Neurological Adverse Events of Immunization: Experience With an Aluminum Adjuvanted Meningococcal B Outer Membrane Vesicle Vaccine

Hanne Nøkleby


Expert Rev Vaccines. 2007;6(5):863-869. 

In This Article

Abstract and Introduction

Throughout the history of vaccination, vaccines have been accused of harmful side effects. Adverse events following immunization may be caused by the active antigen in the vaccine or other constituents, such as adjuvants, or may merely be coincidental. Possible neurological side effects have always obtained high attention. However, the risk of serious events caused by existing vaccines or aluminum adjuvants is very small. Currently, there are several new vaccines and adjuvants in the pipeline. Of these vaccines, many will be offered mainly to adolescents or adults. When taken into general use, some of them will probably be associated with serious adverse events. Although coincidence will be the most probable explanation in most cases, causality will have to be discussed in many situations. Preparing to address the causes of these adverse events is important.

The history of vaccines and vaccination is one long battle, rolling back and forth between victories over diseases and distrust caused by the alleged harmful effects of the vaccines.[1] Some of the harmful effects have been real, caused by deficient production or control of the vaccines. In 1929 and 1930, the use of the bacille Calmette-Guérin (BCG) vaccine made from a contaminated BCG strain led to the deaths of at least 72 infants in Lübeck, Germany.[2] Another tragic consequence of deficient control was the ‘Cutter incident’, where an incompletely inactivated polio vaccine infected 120,000 children, and led to disease in 40,000 of these cases. At least 51 vaccinates were permanently paralyzed and five died.[3] Conversely, as powerful prophylactic measures, the vaccines have also been victims of the ‘paradox of prophylaxis’. Successful prophylaxis removes the disease, thereby making minor or alleged negative vaccine effects very visible with obvious consequences. Recent examples are the events regarding the MMR vaccine and autism,[4] and thimerosal causing different neurological events.[5] Both allegations have been rejected by large and thorough studies.[6]


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