Valneva Totimpfstoff

  • Guten Morgen zusammen.


    Was meint ihr? Ist der gestrige Rücksetzer evtl. eine Einstiegsmöglichkeit oder sollten wir lieber noch an der Seitenlinie bleiben?



    Quelle: Gesundheit.de vom 13.9.2021

    Corona-Impfstoff von Valneva: So funktioniert der Totimpfstoff
    Totimpfstoffe, auch als inaktivierte Impfstoffe bezeichnet, enthalten abgetötete Krankheitserreger (Viren) oder deren Bestandteile, welche sich nicht mehr vermehren können. Das Prinzip des Totimpfstoffs wird bereits bei anderen Impfungen wie Diphterie, Hepatitis B, Hib (Haemophilus influenzae Typ b), Kinderlähmung, Tetanus oder Keuchhusten verwendet.

    Corona-Totimpfstoff – so geht's: Bei VLA2001 werden Zellkulturen des ursprünglichen Coronavirus (Wuhan Variante) im Labor vermehrt und anschließend inaktiviert. Bei dieser Methode bleibt das Eiweiß des Virus intakt, das Coronavirus selbst kann sich allerdings nicht vermehren oder Zellen infizieren.

    Der Körper erkennt die Krankheitserreger als fremd. Das Immunsystem reagiert und beginnt, Antikörper und Helferzellen zu produzieren, ohne dass die jeweilige Krankheit ausbricht. Hat eine geimpfte Person später Kontakt zu SARS-CoV-2 bemerkt der Körper das Virus und beginnt sofort, dieses zu bekämpfen.

    Die abgetöteten Viren werden zudem mit zwei Adjuvanzien (Impfstoffverstärkern) kombiniert:

    Alum: Das Adjuvans basiert auf Aluminium und regt die Immunantwort des Impfstoffs an.
    CpG 1018: Es handelt sich hierbei um Eiweiß, das bereits in einem Hepatitis-B-Impfstoff verwendet wird. CpG 1018 regt besonders die Immunantwort der T-Zellen an. T-Zellen erkennen den Fremdkörper und schlagen Alarm. Zudem erkennen sie bereits infizierte Zellen und töten diese.
    Vorteile des Corona-Totimpfstoffs von Valneva
    Bei den bisherigen Corona-Impfstoffen liegt der Fokus auf dem Spike-Protein des Virus. Dieses ist für das Andocken des Erregers an den menschlichen Zellen verantwortlich und wird im Rahmen der Impfung vom Körper reproduziert, damit Antikörper und Helferzellen gebildet werden.

    Der Vorteil des Totimpfstoffes ist hierbei, dass das Immunsystem auf das gesamte Virus reagieren und somit auch eine Immunantwort beispielsweise gegen die Virushülle entwickeln kann. Der Totimpfstoff könnte deshalb bei Virusvarianten eine höhere Wirksamkeit erzielen.

    Ein weiterer Vorteil liegt in Transport und Lagerung der Totimpfstoffe – das Vakzin kann bei Kühlschranktemperaturen mehrere Jahre lang gelagert werden.

    Valneva-Impfstoff: Mögliche Booster-Impfung
    Der Impfstoffhersteller plant bereits mit einem Zulassungsantrag in Europa im Frühling 2022. Das Vakzin könnte in diesem Zusammenhang besonders als Booster-Impfung eingesetzt werden. Studien zeigen bisher eine gute Immunreaktion. Über die genaue Wirksamkeit des Vakzins ist bisher nichts bekannt.

    Großbritannien unterstützt Studien, die die Wirksamkeit unterschiedlicher Vakzine als Drittimpfung untersuchen. Auch in Neuseeland soll in Zukunft der Totimpfstoff und dessen Wirkung bei Virusvarianten überprüft werden.

    Quellen
    Aktualisiert: 13.09.2021 - Autor: Alexandra Maul, News-Redakteurin


    Ausserdem finde ich den heutigen Artikel und die offizielle Mitteilung von Valneva auch interessant:


    Für risikobereite Anleger: Valneva-Aktie: Impfspezialist als Hoffnungsträger im Börsenhype | Nachricht | finanzen.net


    Valneva Completes Recruitment of Elderly Participants in Phase 3 Trial of its Inactivated COVID-19 Vaccine – Valneva

    NO INVESTMENT ADVICE. My comments do not offer any investment advice and you should not construe them as advice.

