Neue Novavax: Anstieg nach 1:20 Re-Split

Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine

- PREVENT-19 clinical trial expanded to assess the efficacy, safety and immunogenicity of NVX-CoV2373 for the prevention of COVID-19 in up to 3,000 12-17-year-old adolescents

- President of Research and Development, Gregory Glenn, M.D., to provide update regarding the additional trial arm during World Vaccine Congress

https://www.prnewswire.com/news-releases/...19-vaccine-301282123.html  

auch wenn es um die Lieferung in die EU geht , wann wird der Impfstoff von Novavax
zugelassen , egal wo ???  

ich sage im Mai bzw. ich hoffe es.  

alle die jetzt verkauft haben glauben wohl nicht mehr daran ,
ist auch nicht so einfach wenn man bedenkt wieviel Jahre nicht wirklich was passiert ist ,
alles nur Phantasie ???  ich hoffe mal nicht
 

Der Novavax Impfstoff hat einen CPT-Code bekommen!

Definitionen
Was ist der Current Procedural Terminology (CPT)-Code?

https://www.healthcare-computing.de/...terminology-cpt-code-a-961054/


AMA announces update to COVID-19 vaccine CPT codes
MAY 4, 2021

https://www.ama-assn.org/press-center/...x8zDQiYdZTnXYicB8yuQowrzyzck  

Die Meldung zu der Erteilung des CPT - Codes untermauert meine Überzeugung das es hier schon bald wieder steil nach oben geht.
Vielleicht gibt es ja am 10. beim Conference Call was zu verkünden. Zeitlich würde es ja passen...  

Dr. Gregory Glenn's presentation at the World Vaccine Congress Washington 2021.

https://www.novavax.com/sites/default/files/...21-GregGlenn-FINAL.pdf  

with commercial aseptic fill & finish services for vaccine candidate NVX-CoV2373

May 4, 2021
Novavax, a US-based innovative biopharmaceutical company, has chosen the Siegfried Group (SIX: SFZN) as a non-exclusive supplier for the aseptic fill & finish of commercial quantities of its investigational protein-based coronavirus vaccine NVX-CoV2373. The manufacturing and supply agreement between Novavax and Siegfried has an initial term until the end of 2021 with an option to extend. The vaccine candidate is currently under review for approval by different health authorities worldwide and will be filled on Siegfried's manufacturing site in Hameln (Germany) starting around mid-2021.  

Siegfried CEO Dr. Wolfgang Wienand: "We are proud to be able to increase our contribution to the fight against the coronavirus pandemic through our collaboration with Novavax. Implementing this initiative at such speed is proof of the good teamwork between the two companies even under high pressure, and confirms our capabilities and flexibility as one of the leading service providers in the CDMO space. I would like to thank Novavax for entrusting us with their most important project. The Siegfried team as a whole and in Hameln is highly motivated and looking forward to working together with Novavax."

Novavax has begun the rolling submission process with several regulatory agencies worldwide, including the EU's Medicines Agency (EMA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada, among others. The volumes filled by Siegfried are intended for distribution outside the US market. As part of the services, Siegfried will also provide special storage capacity for the vaccine products at its Hameln site.

https://www.siegfried.ch/...dixFKMAqwPTmSpgf7V_DeLOkeCagC5HfxQUOVcabg  

bei fast allen COVID Aktien:
MRNA
BNTX
DVAX....

Hier der Grund für diese Überreaktion:

Biden says he plans to back WTO waiver for vaccines

https://www.reuters.com/business/...k-wto-waiver-vaccines-2021-05-05/  

Im biontech Forum geht ein link um, von einer angeblichen Aufhebung des Patentschutzes  

richtig, bin nur gespannt wie man das durchsetzen will.
Joe Biden hat heute mitgeteilt das er sich dazu äußern wird.

https://www.faz.net/aktuell/wirtschaft/...offe-aufheben-17294864.html  

Leider hat die App meine Antwort ins Nirwana geschickt.

