Neue Novavax: Anstieg nach 1:20 Re-Split

meines postings bzgl. der eingereichten Daten

Ich zitiere die News vom 04.02.21

„As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data.“

Ich bleibe bei meiner Meinung, die Verspätung bezieht sich auf die Fertigungsprozess Daten. Allein aufgrund der US Studie sind nun genügend Klinische Daten vorhanden.

https://ir.novavax.com/news-releases/...ng-review-multiple-regulatory  

Bzgl. Übergabe der relevanten Daten der Fertigung und Qualität:

„.. The TGA has no further information at this time on expected timeframes for the provision of the complete data package although manufacturing and quality information is now expected to be submitted to the TGA in September.”

Novavax, Moderna join vaccine rollout line-up, but it’s still not enough, experts say

https://thenewdaily.com.au/news/coronavirus/2021/...Nw1DMDNTXelnStYL8  

Ist der Grund für die Verspätung in den September hinein, dass raw Material Embargo der USA welches am 4 Juni beendet wurde.  

Serum Institute India set for Novavax COVID vaccine trials on children from July: Report

https://zeenews.india.com/india/...dren-from-july-report-2369841.html  

mgmt during B.Riley chat:

-"clearing up" of raw material shortages, attributed to national coalitions to improve global supply chains
-enables all 8 plants to operate at full capacity beginning Q3
-next 2-3Q delivery schedule > 500M doses

https://twitter.com/propthinker/status/1405506562819563528?s=21  

How Does Novavax Stack Up Against Today's Vaccine Leaders?

…The biggest problem so far
Novavax's main problem so far has been obtaining certain raw materials to make its vaccine. The biotech company said it expects suppliers to add capacity so that it can in turn operate at full capacity; Novavax aims for that to happen by the fourth quarter.

If raw materials continue to be a problem beyond that point, Novavax could struggle to keep up with its more advanced rivals. But if the raw-materials situation improves, the picture looks bright. After all, the company is scaling up to produce -- with help from its partners -- 2 billion doses a year. And it expects to be at that level as early as the end of this year.

Of course, major market share won't happen overnight. Moderna and Pfizer have already gained a lot of ground and established themselves in the top spots. But there still is plenty of room for Novavax to approach -- even pretty closely. So, if the raw-materials problem doesn't hold Novavax back, we could be looking at a third major player in the coronavirus vaccine market.

https://www.fool.com/investing/2021/06/18/...gainst-todays-vaccine-l/  

Die Aussage "Novavax's main problem so far has been obtaining certain raw materials to make its vaccine." stimmt so nicht ganz. In den USA sind sämtliche Materialien im Überfluss vorhanden. Wegen den Exportbeschränkungen nach Europa und Restwelt sind diese Artikel eine Mangelware.
Nonavax könnte diesbezüglich in den USA produzieren. Aber es gibt in keinem Land der Erde eine Zulassung, obwohl eine Einreichung der Studien und die Beantragung der Zulassung ursprünglich für Mai angekündigt war.
 

Ich mache es kurz und knapp.

1. Schau dir die Novavax „Global“ Supply Chain Map an.
2. Die benötigten Daten zur Übermittlung für die Zulassung standen noch nicht vollständig zur Verfügung.
 

ich glaube so wie Tomeck sehen das viele hier
wir haben nicht den ganz so tiefen Einblick wie du und Unicorn71  

Minister Champagne marks the completion of construction of the Biologics Manufacturing Centre in Montréal
Canada NewsWire

MONTRÉAL, June 22, 2021 /CNW/ - As Canadians begin to look towards recovery, the Government of Canada recognizes the importance of building Canada's pandemic resilience. This includes increasing our domestic capacity to produce critical vaccines and therapeutics. The Government will continue to partner with industry and academic partners to protect Canadians from COVID-19, and to build our biomanufacturing capacity as part of our recovery plan.

…Once fully licensed and operational, the Biologics Manufacturing Centre will have full end-to-end manufacturing capabilities. With approximately 5,400 square metres (58,000 square feet) of space, it will have a production capacity of approximately 24 million doses of a vaccine per year, varying based on the specific vaccine requirements.

…The NRC is continuing to work with Novavax, Inc. to produce their COVID-19 vaccine at the Biologics Manufacturing Centre once both the vaccine candidate and the facility receive Health Canada approvals.

