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Shingrix

Shingrix powder and suspension for suspension for injection

Manufacturer
GlaxoSmithKline UK
Label last updated
16 Apr 2026
Source
Official SmPC ↗

Shingles vaccine for adults 50 and over, and for adults 18 and over at increased risk. Two doses, with a strong adjuvant made from a plant extract and a bacterial lipid.

55 findings, each with the section of the label it comes from.

Ingredients and materials

  • Varicella zoster virus glycoprotein E antigen 50 micrograms per 0.5 ml doses.2
  • The antigen is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technologys.2
  • Adjuvanted with AS01B, which contains 50 micrograms of QS-21 - a fraction of an extract from the plant Quillaja saponaria Molina - and 50 micrograms of 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesotas.2
  • The adjuvant effect of AS01B is the result of interactions between MPL and QS-21 formulated in liposomes, which are tiny fat bubbless.5.1
  • Powder excipients: sucrose, polysorbate 80 (E433), sodium dihydrogen phosphate dihydrate (E339), dipotassium phosphate (E340)s.6.1
  • Adjuvant suspension excipients: dioleoyl phosphatidylcholine (E322, lecithin), cholesterol, sodium chloride, disodium phosphate anhydrous (E339), potassium dihydrogen phosphate (E340), water for injectionss.6.1
  • Contains 0.08 mg polysorbate 80 per doses.4.4
  • Declared essentially sodium-free and potassium-free, less than 1 mmol of each per doses.4.4

Manufacture, storage and handling

  • Shelf life 42 monthss.6.3
  • Store at 2C to 8C, do not freeze, store in the original package to protect from lights.6.4
  • Supplied as two vials - a powder (antigen) with a brown flip-off cap and a suspension (adjuvant) with a blue-green cap - which must be mixed before uses.6.6
  • Reconstituted by withdrawing the whole suspension into a syringe and adding it to the powder vial, then shaking gently until dissolved; the result is an opalescent colourless to pale brownish liquids.6.6
  • Do not reconstitute or administer if foreign particulate matter or a variation in appearance is seens.6.6
  • After reconstitution, use promptly; chemical and physical in-use stability has been demonstrated for 24 hours at 30C, but from a microbiological point of view it should be used immediately and if not, normally not longer than 6 hours at 2C to 8Cs.6.3, 6.6
  • Use a new needle to administer after withdrawing the reconstituted vaccines.6.6
  • Intramuscular injection only, preferably the deltoid; should not be administered intravascularly or intradermally, and subcutaneous administration is not recommended because it may increase transient local reactionss.4.2, 4.4
  • Must not be mixed with other medicinal productss.6.2
  • Two doses two months apart; the second can be given between 2 and 6 months after the first if flexibility is needed, or 1 to 2 months later in people who are or may become immunodeficient or immunosuppresseds.4.2
  • The need for booster doses after the primary schedule 'has not been established's.4.2

