Dünyada Yeni Aşı Üretiminde Uygulanan Toksikolojik Değerlendirmelerin Karşılaştırılması
Özet
Vaccines are complex biological medicinal products containing components such as antigens, adjuvants, and preservatives. They prevent diseasesby stimulating the immune system and providing active immunity. In the last century, vaccination has become the most effective medical way to reduce morbidity and mortality from infectious diseases. Vaccines, which are important advences for public health, can cause undesirable effects after administration. These effects are usually mild and rarely serious. Therefore, recent vaccines should be evaluated for their potential toxicity by performing preclinical studies. Therefore, their safety is demonstrated before the vaccine administered to human. As a result of these studies, clinical studies are carried out for candidate vaccines that are considered safe for human use. Assesment of vaccine safety worldwide is performed using various toxicity tests including Single Dose Toxicity Tests, Repeated Dose Toxicity Tests, Reproductive and Developmental Toxicity Tests, Mutagenicity and Genotoxicity Toxicity Tests, Carcinogenicity Tests and Safety Pharmacology Tests. Some test procedures differ among the national health autorities. Compliance with global guidelines reduces regional disparities. Based on this literature survey, the aim of this thesis to examine in detail the toxicity assessments performed before the license following the vaccine production in our country and in the world, and to discuss the similarities and differences. In addition, it is aimed to reveal possible lack of information by examining the reference guides in our country and around the world. It is thought that this study, which was prepared as a result of comprehensive evaluation of national and international current guides, will contribute to a full understanding of the toxicity assessment process in vaccine production and to reveal the possible shortcomings.
