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Title: Acellulaire kinkhoestvaccins. Veilig vaccineren tegen kinkhoest?
Author(s): HOPPENBROUWERS K
Journal: Tijdschrift voor Geneeskunde
Volume: 60    Issue: 20   Date: 2004   
Pages: 1482-1489
DOI: 10.2143/TVG.60.20.5002009

Abstract :
Tijdens de laatste decennia van de twintigste eeuw werd in verschillende geïndustrialiseerde landen de uitvoering van bestaande vaccinatieprogramma’s aanzienlijk gehinderd door de al dan niet terechte bezorgdheid over de veiligheid van de "klassieke" volcellige kinkhoestvaccins. In een aantal landen daalde hierdoor de kinkhoestvaccinatiegraad onder de kritieke drempel, met opnieuw epidemieën van kinkhoest tot gevolg. Tegen deze achtergrond werden sinds 1980 grote inspanningen geleverd voor de ontwikkeling van minder reactogene acellulaire kinkhoestvaccins.
In een groot aantal klinische studies, voorafgaand aan de registratie, werd aangetoond dat vaak voorkomende, maar milde, lokale en algemene reacties minder vaak optreden na acellulaire dan na volcellige kinkhoestvaccins, en dat de beschikbare acellulaire vaccins op dit vlak niet noemenswaardig van elkaar verschillen.
Zoals blijkt uit efficaciteitsstudies, met de vaccinatie van duizenden jonge kinderen, zijn ook ernstige reacties, zoals stuipen en hypotone, hyporesponsieve episoden, veel minder vaak geassocieerd met acellulaire vaccins.
Deze bevindingen werden bevestigd in grootschalige "surveillance"-studies na registratie en systematisch gebruik van de acellulaire vaccins: ernstige neurologische reacties kunnen nog voorkomen na acellulaire kinkhoestvaccinatie, maar zijn uiterst zeldzaam geworden.
Met uitzondering van de kinderen met een evolutieve neurologische aandoening, zijn er voor deze nieuwe generatie kinkhoestvaccins geen contra-indicaties meer voor systematische vaccinatie van jonge kinderen.





Acellular pertussis vaccines:Safe vaccination against pertussis?
In recent decades concerns about the safety of the whole-cell pertussis vaccine have impeded the progress of immunization programs in industrialized countries. Such concerns have led to loss of public confidence, drop in pertussis vaccine coverage, and return of pertussis epidemics in several countries. Since 1980 the development of acellular pertussis (aP) vaccines which are less reactogenic than whole-cell (wP) vaccines has been an important objective of manufacturers.
Numerous pre-licensure safety and immunogenicity studies of many different aP-vaccines have been conducted in infants and children. These studies invariably concluded that the aP-vaccines are associated with lower rates of common adverse reactions, such as local and febrile reactions, than wP-vaccines. Although differences were observed in reactions in a study that compared 2 wP- and 13 aP-vaccine candidates, wP-vaccines were constantly more reactogenic than aP-vaccines, but none of the aP-vaccines were found to be consistently the most or least reactogenic. No association was found between the number of vaccine components and reactogenicity.
The various efficacy trials maintained surveillance for more severe reactions among much larger numbers of infants and thus supplement data from safety and immunogenicity trials by providing more precise estimates for these less common events. For example, hypotonic-hyporesponsiveness episodes and seizures are sometimes, albeit rarely, seen after acellular vaccine, but always less frequently than with whole-cell vaccine.
None of the efficacy trials enrolled adequate numbers of children to evaluate the role of acellular pertussis vaccine in the category of the rare, serious adverse effects. These events require extensive evaluation during postmarketing surveillance for their determination. Data resulting from about 20 years’ experience with acellular vaccines in Japan suggest that the occurrence of severe neurological illnesses within 7 years after the administration of DTaP-vaccines is extremely rare. Consequently, these diseases should not be a concern for daily immunization practice.
Of course, adverse events temporally but not causally associated with vaccination will continue to occur at their background rates, regardless of the vaccine used.

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