Bexsero Adverse Reactions

Clinical trial data: The safety of Meningococcal Group B Vaccine (Bexsero) was evaluated in 13 studies including 9 randomised controlled clinical trials with 7802 subjects (from 2 months of age) who received at least one dose of Meningococcal Group B Vaccine (Bexsero) and in a subsequent study in 974 young adults. Among Meningococcal Group B Vaccine (Bexsero) recipients, 5849 were infants and children (less than 2 years of age), 250 were children (2 to 10 years of age) and 2677 were adolescents and adults. Of the subjects who received primary infant series of Meningococcal Group B Vaccine (Bexsero), 3285 received a booster dose in the second year of life. Data for 988 infants and children (less than 2 years of age) and 801 children (2 to 10 years of age) exposed to Meningococcal Group B Vaccine (Bexsero) in subsequent studies have additionally been evaluated.
In infants and children (less than 2 years of age) the most common local and systemic adverse reactions observed in clinical trials were tenderness and erythema at the injection site, fever and irritability.
In clinical studies in infants vaccinated at 2, 4 and 6 months of age, fever (≥ 38°C) was reported by 69% to 79% of subjects when Meningococcal Group B Vaccine (Bexsero) was co-administered with routine vaccines (containing the following antigens: pneumococcal 7-valent conjugate, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b) compared with 44% to 59% of subjects receiving the routine vaccines alone. Higher rates of antipyretic use were also reported for infants vaccinated with Meningococcal Group B Vaccine (Bexsero) and routine vaccines. When Meningococcal Group B Vaccine (Bexsero) was given alone, the frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials. When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.
In adolescents and adults the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.
No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the vaccination series.
Adverse reactions (following primary immunisation or booster dose) considered as being at least possibly related to vaccination have been categorised by frequency.
Frequencies are defined as follows: Very common: ≥1/10; Common: ≥1/100 to <1/10; Uncommon: ≥1/1000 to <1/100; Rare: ≥1/10000 to <1/1000; Very rare: <1/10000.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infants and children (up to 10 years of age): Metabolism and nutrition disorders: Very common: eating disorders.
Nervous system disorders: Very common: sleepiness, unusual crying, headache.
Uncommon: seizures (including febrile seizures).
Vascular disorders: Uncommon: pallor (rare after booster).
Rare: Kawasaki syndrome.
Gastrointestinal disorders: Very common: diarrhoea, vomiting (uncommon after booster).
Skin and subcutaneous tissue disorders: Very common: rash (children aged 12 to 23 months) (uncommon after booster).
Common: rash (infants and children 2 to 10 years of age).
Uncommon: eczema.
Rare: urticaria.
Musculoskeletal and connective tissue disorders: Very common: arthralgia.
General disorders and administration site conditions: Very common: fever (≥38°C), injection site tenderness (including severe injection site tenderness defined as crying when injected limb is moved), injection site erythema, injection site swelling, injection site induration, irritability.
Uncommon: fever (≥40°C).
Adolescents (from 11 years of age) and adults: Nervous system disorders: Very common: headache.
Gastrointestinal disorders: Very common: nausea.
Musculoskeletal and connective tissue disorders: Very common: myalgia, arthralgia.
General disorders and administration site conditions: Very common: injection site pain (including severe injection site pain defined as unable to perform normal daily activity), injection site swelling, injection site induration, injection site erythema, malaise.
Post-marketing data: In addition to reports in clinical trials, worldwide voluntary reports of adverse reactions received for Meningococcal Group B Vaccine (Bexsero) since market introduction are listed as follows. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Blood and lymphatic system disorders: Lymphadenopathy.
Immune system disorders: Allergic reactions (including anaphylactic reactions).
Nervous system disorders: Hypotonic-hyporesponsive episode, syncope or vasovagal responses to injection.
Skin and subcutaneous tissue disorders: Rash (adolescents from 11 years of age and adults).
General disorders and administration site conditions: Fever (adolescents from 11 years of age and adults), 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).