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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
The majority of reactions were mild to moderate in severity and resolved within 1-2 days of onset.1
The safety profile of ABRYSVO was evaluated in phase 3 clinical studies. Individuals 60 years of age and older (n=18,575) were evaluated after receiving a single dose of vaccine.1
The most frequently reported adverse reaction was vaccination site pain (11%).1
Tabulated Adverse Events (AE) in older adults
Please refer to the SmPC for additional safety information.
System organ class |
Very common (≥1/10) |
Common (≥1/100 to <1/10) |
Uncommon (≥1/1000 to <1/100) |
Rare (≥1/10,000 to <1/1000) |
Very Rare (<1/10,000) |
Not known (cannot be estimated from the available data) |
---|---|---|---|---|---|---|
Immune system disorders | - | - | - | - | Hypersensitivity | - |
Nervous system disorders | - | - | - | Guillain-Barré syndrome | - | - |
Musculoskeletal and connective tissues disorders |
- | - | - | - | - | - |
General disorders and administration site conditions |
Vaccination site pain |
Vaccination site redness, Vaccination site swelling |
- | - | - | - |
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
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)
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 the use of ABRYSVO in older adults.
Find out more about the dosing information of ABRYSVO for older adults.
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.
If you wish to make a medical information inquiry or report an adverse event please contact Pfizer on 1800 633 363
or email Pfizer at [email protected] or visit www.PfizerMedicalInformation.ie
Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
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