitalization rates among children with risk factors to health control among children ages 6–24 months.⁹ Among 3,825 abstracts reviewed, 6 studies were identified. CLD, CHD, and neuromuscular disease were analyzed in these studies. The studies indicated increased risk of hospitalization for these risk factors. No studies evaluating other risk factors were identified. Given the limited evidence available, CDC conducted an analysis of the MarketScan national claims database for select risk factors for severe RSV disease during second RSV season using data from 2015 to 2021.⁹ Using ICD-9-CM/ICD-10-CM codes, children with and without select conditions (CLD, CHD, Down syndrome, neuromuscular disease, pulmonary malformations, immunodeficiency, cystic fibrosis) and children that were hospitalized with RSV were identified. Rates of RSV hospitalization among children with a chronic condition were compared with children without any of the chronic conditions. Increased rates of hospitalization were seen for all conditions. One primary limitation is that RSV testing may be more common for children with risk conditions, inflating RSV-specific hospitalization rates. Research suggests that some American Indian and Alaska Native (AI/AN) children experience high rates of severe RSV disease. A recent study found the incidence of RSV-associated hospitalization among some AI/AN children aged 12–23 months was 4 to 10 times that of similar-aged children across seven sites in the United States.¹⁰ These studies have been limited to specific populations and might not be broadly representative of risk in all AI/AN children.	After reviewing the evidence, the Work Group felt that the RSV disease among children who are at increased risk of severe disease in their 2nd RSV season was of public health importance, defining children who are at increased risk of severe disease in their 2nd RSV season as the following: Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season Children with severe immunocompromise Children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight-for-length <10th percentile American Indian or Alaska Native children

Benefits and Harms

Benefits and Harms
Criteria	Work Group Judgements	Evidence	Additional Information
How substantial are the desirable anticipated effects?	Moderate	The Medley study had a congenital heart disease (CHD) and chronic lung disease (CLD) cohort, which had a 2:1 randomization of nirsevimab to palivizumab for season 1.1-3 For the second season, the nirsevimab group continued to receive nirsevimab and the palivizumab group was randomized 1:1 for nirsevimab or a second season of palivizumab. There were no cases of medically attended RSV-associated LRTI in the second RSV season, which was conducted in 2020 during the COVID-19 pandemic. In the absence of direct efficacy data for high-risk children entering their second RSV season, two pharmacokinetic data endpoints were used to extrapolate efficacy from the phase 2 and phase 3 trials among infants that did not qualify for palivizumab: the day 150 nirsevimab serum concentration and an area under the curve nirsevimab concentration. The day 150 post-dose serum concentration of nirsevimab among high-risk children in their second RSV season of the Medley trial was higher than the concentrations reported in the phase 3 trial among late preterm and term infants. More than 90% of the high-risk children in the Medley trial had nirsevimab area under the curve concentrations that exceeded the target. FDA considered extrapolation of efficacy data from other trials to be appropriate because the pathophysiology of RSV infection, mechanism of action of nirsevimab, and response to nirsevimab is expected to be sufficiently similar between the populations of the efficacy trials and the pharmacokinetic trial.⁴ For the remainder of the domains, the Work Group considered the population to be children aged 8–19 months who are at increased risk of severe RSV disease and entering their second RSV season, with increased risk defined as Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season Children with severe immunocompromise Children with cystic fibrosis who have either 1) manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable), or 2) weight-for-length <10th percentile American Indian or Alaska Native children	The work group felt that the desirable anticipated effects were moderate for children aged 8–19 months entering their second RSV season and belonging to the following groups of children: Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season Children with severe immunocompromise Children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight-for-length <10th percentile American Indian and Alaska Native children
How substantial are the undesirable anticipated effects?	Minimal	Available safety data are from children ≤24 months with CLD or CHD entering their second RSV season who received nirsevimab (one 200 mg dose followed by 4 monthly injection with placebo) or palivizumab (5 monthly injections with a dose of 15 mg/kg). In the groups that received nirsevimab in the second season, approximately 9-10% experienced any serious adverse event (SAE) versus none among those who received palivizumab. However, none of these SAEs were deemed by trial investigators to be related to the product and no deaths were reported. SAEs were not significantly different between the nirsevimab and palivizumab groups.	The work group felt that the undesirable anticipated effects were minimal for children aged 8–19 months entering their second RSV season and belonging to the following groups of children: Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season Children with severe immunocompromise Children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight-for-length <10th percentile American Indian and Alaska Native children
Do the desirable effects outweigh the undesirable effects?	Favors intervention		The Work Group decided that the desirable effects of nirsevimab for the second RSV season outweigh the undesirable effects and favors nirsevimab.
What is the overall certainty of this evidence for the critical outcomes?	Very low certainty	For the critical outcomes, nirsevimab might be effective in preventing medically attended RSV-associated LRTI, but with low certainty. Furthermore, SAEs might not be more common in the intervention group (i.e., recipients of nirsevimab) than the placebo group (i.e., children not receiving nirsevimab), but there was very low certainty. Additionally, there was no data available for the remaining outcomes (i.e., RSV-associated LRTI with hospitalization, RSV-associated LRTI with ICU admission, RSV-associated death, all cause medically attended LRTI and all-cause hospitalization with respiratory disease). There were serious concerns for the evidence pertaining to protection against medically attended RSV-associated LRTI because of indirectness with pharmacokinetics being used as a surrogate outcome, and that the pharmacokinetics target was determined using efficacy data among infants born during or entering their first RSV infection, and that was extrapolated to children entering their second RSV season. Finally, the trial population was limited to children with congenital heart disease and chronic lung disease, while other conditions are being considered as proposed indications for a nirsevimab dose for children entering their second RSV season. The relative risk of having an SAE among those that received nirsevimab in their second season compared with those that received palivizumab in their second season was 8.4, but with a wide confidence interval. Serious concerns about indirectness were raised because the comparison group was palivizumab recipients rather than placebo. Additionally, there were very serious concerns about imprecision because of the small number of participants in the trial. Combined, there was very low certainty in the evidence. The overall certainty of this evidence was downgraded based on indirectness because pharmacokinetic data was used as a surrogate for efficacy, the population did not include children that matches the proposed indication, the study was small and there was no placebo group included for comparison.

