Ich stimme der Verwendung von Cookies zu. Auch wenn ich diese Website weiter nutze, gilt dies als Zustimmung.

Bitte lesen und akzeptieren Sie die Datenschutzinformation und Cookie-Informationen, damit Sie unser Angebot weiter nutzen können. Natürlich können Sie diese Einwilligung jederzeit widerrufen.





Inbox: Valneva: OK von der EU-Kommission für mind. 60 Mio. Dosen vom Covid-Impfstoff VLA2001 ist da


Saint-Herblain (France), November 10, 2021Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (“EC”) has approved an agreement pursuant to which Valneva would supply up to 60 million doses of VLA2001, its inactivated COVID-19 vaccine candidate, over two years including approximately 27 million doses in 2022.

Under the current terms of the agreement, the EC has the option to increase its initial purchase, in 2022, of VLA2001 up to a total of 60 million doses by the end of 2023. The agreement will be completed following final review, including volumes required, by each of the European Union Member States. Today’s announcement follows the conclusion of advanced exploratory talks with the European Commission that began in January 2021. Delivery of the vaccine is currently expected to begin in April 2022, subject to approval by the European Medicines Agency (EMA) human medicines committee (CHMP), which is expected to start a rolling review of VLA2001 shortly.

Thomas Lingelbach, Chief Executive Officer of Valneva, said, “We are grateful to the European Commission for its support and are eager to help address the ongoing pandemic. We continue to receive messages from people across the world who are waiting for an inactivated vaccine. We are deeply committed to bringing an alternative vaccine solution to the market as quickly as possible and continue to work tirelessly to achieve that. Our Phase 3 results confirmed the advantages often associated with inactivated vaccines and we continue to believe that our differentiated vaccine candidate could make an important contribution to the global fight against the COVID-19 pandemic.”

Franck Grimaud, Chief Business Officer of Valneva, commented, “I would like to express my thanks to the respective teams in the EC and across Valneva who have worked assiduously on this agreement. We are looking forward to completing the agreement and getting the rolling review with EMA underway. Our recent Phase 3 data have allowed us to showcase the value of VLA2001 and we believe that other supply deals could follow this one.”

Valneva reported positive Phase 3 results for VLA2001 in October 2021[1]. VLA2001 demonstrated superiority in terms of neutralizing antibody titer levels against the active comparator vaccine, AstraZeneca’s AZD1222, as well as non-inferiority in terms of seroconversion rates and a significantly better tolerability profile.

About VLA2001

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B®  vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

About Valneva SE

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.


Valneva startet an der Nasdaq, Fotoquelle: Screenshot von Nasdaq.com © Aussender


Aktien auf dem Radar:Strabag, Rosenbauer, EVN, Warimpex, FACC, Immofinanz, voestalpine, CA Immo, Bawag, Erste Group, Semperit, BTV AG, Josef Manner & Comp. AG, Polytec Group, SBO, UBM, Wiener Privatbank, Oberbank AG Stamm, Zumtobel, Verbund, S Immo, Cisco, Porsche Automobil Holding, Qiagen, Fresenius Medical Care, Allianz, Deutsche Boerse, Delivery Hero, Deutsche Post, Fresenius, Zalando.

(BSN-Hinweis: Lauftext im Original des Aussenders, Titel (immer) und Bebilderung (oft) durch boerse-social.com aus dem Fotoarchiv von photaq.com)

Random Partner #goboersewien

Palfinger
Palfinger zählt zu den international führenden Herstellern innovativer Hebe-Lösungen, die auf Nutzfahrzeugen und im maritimen Bereich zum Einsatz kommen. Der Konzern verfügt über 5.000 Vertriebs- und Servicestützpunkte in über 130 Ländern in Europa, Nord- und Südamerika sowie Asien.

>> Besuchen Sie 61 weitere Partner auf boerse-social.com/goboersewien


Meistgelesen
>> mehr





PIR-Zeichnungsprodukte
AT0000A2QDR0
AT0000A2X950
AT0000A2CP51
Newsflow
>> mehr

Börse Social Club Board
>> mehr
    Star der Stunde: SBO 4.43%, Rutsch der Stunde: Mayr-Melnhof -0.75%
    wikifolio-Trades Austro-Aktien 15-16: SBO(2), AT&S(1)
    Österreich-Depots: Schnelle Gewinnmitnahme beim Verbund (Depot Kommentar)
    Star der Stunde: SBO 1.44%, Rutsch der Stunde: Erste Group -1%
    wikifolio-Trades Austro-Aktien 14-15: Bawag(1), AT&S(1)
    Star der Stunde: Rosenbauer 1.16%, Rutsch der Stunde: SBO -2.81%
    wikifolio-Trades Austro-Aktien 13-14: S Immo(2), Pierer Mobility(1), Telekom Austria(1), CA Immo(1), Porr(1), AT&S(1)
    Nachlese: Bernd Spalt, Parkpickerl, Urlaub mit der Wiener Börse, wikifolio hat einen Duft
    Star der Stunde: Marinomed Biotech 3.08%, Rutsch der Stunde: SBO -1.23%

    Featured Partner Video

    Wiener Börse Plausch S2/32: P&G-Booster für Marinomed, AT&S nie höher, SBO verdoppelt, European Lithium gefährlich und ein Spoiler

    Die Wiener Börse Pläusche sind ein Podcastprojekt von Christian Drastil Comm. Unter dem Motto „Market & Me“ berichtet Christian Drastil über das Tagesgeschehen an der...

    Inbox: Valneva: OK von der EU-Kommission für mind. 60 Mio. Dosen vom Covid-Impfstoff VLA2001 ist da


    10.11.2021

    Saint-Herblain (France), November 10, 2021Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (“EC”) has approved an agreement pursuant to which Valneva would supply up to 60 million doses of VLA2001, its inactivated COVID-19 vaccine candidate, over two years including approximately 27 million doses in 2022.

