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ABRYSVO®▼(Respiratory Syncytial Virus Vaccine [bivalent, recombinant]) Prescribing Information for the United Kingdom click here.
Older age is a known risk factor for RSV disease in adults2-6
3 minute video from global experts explaining the burden of RSV disease compared to influenza and the impact it has on older adults and the healthcare system.
Each year, RSV is estimated to lead to around 120,000 GP consultations, 13,000 hospitalisations, and 13,000 A&E attendances* for adults 75 years and older in the UK.**5
Hospital admission estimates were nearly 3 times higher† in adults ≥85 years compared to those 75-84 years old in England between October 2018 and April 2023.6
*Only includes A&E attendances that did not result in hospitalisation. **Data published in 2025. †587 admissions per 100,000 per year compared to 221 admissions per 100,000 per year.
ABRYSVO is the vaccine used for the RSV older adult National Immunisation Programme (NIP)
An older adult NIP using ABRYSVO was introduced into the UK in late summer 2024 (12th August in Scotland and 1st September in England)8.9
The eligible cohort for the NIP is now:7
1. Anyone 75 years or over who has not previously received a single dose of ABRYSVO
2. All residents in care homes for older adults
This cohort expansion is based on the advice from the Joint Committee on Vaccination and Immunisation (JCVI).7
A study reviewing ABRYSVO use in the RSV older adult NIP has shown real-world estimated vaccine effectiveness (VE) against hospital admission for RSV-associated acute respiratory infection (ARI) ranging between 72.8% (95% CI 39.5-89.3) and 88.6% (95% CI 75.6-95.6) in adults aged 75-79 who were vaccinated more than 14 days before hospital presentation.
Learn more about the detailed study methodology below.
Study methodology
Estimate the effectiveness of ABRYSVO against RSV-related ARI* hospitalisations among adults aged 75-79 in England during the 2024-2025 RSV season (October 1, 2024 - March 31, 2025).
Adjusted vaccine effectiveness results for the 2024-2025 season
When ABRYSVO was administered at least 14 days before hospital presentation:
| Adjusted VE | Confidence Interval (CI) | Cases (vaccinated) | Controls (vaccinated) | |
|---|---|---|---|---|
| Overall | 82.3% | (95% CI 70.6-90.0) | 16/173 | 308/833 |
| Adults with severe disease† | 86.7% | (95% CI 75.4-93.6) | 10/138 | 211/573 |
| Immunocompetent adults | 86.2% | (95% CI 73.6-93.6) | 9/126 | 218/609 |
| Immunosupressed adults | 72.8% | (95% CI 39.5-89.3) | 7/47 | 90/224 |
| Adults admitted with lower respiratory tract infections(LRTIs) | 88.6% | (95% CI 75.6-95.6) | 6/103 | 200/561 |
| Adults admitted for exacerabation of lung disease‡ | 77.4% | (95% CI 42.4-92.8) | 5/41 | 81/210 |
| Adults admitted for exacerbation of lung disease, heart disease or frailty‡ | 78.8% | (95% CI 47.8-93.0) | 5/45 | 88/230 |
| Chronic heart and vascular disease | 77.0% | (95% CI 59.1-88.0) | 13/110 | 189/506 |
| Chronic respiratory disease | 80.1% | (95% CI 62.4-90.6) | 10/93 | 194/508 |
†Severe disease includes requirement of oxygen supplementation; high-flow nasal oxygen; noninvasive ventilation or continuous positive airway pressure; invasive ventilation or mechanical ventilation; and admission to the intensive care unit on hospital admission and adults who died within 30 days of hospital admission.
‡ No LRTI.
Vaccination with ABRYSVO was associated with a reduction in hospitalisations due to RSV disease among older adults, including those with chronic illnesses and immunosupression.
Real-world analysis of data demonstrated that, when ABRYSVO was administered at least 14 days before hospital admission, the adjusted vaccine effectiveness was 82.3% (95% CI 70.6-90.0) against RSV-associated ARI hospitalisation.
Study limitations
*ARI was defined as respiratory symptoms or fever on admission, with suspected diagnoses including pneumonia or pneumonitis; non-pneumonia lower respiratory tract infection or acute bronchitis; exacerbations of chronic lung (e.g. COPD, asthma) or chronic heart disease (e.g. heart failure); exacerbation of frailty or poor mobility (a fall); or ARI accompanied by another reason for admission.
ARI=acute respiratory infection; VE=vaccine effectiveness; COPD=chronic obstructive pulmonary disease
Although it gets less attention than influenza, RSV is highly contagious and can be spread by asymptomatic carriers.11-13 Learn more about long RSV transmission and incubation periods and how symptoms can vary widely and are more severe at the extremes of age.11-16
In this video Rebecca shares her experience of RSV infection, including her symptoms, hospitalisation and the importance of being aware of RSV within the broader context of respiratory illnesses.