Values

Values
Criteria	Work Group Judgements	Evidence	Additional Information
Does the target population feel that the desirable effects are large relative to undesirable effects?	Probably yes	In a survey, conducted by the University of Iowa, of 523 people who were actively pregnant or pregnant within the last 12 months, about one-third (33%) of respondents thought their baby ‘definitely’ or ‘probably’ would get an RSV infection within one year after being born. Approximately 70% of respondents said they ‘definitely’ or ‘probably’ would get an RSV antibody injection for their baby if safe and effective, approved by FDA, and recommended by CDC.¹ No data was available for values specific to populations at increased risk of severe disease.	The work group determined that the target population probably feels that the desirable effects are large relative to undesirable effects for children aged 8–19 months entering their second RSV season and belonging to the following groups of children: Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season Children with severe immunocompromise Children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight-for-length <10th percentile American Indian and Alaska Native children
Is there important uncertainty about or variability in how much people value the main outcomes?	Probably no	Considering vaccine intentions among survey respondents who were actively pregnant or pregnant within the last 12 months, 63% of respondents said they were more worried or equally worried about their baby experiencing side effects from an RSV antibody injection vs. symptoms if sick with RSV.¹ Moreover, 38% of respondents believe that their baby would have no symptoms or mild symptoms if they were to get sick with RSV; and 24% expressed uncertainty about the disease severity or treatability if their baby got sick with RSV. Despite being unsure or perceiving RSV risk to be low, respondents were worried their baby would need to be hospitalized if they got sick with RSV.¹ No data was available for values specific to populations at increased risk of severe disease.	The work group determined that the target population probably feels that the desirable effects are large relative to undesirable effects for children aged 8–19 months entering their second RSV season and belonging to the following groups of children: Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season Children with severe immunocompromise Children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight-for-length <10th percentile American Indian and Alaska Native children

