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

Tuesday, 15th of November 2016

Vaccine. 2016 Nov 8. pii: S0264-410X(16)30974-4. doi: 10.1016/j.vaccine.2016.10.039. [Epub ahead of print]

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.

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Abstract

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.