Neue Novavax: Anstieg nach 1:20 Re-Split
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Es muss dringend das Approval her, dann wird sich vieles ändern, nur meine Meinung. Der Kurs ist im Moment reines Gezocke, es muss Fundamentales her und das ist die Zulassung.
A factory on Teesside making the new Novavax Covid-19 vaccine is on target to make the 60 million doses ordered by the UK, bosses have confirmed.
Fujifilm Diosynth Biotechnologies in Billingham began production in February ahead of approval for its use, which is expected within weeks. ...
... "So what we will see when this vaccine starts to be used, is its efficiency in the real world against these different versions of the virus circulating in different countries."
https://www.bbc.com/news/uk-england-tees-56836877
geredet nur nicht über Novavax , wieso nicht ???
Jab developed by University of Oxford team proves 77% effective in Burkina Faso mid-stage tests
A trial of a malaria vaccine from the University of Oxford indicated it was 77 per cent effective — dramatically better than the existing shots for preventing one of the world’s most deadly diseases.
The jab, known as R21, is the first that could surpass the World Health Organization goal of an available vaccine with at least 75 per cent efficacy by 2030. Mosquirix, the first malaria vaccine, which was initially deployed in 2015, took GSK more than 30 years to develop and was about 39 per cent effective over four years.
In the phase 2b — mid-stage — trial of R21, participants in a higher-dose group were 77 per cent less likely to develop malaria over 12 months of follow-up than those who received a rabies shot as a control. Those receiving a lower dose of the vaccine’s adjuvant were 71 per cent less likely to develop the illness. There were no serious side effects.
The study inoculated 450 children aged five to 17 months in Burkina Faso.
The Oxford researchers, who are working with India’s Serum Institute and US vaccine maker Novavax, have already launched a phase 3 trial to test the vaccine in a larger population. The existing participants have also been given a booster shot.
The recombinant fusion protein vaccine combined an antigen that signalled the immune system, with Novavax’s Matrix-M adjuvant to boost the efficacy. Novavax is also using the adjuvant in its Covid-19 vaccine, which a phase 3 trial found was 89 per cent effective.
Adrian Hill, director of Oxford’s Jenner Institute, which helped develop the Oxford/AstraZeneca Covid-19 vaccine, co-authored the draft paper outlining the R21 trial data. He said the results supported its “high expectations” for the vaccine.
“With the commitment by our commercial partner, the Serum Institute of India, to manufacture at least 200m doses annually in the coming years, the vaccine has the potential to have major public health impact if licensure is achieved,” Hill said.
Malaria causes more than 400,000 deaths a year, mostly among children in Africa. Some 229m clinical cases of the disease were reported in 2019.
But it has been a struggle to find a vaccine to tackle the disease, with more than 100 candidates examined in clinical trials.
Halidou Tinto, regional director of the Institut de Recherche en Sciences de la Santé in the Burkina Faso department of Nanoro and the trial’s principal investigator, said he looked forward to demonstrating large-scale efficacy in the phase 3 trial.
“These are very exciting results showing unprecedented efficacy levels from a vaccine that has been well tolerated in our trial programme,” he said.
https://www.ft.com/content/...hpFKAFMM8kraT9rOVZt4HlQYroSDlzlu9duXlLg
Des Weiteren werden hier große Unternehmen ganz klar in den Vordergrund gestellt.
Für Deutschland scheinen die Produkte von Biontech, AstraZeneca, J&J sowie Curevac relevant.
Innerhalb der EU wird über Novavax doch schon häufiger diskutiert und viele versuchen hier eigene Wege zu gehen, man erfährt dies aber leider fast nur aus der ausländischen Presse.
Da Novavax noch kein Produkt auf den Markt gebracht hat, ist halt aller Anfang schwer und um z.B. einen EU Deal zu erhaschen müssen wohl mehrere Faktoren stimmen. Einer davon ist die zu produzierende Menge sowie die Produktionsstätten, ein Dank geht hier an AstraZeneca, für die Unsicherheit.
Ach so und zu Sputnik, hier trommelt Putin die Werbetrommel.
Alles nur meine Meinung.
wann ???? zu wenig Transparenz , verlieren Anleger Vertrauen ???
Poland Mabion SA expects to start commercial production of Novavax Inc.’s coronavirus vaccine quickly after it completes test trials around mid 2021 in what could be the start of multiyear cooperation between the companies.
UK: Fujifilm Diosynth Biotechnologies in Billingham began production in February ahead of approval for its use, which is expected within weeks.
D: Novavax tapped Baxter BioPharma Solutions to handle commercial-scale vaccine manufacturing at its facility in Halle, Germany. Once production work kicks off, Baxter will be on deck to crank out supplies for the European and U.K. markets.