Acceptability

Acceptability
Criteria	Work Group Judgements	Evidence	Additional Information
Is the intervention acceptable to key stakeholders?	Yes/probably yes	In a survey by the Alliance for Patient Access and National Coalition for Infant Health using YouGov to poll U.S. pediatric providers, among 175 providers that responded: 99% agree that parents need more information about RSV 86% report including RSV education as part of routine care 97% said immunizations could help prevent RSV 92% agreed that RSV immunization policy should ensure all children get access.¹ The American Academy of Pediatrics has stated that the development of safe and effective RSV immunization is a priority.² In 2021, the National Foundation for Infectious Disease held a roundtable, which agreed on the importance of rapid adoption and deployment of evidence-based RSV prevention. This roundtable included the National Association of County and City Health Officials.³ No additional data was available for acceptability specific to populations at increased risk of severe disease.	The work group determined that the target population probably feels that the desirable effects are large relative to undesirable effects for children aged 8–19 months entering their second RSV season and belonging to the following groups of children: Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season Children with severe immunocompromise Children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight-for-length <10th percentile American Indian and Alaska Native children

Feasibility

Feasibility
Criteria	Work Group Judgements	Evidence	Additional Information
Is the intervention feasible to implement?	Probably yes	Nirsevimab storage, handling and administration is similar to other routine immunizations for children.¹ Nirsevimab is administered as an intramuscular injection using pre-filled, single-use syringes. For children entering their second RSV season, the dose is 200 mg (2 x 100 mg injections). Only one dose of nirsevimab is recommended per RSV season and can be administered simultaneously with other childhood vaccines. Nirsevimab is stored at refrigerator temperatures (2°C-8°C) and may be kept at room temperature (20°C-25°C), when protected from light, for up to 8 hours.² Jurisdictions may have different scope of practice statutes for who can administer injectable therapeutics vs. vaccines, impacting feasibility. A review of state laws indicates that most states allow medical assistants (who frequently administer vaccines) to also deliver injection drugs; however, organizations may have varied practices.¹ CDC determined that nirsevimab is eligible for inclusion in the childhood immunization schedule and Vaccines for Children program and ACIP voted for inclusion of nirsevimab in the Vaccines for Children program. The Vaccines for Children program is a federally funded program that provides immunizations at no cost to children who might not otherwise be immunized because of inability to pay.³ Nirsevimab is the first monoclonal antibody to be included in the VFC program. There are potential challenges entering nirsevimab in the immunization information system (IIS). The demand for nirsevimab is not known. Pricing as well as a historical lag in insurance payment for new products could impact initial investment by pediatricians. Coding challenges exists as nirsevimab is classified as a drug vs a vaccine. Drug administration codes do not include a counseling component, and drugs are not eligible for stand-alone counseling. Additionally, the usual time from FDA approval to administration systems being ready to use these new codes for administration is approximately 6-12+ weeks.¹ Suspected adverse reaction following administration of nirsevimab alone (e.g., when not coadministered with a vaccine) should be reported through MedWatch. However, suspected adverse reactions following coadministration of nirsevimab with any vaccine should be reported to the Vaccine Adverse Event Reporting System (VAERS). One additional factor for feasibility is that an additional visit to a provider might be needed for administration of nirsevimab prior to the beginning of 2^nd RSV season, either at a specialist clinic or the primary care provider.	The work group determined that the target population probably feels that the desirable effects are large relative to undesirable effects for children aged 8–19 months entering their second RSV season and belonging to the following groups of children: Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season Children with severe immunocompromise Children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight-for-length <10th percentile American Indian and Alaska Native children

Resource Use

Resource Use
Criteria	Work Group Judgements	Evidence	Additional Information
Is the intervention a reasonable and efficient allocation of resources?	Probably yes	To estimate cost effectiveness in children at increased risk of severe disease, theoretical groups of children with increased risk created with 2x, 4x, 6x, 10x the incidence of RSV-associated hospitalization than that of the general population aged 8–19 months in October. However, two scenarios were created to account for uncertainty in mortality. The cost used for the CEA was $890 (2x $445/dose assumed in the first season analysis to account for the 2 injections needed). Scenario 1 assumes that only the RSV hospitalization incidence is increased and the mortality per hospitalization is assumed to be constant. With this assumption, the cost effectiveness ranges from approximately $1.5 million per QALY for the general population to approximately $300,000 per QALY at 10 times the baseline risk. Scenario 2 assumes if both the hospitalization incidence and mortality per hospitalization are increased. With this assumption, the cost effectiveness ranges from approximately $1.5 million per QALY for the general population to approximately $25,000 per QALY at 10 times the baseline risk.	The work group felt that at $890 per child, nirsevimab was probably a reasonable and efficient allocation of resources.

