3 gennaio 2021

Vaccino Covid ► Le contraddizioni AIFA-Pfizer su fertilità, gravidanza e allattamento

Si è discusso molto in questi mesi sui tempi record in cui sono stati realizzati e approvati i primi vaccini per il Covid-19.
Molti esperti del settore avevano sottolineato all’inizio della diffusione del virus che sarebbero stati necessari almeno due anni per avere un vaccino contro il nuovo virus.
Queste previsioni sono state polverizzate con la realizzazione di molti vaccini in appena un anno.
Ci si chiede dunque se il periodo impiegato sia stato sufficiente per effettuare tutti i test necessari ad assicurare la distribuzione di un prodotto sicuro.
Il dibattito pubblico è molto acceso su questo tema: la sperimentazione del vaccino è stata troppo breve?Mentre ci si interroga su questo tema, la vaccinazione è già iniziata.

Il primo paese ad aver dato il via alla vaccinazione della popolazione è stato il Regno Unito, il giorno 8 dicembre. A partire dal 27 dicembre anche l’Italia ha iniziato la somministrazione.

Il vaccino scelto è stato il BNT162b2, sviluppato da Pfizer/BioNTech. Si tratta di un vaccino a RNA o vaccino a mRNA, cioè di un nuovo tipo di vaccino che agisce inserendo frammenti di mRNA nelle cellule umane. Queste vengono così indotte a produrre antigeni di organismi patogeni che poi stimolano una risposta immunitaria adattativa.

Sul sito governativo del Regno Unito www.gov.uk sono stati pubblicati i documenti relativi all’approvazione normativa di questo vaccino Pfizer/BioNTech per il Covid-19, nominato come BNT162b2.

La pagina web dedicata titola così: “Informazioni per gli operatori sanitari e il pubblico sul vaccino Pfizer/BioNTech”. All’interno del file PDF è presente vario materiale informativo sul vaccino. Ad aver attirato l’attenzione è stato in particolare il documento chiamato “Information for healthcare professional on Pfizer BioNTech Covid-19 vaccine”. Tradotto: “Informazioni per gli operatori sanitari sul vaccino Pfizer BioNTech Covid-19”

Qui sono indicate le informazioni basilari del vaccino BNT162b2, con specifiche tecniche, modalità d’uso ed eventuali controindicazioni ed effetti collaterali.
Molti dubbi li ha posti il punto 4.6 dove vengono affrontati i temi della gravidanza, della fertilità e dell’allattamento.

In particolare, nel documento si legge che: “I dati sull’uso del vaccino mRNA COVID-19 BNT162b2 non esistono o sono limitati. Gli studi di tossicità riproduttiva sugli animali non sono stati completati”.
Quindi il documento prosegue precisando che:
“Il vaccino mRNA COVID-19 BNT162b2 non è raccomandato durante la gravidanza. Per le donne in età fertile, la gravidanza deve essere esclusa prima della vaccinazione. Inoltre, alle donne in età fertile deve essere consigliato di evitare la gravidanza per almeno 2 mesi dopo la seconda dose”.
Il documento sul sito del governo, inoltre, specifica che “non è noto se il vaccino COVID-19 mRNA BNT162b2 sia escreto nel latte umano“. Per questa ragione “i rischi per i neonati/bambini non possono essere esclusi“, quindi viene sconsigliato l’uso durante l’allattamento.

A lasciare le maggiori perplessità è però l’ultima frase del punto 4.6 che così recita: “Non è noto se il vaccino COVID-19 mRNA BNT162b2 abbia un impatto sulla fertilità“.

Il vaccino in Italia

Da quando è iniziata la somministrazione anche in Italia, sono disponibili informazioni e risposte alle domande frequenti sui canali ufficiali del Governo italiano.

Il sito aifa.gov.it affronta la questione dell’uso del vaccino sulle donne in gravidanza o che stanno allattando.

La risposta ci appare subito in contraddizione con quanto riportato dal sito inglese, perché recita: “Il vaccino non è controindicato e non esclude le donne in gravidanza dalla vaccinazione

Sebbene, dunque, “i dati sull’uso del vaccino durante la gravidanza sono tuttora molto limitati” il Governo italiano sembra quasi invitare alla somministrazione in quanto “la gravidanza potrebbe rendere maggiormente a rischio di COVID-19 grave“.

E per quanto riguarda l’allattamento? “Sebbene non ci siano studi sull’allattamento al seno – si legge su aifa.gov.it – sulla base della plausibilità biologica non è previsto alcun rischio che impedisca di continuare l’allattamento al seno”.

Italia contro Regno Unito: stesso vaccino, indicazioni diverse. Com’è possibile?

Ma non finisce qui. La nota informativa che viene consegnata in Italia a chi si sottopone alla vaccinazione, riporta al punto 4 questa dicitura: “Il vaccino non può essere somministrato alle donne in gravidanza e in fase di allattamento”.

Di chi fidarsi? Della nota informativa o del sito ufficiale dell’Agenzia Italiana del Farmaco?

A chiusura della stessa nota informativa poi la frase che desta maggiori perplessità. Circa il vaccino “non è possibile al momento prevedere danni a lunga distanza”.

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