New 21-valent pneumococcal vaccine: AIFA authorises use in adults

On May 23, 2025, Official Gazette no. 118 published the decision of the Italian Medicines Agency (AIFA) regarding the classification and supply regime of the new 21-Valent Pneumococcal Conjugate Vaccine. This vaccine is indicated for the prevention of invasive diseases and pneumonia caused by Streptococcus pneumoniae in adults aged 18 years and older. Its introduction is an important step forwards in protecting Public Health, particularly for the most vulnerable population groups.

On May 23, 2025, Official Gazette no. 118 officially announced the decision of the Italian Medicines Agency (AIFA) to approve the supply and classification of the new 21-Valent Pneumococcal Conjugate Vaccine, aimed at protecting adults aged 18 and over against Streptococcus pneumoniae. This is an important update in the battle against one of the most serious and underestimated bacterial infections among the adult population.

Streptococcus pneumoniae is a very common bacterium, transmitted through respiratory droplets, and responsible for sometimes serious infections, especially in children under 1 year of age, adults over 65 years of age, and those with certain diseases or conditions. It is not unusual to find the bacterium in the upper respiratory tract (nose and throat) of healthy children and adults: it is estimated that 20-60% of children and 5-10% of adults are carriers of Streptococcus pneumoniae. In most cases, carriers are unaware that they are harboring the germ because, under normal immune conditions, pneumococcus is located in the airways without causing any problems.

There are more than 90 known types (serotypes) of pneumococcus, which differ according to the type of capsule they are made up of.

The onset of symptoms in people carrying pneumococcus is linked to conditions that alter the integrity of the respiratory tract lining, such as concomitant viral infections, exposure to irritants (primarily cigarette smoke), or diseases that reduce the efficiency of the immune system. When the infection becomes manifest, it causes otitis, sinusitis, or conjunctivitis. If the germs reproduce in the blood or other parts of the body where they are not normally present, they can give rise to serious forms of disease (invasive bacterial diseases). Cases of disease occur mainly in winter, when colds and flu are common, predisposing people to the onset of the disease. Infections are sporadic; epidemics are rare but can occur in small communities such as nurseries, schools, and other institutions.

Every year in Europe, there are an estimated 150,000 cases of invasive pneumococcal disease, with mortality rates still high, especially among the elderly, patients with chronic diseases, or those who are immunocompromised. In addition to mortality, these infections can leave disabling sequelae, such as permanent neurological deficits following meningitis or chronic respiratory failure following severe pneumonia.

Prevention through vaccination is currently the most effective measure for reducing the risk of these pathological conditions.

The new 21-Valent vaccine, already authorized at European level and now also approved in Italy, significantly expands the scope of protection available: it covers 21 different serotypes of the bacterium, some of which are particularly aggressive or emerging. Compared to previous versions, it offers enhanced protection, especially against the most severe forms and in at-risk individuals. The introduction of this new vaccine updates and reinforces the vaccination strategy in adults, complementing current recommendations for the protection of people over 65 and those with medical conditions that make them more susceptible to pneumococcal complications. Vaccination reduces the risk of hospitalization, protects the individual, and helps limit the spread of the bacterium in the community. As with all vaccinations, the more people who are vaccinated, the greater the protective effect. Pneumococcal pneumonia is not just a topic for specialists: it is a matter of Public Health. The new tools provided by science must translate into concrete opportunities for the protection of all.

For detailed information on indications, dosage, and access to vaccination, please contact your general practitioner or local vaccination services. The AIFA decision is available in full in the Official Gazette no. 118 of May 23, 2025, and can be consulted in the attachment to this article.

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