  • Valneva holt sich frisches Kapital

    Valneva möchte 5.500.000 Stammaktien im Rahmen eines globalen Angebots ausgeben. Das Angebot betsteht aus einem öffentlichen Angebot von American Depositary Shares („ADSs“), die jeweils zwei Stammaktien repräsentieren, in den Vereinigten Staaten, zudem aus einer Privatplatzierung der Stammaktien außerhalb der Vereinigten Staaten. Das globale Angebot beginnt sofort, so das Unternehmen. Eingesetzt wird das Kapital für die Entwicklung von Impfstoffkandidaten: 50 Mio. US-Dollar zur Finanzierung der weiteren Entwicklung des Lyme-VLA15-Impfstoffkandidaten durch Abschluss der klinischen Phase-2-Studien, einschließlich der Übergabe an Pfizer. Ungefähr 60 Mio. US-Dollar für den Abschluss der Entwicklung des Chikungunya-Impfstoffkandidaten VLA1553 durch die BLA-Zulassung; Ungefähr 100 Mio. US-Dollar zur Finanzierung der weiteren Entwicklung des COVID-19-Impfstoffkandidaten VLA2001 durch bedingte Lizenzierung und kommerzielle Markteinführung, einschließlich Investitionen in Produktionsanlagen. Weitere ca. 20 Mio. US-Dollar zur Finanzierung der Weiterentwicklung präklinischer Impfstoffkandidaten in Richtung der klinischen Entwicklung; und der etwaige Rest für Betriebskapital und allgemeine Unternehmenszwecke.


    Goldman Sachs, Jefferies, Guggenheim Securities und Bryan, Garnier & Co. fungieren als gemeinsame Bookrunner für das Global Offering. Das Unternehmen beabsichtigt, den Konsortialbanken für das Globale Angebot eine 30-tägige Option zum Kauf zusätzlicher ADS (jeweils für zwei Stammaktien) in einem Gesamtbetrag von bis zu 15 Prozent der Gesamtzahl der Stammaktien, die im Rahmen des globalen Angebots verkauft werden sollen. Alle im Rahmen des Globalen Angebots zu verkaufenden Wertpapiere werden von der Gesellschaft angeboten. Die ADSs sind am Nasdaq Global Select Market unter dem Tickersymbol „VALN“ notiert und die Stammaktien der Gesellschaft sind am regulierten Markt der Euronext in Paris („Euronext“) unter dem Symbol „VLA“ notiert.


    https://www.boerse-social.com/…olt_sich_frisches_kapital

  • Valneva Announces European Commission Approval of Advance Purchase Agreement for up to 60 Million Doses of Inactivated COVID-19 Vaccine VLA2001


    November 10, 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.


    https://valneva.com/press-rele…covid-19-vaccine-vla2001/

  • Rückblickend:

    UK PM Johnson: disappointing that Valneva COVID-19


    LONDON, Nov 24 (Reuters) - British Prime Minister Boris Johnson said on Wednesday he was disappointed that Valneva's COVID-19 vaccine had not gained approval in Britain, two months after the government cancelled a supply deal for the shot.


    Britain had secured options for hundreds of millions of doses of the vaccine, but it cancelled the supply deal, worth 1.4 billion euro ($1.57 billion), in September.


    Health minister Sajid Javid had said commercial considerations played into the decision, but he had added it was clear Valneva's shot would not be approved in Britain. read more


    His statement was later corrected to say that the shot had not gained approval and may not gain it. read more


    "I was personally very disappointed when we couldn't get approval for the Valneva vaccine in the way that we had hoped," Johnson told lawmakers on Wednesday after he was asked about the vaccine in parliament.


    "What we are doing is investing massively in this country's vaccine capability across the country so that we are prepared for the next pandemic and I very much hope that Valneva will be part of that."


    Valneva said it was still working with the Medicines and Healthcare products Regulatory Agency (MHRA), the independent medicines regulator, and was hopeful of UK approval.


    "We continue to work closely with the UK MHRA on the rolling submission for initial approval of our inactivated COVID-19 vaccine, VLA2001, and hope that it could receive approval by the end of 2021," a Valneva spokesperson said in a statement.


    "We regret the decision made by HMG (UK government) to end the UK Government's supply contract with Valneva, and remain hopeful that HMG will seek an amicable resolution."


    The MHRA did not respond to a request for comment.


    Earlier this month, Valneva secured a 60 million dose supply deal with the European Commission. read more


    https://www.reuters.com/busine…gain-approval-2021-11-24/

  • Valneva Signs Advance Purchase Agreement with Bahrain for Inactivated COVID-19 Vaccine VLA2001


    December 8, 2021


    Saint-Herblain (France), December 8, 2021Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of an advance purchase agreement with the Kingdom of Bahrain for the supply of one million doses of the Company’s inactivated COVID-19 vaccine candidate VLA2001. This is the second purchase agreement Valneva has secured for VLA2001 since reporting positive data for its Phase 3 clinical trial Cov-Compare.


