
Bavarian Nordics koppevaccine godkendt i Europa til at omfatte abekopper
KØBENHAVN, Danmark, 25. juli 2022 – Bavarian Nordic A/S (OMX: BAVA) meddelte i dag, at Europa-Kommissionen (EF) har udvidet markedsføringstilladelsen for selskabets koppevaccine, IMVANEX®, til også at omfatte beskyttelse mod abekopper og sygdom forårsaget af vacciniavirus. Godkendelsen, der følger efter en positiv udtalelse fra Udvalget for Humanmedicinske Lægemidler (CHMP) den 22. juli 2022, er gyldig i alle EU's medlemsstater samt i Island, Liechtenstein og Norge.
Udvidelsen af markedsføringstilladelsen sker efter en løbende indsendelse af en såkaldt type II-variation application i juni 2022, i overensstemmelse mellem Bavarian Nordic og Det Europæiske Lægemiddelagenturs Emergency Task Force (ETF), rapporteurs og EU’s Myndighed for Kriseberedskab og ‑indsats på Sundhedsområdet (HERA). Kommissionen godkendte den fulde IMVANEX-indikation som: Aktiv immunisering mod kopper, abekopper og sygdom forårsaget af vacciniavirus hos voksne. Godkendelsen af abekopper er et eksempel på et stærkt samarbejde mellem Bavarian Nordic og de europæiske regulatoriske myndigheder, da en sådan udvidelse normalt tager mindst 6-9 måneder at opnå.
Paul Chaplin, administrerende direktør for Bavarian Nordic, udtaler: "Vi er glade for at modtage godkendelsen fra Europa-Kommissionen, der udvider godkendelsen af vores vaccine til også at omfatte abekopper. Tilgængeligheden af en godkendt vaccine kan forbedre landenes beredskab til at bekæmpe nye sygdomme betydeligt, men kun gennem investeringer og struktureret planlægning af det biologiske beredskab. Udviklingen af IMVANEX blev muliggjort gennem betydelige investeringer fra den amerikanske regering i de sidste to årtier, hvilket har vist andre regeringer vejen til at udvikle planer og prioritere for fremtiden for at beskytte deres borgere mod trusler mod folkesundheden. Med denne godkendelse ser vi frem til at arbejde tættere sammen med EU og dens medlemsstater om at løse denne vigtige opgave."
Om IMVANEX®
IMVANEX® (MVA-BN eller Modified Vaccinia Ankara-Bavarian Nordic) er en ikke-replikerende koppevaccine udviklet i samarbejde med den amerikanske regering for at sikre levering af en koppevaccine til hele befolkningen, inklusive immunkompromitterede personer, som ikke anbefales vaccination med traditionelle replikerende koppevacciner. Vaccinen blev godkendt af Europa-Kommissionen i 2013 til immunisering mod kopper hos voksne i alderen 18 år og opefter og har efterfølgende opnået myndighedsgodkendelser i Canada (markedsført under navnet IMVAMUNE® og USA (markedsført under navnet JYNNEOS®, hvor godkendelsen er blevet udvidet til at omfatte indikationen abekopper som den eneste vaccine, der har opnået denne til dato.
Bavarian Nordic har igangværende leveringskontrakter med USA og Canada og har leveret vaccinen til en række ikke-oplyste lande globalt som en del af deres nationale biologiske beredskaber. I de senere år er mindre mængder af vaccinen blevet leveret i forbindelse med sporadiske tilfælde af abekopper. I forbindelse med udbruddet af abekopper i 2022 har Bavarian Nordic samarbejdet med flere regeringer om at imødekomme efterspørgslen på vaccinen gennem en række leveringskontrakter og arbejder desuden på at sikre produktion af yderligere vacciner til at opfylde behovet på den mellemlange til lange bane.
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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