疫苗,一种药物,已成为对抗COVID-19的承诺绝对武器:适当的监管?

IF 0.1 Q4 MEDICINE, LEGAL Medecine & Droit Pub Date : 2021-08-01 DOI:10.1016/j.meddro.2021.01.001
Mathieu Guerriaud (Maître de conférences en Droit pharmaceutique et de la santé, pharmacovigilance et iatrogénie, Docteur en Sciences (PhD)/Docteur en Pharmacie (PharmD), Membre de la société d’Histoire de la Pharmacie)
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引用次数: 0

摘要

随着第一批针对COVID-19的疫苗进入市场,这些产品的安全性问题出现在公众辩论中。主要关注的是可能发生的不良反应,特别是在使用mRNA等新型制药技术的情况下。必须提醒患者和专业人员,疫苗不仅本身是一种医药产品,而且是一种特殊的医药产品:生物和免疫产品。因此,它的监管是严厉的,尽管紧急,要求没有降低。上市的速度是适应临床试验和优化评估程序的结果。
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Le vaccin, un médicament devenu l’arme absolue promise contre la COVID-19 : une réglementation adaptée ?

As the first vaccines against COVID-19 arrive on the market, the question of the safety of these products arises in the public debate. The major concern is about the possible occurrence of adverse effects, particularly in the context of the use of novel pharmaceutical technologies such as mRNA. It is important to remind both patients and professionals that a vaccine is not only a medicinal product in its own right, but also a special medicinal product: biological and immunological. As a result, its supervision is draconian, and despite the urgency, no requirements have been lowered. The speed of marketing is the result both of adapted clinical trials and optimized evaluation procedures.

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来源期刊
Medecine & Droit
Medecine & Droit MEDICINE, LEGAL-
CiteScore
0.30
自引率
0.00%
发文量
27
期刊介绍: The Scientific Committee of the journal Médecine et Droit includes professors of medicine, professors of law, magistrates, lawyers, court medical experts, and specialists in compensation for physical injury. Médecine et Droit provides: • rigorous and clear support for informative and educational matter • a tool for reflection and actualisation of knowledge • an essential link between doctors and lawyers. Médecine et Droit informs: • doctors on different aspects of law and regulations encountered in their profession • lawyers on the specific problems of the medical profession and important bio-ethical issues
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