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ABRYSVO®▼(Respiratory Syncytial Virus Vaccine [bivalent, recombinant]) Prescribing Information for the United Kingdom click here.
RSV imposes a substantial health burden on infants in the UK2,3
RSV infects the airways and can cause infections such as pneumonia or bronchiolitis which interfere with breathing.3
RSV is the leading cause of bronchiolitis4, which accounts for 1 in 6 of all UK hospital admissions of babies and children during the winter months.3
RSV infection in the first 3 years of life is associated with longer term sequelae such as recurrent wheezing and asthma.6
*Data from 2017. **Data from 2019.
Initial studies reviewing this UK NIP have shown real-world estimated vaccine effectiveness (VE) of ABRYSVO ranging between 72% (95% CI 48-85) and 82.2% (95% CI 75.1-87.3) for infants whose mothers were vaccinated >14 days before delivery7,8.
The detailed methodology for these studies can be found below.
Study methodology
Assess the vaccine effectiveness of ABRYSVO when administered during pregnancy at ≥28 weeks* gestation against hospitalisation for RSV-associated acute lower respiratory illness (ALRI)** in infants <6 months (<180 days) of age.
Results from the 2024-2025 season
Study Limitations
*Pregnant women were subsequently offered ABRYSVO at as close as possible to 28 weeks gestation.
**ALRI included a clinician-assigned diagnosis of bronchiolitis (cough, tachypnoea or chest recession, and wheeze or crackles on chest auscultation), lower respiratory tract infection (clinician diagnosis), or first episode of wheeze.
Study methodology
Estimate the vaccine effectiveness of ABRYSVO when administered during pregnancy against RSV-related LRTI hospital admissions in infants ≤ 3 months ( ≤ 90 days) of age.†
Results from the 2024-2025 season
The adjusted effectiveness of ABRYSVO in preventing hospitalisation among infants of mothers vaccinated > 14 days before delivery was
The adjusted effectiveness of ABRYSVO in preventing hospitalisation among infants of mothers vaccinated suboptimally (≤14 days before delivery) was
Study limitations
Transplacental transfer of RSV-neutralising antibodies following maternal vaccination can help protect babies from birth through 6 months of age from RSV-associated lower respiratory tract disease (LRTD).1
In this video, Dr Fatima Husain and Dr George Kassianos share tips on managing vaccination conversations to ensure women receive the right information about maternal vaccination.
A survey of 377 pregnant women across England found:
90% of women said NHS professionals, mainly midwives, had an important influence on their decision to get vaccinated11
68%of women said they would have had the vaccine if they had been given more information, reassurance, and/or advice11
Midwife and nurse, Katie Byrne, discusses the challenges families face regarding maternal vaccination and explains how midwives can support informed vaccination choices.
In this video, Dr. Fatima Husain and Dr. George Kassianos discuss the benefits of healthcare professionals spending more time engaging with patients about maternal vaccination.
Most local and systemic reactions in maternal participants were mild to moderate in severity and resolved within 2-3 days of onset.1,15
The most frequently reported adverse reactions in pregnant women were vaccination site pain (41%), headache (31%), and myalgia (27%).1
| System organ class | Very Common (≥1/10) | Common (≥1/100 to <1/10) | Uncommon (≥1/1000 to <1/100) | Rare (≥1/10,00 to <1/1000) | Very Rare (<1/10,000) | Not known (cannot be estimated from the available data) |
|---|---|---|---|---|---|---|
| Blood and lympahtic system disorders | - | - | - | Lymphadenopathy | - | - |
| Immune system disorders | - | - | - | Hypersensitivity reactions (includes rash, urticaria) | - | - |
| Nervous system disrders | Headache | - | - | - | - | - |
| Musculoskeletal and connective tissue disorders | Myalgia | - | - | - | - | - |
| General disorders and administration site conditions | Vaccination site pain | Vaccination site redness, Vaccination site swelling | - | - | - | - |
Please refer to the SmPC for additional safety information.
No safety signals were detected in infants up to 24 months of age.1
The incidences of adverse events reported within 1 month after birth in infants were similar in the ABRYSVO group (38%) and the placebo group (35%).1
Contraindications1
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the SmPC.
| Special warning | Precaution for use |
|---|---|
| Traceability | In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. |
| Hypersensitivity and anaphylaxis | Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. |
| Anxiety-related reactions | Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from fainting. |
| Concurrent illness | Vaccination should be postponed in individuals suffering from an acute febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. |
| Thrombocytopenia and coagulation disorders | ABRYSVO should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding or bruising may occur following an intramuscular administration to these individuals. |
| Immunocompromised individuals | The efficacy and safety of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of ABRYSVO may be lower in immunosuppressed individuals. |
| Individuals less than 28 weeks gestation | ABRYSVO has not been studied in pregnant individuals less than 24 weeks of gestation and should not be used in pregnant individuals less than 28 weeks of gestation. |
| Limitations of vaccine effectiveness | As with any vaccine, a protective immune response may not be elicited after vaccination. |
| Excipients | This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium‑free’. ABRYSVO contains polysorbate 80. Polysorbate 80 may cause hypersensitivity reactions. |
Click here for information about the preparation, dosing, administration, storage, and co-administration of ABRYSVO.
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1. ABRYSVO (Respiratory Syncytial Virus Vaccine [bivalent, recombinant]) Summary of Product Characteristics for United Kingdom. Available at: https://www.medicines.org.uk/emc/product/15309.
2. Reeves, R. M. et al. J Infect, 2019. 78: 468-475.
3. University of Oxford. Vaccine Knowledge Project. Respiratory Syncytial Virus (RSV). Available at: https://vaccineknowledge.ox.ac.uk/rsv-respiratory-syncytial-virus-infographic [Accessed February 2026].
4. UKHSA. Respiratory syncytial virus (RSV): symptoms, transmission, prevention, treatment. Available at: https://www.gov.uk/government/publications/respiratory-syncytial-virus-rsv-symptoms-transmission-prevention-treatment/respiratory-syncytial-virus-rsv-symptoms-transmission-prevention-treatment [Accessed February 2026].
5. Cromer, D, et al. Lancet Public Health. 2017; 2(8): e367-e374.
6. Fauroux B, et al. Infect Dis Ther. 2017; 6(2): 173-197.
7. Williams TC, et al. Lancet Infect Dis. 2025; 9:655-662.
8. McLachlan I, et al. Lancet Infect Dis. 2025.
9. Suryadevara, M. Journal of the Pediatric Infectious Diseases Society. 2024; 13(2): S110–S114.
10. Niewiesk S. Front Immunol. 2014; 5: 446.
11. MAVIS Study. Available at: https://www.bristol.ac.uk/media-library/sites/ccah/documents/mavis/Mother's%20newsletter_final_print.pdf [Accessed February 2026].
12. Collins J, et al. Hum Vaccin Immunother. 2014; 10(10): 2922–2929.
13. Public Health Scotland. UK-wide report highlights success of Scotland's RSV vaccination programme- News-Public Health Scotland. Available at: https://publichealthscotland.scot/news/2025/july/uk-wide-report-highlights-success-of-scotland-s-rsv-vaccination-programme/. [Accessed February 2026].
14. United Kingdom Health Security Agency (UKHSA). Respiratory syncytial virus (RSV) vaccination programme. Available at: https://www.gov.uk/government/collections/respiratory-syncytial-virus-rsv-vaccination-programme. [Accessed February 2026].
15. Kampmann, B. et al. The New England Journal of Medicine. 2023;388:1451-64.
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