The safety profile of administering a single dose of ABRYSVO to individuals 18 years and older (n=20,275) was evaluated in clinical trials.1
The majority of reactions in individuals 18 years of age and older were mild to moderate in severity and resolved within 1-2 days of onset.1
The most frequently reported adverse reactions were fatigue (23%), headache (20%), vaccination site pain (19%) and myalgia (16%).1
| System organ class | Very common (≥1/10) | Common (≥1/100 to <1/10) | Uncommon (≥1/1000 to <1/100) | Rare (≥1/10,000 to <1/1000) | Very Rare (<1/10,000) | Not known (cannot be estimated from the available data) |
|---|---|---|---|---|---|---|
| Blood and lymphatic system disorders | - | - | - | Lymphadenopathy | - | - |
| Immune system disorders | - | - | - | Hypersensitivity reactions (includes rash, urticaria) | Anaphylaxis | - |
| Nervous system disorders | Headache | - | - | Guillain-Barré syndromea | - | - |
| Musculoskeletal and connective tissues disorders | Myalgia | Arthralgia | - | - | - | - |
| General disorders and administration site conditions | Fatigue, Vaccination site pain | Vaccination site redness, Vaccination site swelling | Pyrexia | Vaccination site pruritus, Vaccination site bruising, Vaccination site haematoma | - | - |
aFrequency reported in individuals 60 years of age and older
Please refer to the SmPC for additional safety information.
Contraindications1
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the SmPC.
| Special warning1 | Precaution for use1 |
|---|---|
| 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. |
| Guillain-Barré syndrome | Guillain-Barré syndrome has been reported rarely following vaccination with ABRYSVO in individuals ≥60 years1. The ABRYSVO patient information leaflet describes Guillain-Barré syndrome as a serious nerve condition that usually starts with pins and needles (an uncomfortable tingling sensation) and weakness of the legs and/or arms that can progress up to paralysis of part or all of the body, and include difficulty breathing. Urgent hospital treatment is required to help prevent the symptoms progressing and improve recovery, however the effects of Guillain-Barré syndrome may sometimes be long-lasting17. Healthcare professionals should be attentive to signs and symptons of Guillain-Barré syndrome in all ABRYSVO recipients to ensure correct diagnosis, in order to initiate adequate supportive care and treatment, and rule out other causes1. |
| 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.
This content is for the United Kingdom only. Please refer to the Summary of Product Characteristics (SmPC) for more information.
1. ABRYSVO (Respiratory Syncytial Virus Vaccine [bivalent, recombinant]) Summary of Product Characteristics for the United Kingdom. Available at: https://www.medicines.org.uk/emc/product/15309.
2. Fleming DM, et al. BMC Infect Dis. 2015;15:443–455.
3. Stephens LM, Varga SM. Vaccines (Basel) 2021;9(6):624.
4. UK Department of Health and Social Care. Respiratory syncytial virus (RSV) immunisation programme for adults aged 80 years and older: JCVI advice, 16 July 2025. Available at: https://www.gov.uk/government/publications/rsv-immunisation-programme-jcvi-advice-16-july-2025/respiratory-syncytial-virus-rsv-immunisation-programme-for-adults-aged-80-years-and-older-jcvi-advice-16-july-2025 [Accessed March 2026].
5. Vyse A, et al. Journal of Pharmaceutical Policy and Practice. 2025; 18:1, 2576618.
6. Johannesen, C. et al. The Lancet Regional Health – Europe. 2025; 51, 101227.
7. UK Health Security Agency. Expansion of RSV vaccine eligibility to those aged 80 years and older and residents in care homes for older adults letter. Available at: https://www.gov.uk/government/publications/rsv-vaccination-for-older-adults-expansion-of-eligibility/expansion-of-rsv-vaccine-eligibility-to-those-aged-80-years-and-older-and-residents-in-care-homes-for-older-adults-letter. [Accessed March 2026].
8. Public Health Scotland. UK-wide report highlights success of Scotland’s RSV vaccination programme. Available at: https://publichealthscotland.scot/news/2025/july/uk-wide-report-highlights-success-of-scotland-s-rsv-vaccination-programme/. [Accessed March 2026].
9. UK Health Security Agency. RSV vaccination of older adults: information for healthcare practitioners. Available at: https://www.gov.uk/government/publications/respiratory-syncytial-virus-rsv-programme-information-for-healthcare-professionals/rsv-vaccination-of-older-adults-information-for-healthcare-practioners. [Accessed March 2026].
10. Symes R, et al. Lancet Infect Dis. 2026; 26: 229-38.
11. Centres for Disease Control and Prevention. How RSV Spreads. Available at: https://www.cdc.gov/rsv/causes/index.html. [Accessed March 2026].
12. Carvajal JJ, et al. Front Immunol. 2019;10(2152):1-19.
13. Hall CB. Clin Infect Dis. 2000;31(2):590-596.
14. Eiland LS. J Pediatr Pharmacol Ther. 2009;14(2):75-85.
15. Talbot HK, et al. Infect Dis Clin Pract. 2016;24(6):295-302.
16. Centres for Disease Control and Prevention. RSV in older adults. https://www.cdc.gov/rsv/older-adults/index.html/ [Accessed March 2026].
17. ABRYSVO Patient Information Leaflet. Available at: www.medicines.org.uk/emc/product/15309/pil. [Accessed March 2026].
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