Vaccini: dall’identificazione del microrganismo alla commercializzazione. Quanto tempo ci vuole?

Elisa Terracciano*, Fabiana Amadori*, Laura Zaratti**, Elisabetta Franco**

*Scuola di Specializzazione in Igiene e Medicina Preventiva, Tor Vergata Università degli Studi di Roma
**Dipartimento di Biomedicina e Prevenzione, Tor Vergata Università degli Studi di Roma

Parole chiave: Nuovi vaccini, 􏰗empistiche, COVID, Pandemia.
Riassunto: Lo sviluppo di un vaccino parte dalla conoscenza del microrganismo responsabile della patologia che si vuole fronteggiare. Le tempistiche che seguono dipendono dalla tipologia di vaccino che si intende sviluppare e dalla necessità della sua immissione in commercio. Alcune tappe possono essere accelerate tramite schemi codificati così i tempi di realizzazione, autorizzazione ed immissione in commercio dei nuovi vaccini possono essere abbreviati in casi particolari. Non trascurare i vaccini già in uso rimane fondamentale nella prevenzione di nuove e vecchie epidemie.

Vaccines: from the identification of the microorganism to marketing. How long does it take?

Key words: New vaccines, 􏰗iming, COVID, Pandemics.
Abstract:The development of a vaccine, particularly one that can help against the recent pandemic, is a topic that has recently attracted public opinion. More than ninety vaccines are currently being developed against Sars-Cov2 by universities and companies around the world. they are protein-based vaccines, viral vector vaccines, DNA or RNA vaccines and inactivated or attenuated viral vaccines. 􏰗he development of a vaccine starts from the identification and characterization of the microorganism that causes the disease. 􏰗he second step is the preclinical phase. 􏰗hen, there is the phase of clinical experimentation, which allows to study the posology, efficacy and safety of the vaccine, on an increasingly larger sample. In the European Union, vaccines are authorized through t􏰌o procedures (EU and national) based on the quality, safety and efficacy requirements defined by the European and international guidelines. 􏰗iming of realization, authorization and mar􏰍eting of ne􏰌 vaccines can be shortened in cases of particular need, through an accelerated evaluation 􏰍no􏰌n as “Priority Medicines”. In this period, it is crucial not to neglect current vaccinations. In fact, during the pandemic period, many countries postponed vaccination campaigns against many vaccine-preventable diseases, causing a mar􏰍ed decrease in routine immunizations in childhood.