RSV Monoclonal Antibodies: A Paradigm Shift in Infant Protection

Introduction

Respiratory syncytial virus is a leading cause of lower respiratory tract disease and hospitalization in infants and young children. For decades, pharmacologic prevention was largely limited to palivizumab for selected high-risk pediatric populations. That model has changed.

Long-acting monoclonal antibodies now allow passive RSV protection across a much broader infant population. Nirsevimab and clesrovimab are not vaccines. They are RSV fusion protein-directed monoclonal antibodies that provide preformed antibodies rather than inducing active infant immunity. This distinction matters for counseling, immunization documentation, adverse-event reporting, and clinician expectations.

For pediatricians, pharmacists, obstetric clinicians, neonatologists, pulmonologists, cardiologists, infectious disease specialists, and clinicians caring for medically complex infants, the central question is no longer whether pharmacologic RSV prevention exists. The practical challenge is implementing it accurately, safely, and equitably.

Why This Matters Now

The RSV prevention landscape is more effective but also more operationally complex. Infants can receive protection through one of two main pathways: maternal RSVpreF vaccination during pregnancy or administration of a long-acting RSV monoclonal antibody to the infant. In most cases, these strategies should not be duplicated.

This framework requires communication across obstetrics, pediatrics, newborn nurseries, NICUs, outpatient primary care, pharmacy, and specialty clinics. Missed opportunities can occur during prenatal visits, delivery, hospitalization, NICU discharge, newborn follow-up, and pre-season visits for high-risk children. Unnecessary duplication can occur when maternal vaccination status is not recorded or clinicians overlook the interval between maternal vaccination and delivery.

The prevention strategy is also evolving. Nirsevimab has been recommended since 2023 for eligible first-season infants and selected high-risk children entering a second RSV season. In 2025, clesrovimab was added as an alternative for eligible infants younger than 8 months who are born during or entering their first RSV season and are not protected through maternal vaccination. The products share a first-season indication under CDC guidance but should not be treated as identical. Their dosing, labeling, diagnostic-test considerations, and second-season roles differ.

Passive Immunity, Not Infant Vaccination

Nirsevimab and clesrovimab provide passive immunity through monoclonal antibodies directed against the RSV fusion protein. Protection does not depend on the infant mounting an active vaccine response, and the intended duration is seasonal rather than lifelong.

This mechanism is useful for young infants, including newborns, because the risk of severe RSV disease and hospitalization is concentrated early in life. Passive protection also has limits. It does not treat established RSV disease, eliminate all breakthrough infections, or replace routine childhood vaccination.

Clinicians should avoid describing these products as infant RSV vaccines. CDC uses the term “immunization” because the products protect against disease, but they provide passive antibody protection rather than active immunization.

Current U.S. Prevention Framework

Current U.S. guidance uses a layered but generally nonduplicative prevention strategy.

For pregnant patients, CDC recommends a single dose of Pfizer’s RSVpreF vaccine, Abrysvo, between 32 0/7 and 36 6/7 weeks’ gestation during the seasonal administration window, generally September through January in most of the continental United States. Abrysvo is the only RSV vaccine approved and recommended during pregnancy for infant protection. Other RSV vaccines approved for adults are not approved for use during pregnancy or in infants and young children.

CDC does not currently recommend repeating maternal RSV vaccination during a subsequent pregnancy when the patient received the vaccine during a previous pregnancy. If the mother was not vaccinated during the current pregnancy, the infant should generally receive a long-acting RSV monoclonal antibody when otherwise eligible.

For infants younger than 8 months who are born during or entering their first RSV season, an RSV monoclonal antibody is recommended if:

• The mother did not receive RSV vaccine during the current pregnancy.

• The mother’s RSV vaccination status is unknown.

• The infant was born within 14 days after maternal RSV vaccination.

Except in rare circumstances, most infants born 14 or more days after maternal RSV vaccination do not need an infant monoclonal antibody.

Administration of an infant RSV antibody may still be considered after maternal vaccination when clinical judgment indicates that the potential incremental benefit warrants it. Examples include maternal immunocompromise, conditions associated with reduced transplacental antibody transfer, procedures that may remove maternal antibodies, or an infant with a substantially increased risk of severe RSV disease.

