Vaccine safety evaluation: Practical aspects in assessing benefits and risks

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• 作者：Alberta Di Pasquale^a ; ¹ ; ^{alberta.di-pasquale@gsk.com} ; Paolo Bonanni^b ; ¹ ; ^{paolo.bonanni@unifi.it} ; Nathalie Garç ; on^c ; ^{nathalie.garcon@bioaster.org} ; Lawrence R. Stanberry^d ; ^{lrs2155@cumc.columbia.edu} ; Mostafa El-Hodhod^e ; ^{moshodhod@med.asu.edu.eg} ; Fernanda Tavares Da Silva^a ; ^{fernanda.tavares@gsk.com}
• 关键词：AE ; adverse event ; AEFI ; adverse event following immunisation ; CDC ; US Centers for Disease Control and Prevention ; DNA ; deoxyribonucleic acid ; DTPa-IPV-HBV/Hib ; combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis b-Haemophilus influenzae type b conjugate vaccine ; MMR ; combined measles-mumps-rubella vaccine ; MMRV ; MMR with addition of varicella vaccine ; RMP ; Risk Management Plan ; RNA ; ribonucleic acid ; US ; United States ; VAPP ; vaccine-associated paralytic poliomyeliti
• 刊名：Vaccine
• 出版年：2016
• 出版时间：20 December 2016
• 年：2016
• 卷：34
• 期：52
• 页码：6672-6680
• 全文大小：401 K
• 卷排序：34

文摘

Vaccine safety is assessed from inception through the entire duration of its use. The vaccine safety label is continuously reviewed based on ongoing surveillance; when needed, actions are taken and communicated promptly to the community. Monitoring vaccine safety is a shared responsibility. Healthcare providers are encouraged to report all adverse events after immunisation. Verification of causality is critical to maintaining public confidence in vaccines.