Newsgroup: it.salute
Titolo: Otto bambini all'ospedale dopo vaccino esavalente

Otto bambini visitati nelle sale d'emergenze dell'ospedale di Salerno 
dopo avere ricevuto il vaccino esavalente. Questo è quello che è stato 
riscontrato dai dottori Panico, Caporale e Attena del servizio 
epidemiologia dell'Asl Salerno 2 e riportato sulla prestigiosa rivista 
medica Vaccine nel numero del 22 aprile 2005. Gli autori dell'articolo 
hanno concluso che questi otto casi rientrano nell'atteso, cioè se li 
aspettavano, rientravano in quanto previsto. Auspichiamo naturalmente 
che i genitori siano stati informati anche di questo.Gli autori 
ammettono anche che il foglietto illustrativo italiano del vaccino in 
questione (Hexavac, Aventis Pasteur) è assolutamente inadeguato a 
fornire informazioni necessarie e sufficienti agli operatori e quindi, 
aggiungiamo noi, anche ai genitori.
Vaccine. 2005 Apr 22;23(22):2841-3.
Adverse events following hexavalent vaccine (Hexavac): Knowledge and 
informative sources.
Panico MG, Caporale V, Attena F.
Servizio di Epidemiologia ASL SA2, Via Fabio 30, 84100 Salerno, Italy.
This report describes adverse events to vaccination in eight children in 
southern Italy. These children were seen in the Emergency Room of a 
hospital of the Local Health Unit SA2 (Salerno, Italy) after 
administration of hexavalent vaccine (Hexavac, Aventis-Pasteur). On 
analysing available documentation on the adverse reactions (label 
instructions, Medline), the Authors concluded the cases reported were to 
be expected. However, the label instructions did not give sufficient 
information on the type and frequency of adverse reactions. If the label 
instructions are to furnish complete, operative information for the 
vaccination units, the Italian instructions for the Hexavac vaccine can 
be considered inadequate.
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# acinacceMaicnarA #
Se quello che dice la "scienza" per te NON è fede
cieca se ti senti a posto quando fai quello che NON
fanno tutti gli altri se non fai parte del nucleo
pensante detto "massa",Allora sei dei nostri !
www.pantellini.org
 
www.comilva.org
 
www.vaccinetwork.org
Vaccini? No grazie!

 aggiungiamo noi, anche ai genitori.
Ovviamente l'articolo "voi" non lo avete letto, oppure pur avendolo letto
"voi" volete strumentalizzare a tutti i costi quel paper e fargli dire
cose che gli autori non si sono *mai* sognati di dire, perché "voi" non
sapete piu a che attaccarvi. 
Tanto per precisare, qui parliamo solamente di irritabilità
comportamentale dei bambini immediatamente dopo l'iniezione e irritazione
e gonfiore nella zona di inoculazione, punto. 
Gli autori erano abbastanza seccati dal fatto che chi si occupa di
monitorare questi eventi non aveva abbastanza informazioni epidemioloiche
dai foglietti illustrativi per decidere subito se gli otto casi
riscontrati in un mese erano nella norma - come si è capito poi quando ci
si è resi conto che ci si trovava semplicemente di fronte ad un gruppo di
genitori iperansiosi - oppure no e quindi poter lanciare un allarme
giustificato. Quindi essi volevano sottolineare semplicemente l'importanza
di riportare i dati epidemiologici anche per le reazioni al vaccino meno
importanti e non solo le statistiche per i casi più gravi. Tutto qua.
Chi volesse il (breve) articolo mi scriva. Comunque mi permetto di
accludere qui un copia ed incolla della discussione ce riassume il tutto:
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4. Discussion
Three factors contributed to inducing the hypothesis of an unexpected
cluster of adverse reactions to hexavalent vaccine.
(1) The inappropriate recourse by the parents of the vaccinated children
to the Casualty Department, which led to an overestimation of the symptom
severity.
(2) The absence of adverse effects notified before and after the 8 cases,
supported the perception by the vaccinators of an unexpected cluster.
(3) Finally, the vaccinators had insufficient knowledge of Hexavac
reactogenity.
The label instructions in Italian of the Hexavac vaccine had the heading
“side effects” divided into the subheadings “data of pharmacosurveillance
from pre-registration studies” and “data of pharmacosurveillance
post-registration”.
In the first subheading, the most frequently reported events (redness,
induration/swelling, and fever <38 °C, etc…) are indicated without
percentage values. Moreover, “most frequently” has a relative and not
absolute meaning (for example, it could mean <1% or <0.1% or other). We
know that many of these mild reactions affect almost half of the
vaccinated children. The less frequently reported events (fever >40 °C,
induration/swelling >7 cm, inconsolable crying, sensitivity at the
injection site) give more reassuring percentages only for fever >40 °C and
for induration/swelling >7 cm (both <1%).
In the second subheading “data of pharmacosurveillance post-registration”
three types of effects are reported: frequent (between 1/100 and 1/10),
for oedema, itching and urticaria; rare (between 1/10000 and 1/1000), for
unusual/inconsolable crying; very rare (<1/10000), for a longer list of
symptoms.
These statements raise the following considerations.
(I) The percentages for the most frequent adverse effects, although mild,
have been omitted.
(II) For fever and erythema very low percentages are reported because
these percentages refer only to the most severe reactions (>40 °C and >7
cm.). This information is misleading and does not reflect the real
frequency of these reactions.
(III) Percentage values are emphasised in bold type in the “data of
pharmacosurveillance post-registration”, but it is well-known that
post-registration data largely underestimate the actual frequency of
adverse events, e.g. unusual crying is reported between 0.1 and 0.01%,
while its real frequency reaches even 40.7% [2].
Medline and Internet research yielded the following results [2], [3] and
[4]: at least one local reaction can affect 36.1% of vaccinated children,
mainly redness and induration/swelling. At least one systemic reaction can
affect 45.7% of vaccinated children, and mostly involves fever,
irritability/unusual crying and drowsiness. On these grounds, the
epidemiologists established that the type and frequency of adverse effects
notified by the DS 102 did not exceed those expected. If the data on the
adverse effects had been taken only from the instruction label the same
conclusions would not have been reached.
The instruction label of Hexavac vaccine shows a minimisation of the high
frequency of the most common, albeit mild, adverse reactions, and presents
more reassuring information by emphasising the post-registration data.
Only a careful reading by expert operators or epidemiologists can afford
correct information, which is, in any case, incomplete.
These considerations regarding the instruction label pose the question of
whether it should furnish general indications, or exhaustive operative
information for the operators of vaccination units. Assuming the latter to
be true, the Italian label instructions of Hexavac vaccine can be
considered inadequate. 
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Carlo Fusco
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