From the 1st September 2023 the Shingles National Immunisation Programme is for :
- Adults 70 and turning 65 years old on or after the 1st September 2023
- Immunocompromised individuals aged 50 years and over ( with no upper age limit ) - Adults aged 71-79 who have been missed remain eligible . 1
Prescribing information - GB Please consult the Summary of Product Characteristics ( SPC ) before prescribing
Shingrix Herpes zoster vaccine ( recombinant , adjuvanted ). Shingrix powder and suspension for suspension for injection . Composition : Following reconstitution , one 0.5ml dose contains 50μg Varicella Zoster Virus glycoprotein E antigen adjuvanted with AS01 B
( containing 50μg of Quillaja saponaria Molina , fraction 21 ( QS-21 ) and 50μg of 3-O-desacyl-4 ’ -monophosphoryl lipid A ( MPL ). Uses : Prevention of herpes zoster ( HZ ) and post-herpetic neuralgia ( PHN ), in adults 50 years of age or older and adults 18 years of age or older at increased risk of HZ . Use of Shingrix should be in accordance with official recommendations . Dosage and administration : Primary vaccination schedule consists of two doses of 0.5 ml each : an initial dose followed by a 2 nd dose 2 months later . If flexibility is needed , second dose can be given between 2-6 months after the first . For those who are or might be immunodeficient / immunocompromised and whom may benefit from a shorter schedule , the 2 nd dose can be given 1-2 months after the initial dose . Shingrix is for IM administration only . Shingrix must be reconstituted prior to administration . The need for booster doses following the primary vaccination schedule has not been established . Contra-indications : Hypersensitivity to the active substances or to any of the excipients . Special warnings and precautions : Shingrix is not indicated for prevention of primary varicella infection . Prior to immunisation , appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration . Administration of the vaccine should be postponed in subjects suffering from an acute severe febrile illness . A protective response may not be elicited in all vaccinees . The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease . Shingrix should not be administered intradermally or intravascularly . Subcutaneous administration is not recommended ; and maladministration via this route may lead to an increase in transient local reactions . Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following IM administration . Syncope ( fainting ) can occur following , or even before , any vaccination . This can be accompanied by neurological signs such as transient visual disturbance , paraesthesia and tonic-clonic limb movements during recovery . In a post-marketing observational study , an increased risk of Guillain- Barré syndrome was observed during the 42 days following vaccination ; available information is insufficient to determine a causal relationship . There are no safety , immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine . There are limited data to support the use of Shingrix in individuals with a history of HZ . Therefore , the benefits and risks of HZ vaccination should be weighed on an individual basis . Interactions : Can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine , 23-valent pneumococcal polysaccharide vaccine ( PPV23 ), pneumococcal conjugate vaccine ( PCV-13 ) or reduced antigen diphtheria-tetanus-acellular pertussis vaccine ( dTpa ). Vaccines should be administered at different injection sites . Fever and shivering were more frequent when PPV23 vaccine is co-administered with Shingrix . Concomitant use with other vaccines is not recommended due to lack of data . Ability to drive and use machinery : May have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination . Pregnancy and lactation : No data in pregnancy , as a precautionary measure , it is preferable to avoid the use of Shingrix during pregnancy . The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied . Adverse reactions : See SPC for full details . Very Common : Headache , GI symptoms ( including nausea , vomiting , diarrhoea and / or abdominal pain ), myalgia , injection site reactions ( such as pain , redness , swelling ), fatigue , chills , fever . Common : injection site pruritus , malaise . Serious : hypersensitivity reactions including rash , urticaria , angioedema . Legal category : POM . Presentation and basic NHS cost : Available in a pack size of 1 vial of powder plus 1 vial of suspension , 1 = £ 160 . Marketing Authorisation Numbers : PLGB 19494 / 0263 . Marketing Authorisation Holder : GlaxoSmithKline UK Limited , 980 Great West Road , Brentford , Middlesex , TW8 9GS , UK . Further information is available from : GlaxoSmithKline Customer Contact Centre , customercontactuk @ gsk . com ; Freephone 0800 221 441 . Shingrix is a trademark of the GlaxoSmithKline group of companies . Date of preparation : June 2023 . Ref : PI-7340 ( V5 ).
