RSV information for you as a healthcare worker

Prevention of RSV through Immunization with Monoclonal Antibodies in Young Children during Their First Year: Communication, Information, and Barriers 

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• Collaboration between General Practitioners and Pediatricians
• Protective Measures and Target Groups
• What Can You Do Now? 
• What Barriers Remain?
• Broader Monitoring

In collaboration with general practitioners (Domus Medica and SSMG) and pediatricians (BVK-SBP and Belgian Academy of Paediatrics), we are working on communication regarding this campaign. We believe urgent action is needed to successfully complete the immunization campaign, and we see value in joining forces. We will keep monitoring the situation closely and update you on developments.

We aim to provide clear information based on confirmed data and clarify any uncertainties. This information has been compiled and streamlined from various official sources, reflecting the most recent and confirmed data available at the time of publication. We ask you not to distribute unverified information and to contact us with any questions.

Two protective measures and four specific target groups

To prevent severe RSV infection and hospitalization in infants, two protective measures will be available in Belgium in 2024. We advise you, as a healthcare professional, to inform your patients about these measures to protect the youngest members of our society:

Technical Product Information and Inclusion Criteria

We offer you objective technical information. It is up to you, as a healthcare professional, to assess with the parents, considering their unique context, which option is most suitable for a specific family.

Practical Administration:

• Can be administered to newborns during their stay in the maternity ward (e.g., during neonatal screening), in a hospital pediatrics consultation, or in a private practice consultation with a general practitioner or pediatrician. Various flowcharts will be provided for this.
• Concurrent administration with vaccines: 
  • As nirsevimab is a monoclonal antibody with passive immunization specifically against RSV, it is not expected to interfere with the active immune response to co-administered vaccines.
  • There is limited experience with concurrent administration of vaccines. When nirsevimab was given with routine childhood vaccines during clinical trials, the safety and reactogenicity profile of the concurrent regimen was similar to that of the vaccines given alone. Nirsevimab can be given concurrently with childhood vaccines.
  • Nirsevimab should not be mixed with any vaccine in the same syringe or vial.
  • When administered concurrently with injectable vaccines, the injections should be given with separate syringes and at different injection sites.
• In Flanders, Kind & Gezin will only provide information (Why vaccinate before, during, and after pregnancy but will not administer the immunization. In Wallonia, ONE will both inform and immunize.

Proactively contact and inform your pregnant patients and/or the parents of pediatric patients who are eligible about the options. You can use the leaflets for parents available in English, Dutch, French and German:

Information for parents

• For pregnant women: Inform them.
• For children born between April 1, 2024, and October 31, 2024: Schedule an immunization appointment between October 1, 2024, and no later than October 31, 2024, if they choose nirsevimab (Beyfortus™). Prepare the prescription, with a reimbursement request.
• Prepare the practical aspects of the immunization for your consultation (both intramurally and extramurally) with your colleagues. Consider not only colleagues in your practice or hospital but also at the regional level: we recommend that hospitals make arrangements with local general practitioner circles on how this immunization campaign can be conducted in their region. By working together, we can reach more children and use everyone's time more efficiently. Also, consider how you can more easily reach vulnerable families in your region and primary care zone (social workers, case managers, Child Houses, etc.). During their rounds in the maternity ward, pediatricians can now inform mothers and fathers about the possibility of administering nirsevimab during October 2024. Inform your nurses and midwives if they are involved in the immunization.
• Don’t forget the policy regarding pain, anxiety, and stress prevention during painful procedures in infants.
• Update your leaflet on general non-pharmacological RSV and bronchiolitis prevention and hand it to parents after immunization.
• Register yourself and your colleagues for our specific RSV newsletter. This can be done by registering via the BAoP or BVK-SBP websites.

Despite the campaign's imminent launch, several barriers remain that hinder a smooth and high-quality immunization campaign with broad reach. Therefore, we strongly urge you to communicate only what is known and confirmed to parents at this time and to schedule an initial appointment in October. This is to avoid parents having to bear the cost of the product (€777.44). We remain in discussions with various governments and RIZIV/INAMI to obtain clear and official answers as soon as possible and/or to simplify the procedures and regulations. As partners, we want to ensure that ownership of these answers and certainties lies with the government, not with us. Therefore, we will transparently involve you in process communication.