    Valneva has initiated a rolling submission process with the Bahraini National Health Regulatory Authority (NHRA).


    Franck Grimaud, Chief Business Officer of Valneva, commented, “We are grateful to the Bahraini government for their trust and confidence in our vaccine and are eager to work with them to start helping to address the pandemic evolution in the Middle-East. Subject to regulatory review and approval, we plan to start deliveries in the first quarter of 2022.”


    A Bahraini government spokesperson stated, “Bahrain is once again at the forefront on adopting new measures to protect the health of citizens and residents against the threat of COVID-19. Subject to approval, Bahraini citizens and residents will have the ability to choose from a variety of vaccines in Bahrain that will have a positive impact on driving up vaccinations rates with 93% of the eligible population now fully vaccinated in the Kingdom.”


    Last month, Valneva announced that the European Commission signed an advanced purchase agreement for up to 60 million doses of VLA2001[1]. Valneva reported positive Phase 3 results for VLA2001 in October 2021[2].


    https://valneva.com/press-rele…covid-19-vaccine-vla2001/

  • Valneva Announces Positive Homologous Booster Data for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001


    December 16, 2021

    • Initial results show excellent immune response after third dose of VLA2001 administered 7 to 8 months after the second dose of primary vaccination
    • Antibody titers increased 42- to 106-fold two weeks after booster dose vs pre-booster levels
    • Antibody titers four-fold higher compared to two weeks after primary immunization
    • Evaluating sera from boosted participants for cross-neutralization against Variants of Concern, including Omicron

    Saint Herblain (France), December 16, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive homologous booster data from the Phase 1/2 study, of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Initial results confirm that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination.


    77 of the 153 original Phase 1/2 study participants, aged 18-55 years, received a booster dose seven to eight months after completion of their primary immunization with either a low, medium or high dose of VLA2001. All participants received a single booster vaccination with VLA2001 at the same (high) dose level used in the pivotal Phase 3 “Cov-Compare” trial.[1] IgG antibody titers (spike protein-based) were measured at the time of the booster as well as two weeks after the booster dose. 45 of the 77 boosted participants were included in the final analysis.[2]


    A third dose of VLA2001 elicited an excellent anamnestic response, with similar antibody levels observed whether participants were initially vaccinated with a low, medium or high dose (GMT 9699.3 (95%CI: 8497.76, 11070.71)). This represents a strong boosting effect, increasing levels of antibodies against the Wuhan virus 42- to 106-fold, depending on the pre-boosting levels of antibodies.


    Antibody levels measured two weeks after the booster dose were approximately four-fold higher compared to those observed two weeks after primary immunization.


    Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented: “We are extremely pleased to report our first booster data, confirming that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination and regardless of the initial neutralizing antibody level at the time of boosting. Boostering several months, typically six months or more, after primary immunisation is generally effective for inactivated, adjuvanted vaccines. Our teams are working diligently on our rolling review regulatory submissions so that we can quickly deploy our vaccine and ensure it reaches the people who need it. I would like to thank again the trial investigators, participants and collaborators, especially the National Institute for Health Research and the clinical teams within the NHS Research Centres.”


    In addition to these initial booster data, Valneva expects to report further homologous booster data from the Phase 3 Cov-Compare study. In parallel, the Company is preparing to launch a dedicated heterologous booster trial, which will evaluate a VLA2001 booster shot provided at least six months after primary vaccination with other vaccines or following natural infection. This study is expected to commence in early 2022.


    Valneva will also evaluate the sera from the boosted participants for cross-neutralization against Variants of Concern, including Omicron.


    About Phase 1/2 Trial VLA2001-201
    VLA2001-201 is a randomized, dose-finding trial to evaluate the safety, tolerability and immunogenicity of the inactivated, adjuvanted SARS-CoV-2 virus vaccine candidate VLA2001 in healthy subjects. VLA2001-201 is the first-in-human Phase 1/2 trial evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 153 healthy young adults aged 18 to 55 years were recruited in the trial. VLA2001-201 is being conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208).


    77 subjects from the 153 study participants originally included in the Phase 1/2 trial received a booster dose approximately 7-8 months after completion of their primary vaccination series.


    https://valneva.com/press-rele…accine-candidate-vla2001/