    Under the current terms of the agreement, the EC has the option to increase its initial purchase, in 2022, of VLA2001 up to a total of 60 million doses by the end of 2023. The agreement will be completed following final review, including volumes required, by each of the European Union Member States. Today’s announcement follows the conclusion of advanced exploratory talks with the European Commission that began in January 2021. Delivery of the vaccine is currently expected to begin in April 2022, subject to approval by the European Medicines Agency (EMA) human medicines committee (CHMP), which is expected to start a rolling review of VLA2001 shortly.

    Thomas Lingelbach, Chief Executive Officer of Valneva, said, “We are grateful to the European Commission for its support and are eager to help address the ongoing pandemic. We continue to receive messages from people across the world who are waiting for an inactivated vaccine. We are deeply committed to bringing an alternative vaccine solution to the market as quickly as possible and continue to work tirelessly to achieve that. Our Phase 3 results confirmed the advantages often associated with inactivated vaccines and we continue to believe that our differentiated vaccine candidate could make an important contribution to the global fight against the COVID-19 pandemic.”

    Franck Grimaud, Chief Business Officer of Valneva, commented, “I would like to express my thanks to the respective teams in the EC and across Valneva who have worked assiduously on this agreement. We are looking forward to completing the agreement and getting the rolling review with EMA underway. Our recent Phase 3 data have allowed us to showcase the value of VLA2001 and we believe that other supply deals could follow this one.”

    Valneva reported positive Phase 3 results for VLA2001 in October 2021[1]. VLA2001 demonstrated superiority in terms of neutralizing antibody titer levels against the active comparator vaccine, AstraZeneca’s AZD1222, as well as non-inferiority in terms of seroconversion rates and a significantly better tolerability profile.

    About VLA2001

    VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B®  vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

    About Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.


    Valneva startet an der Nasdaq, Fotoquelle: Screenshot von Nasdaq.com © Aussender




    BSN Podcasts
    Der Podcast für junge Anleger jeden Alters

    Wiener Börse Plausch S2/32: P&G-Booster für Marinomed, AT&S nie höher, SBO verdoppelt, European Lithium gefährlich und ein Spoiler




     

    Bildnachweis

    1. Valneva startet an der Nasdaq, Fotoquelle: Screenshot von Nasdaq.com , (© Aussender)   >> Öffnen auf photaq.com

    Aktien auf dem Radar:Strabag, Rosenbauer, EVN, Warimpex, FACC, Immofinanz, voestalpine, CA Immo, Bawag, Erste Group, Semperit, BTV AG, Josef Manner & Comp. AG, Polytec Group, SBO, UBM, Wiener Privatbank, Oberbank AG Stamm, Zumtobel, Verbund, S Immo, Cisco, Porsche Automobil Holding, Qiagen, Fresenius Medical Care, Allianz, Deutsche Boerse, Delivery Hero, Deutsche Post, Fresenius, Zalando.


    Random Partner

    Palfinger
    Palfinger zählt zu den international führenden Herstellern innovativer Hebe-Lösungen, die auf Nutzfahrzeugen und im maritimen Bereich zum Einsatz kommen. Der Konzern verfügt über 5.000 Vertriebs- und Servicestützpunkte in über 130 Ländern in Europa, Nord- und Südamerika sowie Asien.

    >> Besuchen Sie 61 weitere Partner auf boerse-social.com/partner


    Valneva startet an der Nasdaq, Fotoquelle: Screenshot von Nasdaq.com, (© Aussender)


    Useletter

    Die Useletter "Morning Xpresso" und "Evening Xtrakt" heben sich deutlich von den gängigen Newslettern ab. Beispiele ansehen bzw. kostenfrei anmelden. Wichtige Börse-Infos garantiert.

    Newsletter abonnieren

    Runplugged

    Infos über neue Financial Literacy Audio Files für die Runplugged App
    (kostenfrei downloaden über http://runplugged.com/spreadit)

    per Newsletter erhalten


    Meistgelesen
    >> mehr





    PIR-Zeichnungsprodukte
    AT0000A2QDR0
    AT0000A2X950
    AT0000A2CP51
    Newsflow
    >> mehr

    Börse Social Club Board
    >> mehr
      Star der Stunde: SBO 4.43%, Rutsch der Stunde: Mayr-Melnhof -0.75%
      wikifolio-Trades Austro-Aktien 15-16: SBO(2), AT&S(1)
      Österreich-Depots: Schnelle Gewinnmitnahme beim Verbund (Depot Kommentar)
      Star der Stunde: SBO 1.44%, Rutsch der Stunde: Erste Group -1%
      wikifolio-Trades Austro-Aktien 14-15: Bawag(1), AT&S(1)
      Star der Stunde: Rosenbauer 1.16%, Rutsch der Stunde: SBO -2.81%
      wikifolio-Trades Austro-Aktien 13-14: S Immo(2), Pierer Mobility(1), Telekom Austria(1), CA Immo(1), Porr(1), AT&S(1)
      Nachlese: Bernd Spalt, Parkpickerl, Urlaub mit der Wiener Börse, wikifolio hat einen Duft
      Star der Stunde: Marinomed Biotech 3.08%, Rutsch der Stunde: SBO -1.23%

      Featured Partner Video

      Wiener Börse Plausch S2/32: P&G-Booster für Marinomed, AT&S nie höher, SBO verdoppelt, European Lithium gefährlich und ein Spoiler

      Die Wiener Börse Pläusche sind ein Podcastprojekt von Christian Drastil Comm. Unter dem Motto „Market & Me“ berichtet Christian Drastil über das Tagesgeschehen an der...