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VACCINATIONS

RSV Immunisation (Beyfortus)


Understanding RSV and Its Impact on Infants

Respiratory Syncytial Virus (RSV) is a common virus that infects the respiratory tract, causing illnesses ranging from mild, cold-like symptoms to severe respiratory conditions, including bronchiolitis and pneumonia. Infants, especially those under six months, are particularly vulnerable to severe RSV infections, which can result in hospitalization.



Current Recommendations in Germany: Protecting Your Newborn with Passive Immunization

To safeguard newborns and infants during their first RSV season, STIKO recommends passive immunization (not a vaccination)  with a monoclonal antibody called Nirsevimab (brand name: Beyfortus). Nirsevimab reduces the risk of severe RSV disease in infants by about 80 percent, effectively protecting against hospitalization and intensive care. This single-dose injection provides immediate protection by supplying antibodies that help prevent severe RSV-related illnesses.



Timing of Administration

All infants can be protected with nirsevimab during their first RSV season:


  • RSV vaccination during pregnancy is not currently recommended by STIKO, as further data on efficacy and safety in widespread use are still being evaluated. However, since 08/2023, an approved RSV vaccine, Abrysvo (Pfizer), has been available for pregnant women. The goal is for the mother to develop antibodies after vaccination, which are then passed on to the child via the placenta. This provides the newborn with so-called nest protection and is already protected during the first months of life, which is why an additional dose of Beyfortus for the infant is not necessary.


  • Babies born between October and March receive the antibody as early as possible, often directly after birth, upon discharge from the hospital, or during the U2 (3rd-10th day of life).


  • Babies born between April and September will receive the gift in the fall (September to November) before the season begins.


  • If the dose is missed at the beginning of the season, it should be given during the season.


  • What applies to children outside the standard time window? Because the RSV season varies from year to year and from region to region, decisions are made on an individual basis for infants born before April, up to their first birthday, who have not yet received prophylaxis. Health insurance coverage plays an important role here. Therefore, parents should consult their health insurance provider early on to clarify their individual eligibility for RSV prophylaxis.



Dosage

  • 50 mg for infants under 5 kg

  • 100 mg for infants weighing 5 kg or more

  • Typically, a single dose per season is sufficient. 

  • For children at risk (e.g., premature babies, children with heart or lung disease, Down syndrome, neuromuscular disorders, or immune deficiencies), an additional dose in a second season may be advisable.



Safety and Efficacy

Clinical studies have demonstrated that Nirsevimab is effective in reducing the risk of severe RSV infections in infants. No major hypersensitivity reactions are reported.



Costs and Reimbursement

One dose of Beyfortus currently costs approximately €450, regardless of whether it is 50 mg or 100 mg (as of October 2025). This includes the doctor's fee.


    Statutory health insurance (GKV):

  • Since September 13, 2024, infants have been entitled to RSV prophylaxis until the end of their first year of life.

  • The costs of the medication and the medical treatment are covered; there are no additional costs for parents.


    Privately insured (PKV):

  • Private health insurance generally covers RSV prophylaxis, but the conditions depend on the plan. 

  • Parents should therefore consult with their insurance beforehand. 

  • Two options are available:

  • The pediatrician’s office purchases Beyfortus directly and bills.

  • A private prescription is issued, parents pick up the dose from the pharmacy (approximately €450), and submit the pharmacy receipt and doctor's bill to the private health insurance provider.
    In addition, medical services can be billed according to the German Fee Schedule (GOÄ).



News from studies: How effective is Nirsevimab really?


     Clinical studies confirm how effective nirsevimab can be in protecting infants

  • France: In a very large study of over 82,000 infants, nirsevimab reduced the risk of hospitalization for RSV by 65%. Severe cases were also significantly reduced: admissions to intensive care units by 74%, and cases requiring ventilation or oxygen by 66–67% (Jabagi et al., 2025).

  • Spain (Navarra): This study demonstrated 88.7% efficacy in preventing PCR-confirmed RSV infections (Ezpeleta et al., 2024).

  • Spain (Catalonia): RSV-related hospitalizations decreased by 74%, and intensive care admissions even decreased by 85% (Perramon-Malavez et al., 2025).

  • Spain (Madrid): In another large cohort study, efficacy was 93.6% against hospital admissions and 94.4% against intensive care admissions – although protection declined somewhat over the course of the season (Barbas del Buey et al., 2024).


     Systematic reviews and meta-analyses also confirm these results:


  • Premature infants benefited from a significant risk reduction for RSV infections requiring medical treatment (odds ratio 0.25) and for hospital admissions (OR 0.27) (Wang et al., 2025).

  • A multi-country review of over 11,000 children also showed a clear reduction in RSV-related disease and hospital admissions (Tanashat et al., 2025).

  • The largest analysis to date, encompassing 32 real-world studies, demonstrated that nirsevimab reduces the overall risk of RSV-related hospitalization by 83% (Sumsuzzman et al., 2025).



Conclusion

Protecting infants from RSV is crucial, given the potential severity of the infection in early life. While maternal vaccination is not currently recommended in Germany, passive immunization offers an effective alternative to safeguard infants during their most vulnerable period.




Status: 10/2025

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