The duration of protection conferred by nirsevimab is at least 5 months.
Resume
Announced in late August 2023, the campaign to prevent respiratory syncytial virus (RSV) infections in infants began as planned on September 15.
This campaign is based on an injection of the BEYFORTUS monoclonal antibody.
The General Directorate of Health (DGS) has provided the latest details on the provisions for this medicine to be available in the city and in hospitals. In the city, BEYFORTUS must be requested directly from the Sanofi laboratory, through an online form.
Furthermore, a ministerial decree now authorizes midwives to prescribe and inject this medication to babies.
Finally, the High Health Authority (HAS) has published a first series of quick responses to guide healthcare professionals in this unprecedented campaign and remind them of the main characteristics of BEYFORTUS.
As announced at the end of August 2023 (cf. our article from September 5, 2023), the first campaign to prevent lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants with or without risk factors began on September 15, 2023 in France.
This campaign is based on a single injection of the monoclonal antibody BEYFORTUS (nirsévimab – cf. Box 1).
Prescription extended to midwives
A decree published in official newspaper from September 15, 2023 (1) includes nirsevimab (BEYFORTUS) in the list of medications that midwives can prescribe, as a first prescription, to newborns.
Consequently, a doctor or midwife can now prescribe BEYFORTUS to children targeted by the prevention campaign (cf. Table 2).
Midwives are also authorized to administer this monoclonal antibody, as are doctors and nurses (2).
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Note: This same decree authorizes midwives to prescribe specific anti-HBs immunoglobulins in combination with the hepatitis B vaccine to newborns of mothers who carry the HBs antigen.
Order conditions and delivery schedule.
The General Directorate of Health (DGS) provided details on ordering methods and availability schedule in two DGS-Urgent published on September 15, 2023 (3, 4).
Community Pharmacy: Direct Order from Sanofi
For community pharmacists in mainland France, requests for delivery of BEYFORTUS have been open since September 15. Delivery time is 3 to 6 business days once the order is placed.
Orders must be placed directly with the Sanofi laboratory. through an online form (connection through prosantéconnect with the e-CPS card):
- within the limit of 5 doses maximum per order;
- only with registered medical prescription. Orders cannot be placed in order to accumulate stock in the pharmacy.
The prescription must be intended for a patient covered by French health insurance (including patients awaiting eligibility).
It is not possible to order and dispense BEYFORTUS for a cross-border patient.
BEYFORTUS is made available by the State, without billing to families (5).
According to information communicated by the pharmacists’ unions (6), the pharmacist receives a remuneration of 6.55 euros without taxes (peninsular rate) for the order and delivery of BEYFORTUS:
- 3.50 euros without VAT for the order
- + 1 euro without VAT for packaging dispensing costs
- + 0.50 euros without VAT prescription fee
- + 1.55 euros without including taxes linked to the patient’s age
Provision in health establishments
The laboratory delivered a first allocation of doses of BEYFORTUS 50 mg to all health facilities with maternity wards that requested it.
Replacement requests will begin on September 25 and will be made by direct order to the laboratory, as for the 100 mg dose.
Stock tracking methods by Dispostock and administrations through The medicalization program for information systems (PMSI) is specified for health establishments. through a rapid health alert message (MARS) and then an information note.
Available in DROM
For overseas departments and regions (DROM), BEYFORTUS is available exclusively through Health establishments.
Help with use: HAS Quick Answers
In parallel with the availability of BEYFORTUS, the High Health Authority (HAS) has put online a first series of Quickly answers to support healthcare professionals in this unique campaign and remind you of the methods of use of nirsévimab (7, 8).
In total, 8 quick answers are provided:
- Two answers related to the mode of action and proper use of nirsevimab (BEYFORTUS):
- Quick response 1 : Nirsevimab is a treatment with monoclonal antibodies, in a single intramuscular injection (anterolateral aspect of the thigh), indicated for the prevention of lower respiratory tract infections due to RSV in newborns and infants during their first year of exposure to this virus.
- Quick response 2 : BEYFORTUS is not a vaccine (cf. our article from September 14, 2023). The duration of protection conferred by nirsevimab is at least 5 months.
- Three answers about the prevention campaign and the population targeted by the campaign:
- Quick response 3 : The 2023-2024 immunization campaign will begin in mainland France from September 15, 2023, until the end of the epidemic, normally at the end of January.
- Quick response 4 : Nirsevimab should be administered with priority before the start of the epidemic to newborns and infants born on or after February 6, 2023 because they are considered not exposed to RSV during the previous epidemic season. This date was determined by Public Health France based on epidemiological data from last year (end of epidemic observed on January 22 in mainland France + time after exposure).
- Quick response 5 : Nirsevimab should preferably be administered before leaving the maternity ward for newborns from September 15, 2023.
- A rapid response for children at high risk of RSV infection:
- Two quick answers regarding co-injection with other vaccines or specific situations:
- Quick response 7 : Nirsevimab can be given on the same day as the child’s vaccines, but at separate injection sites.
- Quick response 8 : Nirsevimab injection is not recommended in cases of fever or an ongoing moderate to severe acute infectious episode, or after an episode of documented RSV infection.
Hypersensitivity to one of the components of the medication constitutes a contraindication.
The HAS also reminds us of the precautions that must be taken before any injection:
- provide clear information to parents and obtain their agreement;
- use special caution when administering to babies with thrombocytopenia, coagulation disorders or under anticoagulant treatment;
- Check with the naked eye the clear appearance of the product, which should not present any anomaly.
