Real World Data | ABRYSVO® (Respiratory Syncytial Virus Vaccine (bivalent, recombinant))

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ABRYSVO^®▼(Respiratory Syncytial Virus Vaccine [bivalent, recombinant]) Prescribing Information for the United Kingdom click here.

UK Real-World Data with ABRYSVO

ABRYSVO is indicated for:¹

Active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.
Active immunisation for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

The use of this vaccine should be in accordance with official recommendations.¹

Since the introduction of RSV immunisation programmes in the UK, published real-world evidence has evaluated ABRYSVO across both adult and maternal vaccination settings.

The studies below include UK data from older adults hospitalised with RSV-associated respiratory illness, UK-wide evidence across England, Wales, Scotland and Northern Ireland, and infant hospitalisation outcomes following maternal vaccination.^2-8

Older Adult Vaccination

HARISS Study (Symes et al., 2025)²

A multicentre test-negative case-control study conducted across 14 NHS hospitals in England found ABRYSVO was associated with 82.3% vaccine effectiveness against RSV-associated ARI hospitalisation in adults aged 75-79 years.

View Study Details²

Study Methodology

Estimates effectiveness of ABRYSVO against RSV-related ARI hospitalisations among adults aged 75-79 in England during the 2024-2025 RSV season (October 1st 2024 - March 31st 2025).

Adjusted vaccine effectiveness results for the 2024-2025 season

When ABRYSVO was administered at least 14 days before hospital presentation:

	Adjusted VE	Confidential 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.

Key takeaway

ABRYSVO was associated with protection against RSV-associated hospitalisation in adults aged 75-79 years in England.²

Study limitations

The study was conducted during a single season
The study sample was not large enough to assess VE against more severe outcomes alone such as intensive care admission
Testing procedures may have varied across sites. RSV subtyping data (RSV-A and RSV-B) was not reported
Because the controls selected for this study were negative for RSV, influenza and SARS-CoV-2, it was not possible to perform a sensitivity analysis using controls who were RSV-negative but positive for influenza and/or SARs-CoV-2
Despite assessing relevant confounders and adjusting for them when appropriate, residual confounding may still influence results

ARI: acute respiratory infection. CI: confidence interval. RSV: respiratory syncytial virus, VE: vaccine effectiveness

England: National impact analysis of RSV vaccination programme (Mensah et al., 2025)³

A national analysis of RSV-associated hospitalisations in England which found a 30% reduction in hospital admissions among vaccine-eligible older adults following introduction of the RSV vaccination programme.

View Study Details³

Study Methodology

This national population-level analysis evaluated the early impact of the RSV vaccination programme in England. RSV-associated hospital admissions among adults aged 70–84 years registered with a general practitioner in England were analysed before and after programme implementation using statistical modelling adjusted for vaccine eligibility and population size.

Key Findings

Estimated 30% reduction

Reduction in RSV-associated hospitalisations observed following introduction of the RSV vaccination programme in England.

72% estimated vaccine effectiveness

Observed reductions in hospitalisations were consistent with an estimated vaccine effectiveness of approximately 72%

Key takeaway

Introduction of the RSV vaccination programme was associated with a reduction in RSV-related hospitalisations among vaccine-eligible older adults in England during the first programme season.

Study limitations

The analysis evaluated the early impact of the programme during the first RSV season following implementation.
As an observational study, causality cannot be definitively established.
Other factors, including seasonal variation in RSV circulation, may have influenced hospitalisation rates.
Findings were derived from population-level modelling and should be interpreted within the context of the study methodology.

Scotland: National impact analysis of RSV vaccination programme⁴(Hameed et al, 2025)

A population-level analysis in Scotland which found a 62.1% reduction in RSV-associated hospitalisations among vaccine-eligible older adults following introduction of the RSV vaccination programme.

View Study Details⁴

Study Methodology

This population-level analysis evaluated the early impact of the RSV vaccination programme in Scotland. RSV-associated hospital admissions among adults aged 70-84 years were assessed using a regression discontinuity design, comparing vaccine-eligible adults aged 75-79 years with neighbouring age groups that were not eligible for vaccination during the same period.

