Bexsero – meningococcal vaccine

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Bexsero is an intramuscular vaccine aimed at generating immunity against Neisseria meningitidis group B bacteria. The vaccine does not fully guarantee its effectiveness against all types of meningococcal B strains. The vaccine is not reimbursed, is available only on prescription and is not a compulsory vaccination. Bexsero can be administered from 2 months of age by a doctor or pharmacist. What is the composition and action of Bexsero? What are the indications and contraindications for its administration and what side effects can it cause? What is the impact of vaccination on pregnancy, lactation and fertility? How to use and dose the vaccine, and with what medicinal products should it not be combined?

Bexsero is a type B meningococcal vaccine that has been available on the market since 2014. It is an important factor in the preventive prophylaxis of meningococcal invasion in the body. Invasive meningococcal disease often results in meningitis and sepsis. As much as 99 percent. these diseases correspond to meningococcus. Infection in a patient progresses very quickly – in a few or several hours and threatens with irreversible necrotic changes, as well as death.

Bexsero and meningococcus – basic information

Meningococci often “inhabit” the bacterial flora in our throats, about 5-10 percent. healthy people are their unconscious carriers. Most often, in the autumn and winter season, when a bacterial infection of the respiratory tract develops, meningococci can dangerously multiply and spread throughout the body. They can be infected through the droplet route, when the carrier spreads the microorganisms by coughing or sneezing, or through contact with saliva. By feeding on a new organism, they can lead to a very rapidly progressive invasion, which can be fatal.

Whether a person develops sepsis or meningitis depends on many factors – how the immune system works, and age (children and the elderly are most at risk). In Poland, the mortality estimate is about 10 percent.

The long waiting time for the vaccine was mainly due to the fact that doctors and scientists still have problems with identifying bacterial antigens of these meningococci. Bexsero vaccine it is based on four antigens – fusion proteins. Its effectiveness is estimated at 80 percent.. People or carers of people who have frequent contact with viruses, live in large crowds and travel should take care of vaccination the most. It is necessary to vaccinate children over 2 months of age, especially preschoolers and school-age children. People with reduced immunity are also at risk of invasion – for example, people with HIV or those who have undergone chemotherapy.

The vaccination schedule depends on the age of the child at the time of the first vaccination – it can be a 4 dose, 3 dose or 2 dose schedule.

What should I know about immunization? Check: Vaccinations – types, compulsory vaccinations, post-vaccination side effects [EXPLAINED]

Bexsero – general characteristics

Bexsero is a vaccine in the form of a white, opalescent liquid suspension. The international name of the preparation is Vaccinum Neisseria meningitidis. Bexsero is given to immunize children from 2 months of age and older against Neisseria meningitidis. The vaccine is available on prescription and is not reimbursed. The following packages are available on the market:

1. 1 pre-filled syringe of 0,5 ml with needles; 
2. 1 pre-filled syringe of 0,5 ml without needles;
3. 10 pre-filled syringes of 0,5 ml with needles;
4. 10 pre-filled syringes of 0,5 ml without needles. 

Price for one Bexsero pre-filled syringe is about PLN 350. The suspension is in a pre-filled syringe (type I glass) with a plunger stopper (type I bromobutyl rubber) and a protective syringe cap (type I or II rubber), with or without needles. Not all pack sizes may be marketed.

The preparation should be stored out of the sight and reach of children in a refrigerator with a set temperature of 2-8 ° C.

The distributor of the Bexsero vaccine in Poland is a global, innovative company in the area of ​​healthcare, GSK Commercial Sp. z o. o. The company is the largest producer of vaccines in the world in terms of revenues. The company’s research and development focuses on developing vaccines against infectious diseases that meet the most pressing medical needs.

