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Dsseldorf The German Society for Pediatric Infectious Diseases (DGPI), together with other specialist societies and organizations, has supplemented the guideline for the prevention of serious illnesses caused by respiratory syncytial virus (RSV) in children at risk (version 5.0 from 2023).

The guideline group explained that the data situation on prophylaxis with monoclonal antibodies has improved significantly since the guideline was published.

In Spain, France, Luxembourg and the USA, extensive recommendations have already been made for the immunization of all full-term newborns, including children at risk, with the new monoclonal antibody Nirsevimab (Beyfortus) in the 2023/24 RSV season.

According to the group of authors, the observational data subsequently collected have significantly expanded the data base on the safety and effectiveness of nirsevimab. This new data has now been incorporated into the guidelines as a so-called amendment.

Since June 2024, the Standing Vaccination Commission (STIKO) has recommended passive immunization against RSV with the monoclonal antibody Nirsevimab for all newborns and infants, regardless of risk factors.

Amendment especially for children at risk in the second RSV season

What is particularly important in the guideline and its amendment is that the group of children at risk is outlined for whom prophylaxis with the antibody should also be carried out in a second RSV season.

The European Medicines Agency (EMA) granted the extended approval of nirsevimab up to the age of 24 months in August 2024. The recommended dose for this is a 200 milligram single dose administered as two intramuscular injections.

In Spain and the USA, immunization with nirsevimab was recommended and carried out in defined risk children in their second RSV season as early as 2023/2024, reports the guideline group.

Prophylaxis against RSV is extended to all premature babies, regardless of gestational age, for the first RSV season and, in the case of ongoing moderate or severe bronchopulmonary dysplasia/chronic lung disease requiring treatment, in addition to the second RSV season, according to the amendment to the guideline (page 52). .

The same applies to infants with previous pulmonary illnesses, regardless of their severity, for their first RSV season, as well as after an individual risk assessment, for example chronic lung disease requiring treatment, in addition to the second RSV season, the guideline continues.

In addition, prophylaxis against RSV is extended to all infants with congenital heart defects, regardless of their severity, for their first RSV season, as well as for the second RSV season if hemodynamically relevant heart disease persists.

The same applies to prophylaxis against RSV for all infants with congenital or acquired forms of severe immune deficiency for their first RSV season, and if the immune deficiency persists, also for the second RSV season.

Prophylaxis against RSV is also being extended to all infants with neurological and syndromic underlying diseases, regardless of their severity, for their first RSV season, and after individual risk assessment (depending on the severity of the underlying disease) in addition for the second RSV season.

The amendment also indicates that infants born between April and September should, if possible, receive nirsevimab in the fall before the start of their first RSV season, for example from September to November. Newborns, who are usually born between October and March during the RSV season, should receive nirsevimab as soon as possible after birth. © hil/aerzteblatt.de