…Novavax choosing to produce their vaccine here in Montréal shows that, with the right investments, Canada can be a destination of choice for biomanufacturing. This project will also support the continued development and growth of Canada's vibrant life sciences industry."
The Honourable François- Philippe Champagne , Minister of Innovation, Science and Industry

"This project is another important step forward in strengthening Canada's capacity to manufacture vaccines, and this new facility will help us be better prepared for future pandemics."
The Honourable Patty Hajdu, Minister of Health

…We are now focused on the next milestones of obtaining the necessary drug establishment licence from Health Canada and working with Novavax to complete technology transfer of its vaccine and beginning the production process as soon as possible."
Mitch Davies , President, National Research Council of Canada

…The National Research Council of Canada and Novavax are working closely together on the technology transfer to establish the step-by-step process of producing the Novavax vaccine at the Biologics Manufacturing Centre. This critical step is expected to take several months with the completion of engineering runs targeted for the end of December 2021 , pending the required Health Canada regulatory approvals.

https://www.theglobeandmail.com/investing/markets/...d-FMfY8Aw0qhmexc










 

of the National Research Council of Canada Biologics Manufacturing Centre
Jun 22, 2021 at 2:58 PM EDT

https://ir.novavax.com/news-releases/...ional-research-council-canada  

The mRNA Vaccines Are Extraordinary, but Novavax Is Even Better

At the end of January, reports that yet another COVID-19 vaccine had succeeded in its clinical trials—this one offering about 70 percent protection—were front-page news in the United States, and occasioned push alerts on millions of phones. But when the Maryland-based biotech firm Novavax announced its latest stunning trial results last week, and an efficacy rate of more than 90 percent even against coronavirus variants, the response from the same media outlets was muted in comparison. The difference, of course, was the timing: With three vaccines already authorized for emergency use by the U.S. Food and Drug Administration, the nation is “awash in other shots” already, as the The New York Times put it.

Practically speaking, this is true. If the FDA sees no urgency, the Novavax vaccine might not be available in the U.S. for months, and in the meantime the national supply of other doses exceeds demand. But the asymmetry in coverage also hints at how the hype around the early-bird vaccines from Pfizer and Moderna has distorted perception. Their rapid arrival has been described in this magazine as “the triumph of mRNA”—a brand-new vaccine technology whose “potential stretches far beyond this pandemic.” Other outlets gushed about “a turning point in the long history of vaccines,” one that “changed biotech forever.” It was easy to assume, based on all this reporting, that mRNA vaccines had already proved to be the most effective ones you could get—that they were better, sleeker, even cooler than any other vaccines could ever be.

But the fascination with the newest, shiniest options obscured some basic facts. These two particular mRNA vaccines may have been the first to get results from Phase 3 clinical trials, but that’s because of superior trial management, not secret vaccine sauce. For now, they are harder and more expensive to manufacture and distribute than traditional types of vaccines, and their side effects are more common and more severe. The latest Novavax data confirm that it’s possible to achieve the same efficacy against COVID-19 with a more familiar technology that more people may be inclined to trust. (The mRNA vaccines delivered efficacy rates of 95 and 94 percent against the original coronavirus strain in Phase 3 trials, as compared with 96 percent for Novavax in its first trial, and now 90 percent against a mixture of variants.

Pandemic-vaccine success, as I wrote last year, was never just about the technology. You needed a good vaccine, sure—but to get it out the door quickly, you also had to have a massive clinical-trial operation going, and it had to be situated in places where the virus would be spreading widely at just the right time. Even if your candidate worked amazingly well, if you weren’t testing it in the middle of a huge outbreak, you’d have to wait a very long time for the evidence to build.

The precise timing of these studies mattered a great deal in practice. The Phase 3 clinical trials for Pfizer and Moderna, for example, were up and running in the U.S. by late summer 2020, and so they caught the nation’s giant wave of infections in the fall. By the time Novavax had finished recruiting in the U.S. and Mexico, in February, case rates had been dropping precipitously. This fact alone, independent of any aspect of vaccine technology, did a lot to shape the outcome.

Corporate strategy was another crucial factor. To “win” the vaccine race, a company would need to be able to produce high-quality vaccine doses reliably and quickly, and in vast numbers. It would also need to field the challenges of working with multiple regulatory agencies around the world. And it would need to do all of this at the same time.

