Pfizer has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved an extension to the licence of the Abrysvo® (respiratory syncytial virus vaccine (bivalent, recombinant)) to include the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18-59 years of age who are at increased risk for lower respiratory tract disease caused by RSV.1
The use of this vaccine in the UK should continue to follow official recommendations as part of the National Immunisation Programme.
In ‘at-risk’ groups, RSV infection can cause serious illness where the lower respiratory tract (smaller airways and lungs) is affected, leading to illnesses such as pneumonia.2,3
Individuals living with chronic medical conditions, RSV can exacerbate illnesses such as chronic obstructive pulmonary disease (COPD) and congestive heart failure. In severe cases, RSV infection may result in hospitalisation and, in some cases, can be life-threatening.1
Further detail on those covered in the ‘at-risk’ groups in the broadened licence comes from the individuals forming the study data submitted to the MHRA and now cited in the licence.
The study concerned was one of individuals aged 18-59 years considered to be at high risk of developing severe lower respiratory tract disease caused by RSV.
The chronic medical disorders of these subjects were Pulmonary (including asthma), Cardiovascular (excluding isolated hypertension/high blood pressure), renal, hepatic, neurologic, haematologic or metabolic (including diabetes mellitus and hyper/hypothyroidism).1
Older adults aged 75-79 years old are currently included in the National immunisation programme to help protect against lower respiratory infection caused by RSV, but infections also occur in younger age groups.
Around 3.2 million RSV infections are estimated to occur each year in 18-74 year olds in the UK,4,5 and each year it is thought 18-74 year-olds with RSV account for around 460,000 GP consultations, 14,000 A&E visits, and 10,000 hospitalisations, placing a significant strain on the NHS.6,7
In 2023, the annual cost to the NHS of caring for adults with RSV was estimated to be around £78.6 million.4 In reality, the prevalence and true burden of RSV is yet to be determined because testing is not routine in the UK, and insights on the NHS impact are provided by statistical modelling.3,4
The licence extension was based on positive data from Pfizer’s clinical trials, which demonstrated the efficacy of Pfizer’s RSV vaccine in preventing RSV-associated LRTD in adults aged 18-59 years considered to be at high risk of developing severe lower respiratory tract disease caused by RSV.1 The RSV vaccine was generally well-tolerated, with a safety profile consistent with that observed in older adults.8,9
Abrysvo is available to certain groups in the UK as part of the National Immunisation Programme.5 This currently includes a routine programme for pregnant women from 28 to 36 weeks of pregnancy and older adults who turned 75 on or after 1 September 2024.6 For the first year of the programme, there was a separate ‘catch-up’ programme for the older adult group but this only covers those aged 75-79 years old.10Pfizer’s RSV vaccine coverage has been estimated to reach 68% of eligible older adults in Scotland and early studies in March 2025 estimated that the programme led to 62% fewer hospital admissions in 75- to 79-year-olds, than would have occurred without vaccination. In England, where the programme was introduced later and uptake tracked slightly lower at 55%, a 30% reduction in hospital admissions was seen (figures from March 2025).11,12
Following a review of emerging real-world evidence and surveillance data, the Joint Committee on Vaccination and Immunisation (JCVI) has recommended broadening the National Immunisation Programme to include all adults aged 80 and over. We remain fully committed to work with relevant authorities to help successfully implement any potential changes to the RSV National Immunisation Programme.
