Vaxneuvance Special Precautions

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Precaution related to route of administration: Vaxneuvance must not be administered intravascularly.
Anaphylaxis: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Concurrent illness: Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
Thrombocytopenia and coagulation disorders: As with other intramuscular injections, the vaccine should be given with caution to individuals receiving anticoagulant therapy, or to those with thrombocytopenia or any coagulation disorder such as haemophilia. Bleeding or bruising may occur following an intramuscular administration in these individuals.
Apnoea in premature infants: The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination generally should not be withheld or delayed.
Immunocompromised individuals: Immunocompromised individuals, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation.
Safety and immunogenicity data for Vaxneuvance are available for individuals with sickle cell disease or living with HIV infection (see Pharmacology: Pharmacodynamics under Actions). Safety and immunogenicity data for Vaxneuvance are not available for individuals in other specific immunocompromised groups (e.g., haematopoietic stem cell transplant) and vaccination should be considered on an individual basis.
Protection: As with any vaccine, vaccination with Vaxneuvance may not protect all vaccine recipients. Vaxneuvance will only protect against Streptococcus pneumoniae serotypes included in the vaccine (see Description and Pharmacology: Pharmacodynamics under Actions).
Sodium: This medicinal product contains less than 1 mmol sodium (23 milligrams) per dose, i.e. essentially 'sodium-free'.
Effects on ability to drive and use machines: Vaxneuvance has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under Adverse Reactions may temporarily affect the ability to drive or use machines.