Safety findings

  • Indicated for prevention of shingles and post-herpetic neuralgia in adults 50 and over, and adults 18 and over at increased risk of shingless.4.1
  • Not indicated for prevention of primary varicella infection (chickenpox)s.4.2
  • The safety and efficacy of Shingrix in children and adolescents have not been established, and the label states 'No data are available's.4.2
  • The only listed contraindication is hypersensitivity to the active substances or excipientss.4.3
  • Vaccination should be postponed during acute severe febrile illness; a minor infection such as a cold is not a reason to defers.4.4
  • As with any vaccine, a protective immune response may not be elicited in all vaccinees, and the vaccine is for prophylactic use only, not for treating established diseases.4.4
  • Give with caution in thrombocytopenia or any coagulation disorder because bleeding may occur after intramuscular administrations.4.4
  • Fainting can occur after or even before any vaccination, and can be accompanied by transient visual disturbance, paraesthesia and tonic-clonic limb movements during recoverys.4.4
  • There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another shingles vaccines.4.4
  • An increased risk of Guillain-Barre syndrome was observed in 2 similar US post-marketing observational studies in people aged 65 and over: an estimated 3 to 7 excess cases per million doses in the 42 days after any dose. On further analysis the increased risk was seen after the first dose, an estimated 6 to 12 excess cases per million doses, with no increased risk after the second doses.4.8
  • Guillain-Barre syndrome is listed as a very rare adverse reactions.4.8
  • Very common reactions in adults 50 and over: pain at the injection site (68.1 per cent overall per dose, 3.8 per cent severe), myalgia (32.9 per cent), fatigue (32.2 per cent) and headache (26.3 per cent), plus injection site redness and swelling, chills, fever and gastrointestinal symptoms. Most lasted a median of 2 to 3 days, and severe reactions 1 to 2 dayss.4.8
  • There was a higher incidence of some adverse reactions in younger age groups: in immunocompromised adults the incidence of injection site pain, fatigue, myalgia, headache, shivering and fever was higher in 18 to 49 year olds than in 50 and over, and in the 50 and over studies the incidence of myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms was higher at 50 to 69 than at 70 and overs.4.8
  • Listed as rare: hypersensitivity reactions including rash, urticaria and angioedemas.4.8
  • Fever and shivering were more frequent when the 23-valent pneumococcal vaccine was given at the same time: 16 per cent and 21 per cent respectively, against 7 per cent for both when Shingrix was given alones.4.5
  • Systemic reactions were much more frequent when Shingrix was given with a COVID-19 mRNA vaccine: myalgia 64 per cent, fatigue 51.7 per cent, headache 39 per cent and arthralgia 30.3 per cent, against 32.9, 32.2, 26.3 and usually uncommon respectively for Shingrix alones.4.5
  • Concomitant administration with vaccines other than those listed has not been studieds.4.5
  • Pregnancy: there are no data from use in pregnant women, and as a precautionary measure it is preferable to avoid Shingrix during pregnancys.4.6
  • Breastfeeding: the effect on breastfed infants of giving the vaccine to their mothers has not been studied, and it is unknown whether Shingrix is excreted in human milks.4.6
  • Fertility: animal studies do not indicate direct or indirect effects on fertility in males or femaless.4.6
  • Overdose: no case has been reporteds.4.9

Evidence and claims

  • Two phase 3 placebo-controlled observer-blind efficacy studies in adults 50 and over: ZOE-50 with 15,405 adults, and ZOE-70 with 13,900 adultss.5.1
  • Efficacy against shingles was 97.2 per cent in adults 50 and over (6 cases against 210) and 91.3 per cent in adults 70 and over (25 cases against 284)s.5.1
  • In immunocompromised groups: in adults 18 and over with autologous haematopoietic stem cell transplants, 49 cases against 135; in adults with haematological malignancies, 2 cases against 14, with vaccine efficacy calculated post-hocs.5.1
  • Two further phase 3 studies evaluated efficacy in immunocompromised adults: Zoster-002 in 1,846 stem cell transplant recipients and Zoster-039 in 562 subjects with haematological malignanciess.5.1
  • 'These studies were not designed to assess the impact of concomitant use of IS therapy on vaccine efficacy or to assess the impact of specific IS treatments on vaccine efficacy.' Most vaccine recipients were not under immunosuppressive therapy at the time of vaccination, and not all types of immunosuppressive therapy were used in the populations studieds.5.1
  • 'The studies were not designed to demonstrate efficacy in subgroups of frail individuals, including those with multiple comorbidities', although such people were not excludeds.5.1
  • Efficacy was evaluated in a modified cohort that excluded adults who did not receive the second dose, or who had a confirmed diagnosis of shingles within one month of the second doses.5.1
  • The safety profile is based on a pooled analysis of 5,887 adults aged 50 to 69 and 8,758 adults aged 70 and over, of whom 7,408 were included in a long-term follow-up extension study over approximately 11 years after vaccinations.4.8
  • In immunocompromised adults aged 18 and over (1,587 subjects) the safety profile was consistent with the older population, but there are limited data in adults aged 18 to 49 at increased risk of shingles who are not immunocompromiseds.4.8
  • Preclinical data reveal no special hazard for humans based on conventional studies of acute and repeated dose toxicity, local tolerance, cardiovascular and respiratory safety pharmacology, and toxicity to reproduction and developments.5.3

