EU-kommissionen godkänner Fluenz Tetra för förebyggande av säsongsinfluensa hos barn

fredag, 6 december 2013

Det första och enda tillgängliga nässpray-vaccinet i Europa som är aktivt mot fyra influensastammar

AstraZeneca meddelar i dag att EU-kommissionen har beviljat marknadsgodkännande för FluenzTM Tetra. Fluenz Tetra är ett vaccin i form av nässpray som innehåller fyra levande försvagade influensastammar, för förebyggande av säsongsinfluensa hos barn och tonåringar från 24 månader upp till 18 år. EU-kommissionens godkännande gör Fluenz Tetra till det första och enda tillgängliga nässpray-vaccinet i Europa som är aktivt mot fyra influensastammar.

Historiskt sett har vaccin mot säsongsinfluensa innehållit tre influensastammar: två influensastammar typ A (H1N1 och H3N2) och en influensastam typ B. Fluenz Tetra innehåller ytterligare en influensastam typ B. Det senaste decenniet har influensa typ B svarat för närmare 25 procent av influensastammarna i Europa.

– Fluenz Tetra representerar nästa generations influensavaccin och vi är mycket glada att det nu är godkänt i Europa. Genom tillägget av en andra influensa typ B stam breddas skyddet som Fluenz Tetra ger, vilket bör ha en värdefull inverkan på folkhälsan, säger Filip Dubovsky, Vice President of Clinical Biologics Infectious Disease and Vaccines hos MedImmune, AstraZenecas globala forsknings- och utvecklingsbolag av biologiska läkemedel.

Marknadsgodkännandet för Fluenz Tetra baseras på data från en studie utförd på barn. Resultaten visade att Fluenz Tetra har en säkerhets- och immunogenicitetsprofil som var jämförbar med Fluenz™, ett levande försvagat influensavaccin baserat på tre stammar (trivalent) som redan är godkänt i Europa.

EU-kommissionens beslut följer ett positivt utlåtande från CHMP, den vetenskapliga kommittén för humanläkemedel, från den 19 september 2013 och omfattar samtliga 28 medlemsländer i EU och de tre länderna i EES.

NOTES TO EDITORS

About Influenza

Influenza is the most common vaccine-preventable disease in the developed world. In Europe and throughout the world, influenza creates a significant medical and economic burden. According to World Health Organization (WHO) estimates, seasonal influenza results in three to five million cases of severe illness and up to half a million deaths globally each year. Rates of infection are highest among children, and school-aged children are recognised as the main transmitters of the flu virus. Vaccinating children can lower the overall burden of influenza. This is achieved through direct protection of the child and through indirect effects that are a result of decreased transmission of the virus from children to others in the community, often referred to as herd immunity.

About Fluenz Tetra

Fluenz Tetra is formulated to contain four live attenuated influenza virus strains that are weakened so as to not cause illness.The vaccine is administered by spraying into each nostril where it induces protective immunity. The most common adverse reactions for Fluenz Tetra include runny nose or nasal congestion.

Fluenz Tetra will replace the Fluenz™ three-strain (trivalent) live attenuated influenza vaccine from the 2014-2015 flu season onwards.

In the US, Fluenz Tetra is marketed by MedImmune Specialty Care Division of AstraZeneca, under the trade name FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal). FluMist Quadrivalent was approved by the US Food and Drug Administration (FDA) on February 29 2012.

About Tetravalent Influenza Vaccines

Vaccine strains are recommended annually by the World Health Organization (WHO) based on anticipated circulating influenza strains for the upcoming season. Historically, seasonal flu vaccines have been trivalent formulations, meaning they contain three strains of influenza: one influenza A (H1N1) virus, one influenza A (H3N2) virus, and one influenza B virus. However, new tetravalent (also referred to as quadrivalent) flu vaccines contain two strains of influenza A and two strains of influenza B to provide broad protection against influenza B.

Since 2001, influenza B strains from two different lineages (B/Yamagata and B/Victoria) have co-circulated each influenza season in Europe. Trivalent vaccine formulations rely on predictions of which influenza B strains will be dominant in the upcoming season. However, B strain circulation has been difficult to predict correctly, and in the last decade, the vaccine B strain only matched the dominant circulating B strain about every other year.

About MedImmune

MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers. For more information please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com.

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  • Infektion