What is the vaccination calendar? Read: Vaccination calendar – when to perform mandatory and recommended vaccinations? [WE EXPLAIN]

Bexsero – composition and method of operation

Bexsero meningococcal vaccine contains four active substances obtained from the surface of the Neisseria meningitidis group B bacteria, adsorbed on aluminum hydroxide. One 0,5 ml pre-filled syringe contains:

1. 50 micrograms of recombinant NHBA fusion protein;
2. 50 micrograms of recombinant NadA protein;
3. 50 micrograms of recombinant fHbp fusion protein;
4. 5 micrograms of outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98 / 254 measured as total amount of PorA P1.4 containing protein.

The auxiliary substances in the vaccine are sodium chloride, histidine, sucrose and water for injections. In addition, there may be traces of latex (natural rubber) in the syringe cap that may cause an allergic reaction.

Due to its complexity and adsorption, Bexsero vaccine stimulates the production of bactericidal antibodies that recognize the vaccine antigens NHBA, fHbp, PorA and NadA, protecting against invasive meningococcal disease.

What vaccinations are compulsory for children? Check: Compulsory vaccinations for children – when to do? Why should children be vaccinated?

Bexsero – method of administration and dosage

Bexsero is a medicinal preparation in the form of a vaccine that is given by a doctor or nurse.

The vaccine is administered deeply into a muscle, preferably in the anterolateral area of ​​the thigh in infants, or in the deltoid region of older patients.

Bexsero must not be injected intravenously, subcutaneously or intradermally, and must not be mixed with other vaccines in the same syringe.

The complete vaccination process usually consists of 2 injections and 1 addition. For patients over 2 years of age, only a primary vaccine is usually sufficient. It depends, inter alia, from the vaccination guidelines for the period of vaccination of a child.

For infants 2 – 5 months of age, primary immunization can be given in two ways:

1. administration of 3 doses of 0,5 ml each with a minimum of 1 month between them;
2. administration of two doses of 0,5 ml with an interval of at least 2 months.

The booster vaccination is the administration of 1 dose of 0,5 ml of the drug at the age of 12-15 months and at least 6 months after the primary vaccination. In the event of a delay, a supplemental dose may be administered up to 24 months of age.

In infants 6-11 months of age, two doses are recommended at intervals of at least 2 months and a third booster dose in the second year of life, at least 2 months after the second dose.

For children between 12 and 23 months of age, the primary vaccine consists of 2 doses of 0,5 ml given at least 2 months apart. A third booster dose of 1 0,5 ml dose should be given 12 to 23 months after the end of the primary cycle.

Children from 2 years of age, adolescents and adults are vaccinated with 2 doses of 0,5 ml, with an interval of 1 month between them. A booster dose is recommended for patients who are still at risk of persistent meningococcal infections.

In the case of special groups, e.g. people over 50, there is no information on the use of the preparation. The vaccine must not be given to infants before 8 weeks of age. The use of the vaccine requires consultation with a physician and must be administered according to the instructions of the physician or nurse in order for the patient to complete the required vaccination course.

What are pneumococcal vaccines? Check: Vaccination against pneumococci

Bexsero – indications for use

Bexsero vaccine is mainly indicated as active immunization of people aged 2 months and older against invasive meningococcal disease caused by the bacterium Neisseria meningitidis group B. This bacterium can cause life-threatening diseases such as: meningitis (inflammation of the the layer covering the brain and spinal cord) and sepsis (blood poisoning).

What could a vaccine fever mean? Check: Post-vaccination fever

Bexsero – contraindications to use

Bexsero vaccine, although there are indications for its administration, cannot always be used in every patient. The main contraindication to the use of this drug is hypersensitivity, i.e. allergy to the active substances or any of the excipients. Therefore, as with all injectable vaccines, appropriate medical treatment and supervision should always be available in the event of a vaccine-induced anaphylactic reaction.

