Type: Multicomponent Meningococcal B Vaccine (recombinant, adsorbed)
Form: Suspension for injection
Dosage Form/Strength: 0.5 mL dose containing:
Neisseria meningitidis serogroup B NHBA fusion protein, 50 mcg
Neisseria meningitidis serogroup B NadA protein, 50 mcg
Neisseria meningitidis serogroup B fHbp fusion protein, 50 mcg
Outer membrane vesicles (OMV) from Neisseria meningitidis serogroup B strain NZ98/254, 25 mcg
Manufacturer: GlaxoSmithKline Inc.
Indications and Clinical Use
Purpose: Active immunization of individuals from 2 months through 25 years against invasive disease caused by Neisseria meningitidis serogroup B strains.
Target Group: Individuals 2 months to 25 years of age.
Contraindications
Hypersensitivity: Known hypersensitivity to any component of BEXSERO or to any ingredient in the formulation or components of the container closure.
Warnings and Precautions
General:
Vaccination with BEXSERO may not protect all vaccine recipients.
The vaccine is not expected to provide protection against all circulating meningococcal serogroup B strains.
Do not inject intravascularly, subcutaneously, or intradermally.
Appropriate medical treatment and supervision should be available in case of an anaphylactic event.
Limited data on use in patients with chronic medical conditions.
Potential risk of apnea and need for respiratory monitoring for very premature infants.
The tip cap of the syringe may contain natural rubber latex; caution for individuals with latex hypersensitivity.
Kanamycin is used in the manufacturing process and is present in trace amounts in the final vaccine.
Special Populations:
Pregnant Women: Insufficient clinical data; vaccination should not be withheld if there is a clear risk of exposure.
Nursing Women: No data available; benefit-risk ratio must be considered.
Pediatrics (<2 months): No data available.
Adults (>25 years): Limited safety and immunogenicity data available; safety and efficacy not established in individuals above 50 years.
Geriatrics (>65 years): No data available.
Adverse Reactions
Very Common (≥10%):
Local reactions: tenderness, erythema, induration
Systemic reactions: fever, irritability, unusual crying, sleepiness in infants; pain, erythema, malaise, headache, myalgia in adolescents and adults
Common (1-10%):
Gastrointestinal symptoms: diarrhea, vomiting
General symptoms: rash, arthralgia, malaise, headache, myalgia
Uncommon (<1%):
Serious allergic reactions, including anaphylaxis
Seizures, thrombocytopenia
Dosage and Administration
Primary Vaccination:
Infants (2-5 months): Three doses of 0.5 mL at least 1 month apart, with a booster in the second year of life.
Infants (6-11 months): Two doses of 0.5 mL at least 2 months apart, with a booster in the second year of life.
Children (12-23 months): Two doses of 0.5 mL at least 2 months apart.
Children (2-10 years): Two doses of 0.5 mL at least 1 month apart.
Adolescents and Adults (11-25 years): Two doses of 0.5 mL at least 1 month apart.
Administration: Deep intramuscular injection, preferably in the anterolateral aspect of the thigh (infants) or the deltoid muscle (older children, adolescents, adults). Separate injection sites should be used if more than one vaccine is administered at the same time.
Storage and Stability
Storage Temperature: 2°C to 8°C (refrigeration).
Protection: Do not freeze; protect from light.
Shelf Life: Use before the expiration date on the label.
Drug Interactions
Concomitant Vaccinations:
Can be administered with other vaccines such as diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, heptavalent pneumococcal conjugate, measles, mumps, rubella, varicella, and meningococcal group C-CRM conjugate.
Higher percentages of systemic reactions reported when given with routine vaccines.
Prophylactic use of acetaminophen reduces incidence and severity of fever without affecting immunogenicity.
Clinical Trials and Immunogenicity
Immunogenicity: Demonstrated strong immune response across various age groups.
Safety: Extensive trials with over 7,526 participants. Most reactions were mild or moderate and transient. No increase in incidence or severity of adverse reactions with subsequent doses.
