Vaccino Pfizer 12-15 anni – Vaccini Pfizer dai 12 ai 15 anni per l’immunizzazione dal coronavirus, arriva il via libera dell’Ema. Le dosi saranno due, con seconda dose somministrata a distanza di 21 giorni dalla prima. “La risposta del vaccino nei 12-15enni è come quella degli adulti o migliore”, spiega l’ente.
La notizia della raccomandazione del comitato Chmp dell’organismo è stata comunicata oggi durante il briefing da Marco Cavaleri, responsabile Vaccini e Prodotti terapeutici per Covid-19 dell’Agenzia europea del farmaco Ema. Si tratta del primo vaccino Covid approvato per bambini e ragazzi di questa fascia d’età nell’Ue.
L’uso del vaccino Comirnaty nei bambini di età compresa tra 12 e 15 anni sarà lo stesso delle persone di età pari o superiore a 16 anni, per cui è già autorizzato. Viene somministrato in due dosi, a distanza di tre settimane.
“Abbiamo dati che mostrano che mostrano che il vaccino” anti-Covid di Pfizer/BioNTech “è sicuro anche nell’età 12-15 anni e che dimostrano che la risposta immunitaria in questo gruppo è simile o anche migliore di quella che vediamo nei giovani adulti”, ha detto Cavaleri. Guardando ai dati dei trial emerge che “il vaccino è altamente efficace nel proteggere e prevenire la malattia” in questa fascia d’età, ha aggiunto Cavaleri.
Lo studio ha dimostrato che la risposta immunitaria a Comirnaty in questo gruppo era paragonabile alla risposta immunitaria nella fascia di età compresa tra 16 e 25 anni (misurata dal livello di anticorpi contro Sars-CoV-2). L’efficacia di Comirnaty è stata calcolata in quasi 2.000 ragazzi di età compresa tra 12 e 15 anni che non presentavano segni di infezione precedente. Questi hanno ricevuto il vaccino o un placebo. Dei 1.005 soggetti che hanno ricevuto il vaccino, nessuno ha sviluppato Covid-19 rispetto a 16 giovanissimi su 978 che hanno ricevuto l’iniezione fittizia. Ciò significa che, in questo studio, il vaccino è stato efficace al 100% nel prevenire il Covid-19 (sebbene il tasso reale potrebbe essere compreso tra il 75% e il 100%).
Vaccino Pfizer 12-15 anni, via libera Ema
“La raccomandazione del Chmp sarà ora trasmessa alla Commissione europea” e, ha chiarito Cavaleri, “spetta a ogni singolo Stato decidere se e quando usare questo vaccino negli adolescenti in futuro. Estendere la protezione del vaccino anche nelle popolazioni più giovani è un passo importante nella lotta alla pandemia. E riconosciamo questo risultato”, ha aggiunto ribadendo l’elevata efficacia osservata nel trial condotto in questa fascia d’età. Quanto alla sicurezza, Cavaleri ha assicurato monitoraggio continuo. “Gli effetti indesiderati più comuni nei bambini di età compresa tra 12 e 15 anni sono simili a quelli nelle persone di età pari o superiore a 16 anni”. Includono dolore al sito di iniezione, stanchezza, mal di testa, dolori muscolari e articolari, brividi e febbre.
Questi effetti sono generalmente lievi o moderati e migliorano entro pochi giorni dalla vaccinazione, spiega l’Ema. Gli effetti del vaccino sono stati studiati in 2.260 bambini di età compresa tra 12 e 15 anni. Analizzando i dati, il Chmp ha concluso che i benefici di Comirnaty in questa fascia di età superano i rischi. E ha osservato che, a causa del numero limitato di bambini inclusi nello studio, lo studio non avrebbe potuto rilevare effetti collaterali rari, viene precisato.
Il comitato per la sicurezza dell’Ema Prac sta attualmente valutando casi molto rari di miocardite (infiammazione del muscolo cardiaco) e pericardite (infiammazione della membrana intorno al cuore) che si sono verificati dopo la vaccinazione con Comirnaty, principalmente in persone di età inferiore a 30 anni. “Attualmente – spiega l’agenzia in una nota – non vi è alcuna indicazione che questi casi siano dovuti al vaccino e l’Ema sta monitorando attentamente questo problema”.
Nonostante questa incertezza, il Chmp ha ritenuto che i benefici di Comirnaty nei bambini di età compresa tra 12 e 15 anni siano superiori ai rischi, in particolare nei bambini con condizioni che aumentano il rischio di Covid grave. La sicurezza e l’efficacia del vaccino sia nei bambini che negli adulti continueranno a essere monitorate attentamente poiché viene utilizzato nelle campagne di vaccinazione negli Stati membri, attraverso il sistema di farmacovigilanza dell’Ue e gli studi in corso e aggiuntivi da parte dell’azienda e delle autorità europee.
SPERANZA
“Una buona notizia. L’Ema, l’Agenzia europea per i medicinali ha appena autorizzato l’utilizzo del vaccino Pfizer dai 12 anni di età. Ora sarà possibile estendere la campagna di vaccinazione anche ai più giovani. È una novità importante, pensando anche alla riapertura delle scuole a settembre”. E’ il commento del ministro della Salute Roberto Speranza.
“Se continuiamo ad avere cautela, con il quadro epidemiologico che mostra segnali incoraggianti, possiamo guardare al futuro con più fiducia”, conclude il ministro.
REZZA
“Noi in questo momento siamo relativamente ottimisti, perché sicuramente la situazione epidemiologica sta migliorando. Abbiamo di fronte la stagione estiva, sebbene con virus nuovi non si possano fare previsione, abbiamo l’esempio di quello che è accaduto lo scorso anno. Se dopo che abbiamo messo in sicurezza anziani e fragili, si vaccinano i giovani daremo botta maggiore a questa epidemia”, le parole di Gianni Rezza, direttore generale della Prevenzione del ministero della Salute.
“E’ chiaro che possiamo affrontare l’autunno in una situazione, teorica, che dovrebbe essere migliore dello scorso anno perché abbiamo 10 milioni di persone che sono guarite e quindi hanno sviluppato l’immunità e tanta parte della popolazione vaccinata”.
![speranza-parla-aula](https://www.ultimenotiziedalmondo.com/wp-content/uploads/2020/10/speranza-parla-aula.jpg)
fonte: adnkronos.com
[…] 12-15enni “in questo momento non sono la categoria prioritaria, ma anche in questa fascia d’età […]
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