Contraindications to the use of Bexsero also include certain diseases and circumstances that may require you to refrain from administering it altogether or change the dose. Particular care should be taken in patients:

1. with severe illness with fever (vaccination should be postponed);
2. suffering from thrombocytopenia or any other blood clotting disorder that may contraindicate intramuscular injection (the vaccine should not be administered unless the potential benefits clearly outweigh the risks associated with the administration of the vaccine);
3. preterm infants (≤ 28 weeks gestation), especially those with symptoms of immaturity of the respiratory system;
4. with haemophilia, using anticoagulants, or with other conditions that affect blood clotting
5. allergic to kanamycin (an antibiotic);
6. prone to fainting or other needle stick stress reactions;
7. reduced immunity as a result of disease or medications.

In immunocompromised patients, the vaccine may not produce the expected immune response. In addition, patients> 50 years of age and patients with chronic diseases should consult a physician as there are no data on the effects of the vaccine on the body in these patients. The risk of using Bexsero in a patient should be assessed by the physician on an individual basis.

When should children not be vaccinated? Read: When not to have a child immunized? Contraindications to vaccinations

Bexsero – possible side effects

Bexsero meningococcal vaccine can cause a side effect which may not be experienced by every person. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The side effects that may occur after vaccination with Bexsero may vary depending on the age of the patient. There are side effects that require immediate medical attention.

Very commonly, reactions such as:

1. pain and tenderness;
2. swelling of the skin;
3. reddening of the skin;
4. hardening of the skin;
5. Headache;
6. general malaise;
7. nausea.

In infants and children under the age of 10, the following additional vaccines appeared after vaccination:

1. very common: injection site tenderness, skin rash (at age 12-23 months, uncommon after booster dose), joint pain, loss of appetite, fever above 38 ° C, irritability, somnolence, unusual crying, headache, diarrhea , vomiting;
2. common: skin rash;
3. uncommon: dry skin, pale skin, fever above 40 ° C, febrile convulsions;
4. rare: skin rash, itchy rash and Kawasaki disease.

In addition, post-vaccination adverse reactions reported included, but were not limited to:

1. allergic reactions such as swelling of the lips, mouth, throat, difficulty breathing, rash, loss of consciousness, very low blood pressure;
2. fainting or feeling faint;
3. blistering appearing at or around the injection site.

The occurrence of side effects after the use of Bexsero depends on the individual patient’s response, sensitivity and resistance to the vaccine. It is important to consult a doctor about any disturbing symptom. It allows continued monitoring of the benefit / risk balance of the medicinal product.

The influence of Bexsero on fertility, pregnancy and lactation

There are no conclusive clinical data on the use of the vaccine in pregnant women. Vaccination should not be withheld when there is a high probability of meningococcal infection. There are also no data on the intake of the vaccine during lactation and breastfeeding. The physician should assess the risk-benefit ratio before deciding whether to vaccinate.

During studies with Bexsero, immunogenicity was demonstrated in animal models in females vaccinated before breastfeeding, antibodies were found in the offspring, and the levels of antibodies in the milk were not measured.

There are also no data on the effects of the vaccine on human fertility. In animal studies, there was no effect on female fertility. The vaccine can be used in pregnant or breastfeeding women who are at high risk of becoming infected with bacteria after consulting their doctor.

What is worth knowing about non-compulsory vaccinations? Check: Optional vaccinations – types, indications, advantages. Why is it worth performing non-compulsory vaccinations?

Using Bexsero with other medicinal products

Before vaccinating with Bexsero, tell your doctor about any prescription, over-the-counter or herbal products you are taking, and about any other vaccines you have recently taken.

Bexsero can be given concurrently with other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae, measles, mumps, rubella, smallpox and pneumococcal vaccines.

It is important that the vaccines are administered at different sites. Due to the frequent occurrence of fever, tenderness at the injection site, changes in eating habits and irritability when co-administered with the meningococcal group B vaccine with the above-mentioned vaccines, your doctor may recommend that you either administer these vaccines separately. vaccines or the use of anti-pyretics such as paracetamol.

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