Equity

Equity
Criteria	Work Group Judgements	Evidence	Additional Information
What would be the impact of the intervention on health equity?	Probably increased	Inclusion in the Vaccines for Children program is critical for maximizing equity to nirsevimab. Equity issues differ by chronic condition among infants and young children. Non-Hispanic Black and Hispanic populations have higher rates of preterm birth than non-Hispanic White population.¹ Research suggests that some American Indian and Alaska Native (AI/AN) children experience high rates of severe RSV disease. A recent study found the incidence of RSV-associated hospitalization among some AI/AN children aged 12–23 months was 4 to 10 times that of similar-aged children across seven sites in the United States.³ These studies have been limited to specific populations and might not be broadly representative of risk in all AI/AN children. Some AI/AN communities live in remote regions, making transportation of children with severe RSV more challenging.⁴	The Work Group felt that with the inclusion in the VFC program, nirsevimab use would probably increase health equity for children aged 8–19 months entering their second RSV season and belonging to the following groups of children: Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season Children with severe immunocompromise Children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight-for-length <10th percentile American Indian and Alaska Native children

Work Group Interpretation Summary

The Work Group recommended nirsevimab for children aged 8–19 months at increased risk for severe disease entering their second RSV season. The Work Group considered the following groups to be considered at increased risk for severe disease for use of nirsevimab for children entering their second RSV season:

Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season
Children with severe immunocompromise
Children with cystic fibrosis who have either 1) manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable), or 2) weight-for-length <10th percentile
American Indian or Alaska Native children

Balance of consequences

For children at increased risk entering their second season (i.e., groups considered for palivizumab in their second RSV season by the American Academy of Pediatrics and American Indian and Native Alaskan children) the majority of the Work Group felt that the desirable consequences probably outweigh undesirable consequences in most settings. A substantial minority felt that the desirable consequences clearly outweigh undesirable consequences in most settings.

Is there sufficient information to move forward with a recommendation? Yes

Policy options for ACIP consideration

ACIP does not recommend the intervention.
ACIP recommends the intervention for individuals based on shared clinical decision making.
ACIP recommends the intervention.

Draft recommendation (text)

Children aged 8–19 months who are at increased risk of severe RSV disease and entering their second RSV season are recommended to receive one dose of nirsevimab (200 mg). On August 3, 2023, ACIP voted (10-0) in favor of recommendation.

Final deliberation and decision by ACIP

ACIP recommends the intervention.

References

Background:

Suh M, Movva N, Jiang X, Bylsma LC, Reichert H, Fryzek JP, et al. Respiratory Syncytial Virus Is the Leading Cause of United States Infant Hospitalizations, 2009-2019: A Study of the National (Nationwide) Inpatient Sample. J Infect Dis. 2022 Aug 15;226(Suppl 2):S154-S63.
Hamid S, Winn A, Parikh R, Jones JM, McMorrow M, Prill MM, et al. Seasonality of Respiratory Syncytial Virus — United States, 2017–2023. MMWR Morb Mortal Wkly Rep. 2023;72:355–361. doi: 10.15585/mmwr.mm7214a1.
Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, 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
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
Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA. The Burden of Respiratory Syncytial Virus Infection in Young Children. New England Journal of Medicine. 2009;360(6):588–98. doi: 10.1056/NEJMoa080487
Rha B, Curns AT, Lively JY, Campbell AP, Englund JA, Boom JA, et al. Respiratory Syncytial Virus–Associated Hospitalizations Among Young Children: 2015–2016. Pediatrics. 2020;146(1):e20193611. doi: 10.1542/peds.2019-3611
McLaughlin JM, Khan FL, Schmitt H-J, Agosti Y, Jodar L, Simões E, et al. Respiratory Syncytial Virus-Associated Hospitalization Rates among US Infants: A Systematic Review and Meta-Analysis. Open Forum Infectious Diseases. 2020;7(Supplement_1): S843. doi: 10.1093/ofid/ofaa439.1897
FDA. FDA Approves New Drug to Prevent RSV in Babies and Toddlers. Press Release. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers

Public Health Problem:

Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, et al. Mortality Associated with Influenza and Respiratory Syncytial Virus in the United States. 2003;289(2):179–186. doi:10.1001/jama.289.2.179
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
Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA. The Burden of Respiratory Syncytial Virus Infection in Young Children. New England Journal of Medicine. 2009;360(6):588-98. doi: 10.1056/NEJMoa080487
Rha B, Curns AT, Lively JY, Campbell AP, Englund JA, Boom JA, et al. Respiratory Syncytial Virus–Associated Hospitalizations Among Young Children: 2015–2016. Pediatrics. 2020;146(1):e20193611. doi: 10.1542/peds.2019–3611
McLaughlin JM, Khan FL, Schmitt H-J, Agosti Y, Jodar L, Simões E, et al. Respiratory Syncytial Virus-Associated Hospitalization Rates among US Infants: A Systematic Review and Meta-Analysis. Open Forum Infectious Diseases. 2020;7(Supplement_1): S843. doi: 10.1093/ofid/ofaa439.1897
New Vaccine Surveillance Network (NVSN). https://www.cdc.gov/surveillance/nvsn/index.html
CDC. New Vaccine Surveillance Network (NVSN). Unpublished.
American Academy of Pediatrics Committee on Infectious Diseases, American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014. 134(2):e620-38. doi: 10.1542/peds.2014-1666
Jones J. Evidence to Recommendations Framework: Nirsevimab Updates. Presentation to ACIP 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-08-3/02-RSV-jones-508.pdf
Atwell JE, Hartman RM, Parker D, et al. RSV Among American Indian and Alaska Native children: 2019 to 2020. Pediatrics 2023;152:e2022060435. PMID:37449336 https://doi.org/10.1542/peds.2022-060435

Benefits and harms:

Domachowske JB, Cheng Y, Atanasova V, Cabañas F, Furuno K, Nguyen KA, et al. Safety of re-dosing nirsevimab prior to RSV season 2 in children with heart or lung disease, Journal of the Pediatric Infectious Diseases Society, 2023;piad052. Doi: 10.1093/jpids/piad052
Domachowske J, Madhi SA, Simões EAF, Atanasova V, Cabañas F, Furuno K, et al. Safety of nirsevimab for RSV in infants with heart or lung disease or prematurity. New England Journal of Medicine. 2023;386(9): 892–894. Doi: 10.1056/NEJMc2112186
Sanofi/AstraZeneca, 2023 personal communication, August 2022 – February 2023.
FDA Briefing Document, Nirsevimab https://www.fda.gov/media/169226/download

Values:

CDC and University of Iowa/RAND survey, unpublished

Acceptability:

Alliance for Patient Access and National Coalition for Infant Health. The Indirect Impact of RSV – RSV Parent & Provider Survey Results. https://admin.allianceforpatientaccess.org/wp-content/uploads/2023/01/AfPA-and-NCfIH_The-Indirect-Impact-of-RSV_Survey-Report_Jan-2023.pdf
Committee on Infectious Diseases and Bronchiolitis Guidelines Committee “Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection.” Pediatrics. 2014;134(2): e620-e638.
National Foundation for Infectious Diseases. Call to Action: Reducing the Burden of RSV Across the Lifespan. January 2022. https://www.nfid.org/wp-content/uploads/2022/04/NFID-RSV-Call-to-Action.pdf

Feasibility:

Peacock G. Nirsevimab: Implementation Considerations. Presentation to ACIP 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-08-3/03-RSV-Peacock-508.pdf
Sanofi Pasteur Inc. BEYFORTUS- nirsevimab injection package insert. https://www.accessdata.fda.gov/spl/data/2f08fa60-f674-432d-801b-1f9514bd9b39/2f08fa60-f674-432d-801b-1f9514bd9b39.xml
CDC. Vaccines for Children. https://www.cdc.gov/vaccines/programs/vfc/index.html
CDC. CDC Vaccine Price List. https://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html

Resource Use:

Jones J. Evidence to Recommendations Framework: Nirsevimab Updates. Presentation to ACIP 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-08-3/02-RSV-jones-508.pdf

Equity:

CDC. Preterm Birth. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm
Atwell JE, Hartman RM, Parker D, Taylor K, Brown LB, Sandoval M, et al. RSV among American Indian and Alaska Native children: 2019 to 2020. Pediatrics 2023;e2022060435. doi:10.1542/peds.2022-060435
Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH, editors. American Academy of Pediatrics, Committee on Infectious Diseases. Respiratory Syncytial Virus [Section 3]. In: Red Book: 2021–2024 report of the Committee on Infectious Diseases. Itasca, IL: American Academy of Pediatrics; 2021:628–36.

Top of Page