Neue Novavax: Anstieg nach 1:20 Re-Split

Kleinvieh macht auch Mist.
Nun sollte die EMA reagieren und auch die Presse kann das diesmal nicht ignorieren.
Das Ergebnis sollte auch der Quad Allianz das Vertrauen geben, dass Sie mit NVX-CoV2373 nun ein wirksames Mittel haben, um gegen die Impfstoffdiplomatie der Chinesen anzukämpfen



 

Novavax said that both the trials met their statistical success criteria, and highlighted that across both trials NVX-CoV2373 showed 100% protection against severe disease, including all hospitalization and death.“

100 %. !

https://seekingalpha.com/news/...cy-against-original-covid-19-variant

Wenn man dann noch die hohe Stabilität mitberücksichtigt, dann ist dieser Impfstoff die klare Nummer 1.

Kein praktischer Arzt  oder Apotheke wird sich für die jährliche Booster-Impfung für einen RNA Impfszoff von Pfizer oder Moderna entscheiden. Diese können nur zeitlich eng begrenzt im Kühlschrank gelagert werden und müssen sehr schnell danach in den Abfall. Novavax (rekombinantes Protein) ist dagegen sehr stabil und der Impfstoff kann über ganze Impfsaison im Kühlschrank gelagert werden. Und dann ist er auch noch billiger als die RNA Impfstoffe.  

https://www.bioworld.com/articles/...rotection-against-severe-disease  

an. Wenn der nur annähernd abgearbeitet  wir....da wird's mir schwindelig! ;)  

Novavax CEO: End of U.S. vaccine trial could come 'earlier than we thought'

https://ca.finance.yahoo.com/video/...eo-end-u-vaccine-182308450.html  

ist nun unterzeichnet:

https://twitter.com/onenewsph/status/1371714095586639872?s=21  

India to get Novavax Covid-19 vaccine, says minister

https://www.straitstimes.com/asia/se-asia/...G_iNodoVW9JoKobFZoY-osQQ  

and Novavax announced as speakers at World Immunisation & Logistics Summit, hosted by Abu Dhabi’s HOPE Consortium

Abu Dhabi’s HOPE Consortium today announces the inaugural World Immunisation & Logistics Summit, a major international gathering of front runners and senior decision-makers leading the charge in the collective human effort against the COVID-19 pandemic.

Among the international speakers will be Dr.Tedros Adhanom Ghebreyesus, Director-General, WHO, Mark Suzman, CEO, Bill & Melinda Gates Foundation, and Stanley C. Erck, President and CEO, Novavax.

The summit is organised by the HOPE Consortium, an Abu Dhabi led public-private partnership responsible for the mass distribution of COVID-19 vaccines to the global population. It will take place virtually on March 29 and 30, and will further cement Abu Dhabi’s pioneering role in the fight against COVID-19.

The summit provides an open forum for global leaders to discuss the logistical challenges associated with vaccine transport and distribution - from production to patient - with the aim of finding scalable, real-world solutions to achieving mass and broad worldwide vaccine delivery and vaccination.

The two-day summit will see the participation of over 1,000 attendees from all corners of the globe representing governments, key multi-national NGOs, IGOs, pharmaceutical and global supply chain players, as well as leading academics.......

https://www.mediaoffice.abudhabi/en/health/...IkUv03rxwK7amq3VuFn0axw  

vaccine gets under way in Billingham

...Fujifilm Diosynth Technologies has begun manufacturing the jab, which is set to be the UK's fourth approved covid vaccine, the company's chief executive has confirmed.

Martin Meeson said production has "ramped up" at the firm's Belasis Avenue facility and others around the world including the US.

But he has not specified how long the vaccine could take to reach patients' arms - saying "if we've learned anything over the last year, it's not to speculate on the timings of things".

The UK has ordered 60m doses of the Novavax vaccine, which has yet to be approved by the MHRA (Medicines and Healthcare products Regulatory Agency).

Speaking to Radio Four's Today programme, Mr Meeson said: "We have ramped up the manufacturing of this key vaccine candidate, and we've done that at sites across the world including the US.

"Our facility is ready here in the UK and we've just commenced the first part of that manufacturing process.

Production of the vaccine by US-based firm Novavax was a "significant undertaking", he added.

