Version May 2024
Meningococcal group B disease prevention: Note: Use of the abbreviation MenB refers to any serogroup B meningococcal conjugate vaccine; MenB-FHbp refers specifically to Trumenba; MenB-4C refers specifically to Bexsero. Products (Bexsero/Trumenba) are not interchangeable; the same product should be used for all doses in the series including booster doses (Ref).
ACIP recommendations (Ref): Note: Vaccines are approved in adults ≤25 years of age; however, ACIP only recommends routine vaccination of persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease. In patients ≥16 years of age who are not at risk, use is per shared clinical decision-making. Consider risk of exposure and patient's susceptibility to the disease when choosing a schedule.
Patients at increased risk for serogroup B meningococcal disease or during serogroup B meningococcal disease outbreak:
Bexsero: IM: 0.5 mL per dose given as 2 doses ≥1 month apart. Administer a booster dose 1 year after primary series and every 2 to 3 years thereafter if risk remains. A one-time booster dose is also recommended during an outbreak if it has been ≥1 year since completion of the primary series (≥6-month interval may be considered by public health professionals).
Trumenba: IM: 0.5 mL per dose given as 3-dose series at 0, 1 to 2 months, and 6 months. If the interval between the first and second dose is ≥6 months, then the third dose is not needed. If the third dose is administered <4 months after the second dose, then a fourth dose should be given ≥4 months after the third dose. Administer a booster dose 1 year after primary series and every 2 to 3 years thereafter if risk remains. A one-time booster dose is also recommended during an outbreak if it has been ≥1 year since completion of the primary series (≥6-month interval may be considered by public health professionals).
Patients 16 to 23 years of age (preferred 16 to 18 years) who are not at increased risk for meningococcal disease (per shared clinical decision-making): Note: To provide short-term protection against most strains of serogroup B meningococcal disease:
Bexsero: IM: 0.5 mL per dose given as 2 doses ≥1 month apart.
Trumenba: IM: 0.5 mL per dose given as 2 doses 6 months apart. If the second dose is given earlier than 6 months, a third dose should be administered ≥4 months after the second dose.
NACI recommendations (Ref): Note: Vaccines are approved in adults ≤25 years of age; however, NACI recommends consideration for vaccination of any adults who are at high risk for serogroup B meningococcal disease. Consider risk of exposure and patient's susceptibility to the disease when choosing a schedule.
Bexsero:
Patients at high risk for serogroup B meningococcal disease or healthy patients ≤24 years of age who are not at high risk for meningococcal disease (per clinical discretion): IM: 0.5 mL per dose given as a 2-dose series ≥4 weeks apart.
Close contacts and outbreak control of meningococcal serogroup B disease:
Unvaccinated: IM: 0.5 mL immediately after exposure; revaccinate with a single dose ≥4 weeks after first dose.
Previously vaccinated: IM: 0.5 mL immediately after exposure.
Booster dose (Ref): Consider a single booster dose for those individuals at continued risk of exposure to meningococcal disease as per current guideline recommendations.
Trumenba:
Patients with underlying medical conditions at higher risk for serogroup B meningococcal disease if exposed: IM: 0.5 mL per dose administered as a 3-dose series at 0, 1 to 2 months, and 6 months.
Patients at higher risk of exposure to serogroup B meningococcal disease or healthy patients ≤25 years of age who are not at high risk for meningococcal disease (per clinical discretion): IM: 0.5 mL per dose given as 2-dose series 6 months apart.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Meningococcal group B vaccine (MenB-4C and MenB-FHbp): Pediatric drug information")
Meningococcal group B disease prevention:
Note: Products (Bexsero/Trumenba) are not interchangeable; the same product should be used for all doses in the series. Use of the abbreviation MenB refers to any serogroup B meningococcal conjugate vaccine; MenB-FHbp refers specifically to Trumenba; MenB-4C refers specifically to Bexsero. Consult CDC/ACIP annual immunization schedules or National Advisory Committee on Immunization (NACI) guidelines (Canada) for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (Ref).
ACIP Recommendations (Ref): Although FDA approved in children and adolescents ≥10 years, use in patients 10 to 15 years of age who are not at risk for infection is not recommended. In patients ≥16 years of age who are not at risk, use is per shared clinical decision making. For children ≥10 years and adolescents, ACIP recommends vaccination in patients at increased risk for serogroup B meningococcal disease, including those with persistent complement component deficiencies, who are taking complement inhibitors (eg, eculizumab, ravulizumab), with anatomic or functional asplenia (including sickle cell disease), or identified to be at increased risk due to an outbreak.
Patients at increased risk for serogroup B meningococcal disease or during serogroup B meningococcal disease outbreak:
Children ≥10 years and Adolescents:
Primary vaccination:
Bexsero: IM: 0.5 mL per dose for a total of 2 doses administered at least 1 month apart.
Trumenba: IM: 0.5 mL per dose given as 3-dose series at 0, 1 to 2 months, and 6 months. If the interval between the first and second dose is ≥6 months, then the third dose is not needed. If the third dose is administered <4 months after the second dose, then a fourth dose should be given ≥4 months after the third dose.