For selected children entering a second RSV season, the recommendation is narrower. Nirsevimab is recommended for children aged 8 through 19 months who are at increased risk for severe RSV disease.

Qualifying groups include:

• Children with chronic lung disease of prematurity who required chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen at any time during the six months before the start of the second RSV season.

• Children with severe immunocompromise.

• Children with cystic fibrosis who have severe lung disease, including a previous hospitalization for pulmonary exacerbation during the first year of life or persistent abnormalities on chest imaging when clinically stable, or a weight-for-length below the 10th percentile.

• American Indian or Alaska Native children.

Children aged 8 months or older who are not at increased risk should not receive an infant RSV antibody for routine second-season protection. CDC does not recommend nirsevimab for anyone aged 20 months or older. The FDA label is broader and includes children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Clinicians should distinguish the FDA-labeled population from the narrower CDC-recommended population.

Clesrovimab is recommended as an alternative to nirsevimab for eligible infants younger than 8 months who are born during or entering their first RSV season and are not protected through maternal vaccination. It is not recommended for children aged 8 months or older and is not FDA-approved or CDC-recommended for second-season use.

Table 1. Practical RSV Prevention Options for Infants and Young Children

Strategy	Main Eligible Population	Timing	Key Clinical Notes
Maternal RSVpreF vaccine	Pregnant patients at 32 0/7 through 36 6/7 weeks’ gestation	Seasonal administration, generally September through January in most of the continental United States	Most infants whose mothers were vaccinated at least 14 days before birth do not need infant antibody. CDC does not currently recommend revaccination during a subsequent pregnancy after a dose in a previous pregnancy.
Nirsevimab	Eligible infants younger than 8 months entering their first RSV season; selected high-risk children aged 8 through 19 months entering a second season	Generally October through March in most of the continental United States; adjust for local epidemiology	First-season dosing is weight based. The second-season dose is 200 mg administered as two 100 mg injections.
Clesrovimab	Eligible infants younger than 8 months entering their first RSV season who are not protected through maternal vaccination	Before or during the infant’s first RSV season	Fixed 105 mg dose. Not recommended for children aged 8 months or older or for second-season use.

Product Selection and Dosing

Product selection should begin with eligibility and the intended season of protection. Both nirsevimab and clesrovimab are options for eligible infants younger than 8 months entering their first RSV season if they are not protected through maternal vaccination. CDC does not identify a preferred monoclonal antibody for this shared population. Selection may reflect product availability, parent preference, timing relative to the RSV season, and product-specific clinical considerations. Only nirsevimab is recommended for selected high-risk children entering a second RSV season.

For first-season protection, nirsevimab dosing is based on body weight at administration. Infants weighing less than 5 kg receive 50 mg intramuscularly. Infants weighing 5 kg or more receive 100 mg intramuscularly. For eligible high-risk children entering a second RSV season, nirsevimab is given as 200 mg through two 100 mg intramuscular injections administered at different sites.

Clesrovimab is administered as a fixed 105 mg intramuscular dose to neonates and infants born during or entering their first RSV season. The fixed dose can simplify inventory planning and dose selection, but clinicians must still verify the infant’s age, maternal vaccination status, seasonal timing, and product-specific indication.

Both products require additional consideration after cardiac surgery with cardiopulmonary bypass. For nirsevimab during the first RSV season, the additional dose is weight based if surgery occurs within 90 days after the previous dose; if more than 90 days have elapsed, the additional dose is 50 mg regardless of weight. During a second season, the additional dose is 200 mg if surgery occurs within 90 days after dosing and 100 mg if more than 90 days have elapsed.

For clesrovimab, an additional 105 mg intramuscular dose is recommended as soon as the infant is stable after cardiopulmonary bypass during or entering the first RSV season. Because these redosing instructions are product and interval specific, clinicians should consult the current prescribing information when managing a child undergoing cardiopulmonary bypass.

Nirsevimab and clesrovimab may be administered at the same visit as routine childhood vaccines. Injectable products should be given with separate syringes at different administration sites. No interval between an infant RSV antibody and a live vaccine is required.

