Η AstraZeneca Plc δήλωσε την Τρίτη ότι «βάζει στον πάγο» τις δοκιμές του εμβολίου για τον κορωνοϊό παγκοσμίως, συμπεριλαμβανομένων και των τελικών δοκιμών Φάσης ΙΙΙ, εξαιτίας μιας ανεξήγητης ασθένειας σε έναν συμμετέχοντα στην έρευνα.
Το εμβόλιο, που αναπτύχθηκε σε συνεργασία με το Πανεπιστήμιο της Οξφόρδης, θεωρείται ευρέως ένα από τα κορυφαία παγκοσμίως υποψήφια εμβόλια κατά του κορωνοϊού και η αναστολή της δοκιμής μειώνει τις προοπτικές για πιθανή διάθεσή του στο τέλος του έτους.
Η AstraZeneca είπε ότι σταμάτησε εθελοντικά τις δοκιμές για να επιτρέψει την επανεξέταση των δεδομένων ασφαλείας από μια ανεξάρτητη επιτροπή και εργάζεται για να επισπεύσει τις διαδικασίες και να ελαχιστοποιήσει τυχόν πιθανές επιπτώσεις στο χρονοδιάγραμμα των κλινικών δοκιμών.
«Πρόκειται για μια συγκεκριμένη διαδικασία, που πρέπει να ακολουθηθεί όποτε υπάρχει δυνητικά ανεξήγητη ασθένεια σε μία από τις δοκιμές», ανέφερε η AstraZeneca Plc.
Η φύση της ασθένειας και το πότε συνέβη δεν είναι γνωστά, αν και ο συμμετέχων αναμένεται να αναρρώσει, σύμφωνα με το Stat News, η οποία μετέδωσε πρώτη την είδηση για την αναστολή των δοκιμών λόγω «υποψίας σοβαρής ανεπιθύμητης αντίδρασης».
Η Αμερικανική Υπηρεσία Τροφίμων και Φαρμάκων ορίζει ως ανεπιθύμητο συμβάν ένα γεγονός στο οποίο τα στοιχεία δείχνουν πιθανή σχέση με το φάρμακο που τεστάρεται.
Σύμφωνα με ρεπορτάζ των «New York Times», που επικαλούνται άτομο με γνώση των γεγονότων, πρόκειται για συμμετέχοντα στις κλινικές δοκιμές με έδρα στο Ηνωμένο Βασίλειο, ο οποίος έχει εγκάρσια μυελίτιδα, ένα φλεγμονώδες σύνδρομο που προσβάλλει τον νωτιαίο μυελό και συχνά προκαλείται από ιογενείς λοιμώξεις.
Το εάν η ασθένεια συνδέεται άμεσα με το εμβόλιο της AstraZeneca παραμένει ασαφές. Η AstraZeneca αρνήθηκε να σχολιάσει.
Σύμφωνα με το Stat News, ο ασθενής αναμένεται να αναρρώσει.
Η αναστολή των δοκιμών έχει επηρεάσει και τις άλλες δοκιμές του εμβολίου της AstraZeneca, καθώς και κλινικές δοκιμές που διεξάγονται από άλλους κατασκευαστές εμβολίων, οι οποίοι αναζητούν σημάδια παρόμοιων αντιδράσεων, δήλωσε το Stat.
Τα Εθνικά Ινστιτούτα Υγείας των ΗΠΑ, τα οποία παρέχουν χρηματοδότηση για τη δοκιμή της AstraZeneca, αρνήθηκαν να σχολιάσουν.
Δοκιμές του εμβολίου, που ονομάζεται AZD1222, βρίσκονται σε εξέλιξη σε διάφορα στάδια στη Βρετανία, τις Ηνωμένες Πολιτείες, τη Βραζιλία, τη Νότια Αφρική και την Ινδία. Δοκιμές προγραμματίζονται επίσης στην Ιαπωνία και τη Ρωσία.
Οι μετοχές της AstraZeneca έπεσαν περισσότερο από 8%, ενώ οι μετοχές των ανταγωνιστών με προγράμματα εμβολίων για τον κορωνοϊό αυξήθηκαν. Η Moderna Inc σημείωσε αύξηση άνω του 4% και η Pfizer Inc αυξήθηκε λιγότερο από 1%.
Η Moderna δήλωσε ότι δεν γνώριζε για καμία επίδραση στη συνεχιζόμενη μελέτη της για το εμβόλιο της Covid-19.
Πηγή: iefimerida.gr
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