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Review
. 2025 Jan 10:13:25151355241310601.
doi: 10.1177/25151355241310601. eCollection 2025.

The recent landscape of RSV vaccine research

Karen Kelleher  1   2 , Nadisha Subramaniam  1   2 , Simon B Drysdale  3   2
Affiliations
Review

The recent landscape of RSV vaccine research

Karen Kelleher et al. Ther Adv Vaccines Immunother. .

Abstract

Respiratory syncytial virus (RSV) causes a significant burden of acute respiratory illness across all ages, particularly for infants and older adults. Infants, especially those born prematurely or with underlying health conditions, face a high risk of severe RSV-related lower respiratory tract infections (LRTIs). Globally, RSV contributes to millions of LRTI cases annually, with a disproportionate burden in low- and middle-income countries (LMICs). The RSV virion outer capsule contains glycoproteins G and F which are essential for viral entry into respiratory epithelial cells and represent key targets for therapeutics development. The F-glycoprotein has several highly conserved antigenic sites that have proven useful targets for the development of monoclonal antibodies (mAbs) against RSV. Historically, prevention in infants was limited to the mAb palivizumab, which, despite its efficacy, was costly and inaccessible in many regions. Recent advancements include nirsevimab, a long-acting mAb that has shown substantial efficacy in reducing medically attended RSV-related disease in infants, in phase III clinical trials, early regional and national real-world data. In addition, three new vaccines have been approved: two protein subunit vaccines and a messenger RNA vaccine. The vaccines are all licenced for use in older adults, with one also approved as a maternal vaccine. Promising candidates in development include the mAb clesrovimab, which has an extended half-life and high levels in the nasal epithelial lining and high safety and efficacy profiles in late-stage trials. There are also a wide range of vaccine candidates currently in late-stage clinical trials. These developments signify a major advancement in RSV prevention strategies, offering improved protection for high-risk populations. With the ongoing rollout of the recently licenced vaccines and mAbs internationally, the landscape of RSV care is rapidly changing. We also must ensure these advances reach those in LMICs who need these therapies most.

Keywords: infants; monoclonal antibodies; older adults; vaccines.

Plain language summary

What’s new in preventing RSV? A common cause of serious chest infections in infants and the elderly. RSV (respiratory syncytial virus) is a virus that causes colds and chest infections. Babies and older adults, whose immune systems are more vulnerable, are much more likely to become severely unwell with RSV and need treatment in hospital. RSV causes millions of people to have serious chest infections worldwide each year. Death is common in lower income countries while in high income countries RSV contributes disproportionately to healthcare expenditure for children and older adults. Recent studies have shown that RSV is a bigger cause of severe illness and death in older adults than previously recognised. RSV has a surface protein, the F protein, that helps it infect cells. Viral proteins usually change frequently, but parts of the F protein are highly conserved (unchanging), making it a key target for new treatments. Monoclonal antibodies (mAbs) are customised medicines working similarly to natural antibodies in our bodies. RSV mAbs attach to the F protein, stopping RSV from entering human cells. Vaccines stimulate the body to produce similar antibodies. For many years, the only option to prevent RSV in infants was monthly injections of the mAb, palivizumab. Although effective, it was too expensive for widespread use. Recently, a new mAb, nirsevimab, showed great promise in protecting infants from RSV and is longer acting, highly effective, has no significant side effects and has high uptake, as shown in clinical trials and early real-world reports. There are also three newly approved vaccines: Abrysvo, Arexvy and mRESVIA. The vaccines were effective in clinical trials at preventing severe chest infections caused by RSV in older adults and were generally well tolerated. A small number of cases of Guillain Barre syndrome (GBS) (a nerve problem) have been reported following RSV vaccination in older adults, however a definitive link has not been established and safety surveillance is ongoing. Innovative upcoming treatments include a promising new monoclonal antibody, and multiple vaccines employing varied technologies. These developments mark a significant step forward in preventing severe RSV infections, offering better protection for those most at risk.

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Figures

Figure 1.
Figure 1.
The RSV genome and virion. RSV, Respiratory syncytial virus.
Figure 2.
Figure 2.
Antigenic sites of the pre-fusion F-protein targeted by various mAbs.
See this image and copyright information in PMC

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