Table 2. Product-Specific Clinical Details

Product	FDA-Labeled Use	Dose	Selected Safety and Clinical Notes
Nirsevimab	Prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months who remain vulnerable through a second season	50 mg if <5 kg; 100 mg if ≥5 kg; 200 mg for eligible second-season high-risk children	Contraindicated with serious hypersensitivity to nirsevimab or an excipient. Use caution with thrombocytopenia, coagulation disorders, or anticoagulation. Post-cardiopulmonary bypass redosing is interval and season specific.
Clesrovimab	Prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season	105 mg IM once	Contraindicated with serious hypersensitivity to any component. May interfere with some RSV rapid antigen assays. RT-PCR confirmation is recommended when rapid antigen testing is negative but clinical suspicion persists.
Maternal RSVpreF vaccine, Abrysvo	Active immunization of pregnant individuals at 32 through 36 weeks’ gestation to prevent RSV LRTD and severe LRTD in infants from birth through 6 months	Single approximately 0.5 mL IM dose after reconstitution, depending on presentation	Contraindicated with a history of severe allergic reaction to any component. Label includes warnings concerning Guillain-Barré syndrome and the potential risk of preterm birth with administration before 32 weeks’ gestation.

Evidence Base

Nirsevimab

Nirsevimab has the most mature evidence base among currently recommended long-acting RSV monoclonal antibodies for infants.

A phase 2b randomized trial in preterm infants and the phase 3 MELODY trial in late-preterm and term infants found that a single dose reduced medically attended RSV lower respiratory tract infection compared with placebo. Pooled phase 2 and phase 3 trial data yielded an efficacy estimate of 79.0% against medically attended RSV-associated lower respiratory tract infection and 80.6% against RSV-associated lower respiratory tract infection requiring hospitalization through 150 days after administration.

The HARMONIE phase 3b pragmatic trial evaluated nirsevimab under routine clinical conditions in more than 8,000 term and preterm infants. RSV lower respiratory tract infection hospitalizations occurred in 11 of 4,037 infants assigned to nirsevimab and 60 of 4,021 infants assigned to no intervention, corresponding to an estimated relative risk reduction of 83.2% with a 95% confidence interval of 67.8% to 92.0%.

Post-licensure data support effectiveness against severe RSV outcomes. An early U.S. surveillance analysis found protection against RSV-associated hospitalization. A subsequent multicenter case-control investigation during the 2024-2025 season estimated 80% effectiveness against RSV-associated ICU admission and 83% effectiveness against acute respiratory failure among infants admitted to an ICU with respiratory symptoms.

These observational findings strengthen confidence in nirsevimab’s effectiveness outside randomized trials, but they require appropriate epidemiologic caution. Estimates can vary with timing of administration, RSV season intensity, product uptake, local testing practices, maternal vaccination, outcome definitions, and residual confounding. Observational data should not be interpreted as randomized comparative evidence.

Clesrovimab

Clesrovimab is a newer long-acting RSV monoclonal antibody. In June 2025, ACIP recommended it as an alternative to nirsevimab for eligible infants younger than 8 months who are born during or entering their first RSV season and are not protected through maternal vaccination.

The pivotal phase 2b/3 trial was randomized, double-blind, placebo-controlled, and included preterm and full-term infants entering their first RSV season. Through 150 days, efficacy against RSV-associated medically attended lower respiratory tract infection was 60.4%, with a 95% confidence interval of 44.1% to 71.9%. Efficacy against RSV-associated lower respiratory tract infection requiring hospitalization was 90.9%, with a 95% confidence interval of 76.2% to 96.5%. Hospitalization was a tertiary endpoint, which should be considered when interpreting the magnitude of that estimate.

All-cause serious adverse events through one year occurred at similar frequencies in the clesrovimab and placebo groups in the pivotal trial. A separate phase 3 study evaluated infants at increased risk for severe RSV disease, including infants born at 35 weeks’ gestation or earlier and infants with chronic lung disease of prematurity or hemodynamically significant congenital heart disease entering their first RSV season. Support for effectiveness in these higher-risk groups includes pharmacokinetic bridging rather than endpoint efficacy trials powered separately for each subgroup.

The clinical implication is specific: clesrovimab is a first-season infant prevention option. It should not be extended to second-season use or to children outside current age-based recommendations unless future labeling and guidance change.