Document and licensing

  • Marketing authorisation holder: GlaxoSmithKline UK Limited, Londons.7
  • First authorised 1 January 2021, latest renewal 9 June 2023s.9
  • Text last revised 1 April 2026s.10
  • The Guillain-Barre finding is given in absolute excess cases per million doses rather than only as a frequency category, which is unusual and specifics.4.8
  • Suspected reactions are reported through the MHRA Yellow Card schemes.4.8

Every line above is a summary of a statement in the manufacturer's own label, with the section number it comes from. Nothing has been added from any other source. The full list of flagged sentences is below, as it came out of the document.

Listed ingredients

Section 2 - qualitative and quantitative composition source ↗

After reconstitution, one dose (0.5 mL) contains:
 Varicella Zoster Virus^1 glycoprotein E antigen^2,3
 50 micrograms
 ^1 Varicella Zoster Virus = VZV
 ^2 adjuvanted with AS01B containing:
 plant extract Quillaja saponaria Molina, fraction 21 (QS-21)
 50 micrograms
 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 
 50 micrograms
 ^3 glycoprotein E (gE) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology 
 Excipients with known effect 
 Each dose contains 0.08 milligrams of polysorbate 80 (E 433) (see section 4.4).
 For the full list of excipients, see section 6.1.

What these are, in plain English

  • qs-21 - A substance extracted from the soap bark tree, used as an adjuvant.
  • monophosphoryl - MPL, a purified piece of bacterial cell wall, used as an adjuvant to strengthen the immune response.
  • recombinant - Made by genetic engineering: the gene for one piece of the germ is put into a laboratory cell or bacterium, which then makes that piece.
  • polysorbate 80 - An emulsifier (E433), also used in some foods and cosmetics. It stops the ingredients separating.

Other ingredients (excipients)

Section 6.1 source ↗

  • Powder (gE antigen)
  • SucroseSugar. Used as a stabiliser so the vaccine keeps its potency in storage.
  • Polysorbate 80 (E 433)An emulsifier (E433), also used in some foods and cosmetics. It stops the ingredients separating.
  • Sodium dihydrogen phosphate dihydrate (E 339)
  • Dipotassium phosphate (E 340)A phosphate buffer, used to hold the liquid at a steady acidity.
  • Suspension (AS01B Adjuvant System)An added ingredient that makes the immune system react more strongly to the vaccine.
  • Dioleoyl phosphatidylcholine (E 322)Lecithin (E322), a fat from soy or egg, used to form the tiny fat bubbles (liposomes) that carry the adjuvant.
  • Cholesterol
  • Sodium chlorideSalt. Used to keep the liquid at the same saltiness as the body.
  • Disodium phosphate anhydrous (E 339)
  • Potassium dihydrogen phosphate (E 340)
  • Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
  • For adjuvant see also section 2.An added ingredient that makes the immune system react more strongly to the vaccine.
Audit trail: every flagged sentence in the document (68)

These are the sentences the mechanical filter pulled out, in the document's own words, grouped by section. They are what the briefing above was built from, kept here so you can check nothing was left out. Some are fragments and some are technical, which is why the briefing exists.

4.2 Posology and method of administration

  1. The need for booster doses following the primary vaccination schedule has not been established (see section 5.1).

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • not been established - There is not yet enough evidence to state a conclusion.

    No data / not studied matched: not been established

  2. Shingrix can be given with the same schedule in individuals previously vaccinated with live attenuated HZ vaccine (see section 5.1).

