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▼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 SmPC for how to report adverse reactions.
Please refer to the ABRYSVO Summary of Product Characteristics for full prescribing information
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%).1
Tabulated Adverse Events (AE) in pregnant women
Please refer to the SmPC for additional safety information.
System organ class |
Very Common
(≥1/10)
|
Common (≥1/100 to <1/10) |
---|---|---|
Immune system disorders | - | - |
Nervous system disorders | Headache | - |
Musculoskeletal and connective tissue disorders |
Myalgia | - |
General disorders and administration site conditions |
Vaccination site pain | Vaccination site redness, Vaccination site swelling |
No safety signals were detected in infants up to 24 months of age.1
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). 1
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%). 1
Contraindications1
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the SmPC.
Special warnings and precautions for use1
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
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, 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.
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.
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.
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.
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 sections 4.2 and 5.1 of the ABRYSVO SmPC for further information)
As with any vaccine, a protective immune response may not be elicited after vaccination
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Learn more about maternal immunisation with ABRYSVO.
Find out more about the dosing information of ABRYSVO for maternal patients.
Watch a video on how to prepare ABRYSVO for administration.
Reference:
Legal Category: S1A
Further information is available upon request
Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
Adverse events should also be reported to Pfizer Medical Information on 1800 633 363
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PP-UNP-IRL-0832. October 2024