Fujifilm's Andy Ross added: "In line with our commitment to Novavax and the UK Government, we started our manufacturing activities in early February and work is going on in earnest right now.....

https://www.gazettelive.co.uk/news/teesside-news/...ts-under-20237098



 

Inside Novavax lab amid race to develop Covid vaccine

https://www.nbcnews.com/news/amp-video/...2?__twitter_impression=true

https://twitter.com/novavax/status/1374521096339398656?s=21  

23 March 2021

Jubilant HollisterStier Announces COVID-19 Vaccine Candidate Manufacturing Agreement with Novavax

Jubilant HollisterStier LLC, a wholly owned subsidiary of Jubilant Pharma Limited, announced that it has entered into a non-exclusive manufacturing agreement with Novavax, a biotechnology company developing next-generation vaccines for serious infectious diseases, to provide fill-finish manufacturing services for the production of COVID-19 vaccine candidate NVX-CoV2373.   Under the terms of the agreement, Jubilant HollisterStier’s Spokane, Washington facility has begun production activities of NVX-CoV2373 final drug product intended for commercial distribution in the United States.

https://www.jublhs.com/media/press-release  

den aktuellen Kursverlauf:

Exclusive: Novavax delays EU vaccine supply deal amid production problems - source

https://finance.yahoo.com/news/...ax-delays-eu-vaccine-155402643.html

Wobei man beachten sollte, dass die Rohstoffknappheit schon länger bekannt war und auch andere Impfstoffhersteller davon betroffen sind.
Meiner Meinung nach wird diese Nachricht gezielt dazu genutzt um den Kurs wieder einbrechen zu lassen.  

" CEO Stanley Erck teilte Reuters am 1. März mit, dass das Unternehmen voraussichtlich mehrere zehn Millionen Dosen bevorratet und versandbereit in den USA haben wird, wenn es dort möglicherweise im Mai die behördliche Genehmigung erhält "

deshalb kann es sein , das der kurs weiter fallen wird

 

Der Nachricht und der daraus konsultierenden Talfahrt habe ich nachgekauft und mich über den günstigen Preis gefreut ... *Ächz *

Na, die News wirkt arg konstruiert. Vielleicht ein letztes Schütteln vor der Explosion  

da bin ich nicht mehr ganz so optimistisch  

Hab auch gekauft.  

hier, habe ich von jemanden der angeblich einen Klienten-Zugang zum JP Morgan Research hat.

JP Morgan just issued a new update. They contacted NVAX mgmt today.

We had the chance to connect with Novavax management following the flow of headlines surrounding vaccine production delays due to raw material supply shortages and wanted to pass along some thoughts as it relates to shares. Indeed
the company confirmed challenges are being faced by contract manufacturers and are primarily related to the sourcing of material necessary for the fill / finish process (ie: filters, stoppers, etc.) rather than constituents of the active vaccine
substances. That said, while specifics were not provided, the company notes that measures are underway to resolve these delays and is still committed to the previously outlined goal of producing 150M doses/month globally by the end of
2Q. With respect to other aspects of its vaccine manufacturing supply chain (antigen and adjuvant production, co-formulation), the company notes no bottlenecks and retains uninterrupted access to its supply of Matrix-M adjuvant.
On the regulatory front (recall rolling authorization reviews in the UK, EMA, Canada, Australia, and New Zealand underway), finalization of submissions are on track for 2Q, where completion of CMC package (which requires coordination across multiple manufacturing sites) remains the gating item. From the standpoint of company news flow, we would anticipate an announcement upon a completion of submission, prior to any authorization announcement(s) from EMA, MHRA or
other jurisdictions. As well, the company continues to engage in discussions with the EU commission towards the finalization of a vaccine supply agreement (hoping to be able to make an announcement “soon”) and notes the process is independent of an EMA authorization. Bigger picture, looking to a number of
potential approvals over the very near term, we note today’s weakness as overdone and continue to see NVAX as undervalued relative to approved peers with current
levels presenting an attractive entry-point.  

