RSV prophylaxis for all infants: STIKO recommends passive...

RSV prophylaxis for all infants: STIKO recommends passive…

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/Artur, stock.adobe.com

Berlin For the first time, the Standing Committee on Vaccination (STIKO) at the Robert Koch Institute (RKI) has issued a recommendation for passive immunization. It recommends a single dose of the monoclonal antibody Nirsevimab (Beyfortus) for newborns and infants in their first season of exposure to respiratory syncytial virus (RSV) infections.

The recommendation applies to all newborns and infants regardless of whether there are possible risk factors for a severe course of RSV infections.

By protecting babies from serious infections during their first RSV season, RSV-related hospital stays and deaths as well as outpatient and inpatient care bottlenecks should be avoided, as STIKO member Julia Tabatabai, doctor at the Center for Pediatric and Adolescent Medicine, Angelika Lautenschler Clinic, Heidelberg University Hospital, emphasized.

Severe respiratory infections with RSV are the most common reason for hospitalization for children in their first year of life, said Tabatabai. Overall, one in four children with an RSV infection in their first year of life would receive medical treatment.

Cost

According to Sanofi, the cost of immunization with the RSV prophylaxis nirsevimab (Beyfortus) currently amounts to 325.50 euros (pharmaceutical company’s selling price of 350 euros less a seven percent manufacturer’s discount). The company has reduced the price as of May 15, 2024, it said. Last season, the price was around 1,058 euros.

Johannes Liese, Head of Pediatric Infectious Diseases and Immunology, Children’s Clinic and Polyclinic, University Hospital Würzburg, also emphasized that the annual RSV season is a huge challenge both in the pediatric practice and in the children’s clinic.

The studies on RSV prophylaxis with Nirsevimab have shown that protection is possible over a period of six months after administration, Liese continued. There is a protective effect of around 75 percent. This has been confirmed by real-world data from France, Spain and the USA – countries in which prophylaxis with Nirsevimab was already carried out in the last RSV season.

In contrast, the STIKO does not currently recommend maternal active RSV vaccination in order to protect the newborn for the first few months after birth. An RSV vaccine (Abrysvo) is currently approved for vaccinating women in the 24th to 36th week of pregnancy.

The data available is currently not sufficient to make a recommendation, as Tabatabai explained. On the one hand, too few pregnant women were included in the studies and, on the other hand, the risk of premature birth cannot be reliably assessed.

Birthday decides when the antibodies are administered

The timing of RSV prophylaxis with Nirsevimab depends on the child’s birthday: If it is between April and September outside the RSV season, the injection should be given in the autumn before the start of their first RSV season, according to the STIKO.

If the birthday falls between October and March, i.e. during the RSV season, the Nirsevimab should be administered as soon as possible after birth. According to the STIKO, it should ideally be administered upon discharge from the birthing facility, for example as part of the U2 check-up, which is carried out on the third to tenth day of life.

Newborns born during the RSV season who have to stay in hospital for a longer period after birth should receive the intramuscular injection in good time before discharge, advises the STIKO. It can also be considered during the hospital stay in order to avoid nosocomial infections under certain circumstances.

For healthy children of mothers who were vaccinated against RSV during pregnancy, Nirsevimab administration is generally not necessary, according to the STIKO. However, if there are risk factors in the newborn or if the pregnant woman was only vaccinated in the two weeks before birth, it is recommended to also administer the antibody.

Even infants who have already had a laboratory-confirmed RSV infection generally do not require nirsevimab prophylaxis.

Nirsevimab is injected intramuscularly into the thigh. The dosage depends on the baby’s body weight. If it is less than five kilograms, the dosage is 50 milligrams. This doubles to 100 milligrams if the infants weigh five kilograms or more. A missed Nirsevimab injection should be given as soon as possible during the first RSV season.

There is currently no STIKO recommendation for RSV vaccination of adults over 60 years of age. The STIKO is looking into the issue, it said in response to a request from the German Medical JournalThere is no date yet for a possible recommendation. © aks/aerzteblatt.de

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