The results show that vaccination was effective in preventing invasive meningococcal disease of both serogroup B and other serogroups in this child population.

The vaccine, which has been sold privately in Spain since 2015, had already been included by several autonomous communities in their vaccination schedules. Last December, the Interterritorial Council of the National Health System (CISNS) approved its inclusion in the vaccination calendar for all of Spain, a scenario demanded by the Spanish Association of Pediatrics (AEP).

Meningitis is one of the leading causes of serious illness in infants and children. Following the introduction of serogroup C vaccines, serogroup B meningococcus has become the leading cause of invasive meningococcal disease in Europe.

The four-component protein-based meningococcal B vaccine (4CMenB; Bexsero, GSK) was licensed in the European Union in 2013.

The authorization was based on the results of immunogenicity studies. And, although some countries have introduced it into publicly funded childhood immunization programs, the low incidence of the disease has limited post-marketing efficacy studies.

For ÁAngel Hernandez Merinoa pediatrician and collaborator of the Vaccine Advisory Committee of the AEP and the Spanish Association of Primary Care Pediatrics, the results are important since «provide essential information for decision-making in the context of a low-frequency disease, but with a high impact on the affected pediatric population and their families due to the high lethality (around 10%), high risk of serious sequelae (around 30% ) and by its form of presentation (abrupt, unpredictable, rapid evolution in a few hours)”.

Speaking to the Science Media Center, this pediatrician points out that the study “supports the decision made by the SNS Interterritorial Council, so desired and repeatedly requested.”

Hernández Merino explains that in January 2023, the CISNS vaccination schedule finally includes vaccination against meningococcus B in the first year of life, although this can be implemented until the end of 2024m, although several autonomous communities already included before this vaccination in their calendars: Castilla y León (since June 2019), the Canary Islands (since July 2019), Andalusia (since December 2021), Catalonia (since March 2022) and Galicia (since September 2022).

There are other communities that have decided to start vaccination, such as Asturias, Castilla-La Mancha, Extremadura, Madrid, Navarra and the Basque Country, but, this pediatrician points out, “it would be desirable for the other communities to decide to incorporate this vaccination into their calendar as soon as possible.

It must not be forgotten, he adds, “that the high cost of the vaccine is an element of inequality for the regions that do not contemplate this vaccination and for the families that have difficulties to assume it.”

The researchers conclude that this new evidence it may be useful in making decisions about the inclusion of this vaccine in the immunization schedule of countries where invasive meningococcal disease in children is problematic and its prevention is a priority.