Key Findings

Estimated 62.1% reduction in RSV-associated hospitalisations

A 62.1% reduction in RSV-associated hospital admissions was observed following introduction of the RSV vaccination programme in Scotland

Estimated vaccine effectiveness of 85.7%

Observed reductions in hospitalisations were consistent with an estimated vaccine effectiveness of 85.7%

Key Takeaway

Introduction of the RSV vaccination programme was associated with fewer RSV-related hospital admissions among vaccine-eligible older adults in Scotland during the first programme season

Study Limitations

The analysis evaluated the early impact of the programme during the first RSV season following implementation
Sample sizes within individual age groups were relatively small
As an observational population-level study, causality cannot be definitively established
Findings were based on aggregated data and statistical modelling and should be interpreted within the context of the study methodology

4-Nation Meta-analysis (Bucholc etc al., 2026)⁵

A UK-wide analysis of 11,117 adults aged 74-79 years across England, Wales, Scotland and Northern Ireland estimated 75% vaccine effectiveness against RSV-related hospitalisation. The RSV vaccination programme was estimated to avert approximately 643 RSV-related hospital admissions during the 2024-25 season.

View Study Details⁵

Study Methodology

The study evaluated the effectiveness of ABRYSVO against RSV-related hospitalisation among adults aged 74-79 years during the first UK RSV vaccination programme season (30th September 2024 to 30th March 2025). National surveillance, vaccination and hospital admissions datasets from England, Wales, Scotland and Northern Ireland were linked at an individual patient level.

Adjusted vaccine effectiveness results

Nation	Adjusted VE (%)
England	74
Northern Ireland	77
Scotland	81
Wales	82
Pooled UK estimate	75

Key findings

75%

Pooled VE against RSV-related hospitalisations

11,117

Adults aged 74-79 years included across the UK

643

Hospital admissions estimated to have been averted

Key takeaways

Real-world evidence from England, Wales, Scotland and Northern Ireland estimated 75% vaccine effectiveness against RSV-related hospitalisation in adults aged 74–79 years.
The RSV vaccination programme was estimated to avert approximately 643 RSV-related hospital admissions across the UK during the first programme season.

Study limitations

The study was conducted during a single season.
The study sample was not large enough to assess VE against more severe outcomes alone such as intensive care admission.
Testing procedures may have varied across sites. RSV subtyping data (RSV-A and RSV-B) was not reported.
Because the controls selected for this study were negative for RSV, influenza and SARS-CoV-2, it was not possible to perform a sensitivity analysis using controls who were RSV-negative but positive for influenza and/or SARs-CoV-2.
Despite assessing relevant confounders and adjusting for them when appropriate, residual confounding may still influence resultsRSV: respiratory syncytial virus. SARs-CoV-2: severe acute respiratory syndrome coronavirus 2. VE: vaccine effectiveness.

Maternal Vaccination

Bronchstop 2024 - 2025 (Williams et al, 2025)⁶

A national programme of bivalent prefusion F vaccination in pregnancy and protection against respiratory syncytial virus hospitalisation in infants until age 6 months in the UK: a multicentre, prospective, test-negative, case–control study.

View Study Details⁶

Study methodologyStudy MethodologyThis multicentre, test-negative, case-control study evaluated the effectiveness of maternal RSV vaccination with ABRYSVO administered at ≥28 weeks' gestation against RSV-associated hospitalisation with acute lower respiratory illness (ALRI) in infants aged under 6 months during the 2024–2025 RSV season in the UK. Vaccine effectiveness was estimated by comparing maternal vaccination status between RSV-positive and RSV-negative infants hospitalised with ALRI.

Results from the 2024-2025 season

Study limitations

Limited vaccine coverage (~30%) in period of study.
- Results don’t reflect full season. RSV-positive infants were younger vs. RSV-negative group. Low initial uptake may reduce precision of effectiveness estimates.
Study population 81% White; aligns with UK demographics but limits ethnic diversity.
Dynamic uptake and unequal case-control ratio (391 vs 146) may impact power; accounted for in sample size.
Powered only for primary objective (VE vs RSV hospitalisation with ALRI); severe outcome analyses are exploratory.

