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Bexsero

Bexsero suspension for injection in pre-filled syringe

Manufacturer
GlaxoSmithKline UK
Label last updated
20 Mar 2025
Source
Official SmPC ↗

Meningococcal group B vaccine for babies from 2 months, given as up to three doses plus a booster. Its efficacy was never measured in a clinical trial - it was inferred from laboratory antibody tests.

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

Ingredients and materials

  • Three recombinant Neisseria meningitidis group B proteins - NHBA fusion protein, NadA protein and fHbp fusion protein - at 50 micrograms each per 0.5 ml doses.2
  • All three are produced in E. coli cells by recombinant DNA technologys.2
  • Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254, measured as total protein containing PorA P1.4, 25 microgramss.2
  • Absorbed on aluminium hydroxide, 0.5 mg Al3+, present as an adjuvants.2
  • Kanamycin is used in the early manufacturing process and is removed later; if present, levels in the final vaccine are less than 0.01 micrograms per dose, but the safe use of Bexsero in kanamycin-sensitive individuals 'has not been established's.4.4
  • Excipients: sodium chloride, histidine, sucrose, water for injectionss.6.1
  • Declared essentially sodium-free, less than 1 mmol (23 mg) per doses.4.4

Manufacture, storage and handling

  • Shelf life 4 yearss.6.3
  • Store at 2C to 8C, do not freeze, store in the original package to protect from lights.6.4
  • A fine off-white deposit may be observed on storage; the pre-filled syringe must be well shaken to form a homogeneous suspensions.6.6
  • Deep intramuscular injection, into the anterolateral thigh in infants or the deltoid in older subjectss.4.2
  • Must not be injected intravenously, subcutaneously or intradermally, and must not be mixed with other vaccines in the same syringes.4.2
  • Separate injection sites must be used if more than one vaccine is given at the same times.4.2
  • Do not pull the syringe plunger out of the barrel; if it happens, do not administer the vaccines.6.6
  • Must not be mixed with other medicinal products; no compatibility studies exists.6.2
  • Dosing depends on the age at first dose: three doses plus a booster for infants starting at 2 to 5 months, two doses plus a booster for 6 to 23 months, two doses plus a booster to be considered for 2 to 10 yearss.4.2
  • In case of delay, the booster should not be given later than 24 months of ages.4.2

