Four-component, meningococcal serogroup B vaccine (4CMenB)

Meningococcal diseases are serious bacterial diseases caused by Meningococcus (Neisseria meningitidis). Meningococcus causes severe cases of meningitis (inflammation of the membranes lining the brain and spinal cord) especially in young children and adolescents.

Moreover, if the bacteria enters the bloodstream, it can affect other organs, resulting in an even more serious clinical picture (sepsis). Meningococcal disease can strike at any age, but the disease is more common in children under one year of age and youths aged between 12 and 21.

In Italy, about 150-200 meningococcal meningitis cases are ascertained each year (although the real number of cases is probably much higher). Although it can be treated with antibiotics, the infection often develops so rapidly that, even with a timely diagnosis and treatment, it causes death in 10-15% of cases. From 11 to 19% of those who survive, may have complications such as amputation of the limbs or parts of limbs, diseases of the nervous system (paralysis, convulsions or stroke), deafness, psychological and emotional disorders, and developmental delay.

There are 12 groups of meningococci, five of which (A, B, C, Y, W135) are responsible for invasive meningococcal disease. Of these, the serogroup B is the main cause of meningococcal disease in Italy.

Indeed, from 2007 to 2011 MenB was responsible for approximately 61% of the total cases of invasive meningococcal disease.

Disease incidence is particularly marked in children under the age of one: as shown in one British study, the cases of MenB are observed mainly between the fourth and ninth month of life, with a peak recorded in the fifth month.

The vaccine

The development of a vaccine against this bacterium has long been a challenge for vaccinologists worldwide. In fact, traditional methods, which had been used successfully for the development of vaccines against the other 4 pathogenic meningococcal serogroups, have proved unsuccessful against this serogroup.

Today, thanks to an innovative technique called "reverse vaccinology" the development of a universal vaccine against meningococcus B has been made possible, and this vaccine is now available in Italy.

The meningococcal type B vaccine provides a wide-reaching defensive response: it consists of four components exposed on the surface of the bacterium, chosen to protect against most strains of meningococcus B in circulation.

The vaccine can be used in infants aged 2 months and older, and administration, which takes place intramuscularly, can also be carried out at the same time as any of the following vaccines: diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, pneumococcal conjugate, measles, mumps, rubella and varicella.

In the case of co-administration with other vaccines, the anti-meningococcal type B vaccine must be injected at a different inoculation site.

When to vaccinate

Infants aged between 2 and 5 months must receive 4 doses of the vaccine:

  • 3 doses for primary immunisation, the first of which is administered at the age of 2 months, with an interval of at least one month between doses;
  • 1 booster dose administered between 12 and 23 months of age.

Infants aged between 6 and 11 months who have not previously been vaccinated must receive 3 doses of the vaccine:

  • 2 doses for primary immunisation, with an interval of at least 2 months between doses
  • 1 booster dose in the second year of life, with an interval of about 2 months between the primary cycle and the booster dose.

Children aged between 12 and 23 months who have not previously been vaccinated must receive 3 doses of vaccine:

  • 2 doses for primary immunisation, with an interval of at least 2 months between doses
  • 1 booster dose after an interval of 12 to 23 months between the primary cycle and the booster dose

Children aged between 2 and 10 years old who have not previously been vaccinated must receive 2 doses of vaccine:

  • 2 doses for primary immunisation, with an interval of at least 2 months between doses
  • The need for a booster dose has not been established

Adolescents (aged 11 or over) and adults must receive 2 doses of vaccine:

  • 2 doses for primary immunisation, with an interval of at least 1 month between doses
  • The need for a booster dose has not been established

Who should not be vaccinated

Children who have experienced severe hypersensitivity (anaphylaxis) to the active ingredients or to any of the excipients contained in the vaccine should not be vaccinated.

In addition, the vaccine should not be given to subjects with thrombocytopenia or any coagulation disorder that contraindicates intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.

When to postpone vaccination

Come per altri vaccini, la somministrazione del vaccino antimeningococco B deve essere rimandata nei soggetti affetti da uno stato febbrile acuto. Tuttavia essa non è da rimandare nel caso di una lieve infezione, come il raffreddore.

Vaccination risks

Like any other drugs, vaccines could cause severe allergic reactions, although the risk of such reactions is extremely low.

The safety of the anti-meningococcal B vaccine has been extensively studied in over 7,000 subjects from 2 months of age. From these studies, it has emerged that the most common adverse reactions observed in children were: soreness and erythema at the injection site, fever and irritability. In adolescents and adults the most common adverse reactions observed were: pain at the injection site, malaise and headache.

What to do if a reaction occurs

Moderate or severe

A severe allergic reaction usually occurs within a few minutes (up to an hour) of vaccination.

The signs and symptoms include difficulty in sucking, weakness, hoarseness, stridor or difficulty breathing, rapid heartbeat, pallor. A severe allergic reaction requires immediate treatment. Over 90% of cases occur in the first few minutes after vaccination. Therefore, after vaccination it is advisable to wait 15-30 minutes in the clinic.

It is necessary to observe any unusual situation, such as high fever or changes in the child's behaviour.

In these cases it is important to contact the paediatrician immediately.

For further information

If you have any doubts, ask your paediatrician and/or at your vaccination clinic, who will be able to provide further information and clarification.

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