2 novembre 2023

FDA concede l'autorizzazione d'emergenza al vaccino Novavax COVID aggiornato, ma restano preoccupazioni

L'iniezione Novavax che si basa su un nuovo coadiuvante nanoparticolato chiamato Matrix-M, presenta problemi di sicurezza ed è largamente inefficace.

La Food & Drug Administration (FDA) degli Stati Uniti ha concesso l'autorizzazione all'uso di emergenza (EUA) per il vaccino Novavax COVID-19 aggiornato nei soggetti di età pari o superiore a 12 anni.

Secondo l'autorizzazione, coloro che hanno già ricevuto l'iniezione COVID possono ricevere una dose, mentre i non vaccinati possono prenderne due. L'FDA sostiene che il vaccino aggiornato "affronta le varianti attualmente in circolazione".

Il vaccino Novavax si basa su un nuovo coadiuvante nanoparticolato chiamato Matrix-M, rispetto alla base di mRNA dei vaccini di Pfizer e Moderna, e presenta una tecnologia di nanoparticelle a base di cellule di falena e polisorbato 80.

All'inizio del lancio dei vaccini COVID-19, che sono stati sviluppati e revisionati in una frazione del tempo normalmente necessario per i vaccini nell'ambito dell'iniziativa Operation Warp Speed dell'ex presidente Donald Trump, alcuni critici di questi vaccini hanno espresso un cauto ottimismo sul potenziale di Novavax come alternativa più sicura, più efficace e più etica, più efficace e più etica rispetto ai vaccini di Pfizer, Moderna e Johnson & Johnson, che hanno dato risultati molto meno efficaci di quanto promesso, sono stati collegati a diversi gravi problemi di salute e presentano sfide morali, dato il uso di cellule da bambini abortiti nel loro sviluppo e/o test.


Tuttavia, anche Novavax presenta motivi di preoccupazione. L'anno scorso, uno studio globale su oltre 39.000 destinatari di diversi vaccini COVID, tra cui il Novavax, ha rilevato che il 56% delle partecipanti di sesso femminile ha subito alterazioni del ciclo mestruale e l'Autorità Sanitaria Pubblica svedese ha raccomandato di non somministrare il vaccino ai giovani di età inferiore ai 30 anni per il timore che, come le sue controparti mRNA, possa causare un aumento del rischio di miocardite. Il costante disinteresse del governo federale nell'indagare a fondo sui problemi dei vaccini precedenti, anche quando cerca di imporli al pubblico, solleva seri dubbi sul rigore del controllo di Novavax.

Inoltre, secondo una panoramica dettagliata di tutti i candidati vaccini dell'Istituto pro-vita Charlotte Lozier, le cellule contaminate feti abortiti non sono state utilizzate per creare i vaccini Novavax, ma sono state usate in alcuni dei loro test di laboratorio.

L'11 ottobre, il cardiologo e critico dell'establishment COVID Peter McCullough ha scritto che l'efficacia del Novavax rimane "inaccettabilmente bassa" alla luce di uno studio su 20.903 riceventi che ha riportato che l'efficacia contro "le infezioni da SARS-CoV notificate in coloro che hanno ricevuto una vaccinazione parziale... è stata del 23%... aumentando dopo la vaccinazione completa al 31%", mentre l'efficacia contro le infezioni sintomatiche è stata del 31% per la vaccinazione parziale e del 50% per quella completa.

"Se un vaccino non è in grado di fornire in modo sicuro almeno il 50% di protezione per un anno, non è praticabile nella mia pratica clinica. Purtroppo Novavax ha fallito in entrambi i casi", ha scritto McCullough. "Con Omicron a basso rischio e una probabile immunità naturale sostanziale entro l'autunno del 2022, solo 26 infezioni hanno portato all'ospedalizzazione durante il periodo di studio; 1 si è verificata durante il periodo di riferimento, 7 durante la vaccinazione parziale e 18 dopo la vaccinazione completa. Non sono stati segnalati decessi".

Al contrario, più di 160 studi hanno rilevato che l'immunità naturale derivante da una precedente infezione da COVID è "uguale o più robusta e superiore ai vaccini esistenti", secondo il Brownstone Institute, un'organizzazione no-profit organizzata in risposta alle politiche di blocco del COVID.

Novavax ha ricevuto più di 90 milioni di dollari dalla Bill & Melinda Gates Foundation per lo sviluppo del vaccino e ha ottenuto quasi 400 milioni di dollari dalla Coalition for Epidemic Preparedness and Innovation, fondata da Gates, per sviluppare e produrre il vaccino COVID-19.  

Negli ultimi mesi, alcune scuole, ospedali e aziende hanno ripreso l'obbligo della maschera, citando l'aumento dei casi di nuove varianti di COVID contro le quali il governo ammette che i vaccini attuali potrebbero essere inefficaci. La notizia ha suscitato speculazioni sull'imminente ritorno a un più ampio blocco delle vaccinazioni. 

Il presidente Joe Biden ha annunciato che sta cercando di ottenere finanziamenti dal Congresso per sviluppare nuovi vaccini COVID per queste varianti, facendo temere nuovi mandati, uno sviluppo altrettanto affrettato e l'eventualità che abbiano problemi simili a quelli dei vaccini sviluppati sotto il suo predecessore.


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