Safety findings

  • The only listed contraindication is hypersensitivity to the active substances or to any of the excipientss.4.3
  • Should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risks.4.4
  • Vaccination may not protect all recipients, and Bexsero 'is not expected to provide protection against all circulating meningococcal group B strains's.4.4
  • Individuals with familial complement deficiencies such as C3 or C5 deficiency, and those receiving treatments that inhibit terminal complement activation such as eculizumab, remain at increased risk of invasive group B disease even if they develop antibodies after vaccinations.4.4
  • There are no data on use in subjects above 50 years of age, and only limited data in patients with chronic medical conditionss.4.4
  • The safe use of Bexsero in kanamycin-sensitive individuals has not been establisheds.4.4
  • The need for and timing of further booster doses beyond those in the schedule 'has not yet been determined's.4.2
  • In infants vaccinated at 2, 4 and 6 months, fever of 38C or above was reported by 69 to 79 per cent of subjects when Bexsero was given with routine vaccines, compared with 44 to 59 per cent of those receiving the routine vaccines alone. Higher rates of antipyretic use were also reported in the Bexsero groups.4.8
  • When Bexsero was given alone, the frequency of fever was similar to that of routine infant vaccines in clinical trialss.4.8
  • Fever of 40C or above is listed as uncommons.4.8
  • Prophylactic paracetamol reduces the incidence and severity of fever without affecting the immunogenicity of either Bexsero or the routine vaccines; the effect of antipyretics other than paracetamol on the immune response has not been studieds.4.5
  • Anxiety-related reactions including fainting, hyperventilation and stress-related reactions may occur as a response to the needle, so procedures should be in place to avoid injury from faintings.4.4
  • The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered in very premature infants born at or before 28 weeks, particularly those with previous respiratory immaturity; vaccination should not be withheld or delayed because the benefit is highs.4.4
  • Individuals with impaired immune responsiveness from immunosuppressive therapy, a genetic disorder or other causes may have a reduced antibody responses.4.4
  • In co-administration studies, inconsistent results were seen for inactivated poliovirus type 2 and pneumococcal conjugate serotype 6B, and lower antibody titres to pertussis pertactin were noted, though the label states these data do not suggest clinically significant interferences.4.5
  • Because of an increased risk of fever, tenderness at the injection site, change in eating habits and irritability when co-administered with other vaccines, separate vaccinations can be considered where possibles.4.5
  • Concomitant administration with vaccines other than those listed has not been studieds.4.5
  • Very common reactions in infants and children: eating disorders, sleepiness, unusual crying, headache, diarrhoea, vomiting, rash in 12 to 23 month olds, arthralgia, fever of 38C or above, injection site tenderness including severe tenderness defined as crying when the injected limb is moved, redness, swelling, induration and irritabilitys.4.8
  • Listed as uncommon: seizures including febrile seizures, pallor, eczemas.4.8
  • Listed as rare: Kawasaki syndrome, urticarias.4.8
  • Listed at frequency not known from worldwide voluntary reports: lymphadenopathy, allergic reactions including anaphylactic reactions, hypotonic-hyporesponsive episode, meningeal irritation (signs such as neck stiffness or photophobia reported sporadically shortly after vaccination, described as mild and transient), and injection site reactions including extensive swelling of the vaccinated limb, blisters and an injection site nodule that may persist for more than a months.4.8
  • Pregnancy: insufficient clinical data on exposed pregnancies are available and the potential risk for pregnant women is unknown, although vaccination should not be withheld when there is a clear risk of exposure to meningococcal infections.4.6
  • Breastfeeding: information on the safety of the vaccine to women and their children during breastfeeding is not available, and the benefit-risk ratio must be examined before deciding to immunises.4.6
  • Fertility: there are no data on fertility in humanss.4.6
  • In a rabbit study at approximately 10 times the human dose based on body weight there was no evidence of maternal or foetal toxicity and no effect on pregnancy, maternal behaviour, female fertility or postnatal developments.4.6
  • Overdose: experience is limited; monitoring of vital functions and symptomatic treatment is recommendeds.4.9

Evidence and claims

  • 'The efficacy of Bexsero has not been evaluated through clinical trials. Vaccine efficacy has been inferred by demonstrating the induction of serum bactericidal antibody responses to each of the vaccine antigens's.5.1
  • The vaccine is intended to stimulate bactericidal antibodies against NHBA, NadA, fHbp and PorA P1.4, which are variably expressed by different strains, so only meningococci expressing them at sufficient levels are expected to be susceptibles.5.1
  • A survey of about 1,000 invasive group B isolates from 5 European countries in 2007-2008 found that 73 to 87 per cent, depending on country, had an antigen profile covered by the vaccine; overall 78 per cent with confidence limits of 63 to 90 per cents.5.1
  • Bactericidal responses after the third dose were high against fHbp, NadA and PorA P1.4 at both schedules, but the NHBA antigen 'appeared to be less immunogenic at the 2, 3, 4-month schedule', and the label states the 'clinical consequences of the reduced immunogenicity of the NHBA antigen at this schedule are not known's.5.1
  • The safety database is 17 studies including 10 randomised controlled trials, with 10,565 subjects from 2 months of age who received at least one dose; 6,837 were under 2 years, 1,051 were 2 to 10 years, and 2,677 were adolescents and adultss.4.8
  • Preclinical data reveal no special hazard for humans based on repeated dose toxicity and reproductive and developmental toxicity studiess.5.3

