Vaxneuvance · 4.8 Undesirable effects · 1

HOS-099725 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile Infants and children aged 6 weeks to less than 2 years The safety of Vaxneuvance in healthy infants, including preterm infants (from 6 weeks of age at first vaccination) and children (11 through 15 months of age) was assessed as a 3 dose or 4 dose regimen in 5 clinical studies with a total of 7 229 participants. All 5 studies evaluated the safety of Vaxneuvance when administered concomitantly with other routine paediatric vaccines. The most frequent adverse reactions are pyrexia ≥38 °C (75%), irritability (75%), somnolence (55%), injection-site pain (44%), injection-site erythema (42%), decreased appetite (38%), injection-site induration (28%) and injection-site swelling (28%). The majority of adverse reactions were mild to moderate (based on intensity or size) and of short duration (≤3 days). Severe reactions (defined as being extremely distressed or unable to do usual activities or size of injection-site reaction >8 cm) occurred in ≤4% of infants and children following any dose, with the exception of irritability which occurred in 11% of participants. 6 Children and adolescents 2 to less than 18 years of age The safety of Vaxneuvance in healthy children and adolescents was assessed in a study that included 352 participants 2 to less than 18 years of age, of whom 177 received a single dose of Vaxneuvance. In this age cohort, 43% of all participants had a history of previous vaccination with a lower valency pneumococcal conjugate vaccine. The most frequent adverse reactions are injection-site pain (55%), myalgia (24%), injection-site swelling (21%), injection-site erythema (19%), fatigue (16%), headache (12%), injection-site induration (7%), and pyrexia ≥38 C (6%). The majority of adverse reactions were mild to moderate (based on intensity or size) and of short duration (≤3 days); severe reactions (defined as being extremely distressed or unable to do usual activities or size of injection-site reaction >8 cm) occurred in ≤5% of children and adolescents. Adults 18 years of age and older The safety of Vaxneuvance in healthy and immunocompetent adults was assessed in 6 clinical studies in 7 136 adults ≥18 years of age. An additional clinical study assessed 302 adults ≥18 years of age living with HIV. Vaxneuvance was administered to 5 630 adults; 1,241 were 18 to 49 years of age, 1 911 were 50 to 64 years of age, and 2 478 were 65 years of age and older. Of those who

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HOS-099721 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to any diphtheria toxoid-containing vaccine.

HOS-099720 · has-indication-information · PDF-Seite 2

Vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. Vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. 2 See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Vaxneuvance should be in accordance with official recommendations.

HOS-099723 · has-interaction-information · PDF-Seite 5

Different injectable vaccines should always be administered at different injection sites. Immunosuppressive therapies may reduce the immune responses to vaccines. Infants and children aged 6 weeks to less than 2 years Vaxneuvance can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, pertussis, poliomyelitis (serotypes 1, 2 and 3), hepatitis A, hepatitis B, Haemophilus influenzae type b, measles, mumps, rubella, varicella and rotavirus vaccine. Children and adolescents 2 to less than 18 years of age There are no data on the concomitant administration of Vaxneuvance with other vaccines. Data from a post-marketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to other pneumococcal vaccines suggest that administration of antipyretics concomitantly or within the same day of vaccination may reduce the immune response after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown. Adults Vaxneuvance can be administered concomitantly with seasonal quadrivalent influenza vaccine (split virion, inactivated). There are no data on the concomitant administration of Vaxneuvance with other vaccines. 5

HOS-099724 · has-pregnancy-information · PDF-Seite 6

Pregnancy There is limited experience with the use of Vaxneuvance in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Administration of Vaxneuvance in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and the foetus. Breast-feeding It is unknown whether Vaxneuvance is excreted in human milk. Human data are not available to assess the impact of Vaxneuvance on milk production, its presence in breast milk, or its effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects on the breastfed child or from the underlying maternal condition. For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine. Fertility No human data on the effect of Vaxneuvance on fertility are available. Animal studies in female rats do not indicate harmful effects (see section 5.3).

HOS-099722 · has-warning-information · PDF-Seite 4

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. Vaxneuvance may be given subcutaneously if the potential benefit clearly outweighs the risks (see section 5.1). 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. 4 Immunocompromised individuals Immunocompromised individuals, whether due to the use of immuno-suppressive 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 or with a haematopoietic stem cell transplant (see section 5.1). Safety and immunogenicity data for Vaxneuvance are not available for individuals in other specific immunocompromised groups 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 sections 2 and 5.1).

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