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.

    Genetic engineering, vectors and GMOs matched: attenuated

  3. Shingrix is not indicated for prevention of primary varicella infection (chickenpox).

    Section 4.2 Posology and method of administration source ↗

    Not recommended, contraindicated or restricted matched: is not indicated

  4. The safety and efficacy of Shingrix in children and adolescents have not been established.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • not been established - There is not yet enough evidence to state a conclusion.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpointsNo data / not studied matched: efficacy, have not been established

  5. No data are available.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.

    No data / not studied matched: no data

4.4 Special warnings and precautions for use

  1. As with any vaccine, a protective immune response may not be elicited in all vaccinees.

    Section 4.4 Special warnings and precautions for use source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  2. Subcutaneous administration is not recommended.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • not recommended - The manufacturer advises against it. This is weaker than 'contraindicated', which means it must not be given.

    Not recommended, contraindicated or restricted matched: not recommended

  3. There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • immunogenicity - How strongly the vaccine provokes an immune response. It is measured in the blood, not by how many people avoided the illness.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  4. This medicinal product contains 0.08 mg of polysorbate 80 per dose.

    Section 4.4 Special warnings and precautions for use source ↗

    Trace residues and process chemicals matched: polysorbate

4.5 Interaction with other medicinal products and other forms of interaction

  1. Shingrix can be given concomitantly with seasonal influenza vaccine (inactivated, unadjuvanted), 23-valent pneumococcal polysaccharide vaccine (PPV23), 13-valent pneumococcal conjugate vaccine (PCV13), reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa), coronavirus disease 2019 (COVID-19) messenger ribonucleic acid (mRNA) vaccine or respiratory syncytial virus (RSV) vaccine [...]

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • inactivated - Killed. The organism cannot replicate at all.
    • conjugate - A design where a sugar from a germ is attached to a carrier protein, so the immune system responds properly.
    • antigen - The part of a germ that the immune system recognises and remembers.

    Genetic engineering, vectors and GMOs matched: mrna

  2. In adults aged 50 years and above, systemic adverse reactions that are very commonly reported (see Table 1; such as myalgia 32.9%, fatigue 32.2%, and headache 26.3%), and arthralgia, uncommonly reported, following administration of Shingrix alone were reported with increased frequency when Shingrix was co-administered with a COVID-19 mRNA vaccine (myalgia 64%, fatigue 51.7%, headache 39%, [...]

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • arthralgia - Joint pain.
    • myalgia - Muscle aches.
    • mrna - Messenger RNA: temporary instructions telling cells to make one protein. It does not enter the cell's own DNA.

    Genetic engineering, vectors and GMOs matched: mrna

  3. Concomitant administration of Shingrix with other vaccines than those listed above has not been studied.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • has not been studied - No trial has been run for this group or this situation.

    No data / not studied matched: has not been studied

4.6 Fertility, pregnancy and lactation

  1. There are no data from the use of Shingrix in pregnant women.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.

    No data / not studied matched: no data

  2. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).

    Section 4.6 Fertility, pregnancy and lactation source ↗

    Animal, human or cell-line derived material matched: foetal

  3. The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • has not been studied - No trial has been run for this group or this situation.

    No data / not studied matched: has not been studied

  4. It is unknown whether Shingrix is excreted in human milk.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    No data / not studied matched: is unknown

4.8 Undesirable effects

  1. In adults ≥ 18 years of age who are immunodeficient or immunosuppressed due to disease or therapy (referred to as immunocompromised (IC)), the safety profile was consistent with that observed in adults 50 years and above.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.

    Immune system, shedding and transmission matched: immunocompromised

  2. There are limited data in adults aged 18-49 years at increased risk of HZ who are not IC.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • limited data - Only a small amount of information exists on this point, so firmer conclusions cannot be drawn.