Document and licensing

  • Marketing authorisation holder: GlaxoSmithKline UK Limited, Londons.7
  • First authorised 1 January 2021s.9
  • Text last revised 14 March 2025s.10
  • The section setting out what the vaccine does is honest about the absence of a clinical efficacy trial, and puts the coverage estimate at 78 per cent of circulating strainss.5.1
  • 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 ↗

One dose (0.5 ml) contains:
 Recombinant Neisseria meningitidis group B NHBA fusion protein ^1, 2, 3
 50 micrograms
 Recombinant Neisseria meningitidis group B NadA protein ^1, 2, 3
 50 micrograms
 Recombinant Neisseria meningitidis group B fHbp fusion protein ^1, 2, 3
 50 micrograms
 Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 ^2
 25 micrograms
 ^1 produced in E. coli cells by recombinant DNA technology
 ^2 adsorbed on aluminium hydroxide (0.5 mg Al^3+)
 ^3 NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
 For the full list of excipients, see section 6.1.

What these are, in plain English

  • 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.
  • neisseria meningitidis - The bacterium that causes meningococcal disease. The vaccine uses purified proteins from it, not the live bacterium.
  • outer membrane vesicles - Small packages pinched off the outer coat of the bacterium. They are purified parts of the germ, not the live bacterium.
  • nz98/254 - The laboratory reference name of the bacterial strain the proteins were copied from.
  • pora p1.4 - A protein from the outer coat of the meningococcal bacterium.
  • e. coli - A common gut bacterium used in the laboratory as a factory to make proteins or DNA. The bacterium itself is not in the finished vaccine.
  • aluminium - An aluminium salt. It is an adjuvant: it makes the immune system respond more strongly to the vaccine. Aluminium in vaccines has been used since the 1930s.

Other ingredients (excipients)

Section 6.1 source ↗

  • Sodium chlorideSalt. Used to keep the liquid at the same saltiness as the body.
  • HistidineAn amino acid, one of the building blocks of protein. Used to keep the liquid at a stable acidity.
  • SucroseSugar. Used as a stabiliser so the vaccine keeps its potency in storage.
  • Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
  • For adsorbent see section 2.
Audit trail: every flagged sentence in the document (42)

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 safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • has not yet 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 endpoints matched: efficacy

  2. 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

  3. ^b In case of delay, the booster should not be given later than 24 months of age.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • should not be given - The label says the product should not be given in this situation.

    Not recommended, contraindicated or restricted matched: should not be given

  4. * There are no data in adults above 50 years of age.

    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. This vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • should not be given - The label says the product should not be given in this situation.
    • thrombocytopenia - A low platelet count, which makes bruising and bleeding easier.

    Not recommended, contraindicated or restricted matched: should not be given

  2. There are no data on the use of Bexsero in subjects above 50 years of age and limited data in patients with chronic medical conditions.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

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

    Limited, insufficient or inconclusiveNo data / not studied matched: limited data, no data

  3. Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture.

    Section 4.4 Special warnings and precautions for use source ↗

    Trace residues and process chemicals matched: kanamycin

  4. If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose.

    Section 4.4 Special warnings and precautions for use source ↗

    Trace residues and process chemicals matched: kanamycin

  5. The safe use of Bexsero in kanamycin-sensitive individuals has not been established.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

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

    No data / not studiedTrace residues and process chemicals matched: kanamycin, not been established

4.5 Interaction with other medicinal products and other forms of interaction

  1. Clinical studies demonstrated that the immune responses of the co-administered routine vaccines were unaffected by concomitant administration of Bexsero, based on non-inferior antibody response rates to the routine vaccines given alone.

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

    Efficacy, effectiveness and endpoints matched: non-inferior

  2. The effect of antipyretics other than paracetamol on the immune response 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.

    Efficacy, effectiveness and endpointsNo data / not studied matched: has not been studied, immune response

  3. Concomitant administration of Bexsero with vaccines other than those mentioned 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. Insufficient clinical data on exposed pregnancies are available.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • insufficient - Not enough to draw a conclusion from.

