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the management of NIMENRIX and MENQUADFI aligned with the recommendations

Résumé

The scope of coverage for meningococcal vaccines A, C, W135 and Y NIMENRIX and MENQUADFI is expanded to comply with the vaccination recommendations of the High Authority for Health (HAS) published in March 2024.

These vaccines are now reimbursable and approved for use in communities, without limitation to populations at risk of invasive meningococcal infection or to specific situations for all subjects:

  • from 6 weeks, for NIMENRIX;
  • from 12 months, for MENQUADFI.

Vaccination of all infants under 1 year of age against meningococci A, B, C, W135 and Y will be compulsory from 1is January 2025. Currently, only that against meningococcus C is obligatory. A 2-dose regimen is recommended:

  • primary vaccination at 6 months: 1 dose of NIMENRIX;
  • booster dose at 12 months with NIMENRIX or MENQUADFI.

The extension of support from which NIMENRIX and MENQUADFI benefit also makes it possible to apply vaccination recommendations in the adolescent population:

  • recommended vaccination for adolescents aged 11 to 14,
  • catch-up recommended between ages 15 and 24.

Lcovered (65% reimbursement and community approval) [1, 2] vaccines NIMENRIX powder and solvent for solution for injection and MENQUADFI solution for injection for active immunization against invasive meningococcal diseases due to Neisseria meningitis groups A, C, W-135 and Y is expanded, according to the current recommendations of the High Authority of Health (HAS) dated March 7, 2024 and June 27, 2024 [34] :

  • for NIMENRIX: from the age of 6 weeks ;
  • for MENQUADFI: from the age of 12 months.

In accordance with the recommended vaccination strategy

This extension of support is based on the opinions of the Transparency Commission (CT) issued in July 2024 [5, 6]. It makes it possible to align the scope of coverage of these vaccines with the vaccination strategy recommended by the HAS in March 2024 (cf. our article of April 3, 2024).

Until now, reimbursement and approval to the communities of NIMENRIX and MENQUADFI were limited to a population deemed at risk of subjects:

  • carriers of terminal complement deficiency or who are receiving anti-C5A treatment ;
  • carriers of a properdin deficiency or having anatomical or functional asplenia ;
  • having received a hematopoietic stem cell transplant.

In March 2024, taking into account the unfavorable evolution of epidemiological data relating to invasive meningococcal infections (IIM), the HAS recommended (cf. Summary table) :

  • to return OBLIGATORY tetravalent vaccination (A, C, W135 and Y) in all infants less than 1 year oldreplacing only meningococcal vaccination directed against serogroup C. This obligation will come into force on 1is January 2025 (cf. our article of July 9, 2024). It also applies to meningococcal vaccination against serogroup B.
    The recommended vaccination schedule with meningococcal vaccines A, C, W135 and Y consists of 2 doses: a single dose of primary vaccination at the age of 6 months followed by a booster dose at the age of 12 months.
    Only the NIMENRIX vaccine has a marketing authorization (AMM) for children under 12 months of age and can be used as a primary vaccination.
    The MENQUADFI vaccine, authorized from 12 months of age, can be used for the booster dose as an alternative to NIMENRIX (interchangeability possible) (cf. our article of July 4, 2024);
  • a tetravalent vaccination (A, C, W135 and Y) according to a 1-dose schedule in adolescents between 11 and 14 years old, regardless of their meningococcal vaccination status, and among 15-24 year olds in catch-up.

The place of these two vaccines for special populations, professionals and around one or more cases of invasive meningococcal infections is maintained:

  • from 6 weeks for NIMENRIX, in accordance with its Marketing Authorization;
  • from 12 months for MENQUADFI, in accordance with its Marketing Authorization.
Table – Summary of HAS 2024 recommendations
Serogroups Infants Adolescents and young adults (11-24 ans) Other populations
A, C, W and Y

✅ Compulsory tetravalent vaccination according to a 2-dose vaccination schedule:

  • Single dose of primary vaccination at 6 months
  • Booster dose at 12 months

as a replacement for vaccination against serogroup C

Vaccines : NIMENRIX, and MENQUADFI but only for reminder

✅ Tetravalent vaccination recommended according to a one-dose schedule administered between 11 and 14 years of age, regardless of vaccination status

✅ Catch-up vaccination recommended for 15-24 year olds

Maintaining current recommendations regarding tetravalent vaccination for special populations, professionals and around one or more cases of invasive meningococcal infections

Vaccines : NIMENRIX, MENQUADFI and MENVEO
B

✅ Compulsory vaccination in infants (recommended since 2021) according to the diagram:

  • 1re dose at 3 months
  • 2e dose at 5 months
  • booster dose at 12 months

Vaccine : BEXERO

❌ Do not extend, at this stage, vaccination against serogroup B to all adolescents

Maintaining the strategy in force in people at risk and in a situation of hyperendemia

Vaccines : TRUMENBA and BEXSERO

These new recommendations have been integrated into the 2024 edition of the 2024 vaccination calendar [7].

What about MENVEUS?

MENVEO powder and solvent for solution for injection is one of the three tetravalent meningococcal vaccines A, C, W135 and Y marketed in . In accordance with its Marketing Authorization (from the age of 2), it can be used for the vaccination of adolescents.

A favorable opinion on the extension of MENVEO reimbursement in the following populations was issued by the CT in July 2024 [8] :

  • in adolescents between 11 and 14 years old;
  • in 15-24 year olds for catch-up treatment for the prevention of invasive meningococcal serogroup A, C, W-135 and Y infections;
  • for special populations, professionals and around one or more cases of invasive meningococcal infections.

The ministerial decree relating to this extension of support is awaiting publication in Official Journal. As of November 28, 2024, MENVEO treatment remains limited to subjects who should be able to benefit from lasting and extensive protection against a broader number of meningococcal serogroups.

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