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Adverse event reporting can be found at the bottom of the page
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The content of this website has been produced in line with the ABRYSVO®▼(Respiratory Syncytial Virus Vaccine [bivalent, recombinant]) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain only. ABRYSVO▼ Prescribing Information for Great Britain click here. ABRYSVO▼ Prescribing Information for Northern Ireland click here.
Please refer to the Summary of Product Characteristics (SmPC) before administering this vaccine.
Most local and systemic reactions in maternal participants were mild to moderate in severity and resolved within 2-3 days of onset.1
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 AEs reported within 1 month after birth in infants (n>4000) were similar in the ABRYSVO group (37%) and the placebo group (35%).1
The safety profile of ABRYSVO was evaluated in phase 3 clinical studies. Pregnant women (n=3,682) at 24-36 weeks of gestation were evaluated after receiving a single dose of vaccine.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.
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.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
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PP-UNP-GBR-7812. January 2024