Booster: Administer a booster dose 1 year after primary series and every 2 to 3 years thereafter if risk remains. A one-time booster dose is also recommended during an outbreak if it has been ≥1 year since completion of the primary series (≥6-month interval may be considered by public health professionals).
Patients not at increased risk (per shared clinical decision-making): Note: To provide short-term protection against most strains of serogroup B meningococcal disease:
Adolescents ≥16 years:
Bexsero: IM: 0.5 mL per dose given as 2 doses ≥1 month apart.
Trumenba: IM: 0.5 mL per dose given as 2 doses 6 months apart. If the second dose is given earlier than 6 months, a third dose should be administered ≥4 months after the second dose.
NACI recommendations and Canadian labeling (Ref):
Patients at high risk for serogroup B meningococcal disease or healthy patients who are not at high risk for meningococcal disease (per clinical discretion) : Consider risk of exposure and patient's susceptibility to the disease when choosing a schedule.
Bexsero:
Infants 2 to 5 months: IM:
3-dose primary infant series: Total of 4 doses (0.5 mL each); a primary infant series is administered at 2, 4, and 6 months of age followed by a booster dose between 12 to 23 months of age; alternatively, may give first 3 doses at 2, 3, and 4 months of age; however, the immune response to 1 component (NHBA) of the vaccine is reduced with this regimen.
2-dose primary infant series: Total of 3 doses (0.5 mL each) with first and second dose administered at least 2 months apart; followed by a booster dose between 12 to 23 months of age.
Infants 6 months to <12 months (unvaccinated): IM: Total of 3 doses (0.5 mL each) with first and second dose administered at least 2 months apart; third dose is administered during second year of life at least 2 months after the second dose. The necessity of further booster doses has not yet been determined.
Children ≥1 year to <2 years of age (unvaccinated): IM: Total of 3 doses (0.5 mL each) with first and second dose administered at least 2 months apart; third dose is administered 12 to 23 months after the second dose. The necessity of further booster doses has not yet been determined.
Children ≥2 years and Adolescents: IM: Total of 2 doses (0.5 mL each) administered at least 1 month apart. Consider a single booster dose for those individuals at continued risk of exposure to meningococcal disease as per current guideline recommendations.
Trumenba: Children ≥10 years and Adolescents:
Patients at increased risk for meningococcal serogroup B disease: IM: 0.5 mL per dose as a 3-dose series with dose 1 and 2 separated by ≥1 month, followed by a third dose administered ≥4 months after the second dose.
Patients not at increased risk (ie, use per clinical discretion): IM: 0.5 mL per dose as a 2-dose series administered 6 months apart (eg, a 0- and 6-month schedule).
Close contacts and outbreak control of meningococcal serogroup B disease: Consider risk of exposure and patient's susceptibility to the disease when choosing a schedule.
Infants 2 months to <6 months: Bexsero:
Unvaccinated: IM: 0.5 mL immediately after exposure; revaccinate with 2 additional doses with ≥4 week interval between doses.
Previously vaccinated: IM: 0.5 mL immediately after exposure.
Infants 6 months to Children <10 years: Bexsero:
Unvaccinated: IM: 0.5 mL immediately after exposure; revaccinate with a single dose ≥8 weeks after first dose.
Previously vaccinated: IM: 0.5 mL immediately after exposure.
Children ≥10 years and Adolescents: Bexsero, Trumenba:
Unvaccinated: IM: 0.5 mL immediately after exposure; revaccinate with a single dose ≥4 weeks after first dose.
Previously vaccinated: IM: 0.5 mL immediately after exposure. Note: Product used for previous doses should be used.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequencies reported may include concomitant administration with other vaccines. Adverse reactions reported in children, adolescents, and adults.
>10%:
Gastrointestinal: Diarrhea (8% to 13%; severe diarrhea: <1%), nausea (18% to 24%; severe nausea: 4%)
Local: Erythema at injection site (12% to 50%), induration at injection site (28% to 32%), pain at injection site (76% to 90%), swelling at injection site (14% to 18%)
Nervous system: Chills (12% to 25%), fatigue (35% to 54%; severe fatigue: 2% to 6%), headache (33% to 52%; severe headache: 1% to 6%)
Neuromuscular & skeletal: Arthralgia (13% to 22%; severe arthralgia: ≤2%), myalgia (16% to 49%; severe myalgia: ≤13%)
1% to 10%:
Gastrointestinal: Vomiting (2% to 4%)
Respiratory: Nasopharyngitis (≥2%)
Miscellaneous: Fever (1% to 7%)
Postmarking:
Cardiovascular: Syncope, vasodepressor syncope
Dermatologic: Injection site blister formation, skin rash
Hematologic & oncologic: Lymphadenopathy
Hypersensitivity: Anaphylaxis, hypersensitivity reaction
Local: Injection site nodule
Ophthalmic: Swelling of eye
Severe hypersensitivity to the meningococcal group B vaccine or any component of the formulation.
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2021]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2021]).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2021]).
• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2021]).
