RSV prophylaxis with nirsevimab: advantages for healthy children in their first RSV season

Nirsevimab was granted marketing authorization in November 2022 for newborns and infants in their first RSV season to prevent lower respiratory tract infections caused by the respiratory syncytial virus (RSV). In accordance with the therapeutic information stipulated by the G‑BA however, reimbursability in Germany was previously limited to children at high risk of RSV disease, for example due to congenital heart defects. The Institute for Quality and Efficiency in Health Care (IQWiG) conducted a benefit assessment commissioned by the Federal Joint Committee ( G‑BA) to examine whether nirsevimab, compared with watchful waiting, also offers an advantage in children who are not at high risk.

The (German-language) report was published in June 2025, an English translation in January 2026.

According to this assessment, prophylaxis with nirsevimab in the first RSV season has exclusively positive effects: Children without an increased risk of RSV disease who are immunized with nirsevimab develop (severe) RSV lower respiratory tract infections notably less frequently. IQWiG therefore determined an indication of a considerable added benefit.

RSV infections are the most common cause of hospitalization in infants

RSV causes acute respiratory diseases. It spreads mainly in autumn and winter. RSV infections range from mild respiratory tract infections to severe lower respiratory tract diseases. Infants in particular are at high risk of becoming severely ill. In severe cases, ventilation is required.

In their first year of life, 50 to 70 percent of infants suffer at least one RSV infection. In Germany, these infections are one of the most common reasons for hospitalization, even though only a small number of children overall require inpatient treatment. Children in their first six months of life are at particular risk.

Two large studies showed consistent results

The IQWiG benefit assessment was based on the two randomized controlled trials HARMONIE and MELODY. Around 8000 healthy children under the age of one year took part in the HARMONIE study, and around 3000 in the MELODY study. The infants were enrolled in the studies before and during their first RSV season and were not eligible for treatment with palivizumab. Palivizumab is an antibody approved exclusively for RSV prophylaxis in children at high risk of severe disease progression.

The most important result of the studies: Severe RSV lower respiratory tract infections occurred significantly less frequently in children who received nirsevimab than in the control group. Of the children in the control groups, 1.7% (HARMONIE) and 2.0% (MELODY) had to be hospitalized 151 days after the injection, compared with only 0.3% and 0.4%, respectively, in the nirsevimab groups. After 366 and 361 days, the values were 2.4% (HARMONIE) and 2.2% (MELODY) in the control groups, and 1.1% and 0.5% in the nirsevimab groups. These positive effects of immunization were not accompanied by significant side effects.

In summary, IQWiG determined an indication of a considerable added benefit of nirsevimab in comparison with watchful waiting. This applies to the prophylaxis of RSV lower respiratory tract disease in children in their first RSV season.

The G‑BA decides on the extent of the added benefit

The dossier assessment is part of the early benefit assessment in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G‑BA. After publication of the dossier assessment, the G‑BA conducts a commenting procedure and makes a decision on the extent of the added benefit.