    Limited, insufficient or inconclusive matched: limited data

  3. Post-marketing observational studies of the risk of Guillain-Barré syndrome

    Section 4.8 Undesirable effects source ↗

    In plain English

    • post-marketing - After the product went on the market and was given to the public, as opposed to during the original clinical trials.

    Rare or very rare serious events matched: guillain

  4. In 2 similar post-marketing observational studies in the US among individuals aged 65 years or older, an increased risk of Guillain-Barré syndrome (estimated 3 to 7 excess cases per million doses administered) was observed during the 42 days following any dose of Shingrix.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • post-marketing - After the product went on the market and was given to the public, as opposed to during the original clinical trials.

    Rare or very rare serious events matched: guillain

  5. In further analyses, the increased risk was observed following the first dose of Shingrix (estimated 6 to 12 excess cases of Guillain-Barré syndrome per million doses administered), but no increased risk was observed following the second dose.

    Section 4.8 Undesirable effects source ↗

    Rare or very rare serious events matched: guillain

5.1 Pharmacodynamic properties

  1. By combining the VZV specific antigen (gE) with an adjuvant system (AS01B), Shingrix is designed to induce antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity against VZV.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • adjuvant - An added ingredient that makes the immune system react more strongly to a vaccine.
    • antigen - The part of a germ that the immune system recognises and remembers.

    Adjuvants, carriers and immune-stimulating ingredients matched: adjuvant

  2. The adjuvant effect of AS01B is the result of interactions between MPL and QS-21 formulated in liposomes.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • adjuvant - An added ingredient that makes the immune system react more strongly to a vaccine.

    Adjuvants, carriers and immune-stimulating ingredients matched: adjuvant

  3. Efficacy against Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN)

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  4. Two phase III, placebo-controlled, observer-blind efficacy studies of Shingrix were conducted in adults ≥ 50 years with 2 doses administered 2 months apart:

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • placebo-controlled - A trial where one group gets a dummy instead of the vaccine, so the two can be compared.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  5. The studies were not designed to demonstrate efficacy in subgroups of frail individuals, including those with multiple comorbidities, although these subjects were not excluded from the studies.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  6. Two phase III, placebo-controlled, observer-blind studies evaluating Shingrix efficacy were conducted in IC adults ≥ 18 years with 2 doses administered 1-2 months apart:

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • placebo-controlled - A trial where one group gets a dummy instead of the vaccine, so the two can be compared.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  7. These studies were not designed to assess the impact of concomitant use of IS therapy on vaccine efficacy or to assess the impact of specific IS treatments on vaccine efficacy.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  8. Incidence of HZ and PHN cases as well as vaccine efficacy were evaluated in the modified Total Vaccinated Cohort (mTVC), i.e. excluding adults who did not receive the second dose of vaccine or who had a confirmed diagnosis of HZ within one month after the second dose.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  9. - adults ≥ 18 years with hematologic malignancies (Zoster-039): 2 vs. 14 cases. Vaccine efficacy was calculated post-hoc.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  10. Vaccine efficacy results against HZ are presented in Table 2.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  11. Data in subjects ≥ 70 years of age are sourced from the pre-specified pooled analyses of ZOE-50 and ZOE-70 (mTVC) as these analyses provide the most robust estimates for vaccine efficacy in this age group.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  12. Post-hoc analysis of efficacy against confirmed HZ undertaken in patients with common conditions (chronic kidney disease, chronic obstructive pulmonary disease, coronary artery disease, depression or diabetes mellitus), indicates that the vaccine efficacy is aligned with the overall HZ efficacy.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.
    • common - In the label's frequency scale, this means it happened in up to 1 in 10 people studied.