Prescribing information - NI Please consult the Summary of Product Characteristics ( SPC ) before prescribing
Shingrix Herpes zoster vaccine ( recombinant , adjuvanted ). Shingrix powder and suspension for suspension for injection . Composition : Following reconstitution , one 0.5ml dose contains 50μg Varicella Zoster Virus glycoprotein E antigen adjuvanted with AS01 B
( containing 50μg of Quillaja saponaria Molina , fraction 21 ( QS-21 ) and 50μg of 3-O-desacyl-4 ’ -monophosphoryl lipid A ( MPL ). Uses : Prevention of herpes zoster ( HZ ) and post-herpetic neuralgia ( PHN ), in adults 50 years of age or older and adults 18 years of age or older at increased risk of HZ . Use of Shingrix should be in accordance with official recommendations . Dosage and administration : Primary vaccination schedule consists of two doses of 0.5 ml each : an initial dose followed by a 2 nd dose 2 months later . If flexibility is needed , second dose can be given between 2-6 months after the first . For those who are or might be immunodeficient / immunocompromised and who may benefit from a shorter schedule , the 2 nd dose can be given 1-2 months after the initial dose . Shingrix is for IM administration only . Shingrix must be reconstituted prior to administration . The need for booster doses following the primary vaccination schedule has not been established . Contra-indications : Hypersensitivity to the active substances or to any of the excipients . Special warnings and precautions : Shingrix is not indicated for prevention of primary varicella infection . Prior to immunisation , appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration . Administration of the vaccine should be postponed in subjects suffering from an acute severe febrile illness . A protective response may not be elicited in all vaccinees . The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease . Shingrix should not be administered intradermally or intravascularly . Subcutaneous administration is not recommended ; and maladministration via this route may lead to an increase in transient local reactions . Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following IM administration . Syncope ( fainting ) can occur following , or even before , any vaccination . This can be accompanied by neurological signs such as transient visual disturbance , paraesthesia and tonic-clonic limb movements during recovery . In a post-marketing observational study , an increased risk of Guillain- Barré syndrome was observed during the 42 days following vaccination ; available information is insufficient to determine a causal relationship . There are no safety , immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine . There are limited data to support the use of Shingrix in individuals with a history of HZ . Therefore , the benefits and risks of HZ vaccination should be weighed on an individual basis . Interactions : Can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine , 23-valent pneumococcal polysaccharide vaccine ( PPV23 ), pneumococcal conjugate vaccine ( PCV-13 ) or reduced antigen diphtheria-tetanus-acellular pertussis vaccine ( dTpa ). Vaccines should be administered at different injection sites . Fever and shivering were more frequent when PPV23 vaccine is co-administered with Shingrix . Concomitant use with other vaccines is not recommended due to lack of data . Ability to drive and use machinery : May have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination . Pregnancy and lactation : No data in pregnancy , as a precautionary measure , it is preferable to avoid the use of Shingrix during pregnancy . The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied . Adverse reactions : See SPC for full details . Very Common : Headache , GI symptoms ( including nausea , vomiting , diarrhoea and / or abdominal pain ), myalgia , injection site reactions ( such as pain , redness , swelling ), fatigue , chills , fever . Common : injection site pruritus , malaise . Serious : hypersensitivity reactions including rash , urticaria , angioedema . Legal category : POM . Presentation and basic NHS cost : Available in a pack size of 1 vial of powder plus 1 vial of suspension , 1 = £ 160 . Marketing Authorisation Numbers : EU / 1 / 18 / 1272 / 001 , EU / 1 / 18 / 1272 / 002 . Marketing Authorisation Holder : GlaxoSmithKline Biologicals S . A . Rue de L ’ Institut 89 , b-1330 Rixensart , Belgium . Further information is available from : GlaxoSmithKline Customer Contact Centre , customercontactuk @ gsk . com ; Freephone 0800 221 441 . Shingrix is a trademark of the GlaxoSmithKline group of companies . Date of preparation : Jan 2023 . Ref : PI-8205 ( V5 ).
Adverse events should be reported . Reporting forms and information can be found at https :// yellowcard . mhra . gov . uk / or search for MHRA yellow card in the Google Play or Apple App store . Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 .