WHO PRODUCT INFORMATION (EN)

es-smpc-combined-mdv.pdf

WHO PRODUCT INFORMATION 1

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es-smpc-combined-mdv.pdf

1. NAME OF THE MEDICINAL PRODUCT Abrysvo powder and solvent for solution for injection Abrysvo powder and solvent for solution for injection in multidose container Respiratory syncytial virus vaccine (bivalent, recombinant) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 mL) contains: RSV subgroup A stabilised prefusion F antigen 1,2 60 micrograms RSV subgroup B stabilised prefusion F antigen 1,2 60 micrograms (RSV antigens) 1 glycoprotein F stabilised in the prefusion conformation 2 produced in Chinese Hamster Ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3.

PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder and solvent for solution for injection in multidose container. The powder is white. The solvent is a clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Abrysvo is indicated for: active immunisation of pregnant individuals for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age (see sections 4.2 and 5.1). active immunisation of individuals 18 years of age and older for the prevention of lower respiratory tract disease caused by RSV.

The use of this vaccine should be in accordance with official recommendations. 4.2 Posology and method of administration Posology Pregnant individuals A single dose of 0.5 mL should be administered in the third trimester of pregnancy (28-36 weeks) (see sections 4.4 and 5.1). Individuals 18 years of age and older A single dose of 0.5 mL should be administered. The need for revaccination has not been established. 2

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es-smpc-combined-mdv.pdf

Paediatric population The safety and efficacy of Abrysvo in children (from birth to less than 18 years of age) have not yet been established. Limited data are available in pregnant adolescents and their infants (see section 5.1). Method of administration Abrysvo is for intramuscular injection into the deltoid region of the upper arm. The vaccine should not be mixed with any other vaccines or medicinal products. For instructions on reconstitution and handling of the medicinal product before administration, see section 6.6. 4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use 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. Hypersensitivity and anaphylaxis Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection.

It is important that procedures are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from an acute febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Thrombocytopenia and coagulation disorders Abrysvo should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding or bruising may occur following an intramuscular administration to these individuals.

Immunocompromised individuals The efficacy and safety of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Abrysvo may be lower in immunosuppressed individuals. Individuals less than 24 weeks of gestation Abrysvo has not been studied in pregnant individuals less than 24 weeks of gestation. 3

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es-smpc-combined-mdv.pdf

Limitations of vaccine effectiveness As with any vaccine, a protective immune response may not be elicited after vaccination. Excipient This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. 4.5 Interaction with other medicinal products and other forms of interaction Abrysvo can be administered concomitantly with: seasonal influenza vaccines, either standard dose adjuvanted or high dose unadjuvanted COVID-19 mRNA vaccines, with or without high dose unadjuvanted influenza vaccine administered concomitantly.

A minimum interval of two weeks is recommended between administration of Abrysvo and administration of a tetanus, diphtheria and acellular pertussis vaccine (Tdap). There were no safety concerns when Abrysvo was co-administered with Tdap in healthy non-pregnant women. Immune responses to RSV A, RSV B, diphtheria and tetanus on co-administration were non-inferior to those after separate administration. However, the immune responses to the pertussis components were lower on co-administration compared to separate administration and did not meet the criteria for non- inferiority. The clinical relevance of this finding is unknown.

4.6 Fertility, pregnancy and lactation Pregnancy Data on pregnant women (more than 4 000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity. Results from animal studies with Abrysvo do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). In a phase 3 study (Study 1), maternal adverse events reported within 1 month after vaccination were similar in the Abrysvo group (14%) and the placebo group (13%). Breast-feeding It is unknown whether Abrysvo is excreted in human milk. No adverse effects of Abrysvo have been shown in breastfed newborns of vaccinated mothers.

Fertility No human data on the effect of Abrysvo on fertility are available. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3). 4 No safety signals were detected in infants up to 24 months of age. The incidences of adverse events reported within 1 month after birth in infants were similar in the Abrysvo group (38%) and the placebo group (35%). Major birth outcomes assessed in the Abrysvo group compared to placebo included premature birth (207 (6%) and 172 (5%), respectively), low birth weight (186 (5%) and 158 (4%), respectively) and congenital anomalies (205 (6%) and 245 (7%), respectively).

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