“Today we have a vaccine designed specifically for adults which is a paradigm shift for pneumococcal disease. The 23 valent was already present, but being glycosidic, it has a weaker antigen and must be remade years later”. V116, which is 21-valent, is instead “protein” and therefore, based on the experience gained with this type of vaccine, “it could be effective with a single administration”. Furthermore, “the 21 serotypes determined a very similar immune response , without causing interference, cover 80% of pneumococcal pathologies in the elderly and, of these, the 8 exclusive strains protect this population from approximately a quarter of invasive pneumococcal pathologies. This vaccine is therefore a game changer not only because it is designed on measure of the adult and fragile population, but also because it worked well for all serotypes. However, for it to have an impact on epidemiology, public health needs to implement a system that favors its administration”. Thus Pier Luigi Lopalco, professor professor of Hygiene at the University of Salento, during a press meeting organized by Msd on the Phase 3 results of the experimental 21-valent pneumococcal conjugate vaccine V116.
“The fact that there is a congress in which only pneumococcus is talked about – he adds – indicates how impactful the disease is on a global level. The news is the green light, with a fast track from the American drug agency, FDA for V116”.
The body of evidence (Stride studies) presented to the ISPPD is very “substantial – explains Lopalco – We are talking about 8 double-blind clinical trials which compared the new 21-valent conjugated vaccine with those which up to now have been the standards of protection against pneumococcus in adults. Not only that, many thousands of subjects belonging to different age groups were also included in these studies and among these some were particularly 'fragile' such as HIV positive individuals who, in a condition of potential immunosuppression, are more susceptible to the disease. The complexity of the body of studies lies in the fact that V116 has been tested under all possible conditions that may be encountered in real life. The positive results presented were not at all obvious because all the serotypes contained in this vaccine met all the criteria required for authorization for use. The V116 vaccine proved to be non-inferior to the products with which it was compared for all those serotypes, 13, which are in common with the other vaccines with which it was compared”.
They are “surprising results – the expert remarks – because unfortunately until now we were well aware that by adding serotypes to a vaccine, the addition could lead to some interference and, therefore, it is not automatic that for example a 15-valent vaccine works better of a 7-valent, nor that a 20-valent works better than a 15-valent vaccine, indeed, sometimes the addition of serotypes can lead to the occurrence of interferences whereby a strain responds less due to the presence of other strains. Clinical studies have shown, therefore, that for all 13 strains contained in the 21-valent vaccine, which are in common with the old vaccines, V116 works the same way or better, i.e. it is not inferior.”
But the novelty of V116 “is represented by the 8 strains – observes Lopalco – which are contained only in this vaccine and it is precisely those strains responsible, in some cases, for up to 30% of the adult disease. V116 was designed to specifically protect adults and the fragile. It is not a vaccine for children which can also protect adults and the elderly. Studies conducted on the epidemiology and ecology of pneumococcus in the elderly have shown that the presence of the 8 strains that are not present in childhood vaccines provide additional and exclusive protection for adults at risk and for the elderly. ”.
“The results in terms of immunogenicity were truly exceptional, because there was no non-response from each strain. Regarding safety, pneumococcal vaccines have been used for many years and have proven to always be well tolerated. V116 in clinical studies confirmed its safety compared to old vaccines, therefore, no surprises emerged regarding safety and tolerability. In addition to the clinical studies, a very interesting epidemiological study conducted in the United States was presented at the Congress, a so-called “field” study, in real world which involved over 2 thousand adult/elderly subjects suffering from pneumonia for whom serotyping of the circulating strains and showed how in these individuals the protection with the 21-valent could have reached up to 84%, thus avoiding over 80% of cases of pneumococcal pathologies in these subjects. Ultimately – he concludes – from the data that suggest coverage of over 80% thanks to the 8 exclusive strains of V116, which was designed specifically for adults and the elderly, we can affirm that this vaccine could really represent a turning point in prevention 360 degrees of pneumococcal disease from childhood to old age”.
#Lopalco #Antipneumococcus #valuable #paradigm #shift #frail #adults
