More than three years ago the Novartis laboratory got the permits for the 'Bexsero' meningitis B vaccine will reach all of Europe so that each government could decide what to do with it: enter it in the calendar for all children, not do it but allow its sale in pharmacies for those parents who wanted to put it, or block it and allow its administration only for hospital use (in cases concrete that could benefit from the vaccine).
While the United Kingdom opted for the first option, vaccinating babies through their health system, most countries decided to leave it for sale in pharmacies. In Spain, on the other hand, the Spanish Agency for Medicines and Health Products (AEMPS) considered it for hospital use only, until October 1, 2015 it was made available to parents in pharmacies.
Since then the distribution has been very poor and many parents have had to wait months to get it. At present, the number of vaccines is increasing in all pharmacies in Spain and it is now when many parents start asking about it and assessing the possibility of giving it to their children. That's why today we talk about the meningitis B vaccine 'Bexsero'explaining everything you need to know.
Why did AEMPS not allow the sale of Bexsero from the beginning?
The AEMPS decision was not without controversy. While most countries allowed the sale, in Spain it was decided not to do so and the Scientific Societies closest to vaccination in Spain: the Spanish Association of Pediatrics (AEP), the Spanish Association of Vacunology (AEV) and the Spanish Society of Preventive Medicine, Public Health and Hygiene (SEMPSPH) issued a statement in which they showed their surprise at this decision:
AdvertisingThis vaccine may be the best preventive measure against meningococcal infection invading serogroup B, a rare but devastating disease, which is accompanied by a uniform lethality of 10% and between 10% and 30% of permanent sequelae. . Without a doubt, it is a crucial advance in the fight against this disease.
However, AEMPS considered that since 2009 the incidence of meningococcal disease was decreasing. The drop in cases of meningitis C seemed to be due to the protection of all children with the vaccine for a few years now, but meningitis B was also decreasing. According to the figures they gave, the rates notified in the European Union between 2011 and 2012 were of 0.80 cases per 100,000 inhabitants, being 65% of the cases caused by meningococcus B.
Being the incidence of cases stable at that time, and at there are still no studies on the clinical efficacy of the vaccine they considered that it should not be used in all children, but only in specific cases.
Why in 2015 did you change your mind?
On October 1, 2015, AEMPS unlocked the distribution of the Bexsero vaccine and allowed parents to buy it if they wanted. It had been 2 and a half years since its use was approved at the hospital level and issued a statement explaining why as of that date the situation changed:
The vaccine was initially rated by the AEMPS as hospital use based on its pharmacological characteristics and its novelty, according to Spanish legislation. However, AEMPS, which continuously evaluates all authorized medications, has evaluated new quality and safety data submitted by the company after the distribution of more than 1,200,000 doses of the vaccine worldwide and has modified the conditions of dispensing the vaccine to be available at the pharmacy offices.
Is it an important vaccine?
It is the million dollar question. The decision to vaccinate a child or not is for each father and mother, since vaccination is optional. Well, in fact it is always optional, but in this case we talk about a vaccine that parents buy, and that means that professionals should be cautious when saying "yes" or saying "no".
Meningitis B is an unlikely disease, it could be said that statistically it is almost impossible for our child to ever take a meningitis B, however it is not impossible, and the disease is serious, so the decision is not easy.
In fact, it is surprising that it is not part of the calendar if we take into account that the meningitis C vaccine is funded by social security and, as we have said, 65% of cases of meningitis in Spain are caused by the meningococcus bacteria B.
The Spanish Association of Pediatrics explains in this regard that in 2013 there were between 400 and 600 affected. Of all cases, it is estimated that one in ten is insurmountable, dies, between 20 and 30% can be left with serious sequelae such as seizures, deafness and mental retardation, and the rest are those that are saved.
In other words: 400-600 annual cases are not many in the total of Spanish children, but if we take into account that many die and that many are left with sequels, the thing is much more serious.
When should the Bexsero be administered?
According to the AEMPS report it is a vaccine that It begins to be administered at 2 months, but that can actually be put at any age (for older children who don't have it on). As it is recommended not to put it on the same day that other vaccines are administered many centers put it after 3 months. Then you have the table with the information of the doses they touch by age (4 if the child is under 6 months, 3 doses if they are between 6 and 24 months, and 2 doses when they are already two years old):
Is it really safe?
AEMPS decided to wait to be sure that it was, so it did not allow its distribution until it was certain of that. An article in the Annals of Pediatrics magazine reads as follows:
Safety has been analyzed in 9 clinical trials, with 4,800 infants under 12 months, 1,600 children aged 12 to 24 months, 84 children aged 40-43 months and 1,738 adolescents and adults aged 11 to 55 years. In children under 24 months of age, it was found that the most commonly observed local and systemic adverse reactions were pain and erythema at the injection site, fever and irritability.In clinical studies in infants, fever appeared more frequently when the vaccine was co-administered with systematic vaccines (61%), than when applied alone (38%) or compared to routine vaccines alone (33%). The fever is usually low, appears in the first 6 hours and rarely lasts more than 36-48 hours.
