Clin Exp Vaccine Res.  2021 May;10(2):93-105. 10.7774/cevr.2021.10.2.93.

Comparison of regulatory framework of clinical trial with genetically modified organism-containing vaccines in the Europe, Australia, and Switzerland

• Jose J
• Pai S

• KMID: 2525795
• DOI: http://doi.org/10.7774/cevr.2021.10.2.93

Abstract

New vaccines production and manufacture have revolutionized by recombinant technology. Various regulatory associations are engaged with the appraisal of a clinical trial with genetically modified organisms. At present safe, effective vaccines are needed in order to control the various emerging diseases which are a major cause of mortality. In reality, most vaccines raise biosafety worries with respect to human wellbeing. “Federal Office for Environment” is the competent authority for environmental risk assessments in Switzerland. Gene Technology Act 2000 is the fundamental direction that provides the necessary information to carry the clinical trials with genetically modified organism-containing vaccines. In addition, regulatory framework for “clinical trial with genetically modified organisms-containing vaccines” is stringent and partially harmonized in Switzerland, the European Union and Australia. In this study, we mainly concerned with regulatory aspects of “clinical trial with genetically modified organism” containing vaccine in three regions. This review includes various aspects like ethics, guidelines related to clinical trials of vaccines with genetically modified organisms.

Keyword

Clinical trial; Genetically modified organism; Vaccine; Regulatory status; Ethical approval