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meningococcal group B vaccine

Meningococcal Vaccines, All Types

Recombinant vaccine comprised of antigenic meningococcal surface proteins
Used for prevention of N. meningitidis serogroup B infections
Administer to patients 10 years of age and older who are considered high risk for serogroup B meningococcal disease; vaccine may be administered at the discretion of the treating clinician to adolescents and young adults aged 16 to 23 years; preferred age is 16 to 18 years

BEXSERO Intramuscular Inj Susp

For meningococcal infection prophylaxis due to Neisseria meningitidis serogroup B.
NOTE: The efficacy of meningococcal Group B vaccine is based on the demonstration of immune response, as measured by bactericidal activity against 3 serogroup B strains representative of prevalent strains in the U.S. Efficacy of meningococcal Group B vaccine against diverse serogroup B strains has not been established.
For booster dosing or revaccination of patients who remain at increased risk for meningococcal infection†.
Intramuscular dosage
Adults

0.5 mL IM. For continued protection of persons at high risk for meningococcal disease, give booster dose 1 year after primary immunization and repeat every 2 to 3 years thereafter.[53026]

Children and Adolescents 10 to 17 years

0.5 mL IM. For continued protection of persons at high risk for meningococcal disease, give booster dose 1 year after primary immunization and repeat every 2 to 3 years thereafter.[53026]

Intramuscular dosage
Adults 18 to 25 years

0.5 mL IM, preferably in the deltoid region. Give as a 2-dose series, with doses administered at least 1 month apart.

Children and Adolescents 10 to 17 years

0.5 mL IM, preferably in the deltoid region. Give as a 2-dose series, with doses administered at least 1 month apart.

Adults

26 years and older: Safety and efficacy not established.
18 to 25 years: 0.5 mL/dose IM.

Geriatric

Safety and efficacy not established.

Adolescents

0.5 mL/dose IM.

Children

10 to 12 years: 0.5 mL/dose IM.
9 years and younger: Safety and efficacy not established.

Infants

Safety and efficacy not established.

Neonates

Safety and efficacy not established.

Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the patient, parent, or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
Record in the patient's permanent record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine. These actions are required by the National Childhood Vaccine Injury Act of 1986.

Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. After vigorous shaking, the meningococcal group B vaccine, recombinant is a homogenous white suspension. If discoloration or visible particulate matter are present, discard the syringe.

Intramuscular Administration

Do not mix with any other vaccine or product in the same syringe.
Prior to administration, clean skin over the injection site with a suitable cleansing agent.
Vigorously shake the prefilled syringe prior to administration to ensure a homogenous white suspension; DO NOT administer if the vaccine cannot be re-suspended.
The preferred injection site is the deltoid muscle of the upper arm; do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.

BEXSERO:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Protect from light
- Store between 36 to 46 degrees F

General Information

Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986. If a dose of a vaccine that immunizes against meningococcal disease has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

Latex hypersensitivity

Use of a meningococcal group B vaccine is contraindicated in patients with a previous allergic reaction to the vaccine. Additionally, caution must be exercised when using the meningococcal group B vaccine (3 strain) in patients with latex hypersensitivity as the tip caps of the pre-filled syringes contain natural rubber latex. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the vaccine.

Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia, vitamin K deficiency

Meningococcal group B vaccine (3 strain) is only indicated for intramuscular (IM) administration. Use caution when administering to patients with an increased risk for bleeding. Patients with thrombocytopenia, vitamin K deficiency, coagulopathy (e.g., hemophilia), or receiving anticoagulant therapy could have bleeding at the IM injection site.

Fever, infection

The decision to administer or to delay vaccination with meningococcal group B vaccine (3 strain) because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices has recommended that vaccinations be delayed during the course of a moderate or severe acute febrile illness. All vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness.

Agammaglobulinemia, chemotherapy, corticosteroid therapy, human immunodeficiency virus (HIV) infection, hypogammaglobulinemia, immunosuppression, neoplastic disease, radiation therapy, severe combined immunodeficiency (SCID)

Patients with significant immunosuppression may not have an adequate antibody response to meningococcal group B vaccine (3 strain). Immunosuppressed persons may include patients with severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to generalized neoplastic disease; or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses). Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Patients vaccinated with the meningococcal polysaccharide vaccine (MPSV4) or the meningococcal conjugate vaccine (MCV4) within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored ; a definitive recommendation for the meningococcal group B vaccine has not yet been made. Similarly, evidence suggests that persons with human immunodeficiency virus (HIV) infection do not respond optimally to a single dose of MPSV4 or MCV4, which is the recommended regimen for immune competent patients. It is not known whether an alternate dosage series will be necessary for the meningococcal group B vaccine for this population.

