Meningococcal B vaccine

The Meningococcal B vaccine is a prescription medication, commonly known as the MenB vaccine, belonging to the vaccine class.

The Meningococcal B vaccine is approved to protect against meningococcal B infections, which can cause severe and perhaps fatal diseases in people, particularly teenagers and young adults. These infections are caused by the invasive disease-causing Neisseria meningitidis serogroup B.

It is not a part of national routine immunization programmes.

The intramuscular administration of the meningococcal B vaccination allows for systemic absorption. Due to its primary function of enhancing the immune system's defences against Neisseria meningitidis B bacteria, it does not go through any metabolism or elimination processes.

The meningococcal B vaccine's common side effects include soreness, swelling, redness at the injection site, nausea, headache, sleepiness, irritability, malaise, and myalgia.

Meningococcal B vaccine is available in the form of suspension for injection.

Meningococcal B vaccine is available in Germany, the United States, Canada, United Kingdom, Australia, India, Brazil, UAE and New Zealand.

Meningococcal B vaccine, belonging to the vaccine class, is a sterile injectable solution.

The meningococcal disease-causing bacteria Neisseria meningitidis serogroup B is targeted by the meningococcal B vaccination. It injects nontoxic fragments of the bacterial outer membrane proteins, or antigens, into the host. The immune system produces an immunological response after being exposed to these antigens by the vaccination because it recognizes them as foreign. This reaction comprises the production of specific antibodies that, if exposed again, may identify and eliminate Neisseria meningitidis serogroup B bacteria. The meningococcal B vaccination lowers the risk of this potentially fatal illness by preparing the immune system to respond quickly and prevent infections.

Meningococcal B vaccine is available in the form of suspension for injection.

Suspension for injection: To be administered parenterally, as applicable

Meningococcal B vaccine can be used as follows:

• To avoid infection caused by serogroup B meningococcal bacteria, vaccination against meningococcal group B is used.
• The meningococcal group B vaccination is recommended for use in children and young adults between the ages of 10 and 25. According to the Centres for Disease Control, the ideal age to receive this vaccination is between the ages of 16 and 18.

Meningococcal B (MenB) vaccine can help support the following health benefits:

• Prevention: Infections brought on by Neisseria meningitidis serogroup B bacteria can be avoided using the MenB vaccination. These infections can spread quickly and have high morbidity and death rates, including meningitis and septicemia. Vaccines lower the risk of contracting and transmitting the disease among communities by immunizing individuals, particularly babies, adolescents, and young adults, who are more susceptible to MenB infections.

• High-risk populations: Meningococcal Group B infections are more common among specific populations, such as military personnel, closely connected college students, people with some medical issues, and those with weakened immune systems. These at-risk groups receive specific protection from the MenB vaccination, which lowers their vulnerability to severe infections and related complications.
• Life-threatening disease: A meningococcal B infection can develop rapidly and result in serious, sometimes fatal illnesses. For instance, meningitis can cause inflammation of the surrounding membranes that protect the brain and spinal cord. In contrast, septicemia involves a bloodstream infection that may result in organ failure. The incidence of mortality and morbidity linked to these significant health disorders is reduced by vaccination.
• Herd Immunity: Herd immunity is considerably strengthened by the Meningococcal B vaccination. When a significant percentage of the population is immunized, it protects others who cannot get the vaccine, including those with compromised immune systems, in an indirect way. This community-wide protection prevents the bacteria from spreading. Vaccination efforts can quickly provide herd immunity during outbreaks or localized MenB case rises, preventing further transmission.

Meningococcal B vaccine is approved for its use in the following clinical indications:

• To protect people who are more susceptible to invasive meningococcal illness from Neisseria meningitides serogroup B
• To protect those under ten years old who are more likely to develop invasive meningococcal illness from Neisseria meningitides serogroup B.

Parenterally: Administer each 0.5-mL dose of the vaccine intramuscularly (IM) using the supplied prefilled syringe and a sterile needle. The preferred site to inject is the deltoid muscle in the upper arm. It's crucial not to combine this vaccine with any other vaccine in the same syringe, ensuring the proper delivery of the meningococcal B vaccine for adequate immunization.

The dosage and duration of treatment should be as per the treating physician's clinical judgment.

IM suspension: 0.5mL/syringe

Dosage Adjustment for Adult Patients

Trumenba

0.5 mL intramuscularly at 0 and 6 months OR

0.5 mL intramuscularly at 0, 1, and 6 months; if the second dosage is given less than six months after the first, the third dose should be given at least four months later.

The patient's exposure risk and meningococcal serogroup B disease susceptibility may influence the choice of dose schedule.

Bexsero

0.5 mL IM in two doses given at least one month apart.

Adults at risk

Immunization for infection should get the primary series (use the same product for each dose).

Booster dose: Administer one year after the initial series is completed, and if the risk persists, repeat the booster dosage every 2-3 years.