• Due to the availability (supply of the company) of nirsevimab (Beyfortus ™) between 23/09 and 26/9 for 50mg and between 30/9 and 4/10 for 100mg and the possibility to immunize the catch-up group before the start of the 2024-2025 RSV season (as indicated in the refund formalities), there is confirmation from the Vandenbroucke Cabinet that the start of the RSV season will be officially set on 01.11.2024, with the remark: “subject to the final approval of the Insurance Committee on 09.09.2024”. This guarantee from the Vandenbroucke cabinet is important to us as partners, but still not 100% certain until 09.09.2024. We will continue to follow up.
• Definition of "every child under 13 months" in government communication: There has been an agreement that this applies to "every child born from April 1, 2024." The regulation provides a dual description: "children under 13 months old who were not born during the previous RSV season '23-'24 (ending March 31, 2024)." It is assumed that every child born before April 1, 2024, has already been exposed to RSV unless the child, for example, spent a long period in neonatal care during this time. The latest confirmation from Minister Vandenbroucke's office concerns every child born from April 1, 2024.
• Cumbersome and complicated procedure via Chapter 4: The requirement to obtain approval from the advisory physician via the Electronic Medical Record (CIVARS) or a paper document remains in place.
• Only infants with a Belgian National Register number (RN) are eligible:Newborns, however, do not yet have these numbers during their stay in the maternity ward. Two confirmed options have been indicated by RIZIV-INAMI and Minister Vandenbroucke's office:
  • Either the application is made on paper, in the child's name, and the mutual insurance company will approve the application as soon as the RN is known.
    If the application cannot yet be made electronically (due to lack of an RN), a paper application can be made using the standard form (with the mother's and child's details). This can be entered into the system retroactively by the VI as soon as an RN is available (with retroactive approval).
  • Or electronically (via CIVARS or your software), but this can only be administratively processed once the applicant has the child's RN. In other words, you will have to make the application retroactively (up to two years back), with the application submitted later but choosing the date of administration as the start date.
• No solution for vulnerable children and families without a National Register number:This large vulnerable group is entirely excluded, even though this group is at higher risk of hospitalization.
  The inability to register the product in Vaccinet for the 2024-2025 RSV season in Flanders. So far, there is no clarity on how the registration of antibody administration should proceed.
• Uncertainty about epidemiological surveillance and data analysis: Discussions have begun with the Federal Public Health Service.
• Inability of pediatricians to verify in the mother's medical record whether she received the RSV vaccine Abrysvo™ during pregnancy.
• Lack of a clear policy: Normally, the regions are responsible for preventive health care. For example, Flanders has an efficient workflow through Kind en Gezin, Wallonia through ONE, and Ostbelgien through Kaleido to ensure that the youngest members of our society are vaccinated. However, in the case of RSV prevention, it involves antibodies, not a vaccine, making the federal government responsible for organizing the campaign. In Flanders, the administration of the monoclonal antibody for the upcoming season will not be done through Kind en Gezin. In contrast, the Walloon counterpart, ONE, will be responsible for administration.

As partners and representatives of your professional group, we continue to monitor not only the above-mentioned barriers but also broader key issues:

• The campaign causes additional administrative burden for doctors. The chosen Chapter IV route adds extra administration for doctors, which could compromise clinical care for the patient and incur additional costs for our healthcare system.
• Vulnerable groups are being excluded. The Chapter IV process makes access to the antibody less accessible for parents. The extra hurdles also threaten to make it more difficult to reach vulnerable target groups, reducing the effectiveness of this campaign. Currently, there is no support to actively seek solutions for this.
• Guarantee of reinvestment in children's health: The expected reduction in RSV hospitalizations, PICU admissions, consultations, long-term complications, and associated healthcare and societal costs (e.g., absenteeism) should not become a one-sided savings operation where the freed-up funds are redirected to the broader pot of healthcare for adults and the elderly. Any savings within pediatrics should lead to reinvestment in children.
• We would propose to create a “ Kind budget ” within the global budget, whether or not under the supervision of a “ Minister for the Child ” (cf Masterplan BAoP).
• We advocate a reinvestment plan in the health of children and the target group of children to view as a huge investment opportunity with a large social (health) profit and achieving health goals in the short and long term term. This includes via:

1. investing in other admission avoiding initiatives such as nurseries, pedopsychiatric beds, pediatrists who support GPs on demand in a VAPH setting;
2. quality and health policy for each child and their context based on health determinants and PROMs
3. integral, developmental and context-oriented pediatric care
4. recognition of core competences around children regardless of place of care
5. reimbursement of pediatric vaccines

• Sustainable collaboration around children: The cooperation between general practitioners, pediatricians, and other partners with diverse disciplines within this dossier, with a common goal and the confrontation with shared external barriers and discussion points, helps us understand each other better and find connection around a larger societal goal. This creates stronger and deeper roots for future sustainable and quality cooperation on other health and social issues.