Eigentlich ist es unwahrscheinlich, dass die Amis die ganze Welt dazu animieren können, mit zu ziehen. Ansonsten verlieren sie nur selbst. Biontech, Astrazeneca, Curevac, Sputnik, sinovac (oder halt der chinesische Impfstoff) sind keine US Firmen.
Sogar bei etablierten Produkten lächelt man in China zum Thema Patente und Urheberrecht.
 

Stanford’s Lisa Ouellette on Waiving COVID-19 Vaccine Patents

The U.S. government is facing pressure to support a proposal before the World Trade Organization (WTO) to suspend patents related to COVID-19 vaccines [and on May 5 came out in support of waiving intellectual property protections for those vaccines]. Here, Stanford Law Professor Lisa Larrimore Ouellette explains this patent waiver proposal and how it relates to efforts to expand global vaccination....

https://law.stanford.edu/2021/05/04/...R1c30ss4VtdLP4G-GviCn1_rxu30sM  

auf deutlich tiefere Kurse ein  

New England Journal of Medicine Publishes Phase 2b Clinical Trial Results Demonstrating Efficacy of Novavax COVID-19 Vaccine Against the B.1.351 Variant
May 05, 2021 at 5:03 PM EDT

- Publication of initial primary analysis highlights NVX-CoV2373 cross-protection against B.1.351 variant prevalent in South Africa during study
GAITHERSBURG, Md., May 5, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the publication of results from the initial primary analysis of a Phase 2b clinical trial conducted in South Africa of its NVX-CoV2373 COVID-19 vaccine candidate in the New England Journal of Medicine (NEJM). The published data provide additional detail of an initial analysis conducted in January, while more robust data from a complete analysis of the study was subsequently shared in March 2021. The data on the initial analysis will be published online ahead of print in NEJM's May 6, 2021 issue.

"This data publication reinforces the encouraging safety profile and cross-protective effect across variants seen in studies of our vaccine to-date," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "It also demonstrates that ongoing evaluation of COVID-19 vaccine efficacy against SARS-CoV-2 variants is urgently needed to inform vaccine development and use."

The Phase 2b randomized, observer-blinded, placebo-controlled trial conducted in South Africa evaluated efficacy, safety and immunogenicity in healthy adults, and in a small cohort of medically stable adults living with human immunodeficiency virus (HIV). The study met its primary endpoint. NVX-CoV2373 demonstrated an overall efficacy of 49% in the initial analysis (published NEJM), and 49% in the subsequent complete analysis (unpublished). Among healthy adults without HIV, NVX-CoV2373 demonstrated efficacy of 60% in the initial analysis and 55% in the subsequent complete analysis. In the initial analysis, cases were predominantly mild-to-moderate and due to the B.1.351 variant. In the subsequent complete analysis, circulation of the B.1.351 variant continued to dominate, and all five cases of severe disease observed in the trial occurred in the placebo group.

The initial analysis, now being published in NEJM, suggested that prior infection with the original COVID-19 strain did not protect against subsequent infection by the variant predominantly circulating in South Africa through 60 days of follow-up. However, with additional follow-up, the complete analysis of the South Africa trial indicates that there may be a modest protective effect of prior exposure with the original COVID-19 strain. Among placebo recipients, at 90 days of follow-up, the illness rate was 8.0% in baseline seronegative participants and 5.9% in baseline seropositive participants.

https://ir.novavax.com/news-releases/...-clinical-trial?sf143290754=1  

Vaccine Containing Recombinant SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin Nanoparticles with Matrix-M Adjuvant