    Efficacy, effectiveness and endpoints matched: efficacy

  13. Vaccine efficacy results against PHN are presented in Table 3.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  14. Data in subjects ≥ 70 years of age are sourced from the pre-specified pooled analyses of ZOE-50 and ZOE-70 (mTVC) as these analyses provide the most robust estimates for vaccine efficacy in this age group.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  15. In the fourth year after vaccination, the efficacy against HZ was 93.1% (95% CI: 81.2; 98.2) and 87.9% (95% CI: 73.3; 95.4) in adults ≥ 50 years (ZOE-50) and adults ≥ 70 years (pooled ZOE-50 and ZOE-70), respectively.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  16. In Zoster-002, during a follow-up period starting 1 month post-dose 2 (i.e. corresponding to approximately 6 months after aHSCT) until 1 year after aHSCT, when the risk for HZ is the highest, the efficacy against HZ was 76.2% (95% CI: 61.1; 86.0).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  17. Efficacy against HZ-related complications other than PHN

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  18. As a consequence of the high vaccine efficacy against HZ, a low number of breakthrough cases were accrued, and it was therefore not possible to draw firm conclusions on these study objectives.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpointsLimited, insufficient or inconclusive matched: efficacy, not possible

  19. The efficacy in reducing BOI was 98.4% (95% CI: 92.2; 100) in subjects ≥ 50 years (ZOE-50) and 92.1% (95% CI: 90.4; 93.8) in subjects ≥ 70 years (ZOE-50 and ZOE-70 pooled).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  20. Additionally, in Zoster-002, the efficacy in reducing BOI score was 82.5% (95% CI: 73.6%, 91.4%).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  21. Long-term efficacy against HZ, PHN and HZ-related complications other than PHN

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  22. The TVC for efficacy included 7 408 subjects (i.e. 50.6% of 14 645 subjects included in the TVC for efficacy for studies ZOE-50 and ZOE-70).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  23. Persistence of efficacy remains unknown in immunocompromised/immunosuppressed population.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpointsImmune system, shedding and transmissionLimited, insufficient or inconclusive matched: efficacy, immunocompromised, remains unknown

  24. Vaccine efficacy was calculated descriptively against HZ, PHN and HZ-related complications other than PHN in the mTVC (i.e. excluding subjects who did not receive the second dose of vaccine in the primary studies, or who developed a confirmed case of HZ within one month after the second dose).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  25. Since the efficacy was estimated with regard to the first or only event, individuals who experienced a HZ, PHN, or HZ-related complication (other than PHN) during studies ZOE-50 and ZOE-70 were excluded from the corresponding efficacy analyses over the Zoster-049 duration.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  26. Estimates of incidence rates in the control group to assess the vaccine efficacy during Zoster-049 study were historical, derived from the ZOE-50 and ZOE-70 placebo groups.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.
    • placebo - A dummy injection with no active ingredient, used as a comparison group in a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  27. Shingrix long-term efficacy results against HZ, from approximately 5 years up to approximately 11 years post-vaccination, are presented in Table 4.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  28. Long-term Shingrix efficacy against HZ (mTVC) from approximately 5 years up to approximately 11 years post-vaccination

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  29. In the eleventh year after vaccination, the efficacy against HZ was 82.0% (95% CI: 63.0; 92.2) in subjects ≥ 50 years (Shingrix group:

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  30. Shingrix long-term efficacy results against PHN, from approximately 5 years up to approximately 11 years post-vaccination, are presented in Table 5.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  31. Long-term Shingrix efficacy against PHN (mTVC) from approximately 5 years up to approximately 11 years post-vaccination

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  32. Shingrix efficacy against HZ-related complications other than PHN, over the duration of Zoster-049, was 91.7% (95% CI: 43.7; 99.8) and 88.9% (95% CI: 19.8; 99.8) in adults ≥ 50 years (1 vs. 12 cases) and adults ≥ 70 years (1 vs. 9 cases), respectively.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  33. An immunological correlate of protection has not been established; therefore the level of immune response that provides protection against HZ is unknown.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • correlate of protection - A lab measurement that is thought to predict whether someone is actually protected. It is a stand-in, not proof.
    • immunological correlate - A lab measurement used as a stand-in for protection.
    • not been established - There is not yet enough evidence to state a conclusion.

