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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.

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.

Scroll left to view table
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

TraceabilityIn 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.

ABRYSVO in Older Adults

Learn more about the use of ABRYSVO in older adults.

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Dosing - Older Adults

Find out more about the dosing information of ABRYSVO for older adults.

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Preparation of ABRYSVO

Watch a video on how to prepare ABRYSVO for administration.

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ABRYSVO (Respiratory Syncytial Virus Vaccine [bivalent, recombinant]) Summary of Product Characteristics for Great Britain. Available at: https://www.medicines.org.uk/emc/product/15309.
PP-A1G-GBR-0207. October 2024

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

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