Maternal RSVpreF Vaccination

Maternal RSVpreF vaccination provides an alternative pathway for protecting infants during early life. Abrysvo is administered during pregnancy to generate maternal antibodies that cross the placenta and protect the infant after birth. Current CDC guidance recommends a single seasonal dose at 32 0/7 through 36 6/7 weeks’ gestation.

The Abrysvo label includes efficacy data for preventing RSV lower respiratory tract disease and severe lower respiratory tract disease in infants from birth through 6 months of age. In the labeled 32-through-36-week gestational subgroup, descriptive analyses supported efficacy against severe RSV lower respiratory tract disease through 90 and 180 days. These subgroup analyses were not controlled for multiple comparisons and should be interpreted within that limitation.

The label also describes a numerical imbalance in preterm births among vaccine recipients compared with placebo recipients. Available data remain insufficient to establish or exclude a causal relationship. To avoid the potential risk associated with administration before 32 weeks’ gestation, Abrysvo should be administered only within the indicated gestational window when used for infant protection.

Safety, Contraindications, and Monitoring

Nirsevimab and clesrovimab are generally administered as single seasonal intramuscular injections, but they are biologic products and should not be treated as risk-free interventions. Both are contraindicated in infants or children with a history of serious hypersensitivity reactions, including anaphylaxis, to the active drug or product components.

For nirsevimab, serious hypersensitivity reactions have been reported after administration, including urticaria, dyspnea, cyanosis, and hypotonia. Anaphylaxis has been observed with human IgG1 monoclonal antibodies. The most common adverse reactions in clinical trials were rash and injection-site reactions. Because nirsevimab is administered intramuscularly, the label advises caution in infants and children with thrombocytopenia, coagulation disorders, or anticoagulation therapy.

For clesrovimab, the label warns that serious hypersensitivity reactions, including anaphylaxis, have been observed with other human IgG1 monoclonal antibodies. The most common labeled adverse reactions are injection-site erythema, injection-site swelling, and rash. Appropriate medications and supportive care should be available if a clinically significant hypersensitivity reaction occurs.

For maternal RSVpreF vaccination, clinicians should follow the product-specific pregnancy indication and warnings. Abrysvo is indicated for pregnant individuals at 32 through 36 weeks’ gestation for infant protection. It is contraindicated in patients with a history of severe allergic reaction to any component.

The current Abrysvo label states that a postmarketing observational study suggests an increased risk of Guillain-Barré syndrome during the 42 days after vaccination. It also warns about the potential risk of preterm birth if the vaccine is administered before 32 weeks’ gestation. The numerical imbalance in preterm births observed in clinical studies does not establish causation, and counseling should preserve that distinction.

Children with moderate or severe acute illness should usually wait until they recover before receiving an infant RSV antibody. Mild illness alone is not generally a reason to delay administration, although clinical judgment remains appropriate.

Diagnostic and Therapeutic Boundaries

RSV monoclonal antibodies are preventive interventions. They are not treatments for active bronchiolitis, pneumonia, or RSV lower respiratory tract infection. Once symptomatic RSV disease occurs, management remains supportive and should be guided by clinical severity, hydration, feeding, oxygenation, apnea risk, age, prematurity, comorbid disease, and the need for hospitalization.

Receipt of an RSV antibody does not rule out RSV infection. Breakthrough infections can occur.

Clesrovimab may interfere with some immunologically based RSV rapid antigen assays, as observed in laboratory studies. When a rapid antigen test is negative but the clinical presentation remains consistent with RSV infection, confirmation with an RT-PCR assay is recommended.

The current nirsevimab label states that nirsevimab does not interfere with RT-PCR or with certain commercially available rapid antigen assays that use antibodies targeting antigenic sites I, II, or IV of the RSV fusion protein. Nevertheless, the label recommends RT-PCR confirmation when an immunologic assay is negative and the clinical findings remain consistent with RSV infection.

Practical Implementation for Clinicians

A practical workflow begins with three questions.

First, was the infant born during or entering the RSV season, and what is the local RSV epidemiology? In most of the continental United States, infant RSV antibody administration is generally aligned with October through the end of March. Eligible infants born during that period should receive an antibody within the first week after birth, ideally during the birth hospitalization.

