Update on RSV prophylaxis

In July 2024, the STIKO issued a new recommendation.

Respiratory syncytial virus (RSV) can cause serious respiratory illnesses, especially in young children. Infants and toddlers under two years of age are particularly vulnerable to severe cases.

Symptoms can range from mild cold-like symptoms to severe respiratory distress. Each year, 10,000 to 20,000 children in Germany are hospitalized due to RSV infections.

Until now, particularly vulnerable babies and infants (for example, very premature infants, babies with congenital lung diseases, etc.) have been protected against RSV infection with passive immunization.

Now, another type of RSV prophylaxis is available and recommended for all babies. This involves a monoclonal antibody that provides immediate protection against RSV after administration. The active ingredient is called 'Nirsevimab,' and the brand name is Beyfortus.

How does the immunization process work?

The baby receives an injection in the thigh muscle (similar to a vaccination). Because this injection contains antibodies against the RSV virus, there is immediate immunity. This is why it's called passive immunization and not a vaccination (because the baby does not produce its own antibodies).

How effective is prophylaxis with nirsevimab (Beyfortus)?

Studies show that administering this monoclonal antibody reduces the risk of severe RSV infection in infants before their first birthday by approximately 80%. The duration of protection is shorter than with a conventional vaccine, lasting about 6 months. Nevertheless, a single dose per RSV season is sufficient.

When should prophylaxis be administered?

For babies born during RSV season (October–March), administration is recommended at the U2 or U3 check-up. Babies born between April and September should receive prophylaxis at the beginning of RSV season, i.e., early October.

How many doses and how much vaccine will my baby receive?

Vapers containing 50 mg and 100 mg are available. Babies weighing less than 5 kg receive 50 mg, children weighing more than 5 kg should receive 100 mg.

Nirsevimab (Beyfortus) can be administered at the same time as the other vaccinations recommended by the STIKO (Standing Committee on Vaccination).

Should babies whose mothers were vaccinated during pregnancy also receive RSV prophylaxis?

If a pregnant woman was vaccinated in time, there is approximately 6 months of protection from the time of birth. If the RSV season continues beyond this period, further immunization of the child may be beneficial. The STIKO does not provide more specific guidance on this.

Should children also be vaccinated in their second year of life?

Children at risk should also be vaccinated in their second year of life. The relevant patient groups are specifically listed in the RSV prophylaxis guideline. In all healthy children, it is assumed that sensitization to the RSV virus has already occurred by the age of two, and therefore, illness is significantly milder, making prophylaxis unnecessary.

Why isn't there a vaccine yet?

Currently, more and more vaccine doses are being delivered. Because there are still some minor supply bottlenecks, high-risk children and young infants are being vaccinated first. However, there should be enough vaccine for all children. Currently, it makes the most sense to stay in contact with your pediatrician and pharmacies and regularly inquire about the current status. Many pharmacies also maintain waiting lists.

Does my statutory health insurance cover Beyfortus?

Generally, (almost) all statutory health insurance companies cover the vaccinations recommended by the STIKO (Standing Committee on Vaccination). When new recommendations are issued, as is currently the case with RSV prophylaxis, it sometimes takes a few months until comprehensive coverage is clearly regulated. Strictly speaking, RSV prophylaxis is not a vaccination, which is why reimbursement is not covered by the vaccination guidelines.

Therefore, it makes sense to contact your health insurance provider directly. Often, submitting a private prescription and the pharmacy receipt to your health insurance provider is sufficient for reimbursement.