MENVEO

What it is

Menveo is a meningococcal vaccine consisting of meningococcal serogroup A, C, W-135 and Y oligosaccharides conjugated individually to Corynebacterium diphtheriae CRM197 protein, administered by intramuscular injection. No preservative or adjuvant is added during manufacturing, and the vaccine contains no thiomersal.

Approved indications

— Active immunisation of infants and children from 2 months of age, adolescents and adults to prevent invasive disease caused by Neisseria meningitidis serogroups A, C, W135 and Y (powder and solution formulation). — Active immunisation of children from 2 years of age, adolescents and adults to prevent invasive disease caused by Neisseria meningitidis serogroups A, C, W135 and Y (solution formulation).

Dosing overview

For infants initiating vaccination from 2 to 6 months of age, a 3-dose schedule is recommended with a minimum interval of 2 months between each dose, with the 3rd dose as early as possible during the second year of life (at 12–16 months). For unvaccinated infants and toddlers 6 to 23 months of age, a 4-dose schedule is recommended. For children from 2 to 10 years of age and adolescents from 11 years of age and adults, a single dose is recommended. For the solution for injection formulation, a single dose is administered. Menveo may be given as a booster dose in subjects who have previously received primary vaccination with Menveo, other conjugated meningococcal vaccine or meningococcal unconjugated polysaccharide vaccine, with the need for and timing of a booster dose based on national recommendations.

Key safety warnings

Menveo has not been evaluated in persons with thrombocytopenia or bleeding disorders. Because of the risk of hematoma, Menveo should not be administered to persons with any bleeding disorder, such as haemophilia or thrombocytopenia, or to persons receiving anticoagulant therapy, unless the potential benefit outweighs the risk of administration. A possible association between Guillain-Barré Syndrome (GBS) and receipt of a quadrivalent meningococcal diphtheria toxoid conjugate vaccine was reported in 2005. The US Centers for Disease Control and Prevention conducted an analysis of 17 cases of GBS and concluded that the relative risk was 1.78 (95% CI 1.02–2.85). Since the background rate of GBS is very low (0.1/100,000 person months) and the disease is generally self-limited with a low case fatality rate, this equates to an extremely small burden of attributable disease impact. When factoring in the prevention of meningococcal disease, the CDC concluded that vaccination was clearly beneficial, with vaccination saving 2400 Quality Adjusted Life Years (QALYs) due to prevention of meningococcal disease at a cost of 5 QALYs due to vaccine-induced GBS. As a precautionary measure, adrenaline injection (1:1000), other appropriate agents and equipment, and appropriate medical treatment and supervision must always be immediately available in case of a rare anaphylactic event or serious allergic reactions following administration of the vaccine. Menveo has not been evaluated in the immunocompromised, including individuals with HIV infection, complement deficiencies and individuals with functional or anatomical asplenia may not mount an immune response to meningococcal group A, C, W-135 and Y conjugate vaccines.

Contraindications

Contraindications include hypersensitivity to the active substances or to any of the excipients of the vaccine, including diphtheria toxoid (CRM197); known hypersensitivity to other diphtheria-containing vaccines; acute febrile illness of any cause; and a life-threatening reaction after previous administration of a vaccine containing similar components.

PBS listing

Menveo was recommended for listing as a designated vaccine on the National Immunisation Program in November 2023 for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

Regulatory history

Menveo was first registered on the Australian Register of Therapeutic Goods on 23 May 2012 (ARTG 192696). In July 2018, the Pharmaceutical Benefits Scheme Advisory Committee recommended Menveo for listing on the National Immunisation Program for adolescents on a cost-minimisation basis with MenACWY-TT. A solution for injection formulation was registered on 26 September 2023 (ARTG 393321). In November 2023, the Pharmaceutical Benefits Scheme Advisory Committee recommended new listing as a designated vaccine on the National Immunisation Program for adolescents for prevention of invasive meningococcal disease, cost-effective if cost-minimised against nominated comparators, with equi-effective doses established.