▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SPC for how to report adverse reactions.
Abrysvo^®▼ powder and solvent for solution for injection (Respiratory syncytial virus vaccine [bivalent, recombinant])
Ireland Prescribing Information:
Before prescribing Abrysvo please refer to the full Summary of Product Characteristics (SmPC). Presentation: Powder and solvent for solution for injection.  The powder is white.  
The solvent is a clear, colourless liquid.  Indications: Abrysvo is indicated for; passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. See SmPC sections 4.2 and 5.1; and active immunisation of individuals 60 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.  Dosage and Administration: Pregnant individuals: A single dose of 0.5 mL should be administered between weeks 24 and 36 of gestation (see SmPC sections 4.4 and 5.1).  Individuals 60 years of age and older: A single dose of 0.5 mL should be administered.  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 SmPC 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 SmPC section 6.6. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1.  Special Warnings and 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. 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. Since protection of the infant against RSV depends on transfer of maternal antibodies across the placenta, Abrysvo should be administered between weeks 24 and 36 of gestation (see SmPC sections 4.2 and 5.1).  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’. Interactions: Abrysvo can be administered concomitantly with seasonal quadrivalent influenza vaccine (QIV, surface antigen, inactivated, adjuvanted). In a randomised study in adults 65 years of age and older, the criteria for non‑inferiority of the immune responses in the co‑administration versus the separate administration group were met. However, numerically lower RSV A and B neutralizing titres and numerically lower influenza A and B haemagglutination inhibition titres were observed when Abrysvo and inactivated adjuvanted seasonal influenza vaccine were co-administered than when they were administered separately. The clinical relevance of this finding is unknown.  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.  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 SmPC 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%).  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 (37%) and the placebo group (35%). Major birth outcomes assessed in the Abrysvo group compared to placebo included premature birth (201 (6%) and 169 (5%), respectively), low birth weight (181 (5%) and 155 (4%), respectively) and congenital anomalies (174 (5%) and 203 (6%), respectively).  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 SmPC section 5.3).  Undesirable Effects:  Pregnant individuals: In pregnant women at 24-36 weeks of gestation the most frequently reported adverse reactions were vaccination site pain (41%), headache (31%) and myalgia (27%). The majority of local and systemic reactions in maternal participants were mild to moderate in severity and resolved within 2-3 days of onset. Individuals 60 years of age and older: In individuals 60 years of age and older the most frequently reported adverse reaction was vaccination site pain (11%). The majority of reactions were mild to moderate in severity and resolved within 1‑2 days of onset.  Refer to SmPC section 4.8 for further information on side effects. Legal Category: Product subject to prescription which may not be renewed (A): S1A. Package quantities and Marketing Authorisation Numbers: One dose pack with needle; EU/1/23/1752/001. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at [email protected]. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500.Marketing Authorisation Holder:  Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Date of Preparation: 02/2024

Ref: bAB 2_0