Abstract

The 2019 outbreak of a severe respiratory disease caused by an emerging coronavirus, SARS-CoV-2, has spread globally with high morbidity and mortality. Co-circulating seasonal influenza has greatly diminished recently, but expected to return with novel strains emerging, thus requiring annual strain adjustments. We have developed a recombinant hemagglutinin (HA) quadrivalent nanoparticle influenza vaccine (qNIV) produced using an established recombinant insect cell expression system to produce nanoparticles. Influenza qNIV adjuvanted with Matrix-M was well-tolerated and induced robust antibody and cellular responses, notably against both homologous and drifted A/H3N2 viruses in Phase 1, 2, and 3 trials. We also developed a full-length SARS-CoV-2 spike protein vaccine stable in the prefusion conformation (NVX-CoV2373) using the same platform technology. In phase 3 clinical trials, NVX-CoV2373 is highly immunogenic and protective against the prototype strain and B.1.1.7 variant. Here we describe the immunogenicity and efficacy of a combination quadrivalent seasonal flu and COVID-19 vaccine (qNIV/CoV2373). In ferret and hamster models, qNIV/CoV2373 vaccine produces high titer influenza hemagglutination inhibiting (HAI) and neutralizing antibodies against influenza A and B strains. The combination vaccine also elicited antibodies that block SARS-CoV-2 spike protein binding to the human angiotensin converting enzyme-2 (hACE2) receptor. Significantly, hamsters immunized with qNIV/CoV2373 vaccine and challenged with SARS-CoV-2 were protected against weight loss and were free of replicating SARS-CoV-2 in the upper and lower respiratory tract with no evidence of viral pneumonia. This study supports evaluation of qNIV/CoV2373 combination vaccine as a preventive measure for seasonal influenza and CoVID-19.


https://www.biorxiv.org/content/10.1101/...460KFC2Bn57U06dceOaoHamyQ4
 

mag das Vorhaben zwar ein nettes Gedankenspiel sein, wird sich aber in der angedachten Form nicht durchsetzen, davon bin ich fest überzeugt! Wir reden hier von einer Koalition milliardenschwerer Groß Konzerne mit unzähligen Arbeitsplätzen. Das werden die schon mit der entsprechenden Dramatik zum Ausdruck bringen und derlei Vorhaben torpedieren.
Ich denke der Kurs Einbruch war nur vorübergehend...  

Alle (!) 164 Mitgliedstaaten zustimmen müssen.  

die Situation hat sich nicht verschlechtert.
Es wird negative Stimmung verbreitet und auf fallende Preise spekuliert, nur meine Meinung.
Gleichzeitig hat Reuters gestern die Überschrift Ihres Artikels korrigiert:

Novavax vaccine shows 43% efficacy against South African variant, study finds
Julie Steenhuysen
Wed, May 5, 2021, 11:00 PM

UPDATE 1-Novavax vaccine shows 51% efficacy against South African variant, study finds
Julie Steenhuysen
Thu, May 6, 2021, 12:45 AM  

Moin!  Ja, bin da bei Dir. Es scheint so, als wollen sich einige nochmal kräftig eindecken. Kann zwar nicht sagen das ich entspannt dem Treiben zusehe, weil das Warten, diese Fahrstuhl Kurse nerven, allerdings hoffe ich in Bälde auf deutlich steigende Kurse bei entsprechenden News.  

ich auch , es nervt wirklich was im Moment gerade so abgeht  

es kostet mich echt Nerven. Jetzt heißt es „durchhalten und hoffen das wir belohnt werden“.  

Schön zu hören, dass ich nicht der Einzige bin, der das Treiben hier eher angespannt verfolgt.
Vielleicht gelingt ja beim CC am 10. sowas wie ein Befreiungsschlag..!  

https://investors.modernatx.com/news-releases/...ers-during-covid-19/

Beyond Moderna’s vaccine, there are other COVID-19 vaccines in development that may use Moderna-patented technologies. We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.

Ich glaube aber, insbesonders Novavax ist hier weniger betroffen.  Kann mir nicht vorstellen, dass jemand schneller/billiger für die 3. Welt produziert als der bereits bestehende Partner  in Indien. Die ganze Entwicklung/Abnahme müsste ja trotzdem noch erfolgen.
 

Combination Respiratory Vaccine Containing Recombinant SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin Nanoparticles with Matrix-M Adjuvant

https://www.biorxiv.org/content/10.1101/2021.05.05.442782v1