Activities requiring coordination and concentration

Syncope can occur in association with administration of the meningococcal group B vaccine (3 strain). Ensure procedures are in place to avoid injury from falling associated with syncope. Observe patients after vaccination, and instruct patients and/or caregivers to avoid activities requiring coordination and concentration during the time period immediately after vaccine receipt.

Children, infants, neonates

Safety and efficacy of the meningococcal group B vaccine (3 strain) have not been established in neonates, infants, or children younger than 10 years.

Geriatric

Meningococcal group B vaccine (3 strain) is indicated for use in adults up to 25 years of age; the vaccine is not approved for administration to geriatric patients.

Pregnancy

No adequate and well controlled studies with Meningococcal group B vaccine (3 strain) have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or affect the reproductive system is unknown. The manufacturer recommends use during pregnancy only if clearly needed. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommends deferring vaccination in pregnant women unless the woman is at increased risk and the benefits of vaccination are considered to outweigh the potential risks. Instruct women who become pregnant at the time of vaccination to report the pregnancy to their health care professional. There is a pregnancy exposure registry that monitors outcomes in pregnant patients exposed to meningococcal group B vaccine (3 strain); information about the registry can be obtained at BexseroPregnancyRegistry.SM@ppdi.com or by calling 1-877-413-4759.

Breast-feeding

Data are limited regarding use of the meningococcal group B vaccine (3 strain) during breast-feeding, and its excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommends deferring vaccination in breast-feeding women unless the woman is at increased risk and the benefits of vaccination are considered to outweigh the potential risks.

Severe

anaphylactoid reactions / Rapid / Incidence not known

Moderate

erythema / Early / 45.0-50.0

Mild

injection site reaction / Rapid / 28.0-83.0
myalgia / Early / 48.0-49.0
fatigue / Early / 35.0-37.0
headache / Early / 33.0-34.0
nausea / Early / 18.0-19.0
arthralgia / Delayed / 13.0-16.0
fever / Early / 1.0-5.0
pharyngitis / Delayed / 2.0
syncope / Early / Incidence not known
rash / Early / Incidence not known

Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 4 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment and for 1 month after discontinuation of siponimod treatment.

Pregnancy

No adequate and well controlled studies with Meningococcal group B vaccine (3 strain) have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or affect the reproductive system is unknown. The manufacturer recommends use during pregnancy only if clearly needed. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommends deferring vaccination in pregnant women unless the woman is at increased risk and the benefits of vaccination are considered to outweigh the potential risks. Instruct women who become pregnant at the time of vaccination to report the pregnancy to their health care professional. There is a pregnancy exposure registry that monitors outcomes in pregnant patients exposed to meningococcal group B vaccine (3 strain); information about the registry can be obtained at BexseroPregnancyRegistry.SM@ppdi.com or by calling 1-877-413-4759.

Data are limited regarding use of the meningococcal group B vaccine (3 strain) during breast-feeding, and its excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommends deferring vaccination in breast-feeding women unless the woman is at increased risk and the benefits of vaccination are considered to outweigh the potential risks.

Meningococcal disease is a result of an invasive infection by Neisseria meningitis; the five main N. meningitis serogroups responsible for meningococcal disease are A, B, C, Y, and W-135. Vaccination with meningococcal group B vaccine provides protection against invasive meningococcal disease caused by serogroup B. The meningococcal group B vaccine (3 strain) is composed of the recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), factor H binding protein (fHBP), and PorA P1.4 (present in outer membrane vesicles [OMV]). These meningococcal surface proteins contribute to the ability of the bacterium to cause disease. Immunization with meningococcal group B vaccine (3 strain) leads to the production of antibodies directed against NadA, NHBA, fHBP, and PorA, which leads to complement-mediated antibody-dependent killing of N. meningitides serogroup B. The vaccine's efficacy depends on the antigenic similarity of the bacterial and vaccine antigens, as well as the amount of antigen expressed on the surface of the invading meningococci.

Meningococcal group B vaccine (3 strain) is administered intramuscularly. Vaccination does not ensure immunity. Distribution, metabolism, and excretion of the vaccine have not been defined.
 
Efficacy of the 2-dose vaccination series was evaluated during clinical trials involving pediatric and young adult patients, ages 11 to 24 years. Serum bactericidal antibodies were measured with hSBA assays using 3 strains selected to measure responses to 1 of 3 vaccine antigens, either fHBP, NadA, or PorA P1.4, prevalent among strains in the U.S. The primary endpoints were the percentage of subjects with >= 4-fold rise in hSBA titers for each of the 3 test strains, and the percentage of subjects who achieved titers >= the lower limit of quantitation (LLOQ) for all 3 strains (composite response). At one month after the second dose, a >= 4-fold rise in hSBA titers was observed in 78—98% for strain fHBP, 94—99% for strain NadA, and 39—67% for strain PorA P1.4; 63—88% of vaccine recipients achieved the composite response of titers >= LLOQ for all 3 strains.

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