People who are at risk include

Asymmetry in both form and function, including sickle cell disease

persistent lack of a complement component

Use of complement inhibitors, such as eculizumab and ravulizumab

Frequently exposed to Neisseria meningitidis by microbiologists

Adults who are not at risk

Based on shared decision-making between the patient and the physician, the need for the primary series immunization in individuals not at high risk is determined.

Meningococcal B vaccine is available in the form of suspension for injection.

Meningococcal B vaccine should be used to prevent poliomyelitis along with no appropriate dietary restrictions. The Meningococcal B vaccine usually has little effect on dietary or food substances when administered, and there is no need to alter regular dietary habits or medication schedules in conjunction with receiving the Meningococcal B vaccine. Consuming regular foods and drinks before and after receiving the vaccine is safe.

It is commonly advised to stay hydrated by drinking water or other fluids after vaccination to reduce the risk of side effects.

The dietary restriction should be individualized as per patient requirements.

Meningococcal B vaccine may be contraindicated in the following conditions:-

• Anaphylaxis (previous dose of the Meningococcal B vaccine or any of its components)
• Hypersensitivity to latex
• Moderate to severe illness
• Immunodeficiency disorders like HIV/AIDS infection.
• History of Guillain Barré syndrome

The treating physician must closely monitor the patient and keep pharmacovigilance as:

• Immunosuppressed people may experience a decreased immune response.
• If the individual has a moderately critical acute sickness (with or without fever of over 101.3°F or 38.5°C), administration of the vaccine should be postponed.
• If an acute anaphylactic reaction occurs after injection, epinephrine and other suitable medications must be readily available to treat immediate allergic reactions.
• Even if they produce antibodies after vaccination, those with particular complement deficits and those using medication that prevents terminal complement activation (such as eculizumab) are more susceptible to invasive illness caused by N meningitidis serogroup B.
• The safety and efficacy of switching meningococcal group B vaccinations to finish the immunization series needs more data.
• Bexsero: Natural rubber latex is included in the tip caps of the prefilled syringes, which may cause allergic responses in those sensitive to latex (Trumenba's caps are not.
• There was a syncope report; precautions should be taken to prevent injury from fainting.

Caution is advised when consuming alcohol with meningococcal B vaccine.

There is no sufficient scientific evidence traceable regarding the use and safety of the meningococcal B vaccine in the breastfeeding population.

There is no sufficient scientific evidence traceable regarding the use and safety of the meningococcal B vaccine in the pregnant population.

There is no sufficient scientific evidence traceable regarding the use and safety of the meningococcal B vaccine in concurrent use with any particular food.

The adverse reactions related to the meningococcal B vaccine can be categorized as

• Common: Soreness, redness, swelling at the injection site, fever, irritability, fatigue, and headaches.
• Less Common: GI symptoms like nausea or diarrhoea, muscle pain, joint pain, or chills.
• Rare: Allergic Reactions, skin rashes, high fever, unusual bleeding or bruising, Seizures (very rare) and Fainting (vasovagal syncope).

The clinically relevant drug interactions of the meningococcal B vaccine are briefly summarized here:

• Immunosuppressants- The immunological response may be suppressed by immunosuppressive treatments such as radiation, antimetabolites, alkylating agents, cytotoxic medicines, and corticosteroids (used in dosages larger than therapeutic doses).
• Other Vaccines: Multiple vaccinations, including meningococcal B vaccine, given at the same time may increase the risk of adverse reactions. Medical professionals frequently adhere to vaccination regimens separated by at least four weeks to reduce such a risk, considering the time and space of vaccines.

The common side of the Meningococcal B vaccine includes the following-

• Headache
• Mild fever
• Being fatigued
• Pain in the muscles or joints
• Irritability
• Sleepiness
• Diarrhoea, nausea, or
• Individuals can experience discomfort, redness, swelling, or a hard lump where the injection was administered.

The use of Meningococcal B vaccine should be prudent in the following group of special populations

• Pregnancy: There is no sufficient scientific evidence traceable regarding the use and safety of meningococcal B vaccine for pregnant populations.

• Paediatrics: The meningococcal B vaccine protects pediatric patients against meningococcal B infections, a potentially severe and life-threatening condition. It offers safety and effectiveness in reducing the risk of this bacterial infection, safeguarding children's health and well-being in high-risk situations.

Dosage Adjustment for Paediatric Patients

Trumenba

0.5 mL IM at 0 and 6 months OR 0.5 mL IM at 1-2 and 6 months; if the second dose is given six months after the first dose, the third dose should be given at least four months following the double dose.

Bexsero

0.5 mL IM in a series of two doses given at least one month apart

Aged ten years or older who are at risk

Immunize at-risk patients using a primary series (use the same product for each dosage).

Booster dose: Administer it one year after the primary series is finished, and give it again every two to three years if the risk continues to exist there.