For infants born outside the seasonal administration window, administration is generally timed shortly before the RSV season begins. Timing may differ in Alaska, tropical climates, and other regions with atypical or unpredictable RSV circulation. Public health authorities and health systems may adjust seasonal timing according to local epidemiology and implementation feasibility.

Second, did the mother receive Abrysvo at least 14 days before delivery during the current pregnancy? If yes, most infants do not require an infant monoclonal antibody. If the mother was not vaccinated, her vaccination status is unknown, or vaccination occurred within 14 days before birth, infant antibody protection is generally recommended when the age and timing criteria are met.

Third, is the child entering a second RSV season with a qualifying high-risk condition? If yes, nirsevimab may be indicated for children aged 8 through 19 months. If not, routine second-season antibody administration is not recommended.

Operationally, RSV prevention should be integrated into prenatal documentation, birth hospitalization, newborn follow-up, NICU discharge planning, and pre-season visits for high-risk children. Documentation should include the product, lot number, dose, administration site, maternal RSV vaccine status, gestational timing of maternal vaccination when applicable, and the eligibility rationale.

Systems should also distinguish adverse-event reporting pathways. Adverse events after administration of an RSV monoclonal antibody alone may be reported to FDA MedWatch. When an infant RSV antibody and a vaccine are coadministered and an adverse event occurs, reporting through the Vaccine Adverse Event Reporting System is appropriate, with the monoclonal antibody documented among medications received.

Clinical Implications for Subspecialists

Although administration often occurs in newborn nurseries, pediatric primary care offices, or immunization clinics, subspecialists frequently influence eligibility and timing.

Pediatric cardiology and cardiothoracic surgery teams should recognize the product-specific redosing instructions following cardiopulmonary bypass. Neonatologists and pulmonologists should identify children with chronic lung disease of prematurity who meet the six-month medical-support criterion for second-season nirsevimab.

Immunologists, transplant clinicians, rheumatologists, infectious disease specialists, and pharmacists may be asked to assess severe immunocompromise or medication-related immune suppression in relation to RSV risk. Cystic fibrosis teams should recognize that second-season eligibility includes defined severe lung disease criteria or weight-for-length below the 10th percentile.

Pharmacists are central to formulary selection, dose verification, cold-chain management, product storage, inventory planning, birth-hospital workflows, medication-use policy, safety reporting, and clinician education. The key operational distinction is that first-season protection is broad, while second-season protection remains selective.

Limitations of the Evidence

The evidence supports prevention of medically attended RSV lower respiratory tract infection, RSV-associated hospitalization, and severe RSV outcomes in the populations studied. It does not show that RSV disease is eliminated, that all infants have the same residual risk, or that antibody products treat established infection.

Evidence is most extensive for nirsevimab because it has randomized, pooled, pragmatic, and post-licensure effectiveness data. Clesrovimab has a growing evidence base, but its clinical use is more recent. No adequately powered head-to-head efficacy trial establishes that one long-acting monoclonal antibody is clinically superior to the other.

Evidence supporting second-season nirsevimab use is less direct than the first-season evidence. Efficacy in selected medically complex children has relied substantially on pharmacokinetic extrapolation and safety data. ACIP rated the certainty of the second-season evidence as very low. The recommendation therefore applies only to defined higher-risk groups rather than to all children entering a second RSV season.

For some medically complex first-season populations, evidence for both products also relies partly on pharmacokinetic bridging rather than endpoint trials powered for each clinical subgroup.

Real-world effectiveness may vary with product uptake, seasonal timing, local RSV circulation, maternal vaccine coverage, access, supply, documentation quality, diagnostic practices, and residual confounding. Continued surveillance remains necessary for rare adverse events, breakthrough severe disease, immunogenicity, duration of protection, and potential resistance-associated substitutions.

Future Directions

The next phase of RSV prevention will be defined as much by implementation as by product efficacy. Key questions include how best to coordinate maternal vaccination with infant antibody programs, avoid both missed doses and unnecessary duplication, maintain equitable access during seasonal surges, and evaluate effectiveness in medically complex children.

Future studies should clarify comparative implementation outcomes, durability across varied RSV seasons, cost-effectiveness, protection in high-risk subgroups, safety in broad infant populations, and the clinical significance of resistance-associated substitutions. Additional evidence is also needed to characterize effectiveness later in the protection interval and to define the role of maternal revaccination in subsequent pregnancies.

