Vaccine safety

Abstract

Vaccinations rank among the most effective preventive measures for protection against infectious diseases. Advances in development, production, and control of vaccines facilitate the increasing standards of vaccine safety and tolerance. Comprehensive pre-clinical and clinical tests as well as modern manufacturing and testing methods ensure that vaccines marketed nowadays are safe. As a rule, clinical trials performed before granting the marketing authorisation identify the most frequent adverse events and these results are used to evaluate the safety of the product. Such trials can identify relatively rare adverse events, which occur with a frequency of 1:1,000 to 1:10,000 of all vaccinated individuals. These adverse events will then be included in the summary of product characteristics (SPC) for the vaccine. Even after comprehensive clinical trials of vaccines, it is possible that very rare adverse events may be observed for the first time during general use of a vaccine. In recent years concern over real and alleged risks of vaccines relative to their benefit has grown in many countries including Germany. One reason for this is the fact that most infections that were previously feared have now faded from memory. This situation can be ascribed in part to the success of vaccination. In recent years an increased awareness of substantiated and assumed risks following immunization has been reported in Germany as well as many other countries. In part this may be due to the absence of infectious disease-related mortality and morbidity and to the fact that the severity of vaccine-preventable diseases is no longer observable. Consequently, rare and hypothetical adverse events attain undue public attention. As vaccination willingness diminishes, a resulting lower vaccination rate renders the population susceptible to the natural wild type infection with concomitant increases in mortality and morbidity of vaccine-preventable diseases. Thus, very rare or even unproven adverse events have attracted public attention. Declining vaccination rates resulting from these fears may result in a renewed increase of vaccine-preventable diseases. Adverse events following immunization (AEFI) need to be recognized and adequately assessed. This review presents the scientific knowledge concerning causality and frequency of several AEFI and hypothetical risks.

Review: Vaccine Myth-Buster – Cleaning Up With Prejudices and Dangerous Misinformation

“…Likewise, the journal retracted the publication and Wakefield was barred from practicing medicine (148)(149)(150). Numerous other studies found no significant association between the MMR vaccine or the mumps virus and autism spectrum disorder (ASD) (72,81,(151)(152)(153)(154)(155)(156)(157)(158)(159)(160)(161)(162)(163)(164). A recent nationwide cohort study in Denmark by Hviid et al (164) used the Danish population registries to evaluate whether the MMR vaccine increased the risk for autism in children, subgroups of children or time periods after vaccination.…”

“…The threshold level for formaldehyde in vaccines is 0.02 % (0.2 g/L) ( 81 , 82 ). Additionally, nowadays the formaldehyde-based inactivation is followed by its removal.…”

Vaccination in Elite Athletes

“…Other hypothetical side effects of vaccination have almost been ruled out, such as multiple sclerosis, diabetes mellitus type 1, or autism [46–49]. …”

Empfehlungen zum Vorgehen bei Auftreten ungewöhnlicher neurologischer Symptome in zeitlichem Zusammenhang mit Impfungen im Kindes- und Jugendalter

“…Impfungen verursachen keine Epilepsie [7], jedoch können im Rahmen von mit Impfungen assoziiertem Fieber bei entsprechender genetischer Disposition Fieberkrämpfe auftreten. Eine retrospektive Analyse von Berkovic et al [8] konnte bei 11 von 14 Patienten mit der Diagnose einer vermeintlichen "chronischen postvakzinalen epileptischen Enzephalopathie" nachweisen, dass die Symptomatik nicht [11]. HHE wurden nach Verabreichung zahlreicher Impfstoffe, am häufigsten nach den früher verwendeten Pertussisganzkeim-Kombinationsimpfstoffen beschrieben.…”

“…Hypoton-hyporesponsive Episoden (HHE) sind kollapsähnliche Reaktionen bei Säuglingen und Kleinkindern, die durch plötzliches Auftreten einer erniedrigten Muskelspannung (hypoton), reduzierte Ansprechbarkeit und Reaktion auf Reize (hyporesponsiv) und bläuliche Hautfärbung oder Blässe charakterisiert sind. Die mittlere Zeit zwischen Impfung und Auftreten der Symptomatik liegt bei 3–4 h (Zeitspanne: wenige Minuten bis 48 h), die Dauer beträgt zwischen 6 und 30 min (bis zu einigen Tagen) [ 11 ]. HHE wurden nach Verabreichung zahlreicher Impfstoffe, am häufigsten nach den früher verwendeten Pertussisganzkeim-Kombinationsimpfstoffen beschrieben.…”