2023-09-27 13:00:04
AIFA gives green light to an anti-Dengue vaccine. The Italian Medicines Agency has approved Takeda’s Tak-003 (Qdenga*), for the prophylaxis of Dengue disease caused by any of the 4 serotypes of the virus. It can be administered from 4 years of age. “This – explains the company in a note – is the only vaccine for the prevention of the disease approved in Italy even for those who have not had previous exposure to the virus and without the need to carry out a pre-vaccination test”.
“Dengue – recalls Nicola Petrosillo, head of the Infection Prevention and Control Service of the Campus Bio-Medico University Polyclinic Foundation of Rome – is an infectious disease caused by the virus of the same name, belonging to the Flaviviridae family, which is transmitted by mosquito bites of the genus Aedes, including the tiger mosquito present in our territory. It is an infectious disease which in some cases can evolve into a serious form requiring hospitalization. The new Takeda vaccine is innovative because it is structured on the basis of serotype 2 of the Dengue virus ( Denv-2), exploiting recombinant technology to ensure immunization against all 4 serotypes of the virus. Approximately half of the world’s population lives in areas where Dengue is endemic and Asian countries are among the most affected.”
“Every year, around 390 million cases of infection are reported around the world, with an incidence that has increased 30 times in the last 50 years – remarks Petrosillo – In Europe, Dengue is not endemic, but imported cases are almost exclusively recorded from subjects who have recently visited endemic areas; in Italy several cases of Dengue disease contracted in endemic countries are reported every year. It should be noted that some small and limited indigenous outbreaks have occurred in Europe and also in Italy. This new vaccine will represent a powerful tool in the prevention of the disease in international travellers, for tourism, work or return to their countries of origin”.
Dengue has been listed by the World Health Organization among the 10 threats to global health and is endemic in over 125 countries. It is in fact among the most rapidly spreading viral diseases transmitted by vectors in the world, mainly due to climate change, urbanization and globalisation. Over the last 10 years there has been an increase in infections in European travelers returning from countries where Dengue is endemic: North America, South America, the Caribbean, Africa, Asia, Oceania.
“Once made available in the various Regions after acquisition from them, the citizen’s access to the new vaccine, for tourism or work reasons towards the tropical and subtropical areas of the world where Dengue is endemic – underlines Roberto Ieraci, infectious disease specialist vaccinia , senior associate researcher of the National Research Council – may take place in the centers authorized to carry out the yellow fever vaccine and vaccinations against quarantine diseases and to issue the relevant certificate for international use on a specific WHO model. The lists are available online in the various regional websites. The vaccination schedule consists of 2 doses 3 months apart from each other, in people from 4 years of age. For those who travel, at short notice, a program before departure would be desirable approved accelerated vaccination”.
Tak003 is built on the basis of serotype 2 of the Dengue virus (Denv-2), which represents the genetic ‘backbone’ of the vaccine, and through recombinant technology it is able to guarantee immunization against all 4 serotypes of the virus Dengue. It was evaluated as part of a large clinical development program with various phase 1, phase 2 and phase 3 studies and over 28 thousand participants. It was generally well tolerated, with no evidence of an increase in hospitalizations due to severe dengue in vaccinated people.
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