    Efficacy, effectiveness and endpointsNo data / not studied matched: correlate of protection, is unknown

  34. In adults ≥ 50 years, the immune responses to Shingrix, given as 2 doses 2 months apart, were evaluated in a subset of subjects from the phase III efficacy studies ZOE-50 [humoral immunity and cell-mediated immunity (CMI)] and ZOE-70 (humoral immunity).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  35. ^ Anti-gE immune response = anti-gE antibody levels, measured by anti-gE enzyme-linked immunosorbent assay (gE ELISA)

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  36. ^ Anti-gE immune response = anti-gE antibody levels, measured by anti-gE enzyme-linked immunosorbent assay (gE ELISA)

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  37. The clinical relevance in terms of impact on efficacy, on the short and long term, is unknown.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpointsNo data / not studied matched: efficacy, is unknown

  38. * Blood for CMI was only collected from the group of subjects that received the first dose of Shingrix 8-30 days before the start of a chemotherapy cycle (i.e. largest group of the study)

    Section 5.1 Pharmacodynamic properties source ↗

    Animal, human or cell-line derived material matched: blood

  39. Efficacy has not been assessed for the 0, 6-month schedule.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpointsNo data / not studied matched: efficacy, not been assessed

  40. In a phase III, open-label clinical study (Zoster-026) where 238 adults ≥ 50 years of age were equally randomised to receive 2 doses of Shingrix 2 or 6 months apart, the humoral immune response following the 0, 6-month schedule was demonstrated to be non-inferior to the response with the 0, 2-month schedule.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • randomised - A trial where people are assigned to groups by chance.

    Efficacy, effectiveness and endpoints matched: immune response

  41. Immunogenicity in individuals previously vaccinated with live attenuated herpes zoster (HZ) vaccine

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.
    • immunogenicity - How strongly the vaccine provokes an immune response. It is measured in the blood, not by how many people avoided the illness.

    Genetic engineering, vectors and GMOs matched: attenuated

  42. In a phase III, open-label, multicentre clinical study (Zoster-048), a 2 dose schedule of Shingrix 2 months apart was assessed in 215 adults ≥ 65 years of age with a previous history of vaccination with live attenuated HZ vaccine ≥ 5 years earlier compared to 215 matched subjects who had never received live attenuated HZ vaccine.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.

    Genetic engineering, vectors and GMOs matched: attenuated

  43. The immune response to Shingrix was unaffected by prior vaccination with live attenuated HZ vaccine.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.

    Efficacy, effectiveness and endpointsGenetic engineering, vectors and GMOs matched: attenuated, immune response

6.1 List of excipients

  1. For adjuvant see also section 2.

    Section 6.1 List of excipients source ↗

    In plain English

    • adjuvant - An added ingredient that makes the immune system react more strongly to a vaccine.

    Adjuvants, carriers and immune-stimulating ingredients matched: adjuvant

6.6 Special precautions for disposal and other handling

  1. Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial with a blue-green flip-off cap containing the suspension (adjuvant).

    Section 6.6 Special precautions for disposal and other handling source ↗

    In plain English

    • adjuvant - An added ingredient that makes the immune system react more strongly to a vaccine.
    • antigen - The part of a germ that the immune system recognises and remembers.

    Adjuvants, carriers and immune-stimulating ingredients matched: adjuvant

  2. If either is observed, do not administer the vaccine.

    Section 6.6 Special precautions for disposal and other handling source ↗

    In plain English

    • do not administer - The label instructs that it must not be given.

    Not recommended, contraindicated or restricted matched: do not administer

  3. After reconstitution, the vaccine should be used promptly; if this is not possible, the vaccine should be stored in a refrigerator (2 °C - 8 °C).

    Section 6.6 Special precautions for disposal and other handling source ↗

    Limited, insufficient or inconclusive matched: not possible

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