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

Igiene e sanita pubblica Pub Date : 2020-03-01
Elisa Terracciano, Fabiana Amadori, Laura Zaratti, Elisabetta Franco
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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. The development of a vaccine starts from the identification and characterization of the microorganism that causes the disease. The second step is the preclinical phase. Then, 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 two procedures (EU and national) based on the quality, safety and efficacy requirements defined by the European and international guidelines. Timing of realization, authorization and marketing of new vaccines can be shortened in cases of particular need, through an accelerated evaluation known 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 marked decrease in routine immunizations in childhood.

疫苗:从微生物鉴定到营销。要花多长时间?]
研制一种疫苗,特别是研制一种有助于预防最近的大流行的疫苗,是最近吸引公众舆论的一个话题。目前,世界各地的大学和公司正在开发针对Sars-Cov2的90多种疫苗。它们是基于蛋白质的疫苗、病毒载体疫苗、DNA或RNA疫苗以及灭活或减毒病毒疫苗。疫苗的研制从鉴定和鉴定引起疾病的微生物开始。第二步是临床前阶段。然后是临床试验阶段,这允许在越来越大的样本上研究疫苗的免疫学、有效性和安全性。在欧洲联盟,疫苗是根据欧洲和国际准则规定的质量、安全性和有效性要求,通过两个程序(欧盟和国家)获得批准的。在特别需要的情况下,可通过称为“重点药物”的加速评估缩短新疫苗的实现、批准和销售时间。在此期间,至关重要的是不要忽视当前的疫苗接种。事实上,在大流行期间,许多国家推迟了针对许多疫苗可预防疾病的疫苗接种运动,导致儿童常规免疫接种显著减少。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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