• Meningococcal infections: Not to be used to treat meningococcal infections or to provide immunity against N. meningitidis serogroups A, C, W-135, or Y. In addition, vaccine does not provide protection against all circulating meningococcal group B strains.
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration; ideally, vaccinations should be administered prior to initiation of anticoagulant therapy if possible (ACIP [Kroger 2021]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. Because of differences in components and dosing regimen, meningococcal group B vaccines are not interchangeable (ACIP [Kroger 2021]).
Special populations:
• Altered immunocompetence: Patients with complement component deficiencies, anatomic or functional asplenia, and patients receiving complement inhibitors (eg, eculizumab, ravulizumab) are at an increased risk for invasive meningococcal infection, including post-vaccination. Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2021]; IDSA [Rubin 2014]).
• Pediatric: Apnea has occurred following intramuscular vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (AAP [Saari 2003]; ACIP [Kroger 2021]).
Dosage form specific issues:
• Kanamycin: May contain kanamycin.
• Latex: Note: Prior to April 2023, the Bexsero prescribing information stated the product packaging contained latex. The Bexsero prescribing information approved by the FDA in April 2023 states the packaging is not made with latex. Providers should confirm if product in inventory contains latex prior to administering to patients with a latex allergy.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2021]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends on multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2021]).
Clinical studies of infants <12 months of age using a lower dosage than indicated for older children resulted in fever in most patients (90%).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Prefilled Syringe, Intramuscular:
Bexsero: (0.5 mL)
Suspension Prefilled Syringe, Intramuscular [preservative free]:
Trumenba: (0.5 mL) [contains polysorbate 80]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Prefilled Syringe, Intramuscular:
Bexsero: (0.5 mL)
Suspension Prefilled Syringe, Intramuscular [preservative free]:
Trumenba: (0.5 mL) [contains polysorbate 80]
IM: For IM administration only, preferably into the upper deltoid region. Do not administer via IV, SubQ, or intradermal route. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement edition date and date it was provided, and the administering person's name, title, and address be recorded.
For patients at risk of hemorrhage, the vaccine should be administered IM if, in the opinion of a health care provider familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient or family should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
Shake vigorously to ensure that a homogenous white suspension is obtained. Do not use the vaccine if it cannot be resuspended. Administer by IM injection into upper deltoid region; not for intradermal, subcutaneous, or IV administration. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (Ref). To prevent syncope related injuries, adolescents should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, vaccine information statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
For patients at risk of hemorrhage, the vaccine should be administered IM if, in the opinion of a physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law. VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/mening-serogroup.html.
Meningococcal group B disease prevention:
US labeling: Active immunization of children, adolescents, and adults aged 10 to 25 years against invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of the following persons ≥10 years of age at increased risk of meningococcal disease (CDC/ACIP [Mbaeyi 2020]):
- Persons with complement component deficiencies (eg, C3, C5-C9, properdin, factor H, or factor D deficiencies; patients receiving complement inhibitors [eg, eculizumab, ravulizumab]).
- Persons with anatomic or functional asplenia (including sickle cell disease).
- Microbiologists routinely exposed to isolates of N. meningitidis.
- Persons identified to be at increased risk during an outbreak caused by serogroup B meningococcal disease.
The ACIP states that a meningococcal group B vaccination series may be administered to adolescents and young adults aged 16 to 23 years as determined by shared clinical decision-making to provide short-term protection against most strains of serogroup B meningococcal disease. The preferred age for vaccination is 16 to 18 years of age (CDC/ACIP [Mbaeyi 2020]).
Canadian labeling: Active immunization against invasive meningococcal disease caused by N. meningitidis serogroup B (Bexsero: patients 2 months through 25 years of age; Trumenba: patients 10 through 25 years of age).
The Canadian National Advisory Committee on Immunization (NACI) recommends use of Bexsero (patients ≥2 months of age) or Trumenba (patients ≥10 years of age) in patients at high risk for serogroup B meningococcal disease (including disease outbreaks) and may be considered on an individual basis in healthy patients (Bexsero: 2 months to 25 years of age; Trumenba: 10 to 25 years of age) (NACI/CATMAT 2015; NACI 2019).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
Information related to the use of meningococcal group B vaccines in pregnancy is limited (CDC/ACIP [Mbaeyi 2020]).
Inactivated vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2021]). However, the Advisory Committee on Immunization Practices recommends deferring meningococcal group B vaccination during pregnancy unless the patient is at increased risk for meningococcal disease and vaccination benefits outweigh the potential risks.
It is not known if components of this vaccine are present in breast milk.
According to the manufacturer, the decision to continue or discontinue breastfeeding following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of vaccination to the mother.
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2021]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Bexsero: Induces immunity against meningococcal disease caused by serogroup B Neisseria meningitidis (MenB) via the formation of antibodies directed toward the recombinant protein antigens combined together with outer membrane vesicles (OMV) from a group B strain.
Trumenba: Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis.
Efficacy:
Bexsero: Composite hSBA titer response one month after the second dose: 63% to 88%
Trumenba: 84% of adolescents had a ≥4-fold rise in hSBA titer and composite response after the third dose.
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