People who are at risk include

Asymmetry in both form and function, including sickle cell disease

Prolonged lack of a complement component

Use of complement inhibitors, such as eculizumab and ravulizumab

Adolescents who are not at risk

Based on shared decision-making between the patient and the physician, teenagers aged 16 to 23 years (recommended age, 16 to 18 years) who are not at high risk may need a primary series immunization.

• Geriatrics: There is no sufficient scientific evidence traceable regarding the use and safety of the oral polio vaccine for geriatric populations.

• Lactating mothers: There is no sufficient scientific evidence traceable regarding the use and safety of the meningococcal B vaccine for lactating mother populations.

Dosage Adjustment in Kidney Impairment

There are no specific dosage adjustments provided.

Dosage Adjustment in Hepatic Impairment

There are no specific dosage adjustments provided.

According to the established guidelines, the Meningococcal B vaccine is generally safe and effective. Overdosage of meningococcal B vaccine rarely occurs because healthcare professionals help it according to specific or precise dosing guidelines.

There is no specific antidote or treatment for excessive intake of meningococcal B vaccine. Medical attention should be sought immediately when an overdose is suspected, followed by monitoring any adverse effects or allergic reactions. Supportive therapy should also be given, addressing any symptoms that persist or worsen. Physical treatment might be added if necessary.

Pharmacodynamics of Meningococcal B vaccine:

The Meningococcal B vaccine has a physiological mechanism that plays a role in its pharmacodynamics. The meningococcal B vaccination stimulates immune system production of particular antibodies directed against Neisseria meningitidis serogroup B. The fHbp, NadA, and PorA surface proteins are on the bacterial outer membrane. These proteins prompt the immune system to respond to vaccination, producing antibodies. The appropriate surface proteins on the bacterium are recognized and bound by these antibodies, preventing the bacteria from infecting the body's cells. In addition, the vaccination stimulates immunological memory, enabling a prompt and effective response upon later exposure to the meningococcus B bacteria. A person's risk of contracting invasive meningococcal B illness is reduced due to this immunization process.

Pharmacokinetics of Meningococcal B vaccine:

Absorption: Meningococcal B vaccination is absorbed directly into the circulation after intramuscular injection.

Distribution: It distributes throughout the body, reaching different tissues and organs via the circulatory system.

Unlike drugs, Meningococcal B vaccines don't involve metabolism or elimination processes because vaccines contain inert viral proteins, not active drugs. The vaccine's effectiveness comes from the body's immune response and antibody production, which provides long-term defence against meningococcal infections and related diseases.

• Balmer, Paul, and Laura J York. “Optimal use of meningococcal serogroup B vaccines: moving beyond outbreak control.” Therapeutic advances in vaccines and immunotherapy vol. 6,3 49-60. June 21. 2018, doi:10.1177/2515135518781757
• Ruiz García, Yara et al. “Looking beyond the meningococcal B with the 4CMenB vaccine: the Neisseria effect.” NPJ vaccines vol. 6,1 130. October 29 2021, doi:10.1038/s41541-021-00388-3
• Thng, C., Semchenko, E.A., Hughes, I. et al. An open-label randomized controlled trial evaluating the efficacy of a meningococcal serogroup B (4CMenB) vaccine on Neisseria gonorrhoeae infection in gay and bisexual men: the MenGO study protocol. BMC Public Health 23, 607 (2023). https://doi.org/10.1186/s12889-023-15516-y
• Ostergaard L, Vesikari T et al. A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults. December 14, 2017. N Engl J Med 2017; 377:2349-2362; DOI: 10.1056/NEJMoa1614474

• Explain to the caregivers the vaccine's dosage and schedule, including the benefits of completing the whole series for maximum protection.
• • Explain to the patients that even though the meningococcal vaccine significantly lowers the chance of developing the disease, it does not provide complete protection. Encourage using appropriate hygiene while staying up with illness outbreaks.
• Remind the vaccine recipient, their parents, or guardians whether they experienced any adverse reactions from a previous dose of the meningococcal B vaccine.
• Assure caregivers that meningococcal B immunizations are generally safe, with only minor, short side effects. Encouraging them to immediately report any unexpected or severe responses to the healthcare physician and, whenever applicable, to use reporting systems like the Vaccine Adverse Event Reporting System (VAERS)
• Inform caregivers of the recommended immunization schedule, which usually consists of two or three doses, depending on the vaccine brand. Also, mention the ages at which the doses should be administered and give the Vaccine Information Statements, which must be disclosed before immunization by the National Childhood Vaccine Injury Act of 1986 about the Centres for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines), these resources are freely accessible.

• http://www.cdc.gov/vaccines/schedules/
• https://www.indianpediatrics.net/oct2014/785 figure1.pdf
• https://main.mohfw.gov.in/sites/default/files/Universal.pdf
• https://www.ncbi.nlm.nih.gov/books/NBK553102/
• Banzhoff, Angelika, and Federico Martinón-Torres. “Meningococcal B vaccine effectiveness.” The Journal of pediatrics vol. 244 (2022): 250-254. doi:10.1016/j.jpeds.2021.12.074