an einen deutlichen Kurs Anstieg nach entsprechenden Nachrichten. Das wir scheinbar nun allerdings frühestens Ende Q2 damit rechnen können entsetzt mich einigermaßen und ich stelle mir die Frage, was die Luschen eigentlich in den vergangenen Monaten gemacht haben? Andere Unternehmen sind uns mittlerweile meilenweit voraus, während wir auf der Stelle treten und der Kurs immer wieder unter die Räder kommt. Ankündigungen Q1 aus dem vergangenen Jahr wurden heimlich, still und leise kassiert und es verschiebt sich immer weiter ins laufende Jahr hinein, zumal wenn Q2 lediglich die Einreichungen erfolgen sollen! Ich hatte längst mit Zulassungen seitens US und EU gerechnet, nein, hatte sie erwartet!
Man kann nur hoffen, dass  zeitnah ein sehr positiver Newsflow einsetzt, sonst stehen wir bald wieder unter 100.  

schau dir mal die Zeiträume zwischen den EMA rolling reviews und der Zulassungen an, es sind immer 4 Monate:

AZN rolling review start: 01.10.20
Zulassung: 29.01.21

J&J rolling review start: 01.12.20
Zulassung: 11.3.21

Novavax rolling review start: 03.02.21
Die Zulassung wäre dann voraussichtlich im Mai.  

Ich denke, die Zulassung kommt schon im April. Europa braucht dringend den Impfstoff.  

für die Info. Denke auch eher April wegen der Dringlichkeit, aber selbst das können ja noch bis zu 4 Wochen sein, wo der Kurs Samba tanzen kann... Ich hatte einfach gehofft es ginge schneller, diese Kurse von über 300 waren fantastisch :0) Üben wir uns also weiter in Geduld und hoffen nicht weiter durchgereicht zu werden...  

it will boost the vaccine roll-out across multiple geographies in H2, which will help bring the pandemic under control.

...NVX-CoV2373 is forecast to have $33.3bn total sales for 2021–2027, according to a Q1 2021 drug sales analyst consensus forecast from GlobalData’s Pharma Intelligence Center Drug Sales and Consensus Forecast Database....

https://www.pharmaceutical-technology.com/comment/...svdJzNL54RF2T2hE  

meine Zusammenfassung nochmals erweitert:

AZN rolling review start: 01.10.20
Zulassung: 29.01.21
Zeitraum: 4 Monate

PFE/BNTX rolling review start: 06.10.20
Zulassung: 21.12.20
Zeitraum: 3 Monate

MRNA rolling review start: 16.11.20
Zulassung: 06.01.21
Zeitraum: 3 Monate

J&J rolling review start: 01.12.20
Zulassung: 11.03.21
Zeitraum: 4 Monate

Novavax rolling review start: 03.02.21
Die Zulassung müsste dann voraussichtlich im Mai erfolgen.  

29.03.21

12:40 COVID-19 Vaccines Pharma and Manufacturers Panel: The race against time
The global pharmaceutical research community has been working at a truly historic pace to develop vaccines
to combat the novel coronavirus in record-setting time. This session will bring together a panel of experts representing a range of pharmaceutical companies, manufacturers and experts to deliver an update on vaccine R&D and production as well as the WHO Chief Scientist, mainly on:
• The unprecedented accelerated process of COVID-19 vaccines R&D
• vaccine efficacy against current and future strains of COVID-19
• WHO recommendations on vaccines use
• Understanding the unique vaccine properties and distribution requirements
• Forecasting the vaccine pipeline
• Equity in distribution and access to the COVID-19 vaccines

Moderator: Becky Anderson, Managing Editor and Anchor, CNN International

Panelists:
Stanley C. Erck, President and CEO, Novavax

https://custom.cvent.com/...iles/60fbd9d4df234d3796a055a62690d37a.pdf

https://www.hopeconsortiumevent.com/event/...ngPage&utm_source=HC  

die Teilnehmer des HOPE Consortium anschaue, dann geht es hier um die Planung bzw. Diskussion über die weltweite Lieferung eines Impfstoffs.
Die Teilnehmer Bill & Melinda Gates Foundation, Gavi und CEPI haben alle einen enge Bindung zu Novavax.

Gavi:
The signed memorandum of understanding (MoU) between Gavi and Novavax is to make a cumulative volume of 1.1 billion doses of the Novavax vaccine candidate available to the COVAX Facility

CEPI:
CEPI was one of the first investors of Novavax’s COVID-19 vaccine candidate, NVX-CoV2373, and has to date provided up to US $388 million in funding to accelerate its development and manufacture.

Bill & Melinda Gates Foundation:
Billionaire Bill Gates told CNBC that Johnson & Johnson's and Novavax's Covid-19 vaccines will still be essential tools against new, emerging variants of the virus.