ALRI: acute lower respiratory illness. RSV: respiratory syncytial virus.

Bronchstop 2025 - 2026 (O'Hagen et al, 2026)⁷

View Study Details⁷

Study Methodology

This multicentre, prospective, test-negative, case-control study evaluated the effectiveness of maternal RSV vaccination against RSV-associated hospitalisation in infants up to 6 months of age across the United Kingdom during the 2025–2026 RSV season.

Key Findings

Protection against RSV hospitalisation

Maternal RSV vaccination was associated with protection against RSV-associated hospitalisation in infants up to 6 months of age.

National programme evidence

The study evaluated outcomes following implementation of the UK maternal RSV vaccination programme.

Key Takeaway

National programme data demonstrated continued protection against RSV-associated hospitalisation in infants up to 6 months of age following maternal RSV vaccination.

Study Limitations

The study was conducted during a single RSV season
Findings represent programme experience during an early phase of implementation
As an observational study, causality cannot be definitively established
Findings should be interpreted within the context of the study design and population assessed

Scotland Population level study (McLachlan et al, 2025)⁸

Effectiveness of the maternal RSVpreF vaccine against severe disease in infants in Scotland, UK: a national, population-based case-control study and cohort analysis.

View Study Details⁸

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

82.2% (95% CI, 75.1-87.3; p<0.0001)
43 (12·1%) cases and 1518 (43·2%) controls.

The adjusted effectiveness of ABRYSVO in preventing hospitalisation among infants of mothers vaccinated suboptimally (≤14 days before delivery) was

31.7% (95% CI, -15.2-59.5; p=0.2)

18 (5·1%) cases and 205 (5·8%) controls.

Study limitations

The study was conducted during a single season, precluding analysis of duration of protection beyond 90 days and potential variation in VE across different seasons.
The study was unable to determine which infants might have also received a monoclonal antibody. However, the numbers of doses given were expected to be small and restricted specifically to preterm or at-risk infants. Therefore, it is unlikely to have materially influenced overall VE estimates.
A larger sample size is required to allow analysis of RSV-related hospitalisations by severity, such as ICU admissions.
Estimates of averted hospitalisations did not account for wider population-level transmission dynamics following introduction of the vaccine programme.

Within this population, cases were defined as infants aged 90 days or younger with an RSV-related hospital admission for (LRTI; first event only) and an RSV-positive PCR test within 14 days before or 2 days after hospital admission.

CI: confidence interval. ICU: intensive care unit. LRTI: lower respiratory tract infections. VE: vaccine effectiveness.

This content is for the United Kingdom only. Please refer to the Summary of Product Characteristics (SmPC) for more information.

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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.

Symes R, et al. Lancet Infect Dis. 2025; doi:10.1016/S1473-3099(25)00546-8.

Mensah A. Early impact of RSV vaccination in older adults in England. Lancet. Published online 24 March 2025. doi:10.1016/S0140-6736(25)00346-0.

Hameed S, et al. Early evidence of RSV vaccination impact on hospitalisation rates of older people in Scotland. Lancet Infect Dis. 2025. doi:10.1016/S1473-3099(25)00064-7.

Bucholc M, et al. Lancet Reg Health Eur. 2026;64:101620.

Williams TC, Marlow R, Cunningham S, et al. Bivalent prefusion F vaccination in pregnancy and respiratory syncytial virus hospitalisation in infants in the UK: results of a multicentre, test-negative, case-control study. Lancet Child Adolesc Health. 2025;9(9):655-662.

O'Hagan S, et al. A national programme of bivalent prefusion F vaccination in pregnancy and protection against respiratory syncytial virus hospitalisation in infants until age 6 months in the UK: a multicentre, prospective, test-negative, case-control study. Lancet Child Adolesc Health. 2026; doi:10.1016/S2352-4642(26)00134-3.

McLachlan I, et al. Effectiveness of the maternal RSVpreF vaccine against severe disease in infants in Scotland, UK: a national, population-based case-control study and cohort analysis. Lancet Infect Dis. 2025.

PP-A1G-GBR-0668. August 2026

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