Tschechien, SK Bioscience will start producing a protein-based vaccine developed by Novavax for domestic use in June under a technology transfer deal with the American vaccine development company, which has promised to provide doses for 20 million people in South Korea.
Osaka, Japan, February 24, 2021 -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced today that the first subject was dosed in its Phase 1/2 immunogenicity and safety study of Novavax’ COVID-19 vaccine candidate (TAK-019) in Japan.
Novavax facilities (Novavax HQ MD, NovavaxAB, Novavax CZ)
Vaccine distribution & license agreement (Serum Institute, SK Bioscience, Takeda)
Matrix-M production (AGC Biologics, PolyPeptideGroup)
Antigen production (Biologics Manufacturing Centre, FujiFilmNC, FujiFilmTX, FujiFilmUK, Biofabri)
Fill/Finish (Jubilant HollisterStier, Par Pharma, GSK, Baxter, Siegfried)
https://www.novavax.com/sites/default/files/...storDeck-April2021.pdf
Weden die endlich mal wach?
Th EU Commission may eventually expand its portfolio of COVID-19 jabs to protein-based vaccines, the EU executive's President Ursula von der Leyen suggested on Friday.
"We will certainly add other potential vaccines, for example protein-based vaccines have also quite a potential," von der Leyen said at a news briefing.
The vaccines currently being developed by Novavax (NVAX.O) and Sanofi/Glaxo-Smith-Kline (SASY.PA), (GSK.L) are examples of protein-based vaccines.
https://www.reuters.com/world/europe/...covid-19-vaccines-2021-04-23/
-- Vaccine candidate demonstrates high efficacy at 77% in a study of children aged 5-17 months conducted in Africa
-- Novavax' Matrix-M adjuvant used in combination with University of Oxford malaria vaccine candidate, R21, and developed in collaboration with Serum Institute of India
-- Phase 3 clinical trial to evaluate safety and efficacy begun in 4,800 participants aged 5-36 months
https://ir.novavax.com/news-releases/..._wjAKrJIbvgr_mEAVzRwtJXxM37k4
BILD berichtet über ein neues Mittel gegen Malaria, von der Uni Oxford entwickelt... Von Novavax mal wieder kein Wort.
Wenn wir die Zulassungen haben, werden sich viele fragen... Wer soll das sein? Taugt das was?
Da muss wohl die PR Abteilung noch n büschen arbeiten...
Schönes Wochenende @all!
Inovio Pharmaceuticals teilte heute mit, dass die US-Regierung die Finanzierung einer Spätstudie zum Testen ihres COVID-19-Impfstoffkandidaten aufgrund der zunehmenden Verfügbarkeit zugelassener Impfstoffe im Land eingestellt habe.
https://ir.inovio.com/news-releases/...rial-for-INO-4800/default.aspx
ADJUVANT (MATRIX M):
Novavax AB (Novavax Swedish Subsidiary in Uppsala, Sweden)
AGC Biologics (Seattle, Washington, USA)
http://www.agcbio.com/facilities/seattle_facilities
AGC Biologics (Copenhagen, Denmark)
http://www.agcbio.com/facilities/copenhagen_facilities
Manufacturing 2 key intermediaries used in Matrix-M
Polypeptide Group (Limhamn, Sweden)
https://www.polypeptide.com/...ation-request/facilities/malmo-sweden/
Polypeptide Group (San Diego and Torrance, California, USA)
https://www.polypeptide.com/...facilities/san-diego-and-torrance-usa/
ANTIGEN COMPONENT:
Novavax CZ (formerly Praha Vaccines) in Bohumil, Czech Republic
Fujifilm Biosynth Biotechnologies
- Teesside, UK
- Morrisville, North Carolina, USA
- College Station, Texas, USA
https://fujifilmdiosynth.com/about-us/
Biofabri (Galicia, Spain)
https://biofabri.es/en/
National Research Council's Biologics Manufacturing Centre (Montreal, Canada)
https://nrc.canada.ca/en/covid-19-response-vaccines-therapeutics
ANTIGEN PRODUCTION:
SK Bioscience (IPO ~ 4 weeks ago)
Gyeonggi-do, Korea
https://www.skbioscience.co.kr/kr/main
Takeda Pharmaceutical Company Limited
Tokyo, Japan
https://www.takeda.com/who-we-are/...-pharmaceutical-company-limited/
Serum Institute of India
Pune, India
https://www.seruminstitute.com/
FILL/FINISH:
Baxter International (Bavaria, Germany)
https://www.baxter.de/de
Jubilant HollisterStier LLC (Spokane, Washington, USA)
https://www.jublhs.com/
Par Pharmaceautical (New York, California and/or Michigan, USA)
https://www.parpharm.com/
Siegfried AG (Hameln, Germany)
https://www.siegfried.ch/about-siegfried/
GlaxoSmithKline (Barnard Castle, UK)
https://uk.gsk.com/en-gb/about-us/uk-locations/barnard-castle/
As of March 2, 2021 - manufacturing technical batch of NVX-CoV2373, then assessment of manufacturing feasibility at a commercial scale in future):
Mabion SA ( Konstantynów Łódzki, Poland)
https://www.mabion.eu/en/
Future manufacturing - estimated as only "end of year" (2021):
Montreal, Canada
National Research Council
Royalmount facility (construction expected finalized in July, 2021 at which time facility will be required to secure GMP approvals from Health Canada)
Production of "up to 24M doses" per year (4,000 liters per month which ~2M doses).
