Hypersensitivity Including Anaphylaxis

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available. Anaphylactic, anaphylactoid or other allergic type reactions are theoretically possible following administration of MenFive.

Risk of bleeding with intramuscular administration

As with other intramuscular injections, MenFive should be given with caution to individuals with thrombocytopenia, any coagulation disorder or to persons on anticoagulation therapy, because bleeding or bruising may occur following an intramuscular administration in these individuals.

Concurrent Illness

As with other vaccines, administration of MenFive should be postponed in individuals suffering from an acute febrile illness. Any body temperature ≥ 38ºC or active infection is reason to delay immunization.

Syncope

Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.

Immunocompromised individuals

No safety or efficacy data are available for the administration of MenFive to individuals living with HIV infection. Practitioners should evaluate the potential risks and benefits of administering the vaccine in these populations, considering the fact that subjects living with HIV infection are at increased risk for meningococcal disease. It is not known whether individuals with impaired immune responsiveness, including individuals receiving immunosuppressant therapy, will elicit the same response as immunocompetent individuals to the vaccine regimen.

Protection against meningococcal disease

As with any vaccine, vaccination with MenFive may not protect all vaccine recipients. MenFive will only confer protection from meningitis caused by Neisseria meningitidis serogroups A, C, W, Y and X. MenFive will not protect from meningitis caused by any other Neisseria meningitidis serogroups, other bacteria, viruses, fungi , mycobacteria etc.