Vaccination against the B-type meningococcal bacterium
Recently, after approval by the Ministry of Health, a new vaccine against the B-type meningococcus bacterium arrived in Israel.
Until now, there has only been a vaccine in Israel against other strains of the bacterium and not against type B.
The vaccine is called Bexsero and is made by GSK.
At the beginning of May 2020, a similar vaccine was registered in Israel by the Pfizer company called Trumenba. However, the Trumanba vaccine is intended for registration only from the age of 10 years and upwards and is therefore not relevant for infants and young children.
The introduction of this important vaccine into the routine immunization program is accompanied by quite a few difficulties and I encounter many questions from parents about this vaccine.
In this chapter I will try to answer these questions and pinpoint the infant population that deserves to be vaccinated.
What is the meningococcal bacterium and what disease does it cause?
The bacterium is called Neisseria meningitides and is located in the nose and pharynx of a significant percentage of the population without causing disease (up to 10% of adults and 25% of children).
In rare cases, carrying can become an invasive disease, including sepsis (the presence of the bacterium in the blood), meningitis and more.
Due to the fact that the early signs of infection in children are not specific and the fact that the invasive disease is usually rapid and severe, the bacterium has earned the media the dubious nickname "the violent bacterium".
Who is at risk of contracting an invasive meningococcal disease?
By and large everyone. However there are groups that are at high risk for the disease. Among the groups:
- Children up to the age of five, and especially infants up to the age of two.
- Children or adults with specific and defined immune disorders.
How does the meningococcus bacterium spread from person to person?
The bacterium is transmitted from person to person by secretions from the airways of a carrier / patient.
It can be understood that the high carrier rates indicate that there is quite a bit of transmission of the bacterium from person to person and most people who become infected will become carriers themselves but will not start.
Only a minority of those infected or carriers will develop an invasive disease.
What's the matter with the different strains (types) of this bacterium? What is type B?
Meningococcus has several strains / types that differ from each other in the presence of different sugars on the capsule (capsule) that envelops the bacterium.
The strains that cause most diseases in humans are A / C / Y / W135 and strain B. Strain B is the main cause of the disease in various countries including Israel, especially in young children.
In Israel, there are 3 conjugated vaccines ("new generation" vaccines that are more effective than the old polysaccharide vaccines) against the other four strains of the meningococcus (A / C / Y / W135). Immune system disorders or travelers).
This chapter does not discuss these vaccines at all, but only the vaccine against meningococcus B.
What is the prevalence of morbidity in the State of Israel?
It is not easy to find accurate data regarding the prevalence of morbidity in the State of Israel, possibly due to under-reporting.
However, in the work of Dr. Ben Shimol (a specialist in infectious diseases in children from Soroka Hospital) published in 2013, it was found that in a period of 22 years there were about 743 cases of invasive infection from this bacterium (all subtypes) in children under 15 years.
In a simple calculation it can be understood that these are about 33 cases per year on average.
Young children from the age of 5 years, and especially infants under the age of one year, constituted the main group of patients.
Divided by bacterial strains it was found that strain B of the bacterium was the dominant strain in young children under 5 years of age.
In another work by Dr. Stein-Zamir from the Ministry of Health, 1349 cases were identified at all ages over a period of 20 years, an average of 71 cases per year.
Also in this work the incidence of the disease was higher in children under one year of age (rate of 10.9 cases per 100,000).
About 68% of cases were caused by type B (in children the incidence of strain B was of course even higher).
Is there any experience in the world with this vaccine?
Certainly, in September 2015 the vaccine entered the routine vaccination program in England, due to a considerable morbidity from this bacterium.
The vaccine is routinely given to infants under one year of age, according to a schedule similar to what is written later in the State of Israel (first dose at 2 months of age, second at 4 months of age and third per year, all doses are given at the same time as routine vaccinations).
Other countries that routinely stockpile are Ireland, Italy, Lithuania, New Zealand, Spain, Andorra and more.
Other countries have recommended (as in the State of Israel) receiving the vaccine, including Australia, Austria, Belgium, Canada, France, Germany, Portugal and more.
It should be noted that the B-type morbidity differs from continent to continent, and from country to country. And therefore a recommendation (or lack of recommendation) can be found according to local morbidity in that country.
The U.S. Food and Drug Administration has registered the vaccine in the United States since the age of 10 and recommended vaccination before entering college.
What is the effectiveness of the vaccine against this bacterium?
Vaccine efficacy can be evaluated in several forms. I have chosen to give the example here, in my best taste, and it is England that was the first country to introduce the vaccine into the routine immunization program.
After 10 months of immunization, a decrease of about 50% was demonstrated in the number of cases.
A study published in January 2020 in the best clinical scientific journal in the medical world (NEJM) found that the effectiveness of the vaccine in preventing disease was 52.7% after 2 doses of vaccine and 59.1% after a third dose at one year of age. For those interested in expanding reading the article is summarized At the following link .
It makes sense to expect that in the longer term the decline in disease rates will be higher.
According to the minutes of the Advisory Committee to the Ministry of Health in Israel dated December 25, 2018, it was estimated that the introduction of the vaccine in Cesaro into the vaccination routine in the State of Israel will prevent about 18 cases of illness and up to one infant death per year.
Well then a rare disease, vaccine reduces morbidity by 50%, is it worth getting vaccinated?
This is of course the question of the questions, and assumes that many of the parents who came to read this chapter, sought the answer to this question.
It is true that on the one hand the disease is not common, and it is true that a vaccine as we will see below has limitations (logistics, cost, side effects), but if there is a vaccine that prevents a serious illness there is room for me to overcome all the limitations around.
My recommendation is to vaccinate the children, as you will see below.
So who is the vaccine recommended for?
