Establishment of the safety of African swine fever attenuated live vaccines: The role of viremia and post-market surveillance systems

• 발행기관: 한국예방수의학회
• 저자명: Hyoung Joon Moon
• 간행물 정보: 『Journal of Preventive Veterinary Medicine』Vol.49, No.3, 158~168쪽, 전체 11쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2025.09.30

국문 초록

African Swine Fever (ASF) live-attenuated vaccines (LAVs) present multiple safety concerns, including virulence reversion, recombination, persistent viremia, and reproductive safety in gestating sows. The Vietnam's commercialization experience high light the need to re-evaluate the safety of gene-deleted LAVs. The magnitude and duration of viremia are key indicators of vaccine safety. Cases of fetal abnormalities, transplacental transmission, and virulence reversion following vaccination of pregnant sows underscore the limitations of clinical trials and the long-term, multi-generational risks associated with vaccine use. Accordingly, broad regulatory standards are required, covering safety in piglets and sows, horizontal transmission, virulence reversion, and environmental risks from living modified organisms (LMOs). The establishment of a molecular epidemiology-based post-marketing surveillance (PMS) system is needed. This system should include pre-introduction characterization of regional circulating strains, post-vaccination active surveillance, and whole-genome sequencing to monitor for mutations. A regulatory-scientific framework ensuring both safety and efficacy must be established through international collaboration and standardized reporting systems.

목차

INTRODUCTION

GENERAL SAFETY CONSIDERATIONS FOR LIVE VACCINES

WOAH GUIDELINES FOR AFRICAN SWINE FEVER VACCINE

SAFETY ISSUES AFTER THE ASF VACCINE LAUNCH IN VIETNAM

VIREMIA AS A SAFETY ASSESSMENT FACTOR

POST-MARKETING MEASURES TO ENSURE COMMERCIAL VACCINE SAFETY

CONCLUSION

ACKNOWLEDGEMENTS

REFERENCES

키워드

ASF LAV viremia PMS safety