Prevention of pertussis: from clinical trials to Real World Evidence.

Pertussis, a highly contagious infective disease caused by Bordetella pertussis, was in the past very common among newborns and children, causing significant medical, social and economic issues burden, also due to frequent need of hospitalization and high mortality. Following the introduction of vaccines against pertussis, the burden of the disease dramatically decreased, although nowadays, this disease it is still the most widespread among the vaccine preventable ones. First vaccine formulations were composed with whole cell antigen of Bordetella pertussis and were followed by formulations with acellular antigens (PT, FHA, PRN, FIM), that showed to have similar efficacy and less reactogenicity. In particular, all the acellular vaccines, regardless the number of antigenic component included, demonstrated good immunogenicity in clinical trials and high effectiveness in real world evidence studies. Nevertheless, in the recent years it has been notified an increasing number of cases of pertussis. The most recent evidence demonstrated that for an effective control and prevention of pertussis it is necessary to strengthen vaccination coverage among the whole population, providing primary vaccination to newborns and booster in infancy, adolescence and adulthood every 10 years. Finally, vaccination of women at the third trimester of every pregnancy is the most effective intervention to protect the newborn from pertussis in his first months of life, before developing a protective response after the primary vaccination.