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Bavarian Nordics vaccinefyldefabrik er blevet godkendt af de amerikanske og europæiske myndigheder

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  • Godkendelse af de amerikanske myndigheder sker efter en succesfuld inspektion af det amerikanske lægemiddelagentur, FDA
  • Europæisk godkendelse er opnået efter indsendelse af ansøgning til Det Europæiske Lægemiddelagentur, EMA, i juni 2022

KØBENHAVN, Danmark, 27. juli 2022 – Bavarian Nordic A/S (OMX: BAVA) meddelte i dag, at selskabet har modtaget godkendelser fra de amerikanske og europæiske tilsynsmyndigheder til at fremstille JYNNEOS®/IMVANEX® koppe- og abekoppevaccine på selskabets fyldefabrik i Danmark. Med godkendelserne af færdigvareproduktionen – den proces, hvormed vaccinen formuleres og fyldes i hætteglas – får virksomheden nu lov til at levere vacciner fremstillet på eget anlæg til markederne i USA og EU.

Det amerikanske lægemiddelagentur, U.S. Food and Drug Administration (FDA) gennemførte i begyndelsen af juli 2022 en fremskyndet inspektion af fabrikken. Inspektionen omfattede færdigvareproduktionen af JYNNEOS®, som tidligere blev udført hos en kontraktproducent. Inspektionen blev afsluttet med succes og uden nogen observationer, hvilket nu har ført til godkendelsen af Bavarian Nordic som ny lægemiddelproducent af JYNNEOS.

Godkendelsen fra Det Europæiske Lægemiddelagentur (EMA) blev givet efter behandling i Udvalget for Humanmedicinske Lægemidler (CHMP) af en såkaldt type II-variation-ansøgning, indsendt af selskabet i juni 2022. I lighed med FDA-godkendelsen anerkender godkendelsen fra EMA Bavarian Nordic som den nye lægemiddelproducent af IMVANEX-vaccinen, i tillæg til den inspektion og tilhørende godkendelse, som tidligere er givet af de danske myndigheder ved Lægemiddelstyrelsen.

De fremskyndede godkendelser er blevet muliggjort via et tæt samarbejde mellem Bavarian Nordic og de regulatoriske myndigheder om datapakken og indsendelsesstrategien, og markerer det sidste skridt for selskabet i at opfylde strategien om at blive en best-in-class vaccineproducent, der kontrollerer hele værdikæden fra fremstilling, påfyldning, pakning og frigivelse til distribution af vacciner.

Paul Chaplin, administrerende direktør for Bavarian Nordic, udtaler: "Vi er stolte over at kunne annoncere en succesfuld inspektion og efterfølgende godkendelse af FDA af vores topmoderne fyldefabrik sammen med godkendelsen fra EMA. Godkendelserne, som understreger kvaliteten af vores vaccinefabrik, skal i høj grad tilskrives det store engagement fra vores dedikerede og dygtige medarbejdere. Vi er taknemmelige over for både FDA og EMA for at fremskynde deres arbejde under det igangværende udbrud af abekopper, som Verdenssundhedsorganisationen nu har udråbt til en global sundhedskrise, og vi ser frem til at fortsætte vores arbejde med sundhedsmyndigheder over hele kloden for at sikre forsyningen af vacciner mod abekopper.”

Om Bavarian Nordic
Bavarian Nordic er et fuldt integreret vaccineselskab, der er fokuseret på udvikling, produktion og kommercialisering af livsvigtige vacciner. Vi er globalt førende inden for koppevacciner, og er mangeårig leverandør til den amerikanske regering af en ikke-replikerende koppevaccine, som er godkendt af de amerikanske sundhedsmyndigheder, også til beskyttelse mod abekopper. Vaccinen er desuden godkendt som koppevaccine i Europa og Canada. Vores kommercielle produktportefølje består endvidere af markedsledende vacciner mod rabies og flåtbåren hjernebetændelse. Med udgangspunkt i vores virale vaccineplatform, MVA-BN®, har vi udviklet en bred portefølje af produktkandidater, der sigter mod at forbedre og beskytte liv ved at frigøre immunsystemets egne kræfter. Blandt andet har vi udviklet en ebolavaccine, der er licenseret til Janssen Pharmaceutical Companies of Johnson & Johnson. Vi er desuden engageret i udviklingen af en næstegenerations COVID-19 vaccine. For yderligere information besøg www.bavarian-nordic.com.

Kontakt
Rolf Sass Sørensen, Vice President Investor Relations, Tlf. +45 61 77 47 43

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