VAXNEUVANCE Suspension for injection Ref.[28342] Active ingredients: Pneumococcus, purified polysaccharides antigen

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.

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 living with HIV infection (see section 5.1). 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 sections 2 and 5.1).

Sodium

This medicinal product contains less than 1 mmol sodium (23 milligrams) per dose, i.e. essentially ‘sodium-free’.

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.

Different injectable vaccines should always be administered at different injection sites.

Immunosuppressive therapies may reduce the immune responses to vaccines.

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 pregnancy, embryo/foetal development, parturition or post-natal development (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.

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).

Vaxneuvance has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines.

Summary of the safety profile

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 received Vaxneuvance, 1,134 were immunocompetent adults 18 to 49 years of age who had no (n=285), 1 (n=620) or ≥2 (n=229) risk factors for pneumococcal disease and 152 were adults ≥18 years of age living with HIV. In addition, 5,253 adults were pneumococcal vaccine-naïve and 377 adults were previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPV23) at least 1 year prior to enrolment.

The most frequently reported adverse reactions following vaccination with Vaxneuvance were solicited. In the pooled analysis of the 7 studies, the most frequent adverse reactions were injectionsite pain (64.6%), fatigue (23.4%), myalgia (20.7%), headache (17.3%), injection-site swelling (16.1%), injection-site erythema (11.3%) and arthralgia (7.9%). The majority of solicited adverse reactions were mild (based on intensity or size) and of short duration (≤3 days); severe reactions (defined as an event that prevents normal daily activity or size >10 cm) occurred in ≤1.5% of adults across the clinical program.

Older adults reported fewer adverse reactions than younger adults.

Tabulated list of adverse reactions

Local and systemic adverse reactions were solicited daily after vaccination for 5 and 14 days, respectively. Unsolicited adverse reactions were reported for 14 days after vaccination. The table presented below is based on safety data from 7 clinical studies in adults who received Vaxneuvance, of whom 4,389 were ≥50 years of age and 1,241 were 18 to 49 years of age. Frequencies are reported as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Table 1. Tabulated list of adverse reactions:

^* very common in adults 18 to 49 years of age
^† common in adults 18 to 49 years of age

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.