In children older than 12 months, up to 37% have a fever above 38.5 ° C and only 2-5% of adolescents.
That is, in studies that add more than 8,000 children of different ages the symptoms were pain and inflammation in the puncture area, irritability and fever.
But in the leaflet it says that it can cause Kawasaki disease
So is. The leaflet indicates that as "rare" side effects (up to 1 in 1,000 people), Kawasaki disease may occur, which can lead to coronary problems and, although treated, can be dangerous if not treated in time.
As the pediatrician reference Lucia Galán On its website, weeks after the vaccine, a consultation was made to the Vaccine Advisory Committee of the AEP, which replied as follows:
Indeed, the Kawasaki disease is recorded as a possible rare complication (≥1 / 10,000 to <1 / 1,000) in the Bexsero vaccine. As you know, during the development of a clinical trial it is obligatory to notify all the processes, diseases, accidents, etc ... that the subjects included in the trial present, even when the cause-effect relationship is unlikely. During the trials with Bexsero, some case of Kawasaki disease was recorded and therefore it appears on the vaccine's technical data sheet.Subsequently, the use of the vaccine in the general population allows to know if there really is an association with Kawasaki or not. So far, the vaccine has been used in two outbreaks of meningococcal disease by serogroup B at two universities in the United States, in which more than 28,000 doses of Bexsero have been administered without registering any case of Kawasaki disease. In this link you can consult the article published in Pediatrics 2015.
The same has happened in Saguenay-Lac-St-Jean, district of Quebec, Canada, where there was an outbreak of invasive meningococcal disease B and the health authorities decided to administer vaccination with Bexsero to almost 50,000 people aged between 2 months and 20 years. A close epidemiological follow-up was established and no cases of Kawasaki disease have been recorded (nor have they had any more cases of meningococcal disease B). You can check it in this link.
All this allows us to consider that the development of Kawasaki disease as a complication of vaccination against meningococcus B is very unlikely. Time will allow to establish with certainty the existence or not of this relationship. Remember that, at the start of vaccination against rotavirus, the possible relationship with Kawasaki was also considered, a fact that practical experience has managed to rule out.
Is it really such a dangerous disease?
Yes it is. Especially in younger children, whose immune system is not so able to stop the infection. In November of last year we told you a case that was talked about a lot in Spain, happened in Galicia, of a 13-month-old baby who died of meningitis B when he had not yet been vaccinated.
In February we learned of another death of a baby from this same disease in Seville, and we also discovered that in the United Kingdom, although all babies are vaccinated, there are older children who were left out of such vaccination (they were no longer babies when the vaccine was introduced in the calendar) and whose parents decided to collect signatures asking for the vaccination of all the children, especially after the death of a 2-year-old girl who shocked the whole country.
But if it is a bacterium, does it have no treatment?
Yes there are. There are antibiotics to cure a meningitis B infection, however, the prognosis will depend on the age of the child, as well as of the time that has passed since the beginning of the infection. If we talk about a baby, the speed with which the infection spreads can cause the treatment not to arrive on time, and in the case of older children it happens similar: if it takes to diagnose meningitis the antibiotic may not be completely effective. That is why it is considered that the best option is to try to prevent the disease.
Is the vaccine effective?
Yes. At least that is what emerges from the data made public yesterday regarding vaccination in the United Kingdom. Thanks to the vaccination of babies, the number of cases of meningitis B in infants under one year of age, which is the age group most likely to catch the disease, and in those who are more serious, has been cut in half.
Since the beginning of the vaccination program, 37 cases of meningitis B have occurred, while in the same period of time, in the previous 4 years the average number of cases was 74.
How much does the Bexsero cost?
Why deny it: the price scares. Each dose costs € 106.15 and that makes the disbursement important, and more if we take into account that in Spain salaries are not at the same level as other European countries. Taking into account that meningitis C is part of the calendar, the logical thing is that this vaccine also ends up being part of it (more if we take into account that in the United Kingdom the government pays about € 27 for each dose), but what is known for now is that AEMPS will continue studying the data on the effectiveness of the Bexsero to assess the possibility of approving such change.
Meanwhile there is no choice but to choose between paying or not paying, vaccinating or not vaccinating, protecting or not protecting. My argument about it in the consultation is always the same: "It is almost impossible for your child to take meningitis B, because it is very rare ... but if he takes it, anything can happen, because it is very serious."
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In Babies and more | Where is the 'Bexsero' meningitis B vaccine and what to do if you only get one dose ?, The AEP asks that the meningitis B vaccine be included in the vaccine schedule, Meningitis, know it better: prevention and warning symptoms
