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Milan, March 14 (Adnkronos Salute) – Green light from the Italian drug agency Aifa to the 15-valent anti-pneumococcal conjugate vaccine Vaxneuvance *. In fact, MSD announces the publication in the Official Journal of the determination relating to the classification in class Cnn of the new product, indicated for active immunization in the prevention of invasive disease and lung infection caused by Streptococcus pneumoniae in people aged 18 years or older. .
According to the report of the Invasive Bacterial Diseases Surveillance System of the Higher Institute of Health – the company recalls in a note – in the absence of measures of restriction to sociability and the use of individual protection means, in Italy 1,500 cases of invasive diseases (meningitis, sepsis and pneumonia with bacteremia) due to Streptococcus pneumoniae (Ipd). Furthermore, it is estimated that a significantly higher number of non-invasive diseases (pneumonia, sinusitis and otitis media) occur. In accordance with the recommendations included in the National Vaccine Prevention Plan 2017-2019 currently in force, adult pneumococcal vaccination is recommended in subjects aged 65 years and in subjects at risk and at high risk, according to the sequential scheme. which involves a first vaccination with the anti-pneumococcal conjugate vaccine and a subsequent administration of polysaccharide vaccine one year later (2 months for high-risk subjects). The new 15-valent anti-pneumococcal conjugate vaccine has also been developed including population categories at increased risk of pneumococcal disease and with specific clinical needs.
The development program – Msd details – includes 7 phase III studies, of which 3 conducted in special populations such as immunocompetent subjects aged 18-49, but with risk conditions; HIV-positive individuals aged 18 years or older; subjects 18 years of age or older undergoing haematopoietic stem cell transplantation. These 3 trials evaluated the safety, tolerability and immunogenicity of the 15-valent pneumococcal conjugate vaccine in a sequential scheme, i.e. followed by the administration of the 23-valent polysaccharide vaccine. The sequential vaccination scheme was also investigated in a fourth study conducted in immunocompetent individuals over the age of 50. Vaxneuvance has been significantly shown to induce: non-inferior immunogenic response for the 13 serotypes shared with the currently available 13-valent anti-pneumococcal conjugate vaccine; superior response for the 2 specific serotypes (22F and 33F) and for the shared serotype 3, the latter responsible for about 20% of cases of Ipd in subjects aged 65 or over in Italy.
“For over 100 years – says Nicoletta Luppi, president and managing director of Msd Italia – Msd has played a fundamental role in the discovery and development of vaccines, renewing a commitment to protection towards the population of all ages. Considering the progressive increase in longevity , adult vaccination is a crucial element for healthy aging. We recognize every day the power of prevention and the enormous value of vaccines for public health and continue to work relentlessly with health institutions to protect more and more lives from serious diseases. Investing in research for innovation in prevention through immunization has always been part of our DNA “.
In December 2021, the 15-valent pneumococcal conjugate vaccine received European Commission approval for marketing in all 27 EU Member States plus Iceland, Norway and Liechtenstein.