Guidance will likely continue to evolve as post-licensure data accumulate.

 

References

Centers for Disease Control and Prevention. (2024, August 30). RSV vaccine guidance for pregnant women. Retrieved July 13, 2026, from

https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/pregnant-people.html

Centers for Disease Control and Prevention. (2024, July 26). ACIP recommendations: Respiratory syncytial virus vaccine immunizations. Retrieved July 13, 2026, from

https://www.cdc.gov/acip-recs/hcp/vaccine-specific/rsv.html

Centers for Disease Control and Prevention. (2025, August 18). RSV immunization guidance for infants and young children. Retrieved July 13, 2026, from

https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/infants-young-children.html

Domachowske, J. B., Madhi, S. A., Simões, E. A. F., Atanasova, V., Cabañas, F., Furuno, K., Garcia-Garcia, M. L., Grantina, I., Nguyen, K. A., Brooks, D., Chang, Y., Leach, A., Takas, T., Yuan, Y., Griffin, M. P., Mankad, V. S., & Villafana, T. (2022). Safety of nirsevimab for RSV in infants with heart or lung disease or prematurity. The New England Journal of Medicine, 386(9), 892-894.

https://doi.org/10.1056/NEJMc2112186

PMID: 35235733

Drysdale, S. B., Cathie, K., Flamein, F., Knuf, M., Collins, A. M., Hill, H. C., Findlow, H., Quinn, P., Fernandez, P., Thomas, N., & Faust, S. N. (2023). Nirsevimab for prevention of hospitalizations due to RSV in infants. The New England Journal of Medicine, 389(26), 2425-2435.

https://doi.org/10.1056/NEJMoa2309189

PMID: 38157500

Fleming-Dutra, K. E., Jones, J. M., Roper, L. E., Prill, M. M., Ortega-Sanchez, I. R., Moulia, D. L., Wallace, M., Godfrey, M., Broder, K. R., & Brooks, O. (2023). Use of the Pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in infants: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023. MMWR. Morbidity and Mortality Weekly Report, 72(41), 1115-1122.

https://doi.org/10.15585/mmwr.mm7241e1

PMID: 37824423

Food and Drug Administration. (2023, July 17). FDA approves new drug to prevent RSV in babies and toddlers. Retrieved July 13, 2026, from

https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers

Food and Drug Administration. (2025, January 7). FDA requires Guillain-Barré syndrome warning in prescribing information for RSV vaccines Abrysvo and Arexvy. Retrieved July 13, 2026, from

https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and

Griffin, M. P., Yuan, Y., Takas, T., Domachowske, J. B., Madhi, S. A., Manzoni, P., Simões, E. A. F., Esser, M. T., Khan, A. A., Dubovsky, F., Villafana, T., & DeVincenzo, J. P. (2020). Single-dose nirsevimab for prevention of RSV in preterm infants. The New England Journal of Medicine, 383(5), 415-425.

https://doi.org/10.1056/NEJMoa1913556

PMID: 32726528

Hammitt, L. L., Dagan, R., Yuan, Y., Baca Cots, M., Bosheva, M., Madhi, S. A., Muller, W. J., Zar, H. J., Brooks, D., Grenham, A., Wählby Hamrén, U., Mankad, V. S., Ren, P., Takas, T., Abram, M. E., Leach, A., Griffin, M. P., Villafana, T., & MELODY Study Group. (2022). Nirsevimab for prevention of RSV in healthy late-preterm and term infants. The New England Journal of Medicine, 386(9), 837-846.

https://doi.org/10.1056/NEJMoa2110275

PMID: 35235726

Jones, J. M., Fleming-Dutra, K. E., Prill, M. M., Roper, L. E., Brooks, O., Sánchez, P. J., Kotton, C. N., Lee, G. M., Talbot, H. K., & Cohn, A. C. (2023). Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023. MMWR. Morbidity and Mortality Weekly Report, 72(34), 920-925.

https://doi.org/10.15585/mmwr.mm7234a4

PMID: 37616235

Kampmann, B., Madhi, S. A., Munjal, I., Simões, E. A. F., Pahud, B. A., Llapur, C., Baker, J., Pérez Marc, G., Radley, D., Shittu, E., et al. (2023). Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. The New England Journal of Medicine, 388(16), 1451-1464.

