Several respiratory syncytial virus immunisation agents are available in Belgium. It is essential not to confuse them: each one is intended for a different target group.
The FAMHP has been informed of new cases of incorrect administration of the Abrysvo vaccine to infants. This type of incident is not isolated: similar cases of administration to children of vaccines against respiratory syncytial virus (RSV) designed for adults have been reported by the pharmacovigilance systems in the United States and Canada.
Administration errors do not only concern infants. Cases of Arexvy vaccine being administered to pregnant women have also been reported, even though only Abrysvo vaccine is indicated for this population.
This Flash VIG-news aims to remind you of the current indications for each RSV immunisation agent in order to reduce the risk of administration errors and ensure the safety and efficacy of immunisation.
RSV immunisation products and target groups
The table below summarises the therapeutic indications defined in the marketing authorisations issued by the European Commission.
The recommended vaccination schedules in Belgium and the opinions of the Superior Health Council can be consulted on the dedicated websites.
| Agent | Résumé des indications thérapeutiques selon le RCP* | |
| Abrysvo (Pfizer) Vaccine |
Vaccination of pregnant women between the 24th and 36th week of the pregnancy, for passive immunisation of newborns**.
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Vaccination of adults aged 18 years and older.
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| Arexvy (GSK) Vaccine |
Vaccination of adults aged 60 years and older. Vaccination of adults aged 50 to 59 years at increased risk of RSV. |
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mRESVIA (Moderna) |
Vaccination of adults aged 60 years and older. Vaccination of adults aged 18 to 59 years at increased risk of RSV. |
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| Beyfortus (Sanofi) Nirvesimab Monoclonal antibodies |
Passive immunisation: |
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| Synagis (AstraZeneca) Palivizumab Monoclonal antibodies |
Passive immunisation: - of newborns and infants born prematurely; - of some children at increased risk of RSV disease up to the age of 2 years**. |
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*Therapeutic indications may change over time. The latest versions of the package leaflets and summaries of product characteristics (SmPC) for medicinal products authorised in Belgium are available via https://medicinesdatabase.be/human-use.
**Strategies for preventing RSV in young children: several sources offer information to guide the choice between maternal vaccination and monoclonal antibody immunisation: Vaccination-info.be, Laatjevaccineren.be, Belgian Academy of Paediatrics.
Additional information
• Information du CBIP : RSV Vaccine
• Opinion of the Superior Health Council: prevention of RSV in children, adults
• Vaccination schedules for the Flemish Community: 0-3 years, 4-18 years, Adults
• Vaccination schedule for the French Community: Children and adults
• Vaccination schedule for the German-speaking Community: Children
How to notify a medication error?
• Errors with no adverse reactions
Potential or actual errors with no adverse reactions can be reported to medication-errors@fagg-afmps.be.
• Errors with adverse reactions
If the error led to an adverse reaction, the classic reporting system should be used and the context of the medication error should be described via www.famhp.be/en/side_effect.