This site contains promotional information intended only for healthcare professionals resident in Great Britain

Visit Pfizer Medical site

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias
Search

Menu

Close

Sign In or RegisterLog Out
Pfizer MedicinesTherapy AreasExplore ContentEventsVideosMaterialsFeatured ArticlesLet’s ConnectSupplyAlliance HealthcareOff-contract claims

Adverse event reporting can be found at the bottom of the page

Menu

Close

Maternal ImmunisationMaternal
Immunisation
Maternal Immunisation HomepageSafety ProfileDosing
Older AdultsOlder AdultsOlder Adults HomepageSafety ProfileDosingPreparationUseful ResourcesUseful
Resources
VideosMaterials

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 syndromea - -
Musculoskeletal and connective
tissues disorders
- - - - - -
General disorders and administration
site conditions
Vaccination
site pain
Vaccination
site redness,
Vaccination 
site swelling
- - - -

a  In a study in individuals 60 years and older, one case of Guillain-Barré syndrome and one case of Miller Fisher syndrome were reported with onset of 7 and 8 days, respectively, after receiving ABRYSVO and assessed by the investigator as possibly related to the administered vaccine. Both cases had either confounding factors or an alternative aetiology. One additional case, with onset 8 months after receiving ABRYSVO, was assessed as not related to the administered vaccine by the investigator. One case of Guillain-Barré syndrome was reported in placebo group 14 months after administration.
 

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
bnk

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.

Blank

ABRYSVO in Older Adults

Learn more about the use of ABRYSVO in older adults.

Learn moreLoading
Dosing - Older Adults

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

Learn moreLoading
Preparation of ABRYSVO

Watch a video on how to prepare ABRYSVO for administration.

Click hereLoading
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-0011. January 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

PfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign In or RegisterAccountSign Out

This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc

 

This website is brought to you by Pfizer Limited, a company registered in England 

and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ

 

Copyright © 2024 Pfizer Limited. All rights reserved.

 

VAT registration number GB201048427

PP-UNP-GBR-7866. January 2024
For UK Healthcare Professionals*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-UNP-GBR-7812. January 2024

YesNo
You are now leaving PfizerPro​​​​​

​​​​​​​You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned or controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site.​​​​​​​​​​​​​​

​​​​​​​PP-PFE-GBR-3858. November 2021​​​​​​​
​​​​​​​
You are now leaving PfizerPro
​​​​​​​
​​​​​​​You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site other than the information or other materials relating to ​​​​​Pfizer medicines or 
business which it has provided or reviewed.

PP-PFE-GBR-3859. November 2021
​​​​​​​