    Limited, insufficient or inconclusive matched: insufficient

  2. The potential risk for pregnant women is unknown.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    No data / not studied matched: is unknown

  3. There was no evidence of maternal or foetal toxicity, and no effects on pregnancy, maternal behaviour, female fertility, or postnatal development in a study in which female rabbits received Bexsero at approximately 10 times the human dose equivalent based on body weights.

    Section 4.6 Fertility, pregnancy and lactation source ↗

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

  4. There are no data on fertility in humans.

    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

4.8 Undesirable effects

  1. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency and they are consequently listed with the frequency unknown.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • uncertain - The evidence does not settle the question.

    Limited, insufficient or inconclusive matched: uncertain

  2. Not known: allergic reactions (including anaphylactic reactions)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  3. Not known: hypotonic-hyporesponsive episode, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  4. Not known: injection site reactions (including extensive swelling of the vaccinated limb, blisters at or around the injection site and injection site nodule which may persist for more than one month)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  5. Not known: allergic reactions (including anaphylactic reactions)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  6. Not known: syncope or vasovagal responses to injection, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  7. Not known: fever, injection site reactions (including extensive swelling of the vaccinated limb, blisters at or around the injection site and injection site nodule which may persist for more than one month)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

5.1 Pharmacodynamic properties

  1. The efficacy of Bexsero has not been evaluated through clinical trials.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • has not been evaluated - It has not been tested or measured in this group or situation.
    • efficacy - How well it works in the controlled conditions of a trial.

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

  2. Vaccine efficacy has been inferred by demonstrating the induction of serum bactericidal antibody responses to each of the vaccine antigens (see section Immunogenicity).

    Section 5.1 Pharmacodynamic properties 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

  3. Bactericidal antibodies against these strains were measured by the Serum Bactericidal Assay using human serum as the source of complement (hSBA).

    Section 5.1 Pharmacodynamic properties source ↗

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

  4. In an extension study the persistence of the immune response was assessed one year after the booster dose (see Table 3).

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  5. The clinical consequences of the reduced immunogenicity of the NHBA antigen at this schedule are not known.

    Section 5.1 Pharmacodynamic properties 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.
    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.
    • antigen - The part of a germ that the immune system recognises and remembers.

    No data / not studied matched: not known

  6. ** GMT = geometric mean titer.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  7. Persistence of the immune response one year after the booster dose is also presented in Table 3.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  8. *** GMT = geometric mean titer.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  9. The clinical significance of this observation and the need for additional booster doses to maintain longer term protective immunity has not been established.

    Section 5.1 Pharmacodynamic properties 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

  10. ** GMT = geometric mean titer.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  11. ** GMT = geometric mean titer.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  12. An early immune response after the first dose was also evaluated.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  13. ** GMT = geometric mean titer.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  14. ** GMT = geometric mean titer.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  15. ** GMT = geometric mean titer.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  16. Serum bactericidal response to NHBA antigen has not been evaluated.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • has not been evaluated - It has not been tested or measured in this group or situation.
    • antigen - The part of a germ that the immune system recognises and remembers.

    No data / not studied matched: has not been evaluated

  17. At 1 month following the 2-dose vaccination course, the percentages of subjects with hSBA ≥ 1:5 in individuals with complement deficiencies and asplenia or splenic dysfunction were 87% and 97% for antigen fHbp, 95% and 100% for antigen NadA, 68% and 86% for antigen PorA P1.4, 73% and 94% for antigen NHBA, respectively, indicating an immune response in these immunocompromised subjects.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.
    • antigen - The part of a germ that the immune system recognises and remembers.

    Efficacy, effectiveness and endpointsImmune system, shedding and transmission matched: immune response, immunocompromised

6.6 Special precautions for disposal and other handling

  1. In the event of any foreign particulate matter and/or variation of physical aspect being 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

  2. If it happens, 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

Read the whole document at the source ↗