https://doi.org/10.1056/NEJMoa2216480

PMID: 37018474

Moline, H. L., Toepfer, A. P., Tannis, A., Olson, S. M., Ball, S. W., Newhams, M. M., Halasa, N. B., Staat, M. A., Boom, J. A., Pannaraj, P. S., et al. (2024). Early estimate of nirsevimab effectiveness for prevention of respiratory syncytial virus-associated hospitalization among infants entering their first respiratory syncytial virus season, New Vaccine Surveillance Network, October 2023-February 2024. MMWR. Morbidity and Mortality Weekly Report, 73(9), 209-214.

https://doi.org/10.15585/mmwr.mm7309a4

PMID: 38457312

Moline, H. L., Tannis, A., Toepfer, A. P., et al. (2025). Respiratory syncytial virus disease burden and nirsevimab effectiveness in young children from 2023-2024. JAMA Pediatrics, 179(2), 179-187.

https://doi.org/10.1001/jamapediatrics.2024.5572

PMID: 39652359

Moulia, D. L., Link-Gelles, R., Chu, H. Y., Jamieson, D. J., Brooks, O., Meyer, S., Weintraub, E. S., Shay, D. K., Prill, M. M., Thomas, E. S., Hutton, D., Ortega-Sanchez, I. R., MacNeil, A., McMorrow, M. L., & Jones, J. M. (2025). Use of clesrovimab for prevention of severe respiratory syncytial virus-associated lower respiratory tract infections in infants: Recommendations of the Advisory Committee on Immunization Practices, United States, 2025. MMWR. Morbidity and Mortality Weekly Report, 74(32), 508-514.

https://doi.org/10.15585/mmwr.mm7432a3

PMID: 40880502

National Library of Medicine. (2025). DailyMed: Abrysvo, respiratory syncytial virus vaccine, prescribing information. Revised December 2025. Retrieved July 13, 2026, from

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=be18292e-b1a2-4815-a0ed-003efaa6bea3&type=display

National Library of Medicine. (2025). DailyMed: Enflonsia, clesrovimab-cfor injection, prescribing information. Revised June 2025. Retrieved July 13, 2026, from

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9004a92-40e8-4cdb-b22d-d07929f8fc3b

National Library of Medicine. (2026). DailyMed: Beyfortus, nirsevimab-alip injection, prescribing information. Revised April 2026. Retrieved July 13, 2026, from

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f08fa60-f674-432d-801b-1f9514bd9b39

Simões, E. A. F., Madhi, S. A., Muller, W. J., Atanasova, V., Bosheva, M., Cabañas, F., Furuno, K., Garcia-Garcia, M. L., Grantina, I., Nguyen, K. A., Brooks, D., Grenham, A., Wählby Hamrén, U., Mankad, V. S., Ren, P., Takas, T., Abram, M. E., Leach, A., Griffin, M. P., & Villafana, T. (2023). Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: A pooled analysis of randomized controlled trials. The Lancet Child & Adolescent Health, 7(3), 180-189.

https://doi.org/10.1016/S2352-4642(22)00321-2

PMID: 36634694

Sumsuzzman, D. M., Wang, Z., Langley, J. M., & Moghadas, S. M. (2025). Real-world effectiveness of nirsevimab against respiratory syncytial virus disease in infants: A systematic review and meta-analysis. The Lancet Child & Adolescent Health, 9(6), 393-403.

https://doi.org/10.1016/S2352-4642(25)00093-8

PMID: 40319903

Zambrano, L. D., Simeone, R. M., Newhams, M. M., et al. (2025). Nirsevimab effectiveness against intensive care unit admission for respiratory syncytial virus in infants: 24 states, December 2024-April 2025. MMWR. Morbidity and Mortality Weekly Report, 74(37), 580-588.

https://doi.org/10.15585/mmwr.mm7437a1

PMID: 41348586

Zar, H. J., Madhi, S. A., Simões, E. A. F., et al. (2025). Clesrovimab for prevention of RSV disease in healthy infants. The New England Journal of Medicine, 393(13), 1292-1303.

https://doi.org/10.1056/NEJMoa2502984

PMID: 40961446