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Bexsero Safety Information

The only meningitis B vaccine with safety data in infants, Bexsero has a demonstrated safety profile based on an evaluation of >39,000 subjects in clinical and postmarketing studies (from 2 months of age).1-3

Bexsero in clinical trials: The only meningitis B vaccine with safety data in infants¹⁻²

Adverse reactions in clinical trials

  • Acceptable safety and tolerability with Bexsero in clinical trials³
  • No increase in incidence or severity of adverse reactions with subsequent doses in the vaccination series¹
  • Marketing surveillance consistent with findings of prelicensure clinical studies³
 

Most common adverse reactions with Bexsero¹

Infants and children
(less than 2 years of age)

Tenderness and erythema at the injection site, fever, and irritability

  • With Bexsero alone, frequency of fever was similar to that associated with routine vaccinesᵃ
  • Higher rates of fever were reported when Bexsero was co-administered with routine vaccinesᵇ

Adolescents and adults
Pain at injection site, malaise, and headache

ᵃPneumococcal 7-valent conjugate vaccine, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis, and Haemophilus influenzae type b vaccine.
ᵇSeparate injection sites must be used if more than one vaccine is administered at the same time.

Frequency of adverse reactions¹

 

Up to 10 years of age

Allergic reactionsᶜ
Hypotonic-hyporesponsive episode
Meningeal irritationᵈ
Injection-site reactionsᵉ

11 years of age and older

Allergic reactions
Syncope or vasovagal responses to injection
Meningeal irritationᵈ
Fever

(≥1/10,000 to <1/1,000)

Up to 10 years of age

Pallor after booster
Kawasaki syndrome
Urticaria

(≥1/1,000 to <1/100)

Up to 10 years of age

Seizures (including febrile seizures)
Pallor
Eczema
Fever (≥40°C)
Vomiting after booster
Rash after booster (children aged 12 to 23 months)

(≥1/100 to <1/10)

Up to 10 years of age

Rash (infants and children 2 to 10 years of age)

(≥1/10)

Up to 10 years of age

Eating disorders
Sleepiness
Unusual crying
Headache
Diarrhoea
Vomiting
Rash (children aged 12 to 23 months)
Arthralgia
Fever (≥38C)
Injection-site tendernessᶠ, erythema, swelling, and induration
Irritability

11 years of age and older

Headache
Nausea
Myalgia
Arthralgia
Injection-site painᵍ, swelling, induration, erythema
Malaise

ᶜIncluding anaphylactic reactions.
ᵈSigns of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination. These symptoms have been of mild and transient nature.
ᵉIncluding 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.
ᶠIncluding severe injection-site tenderness defined as crying when injected limb is moved.
ᵍIncluding severe injection-site pain defined as unable to perform normal daily activity.

Special warnings and precautions for use¹

As with other vaccines, administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness.
However, the presence of a minor infection, such as colds, should not result in the deferral of vaccination.

  • Do not inject intravascularly
  • As with all injectable vaccines, 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, 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
  • 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
  • As with any vaccine, vaccination with Bexsero may not protect all vaccine recipients
  • Bexsero is not expected to provide protection against all circulating meningococcal group B strains
  • As with many vaccines, healthcare professional should be aware that a temperature elevation may occur following vaccination of infants and children (less than 2 years of age). Prophylactic administration of antipyretics at the time and closely after vaccination can reduce the incidence and intensity of post-vaccination febrile reactions. Antipyretic medication should be initiated according to local guidelines in infants and children (less than 2 years of age)
  • Individuals with impaired immune responsiveness, whether due to the use of immune-suppressive therapy, a genetic disorder, or other causes, may have reduced antibody response to active immunisation
  • Immunogenicity data are available in individuals with complement deficiencies, asplenia, or splenic dysfunctions
  • Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group B, even if they develop antibodies following vaccination with Bexsero
  • There are no data on the use of Bexsero in subjects above 50 years of age or in patients with chronic medical conditions
  • The potential risk of apnoea and the need for respiratory monitoring for 48–72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed
  • The tip cap of the syringe may contain natural rubber latex. Although the risk for developing allergic reactions is very small, healthcare professionals should consider the benefit-risk prior to administering this vaccine to subjects with known history of hypersensitivity to latex
  • Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture. If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose. The safe use of Bexsero in kanamycin-sensitive individuals has not been established

Pregnancy

  • Insufficient clinical data on exposed pregnancies are available
  • The potential risk for pregnant women is unknown. Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection
  • 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

Breast-feeding & Lactation

  • Information on the safety of the vaccine to women and their children during breast-feeding is not available. The benefit-risk ratio must be examined before making the decision to immunise during breast-feeding
  • No adverse reactions were seen in vaccinated maternal rabbits or in their offspring through day 29 of lactation. Bexsero was immunogenic in maternal animals vaccinated prior to lactation, and antibodies were detected in the offspring, but antibody levels in milk were not determined

Fertility

  • There are no data on fertility in humans. There were no effects on female fertility in animal studies

Effects on ability to drive and use machines

  • Bexsero has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 of the SmPC “Undesirable effects” may temporarily affect the ability to drive or use machines

References:

  1. Bexsero Summary of Product Characteristics. GSK Vaccines S.r.l.; 2020.
  2. Pfizer Ltd. Trumenba. Annex I; Summary of Product Characteristics. EMA; May 2018.
  3. Watson PS, Turner DPJ. Clinical experience with the meningococcal B vaccine, Bexsero: prospects for reducing the burden of meningococcal serogroup B disease. Vaccine. 2016;34(7):875–880.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/.
Adverse events should also be reported to GlaxoSmithKline UK on 0800 221 441.

L.K January 2021 PM-GB-BEX-WCNT-200004