https://www.investorvillage.com/...;mid=21937093#.YIOSNR3-aC0.twitter
... "The federal government said 'We built this program up, y'all train some people'. Basically, we are working with FUJIFILM Diosynth Biotechnologies Texas, who is the contractor for the federal government to mass manufacture Novavax vaccine candidates," Jenny Ligon, Assistant Director for Workforce Development at National Center for Therapeutics Manufacturing shared with KRHD 25 News.
..."So the federal government will come to us and say 'Alright start mass-manufacturing the Novavax vaccine' and we will do that... but right now, what the government is doing is reserving our capacity here in Bryan College Station...which is huge," Ligon added.
... "The federal investment in our community has been enormous. We are excited, and to date, we have trained 200 people since August of last year for FUJIFILM Diosynth Biotechnologies Texas and it's going to keep continuing on for as long as we know. This is not over by any chance... by any long shot," Ligon added.
Leaders say it's just a matter of time before Novavax gets to the market.
https://www.kxxv.com/brazos/...MI9Jes_NCDPL80ibTAX73c5mUDSSE1kMHT6VaM
Wenn diese Woche womöglich auch UK endlich aus dem Quark kommt könnte es eine nette Woche werden...
Viel Erfolg allen Investierten:0)
Novavax CEO to visit SK Bioscience’s vaccine plant in Korea
Stanley C. Erck, President and CEO, U.S. biotechnology company Novavax, is soon to visit SK Bioscience’s vaccine plant, L House, in Andong, North Gyeongsang Province to discuss local production of Novavax’s Covid-19 vaccine. The two companies signed a technology transfer agreement in August last year to roll out 40 million doses of Novavax’s Covid-19 vaccine in Korea.
https://m.pulsenews.co.kr/...aPOjn8c9WOEelzkirAITw3VMXlggODOLriNaGf20
President Moon Jae-in is expected to hold a face-to-face meeting with Novavax CEO Stanley Erck on Tuesday amid the pending production of the US drugmaker’s new COVID-19 vaccine here, Cheong Wa Dae sources said Monday.
Moon and Erck held their first video chat in January and agreed to produce 40 million doses of Novavax’s vaccine at the local facilities of South Korean contract manufacturer SK Bioscience. The deal also includes technology transfer to the drugmaker that would elevate production efficiency overall.
The Novavax CEO arrived in Seoul on Monday to hold multiple meetings with SK Bioscience officials and the nation’s health authorities affiliated with the vaccine campaign task force. He was also scheduled to look around the drugmaker’s production facilities in Andong, North Gyeongsang Province, where AstraZeneca’s vaccine is also being produced for local consumption.
... Over the weekend, the government said it had secured an additional 40 million doses of Pfizer’s vaccine, raising the total quantity of COVID-19 vaccines secured to 192 million doses -- enough for 99 million people, nearly double the nation’s population.
...The new Novavax vaccine is currently being assessed by US and UK regulators. As soon as both countries grant approval, possibly in the coming weeks, the Korean drug agency is also expected to complete its review.
http://m.koreaherald.com/view.php?ud=20210426000914
... According to presidential spokeswoman Park Kyung-mee, President Moon told Erck that the government will set up a team in charge of assessing the Novavax vaccine at the Ministry of Food and Drug Safety for rapid approval of the vaccine.
... The Novavax jab has been regarded as the safest vaccine as it takes a more traditional approach to vaccine development than the never-before-used mRNA technology that Pfizer and Moderna rely on, which has a lot more unknowns in terms of side effects.
... According to the Ministry of Health and Welfare, SK Bioscience will be able to start manufacturing the Novavax vaccine as early as June, with a plan to produce enough to inoculate 10 million people by the end of the third quarter and 20 million by the year-end.
... The government plans to extend the licensing deal with Novavax until next year to ensure a stable supply of the vaccine for local consumption," Health Minister Kwon Deok-cheol, who heads the interagency taskforce, said during a briefing.
https://www.koreatimes.co.kr/www/nation/2021/04/119_307894.html
...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.