The recommendation of the Ministry of Health is to vaccinate the population of infants and toddlers under the age of two. You can of course be vaccinated even after this age.
In the young age group, this vaccine can be integrated into the routine "milk drop" program, see my suggestion below.
The vaccine is recommended at any age and enters the health basket for certain populations suffering from specific immune system disorders (HIV carriers, spleen dysfunction or patients treated with a drug called EcoLizumab).
Who can get the vaccine?
Any baby over the age of two months.
Where is the vaccine given?
The vaccine is given intramuscularly, to the thigh or arm area depending on the age of the vaccinated person.
How many servings do I need to get vaccinated?
Unfortunately a bit complicated, because it depends on the risk factors (whether it is a healthy baby / child or with a background illness) and the age of onset of vaccinations.
In healthy babies in the background who begin to be vaccinated as usual at the age of up to six months there is room for three doses when the time interval between the first and second dose is two months and between the second dose and the impulse dose (the third dose) is at least half a year. Before the age of two years).
At the beginning of the vaccine series at a different age (over the age of six months) or given a child with a background illness, the amount of doses and the time differences between them varies.
For your convenience, see a table that defines the number of doses and the minimum time intervals between them in healthy children without risk factors.
Number of servings required: 2 + 1
Minimum time interval between first and second course: two months
Minimum time interval between second and third dose (impulse dose): 6 months
Remarks: It is recommended to give the booster dose before the age of two years
What is the right time to get vaccinated and is it right to postpone the vaccine during the current corona period?
Since the disease is more common in infants, I recommend that you start the series of vaccines at a young age.
In addition, I understand that in light of the transition of milk drops to an emergency format, and the rejection of other routine vaccines, some families have chosen to postpone this vaccine as well.
I recommend that you take care of all routine vaccines, including this additional vaccine. See my specific suggestion below regarding the age of vaccination.
What is the expected duration of protection for infants after this series of vaccines?
It is estimated that giving two doses provides protection for babies for about a year and a half and receiving an impulse dose provides protection for over 3 years. In adolescents, the duration of protection is even longer (over 7 years).
Since as we wrote earlier, most morbidity is caused in infants, toddlers and young children, the expectation is that the vaccine will protect them just during this important time period.
Side effects of the vaccine?
As with any vaccine, local side effects such as redness and sensitivity at the injection site are the most common.
Fever and restlessness, were observed more frequently when the vaccine was given in parallel with the other routine vaccines.
In light of the relatively high incidence of these side effects, although not dangerous, it was written for the first time in the vaccination guide of the State of Israel that it is recommended to give 3 doses of acetaminophen (paracetamol or novimol) to vaccine recipients under one year of age. A first dose within one hour of administering the vaccine and two additional doses thereafter at 4-6 hour intervals.
Over six months ago I reported to the Ministry of Health a higher than expected rate and intensity of local side effects to this vaccine, read more At the following link . This potential local side effect should be recognized, but at the end of the day it is not a reason not to vaccinate children.
Who can not get vaccinated?
People / children who have a known sensitivity to one of the vaccines.
Can and how can this vaccine be combined with other routine vaccines?
It is permissible to give this vaccine together with all other routine vaccines, at the same time or at any interval before or after. Vaccines should be given in different anatomical regions. However and as we wrote earlier, the incidence of mild side effects was observed with a higher incidence when the vaccine was given with the other routine vaccines. Therefore, the Ministry of Health recommended a separation of at least 3 days between the other routine vaccines for this vaccine in the vaccine recipients younger than one year of age.
I recommended that parents want to vaccinate in terms of dates for meetings in tipat halav
Since the vaccine causes restlessness and fever with high frequency when given in conjunction with routine vaccines, then I recommend giving it separately, in another session dedicated only to this vaccine at the ages:
3 months, 5 months and 13 months.
This is at a discount and the routine vaccinations and dates of visits to the milk drop were carried out in an orderly manner at monthly, 4-month, half-year and one-year-olds.
The vaccine can of course be given earlier than the written offer above, about 3 days before or after the administration of the other routine vaccines.
How can I actually get the vaccine?
As mentioned, the Ministry of Health has recommended receiving the vaccine for healthy children under the age of two but will not budget it. This means that the vaccine is not in the health basket and therefore is not routinely given at the milk drop stations.
Most HMOs understood the importance of this vaccine and reached agreements with GSK.
This means that the vaccine can be purchased at any of the health funds at a subsidized price (depending on the age and supplementary insurance of the insured).
In practice, you need to go to the pediatrician / family doctor, ask for a prescription for the vaccine and usually also an instruction for the nurse to vaccinate.
With the prescription to go to the pharmacy that works with the same HMO, buy the vaccine, arrange for it to be transferred as soon as possible with some ice to the nurse at the HMO and vaccinate (some HMOs also require a referral to a nurse from the doctor to administer the vaccine).
I heard that in some of the milk drops, the nurses are willing to get the vaccine from the parents and vaccinate. At the same time, I heard that in some milk drops, nurses refuse to be vaccinated with this vaccine, because they have now been given work that is not part of the routine milk drop. In some HMOs, this problem has been solved and can also be vaccinated as part of the HMO’s milk drops by prior arrangement.
If there is a serious HMO in Israel, then I recommend that its captains sit on the bench and resolve these bureaucratic issues that also make it difficult for parents who want to be vaccinated.
How much does the vaccine cost?
The full price of the vaccine is 410 NIS. However all HMOs participate in having this vaccine according to the following table:
So how do we sum up?
After over one and a half million children who have been successfully vaccinated in England, and after over 50 million doses distributed worldwide, my impression is that the availability of the vaccine in Israel is another important tier in protecting the health of our children. I hope this chapter will help parents make the right decision regarding this vaccine in their young child.