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Vaccine safety evaluation: practical aspects in assessing benefits and risks [Special Issue]

Tuesday, 20th of December 2016

Vaccine, 34 (52) (2016), pp. 6665–6671 http://dx.doi.org/10.1016/j.vaccine.2016.10.079

Alberta Di Pasquale, Paolo Bonanni, Nathalie Garçon, Lawrence R. Stanberry, Mostafa El-Hodhod, Fernanda Tavares Da Silva

Vaccine safety evaluation: practical aspects in assessing benefits and risks [Special Issue]

Vaccine, 34 (52) (2016), pp. 6672–6680

Vaccine. 2016 Dec 20;34(52):6672-6680. doi: 10.1016/j.vaccine.2016.10.039. Epub 2016 Nov 8.

Vaccine safety evaluation: Practical aspects in assessing benefits and risks.

Di Pasquale A1, Bonanni P2, Garçon N3, Stanberry LR4, El-Hodhod M5, Tavares Da Silva F6.

Author information

1GSK Vaccines, Avenue Fleming 20, Parc de la Noire Epine, B-1300 Wavre, Belgium. Electronic address: alberta.di-pasquale@gsk.com.

2Department of Health Sciences, University of Florence, Viale GB Morgagni 48, 50134 Florence, Italy. Electronic address: paolo.bonanni@unifi.it.

3Bioaster, 40 Avenue Tony Garnier, 69007 Lyon, France. Electronic address: nathalie.garcon@bioaster.org.

4Columbia University College of Physicians and Surgeons and New York-Presbyterian/Morgan Stanley Children´s Hospital, New York, NY, USA. Electronic address: lrs2155@cumc.columbia.edu.

5Ain Shams University, Faculty of Medicine, Pediatrics Department, Cairo, Egypt. Electronic address: moshodhod@med.asu.edu.eg.

6GSK Vaccines, Avenue Fleming 20, Parc de la Noire Epine, B-1300 Wavre, Belgium. Electronic address: fernanda.tavares@gsk.com.

Abstract below; full text is at http://dx.doi.org/10.1016/j.vaccine.2016.10.039

Vaccines are different from most medicines in that they are administered to large and mostly healthy populations including infants and children, so there is a low tolerance for potential risks or side-effects. In addition, the long-term benefits of immunisation in reducing or eliminating infectious diseases may induce complacency due to the absence of cases. However, as demonstrated in recent measles outbreaks in Europe and United States, reappearance of the disease occurs as soon as vaccine coverage falls. Unfounded vaccine scares such as those associating the combined measles-mumps-rubella vaccine with autism, and whole-cell pertussis vaccines with encephalopathy, can also have massive impacts, resulting in reduced vaccine uptake and disease resurgence. The safety assessment of vaccines is exhaustive and continuous; beginning with non-clinical evaluation of their individual components in terms of purity, stability and sterility, continuing throughout the clinical development phase and entire duration of use of the vaccine; including post-approval. The breadth and depth of safety assessments conducted at multiple levels by a range of independent organizations increases confidence in the rigour with which any potential risks or side-effects are investigated and managed. Industry, regulatory agencies, academia, the medical community and the general public all play a role in monitoring vaccine safety. Within these stakeholder groups, the healthcare professional and vaccine provider have key roles in the prevention, identification, investigation and management of adverse events following immunisation (AEFI). Guidelines and algorithms aid in determining whether AEFI may have been caused by the vaccine, or whether it is coincidental to it. Healthcare providers are encouraged to rigorously investigate AEFIs and to report them via local reporting processes. The ultimate objective for all parties is to ensure vaccines have a favourable benefit-risk profile.

Copyright © 2016. Published by Elsevier Ltd.