BioNTech, the German company that developed the Pfizer mRNA vaccine, could not have accomplished so much, so quickly by itself. Last October, the company’s CEO, Uğur Şahin, told German interviewers that BioNTech had sought out Pfizer for help because of the scale of the clinical-trial program necessary for drug approvals. That strategic partnership, and not simply the “triumph of mRNA,” was what propelled them past the post. (Moderna had the advantage of its partnership with the National Institutes of Health.) Consider this: The BioNTech-Pfizer first-in-human vaccine study appeared on the U.S. government’s registry of clinical trials on April 30, 2020—the same day as the first-in-human vaccine study for Novavax, which would be going it alone. In a parallel universe where Novavax had paired up with, say, Merck, this story could have come out very differently.

In the meantime, the early success of two mRNA vaccines pulled attention away from the slower progress of other candidates based on the same technology. Just two days after last week’s Novavax announcement came the news that an mRNA vaccine developed by the German company CureVac had delivered a weak early efficacy rate in a Phase 3 trial, landing below even the 50 percent minimum level set by the World Health Organization and the FDA. “The results caught scientists by surprise,” The New York Times reported. CureVac is the company that President Donald Trump reportedly tried to lure to the U.S. early in the pandemic, and the one that Elon Musk said he would supply with automated “RNA microfactories” for vaccine production. In the end, none of this mattered. CureVac’s mRNA vaccine just doesn’t seem to be good enough.

The “sobering” struggles of CureVac perfectly illustrate what epidemiologists call “survivor bias”—a tendency to look only at positive examples and draw sweeping conclusions on their basis. When the Pfizer and Moderna vaccines triumphed, The Washington Post suggested that a bet on “speedy but risky” mRNA technology had paid off with a paradigm-shifting breakthrough. Anthony Fauci called the gamble “a spectacular success.” Such analyses usually had less to say about the non-mRNA vaccines that had gotten into clinical trials just as quickly—and about the other mRNA vaccines that were hitting snags along the way.

Now we’ve seen what happened to CureVac, and that some mRNA formulations clearly work much better than others. By one count, nine groups were testing mRNA COVID-19 vaccines in animal studies as of May 2020, and six were expected to be in clinical trials a few months later. By the end of the year, only BioNTech-Pfizer, Moderna, and CureVac had reached Phase 3 testing, compared with 13 non-mRNA vaccines. Of the nine mRNA-vaccine candidates that were already testing in animals in mid-2020, just two have proved efficacy at this point, while no fewer than nine vaccines based on more traditional technologies have reached the same mark.

These other, non-mRNA vaccines have been widely used throughout the world—and some could still make an important difference in the U.S. Although the U.S. has plenty of doses of the Pfizer and Moderna vaccines available right now, demand for them has cratered. The Washington Post reports that in 10 states, fewer than 35 percent of American adults have been vaccinated. An international study of COVID-19 vaccine misinformation, published in May, found that among the most common online rumors were those alleging particular dangers of mRNA technology—that it leads, for example, to the creation of “genetically modified human beings.” The CDC has also made a point of debunking the circulating falsehood that COVID-19 vaccines can change your DNA. For a time, it looked as though the Johnson & Johnson vaccine would help address this worry. It’s based on a fairly new technology, but not as new as mRNA. However, concerns about tainted doses made at a Baltimore factory and the emergence of a very rare but serious side effect have pretty much dashed that hope. The Johnson & Johnson single-dose vaccine has reportedly accounted for fewer than 4 percent of doses administered in the country.

In this context, the success of the Novavax vaccine should be A1 news. The recent results confirm that it has roughly the same efficacy as the two authorized mRNA vaccines, with the added benefit of being based on an older, more familiar science. The protein-subunit approach used by Novavax was first implemented for the hepatitis B vaccine, which has been used in the U.S. since 1986. The pertussis vaccine, which is required for almost all children in U.S. public schools, is also made this way. Some of those people who have been wary of getting the mRNA vaccines may find Novavax more appealing.

The Novavax vaccine also has a substantially lower rate of side effects than the authorized mRNA vaccines. Last week’s data showed that about 40 percent of people who receive Novavax report fatigue after the second dose, as compared with 65 percent for Moderna and more than 55 percent for Pfizer. Based on the results of Novavax’s first efficacy trial in the U.K., side effects (including but not limited to fatigue) aren’t just less frequent; they’re milder too. That’s a very big deal for people on hourly wages, who already bear a disproportionate risk of getting COVID-19, and who have been less likely to get vaccinated in part because of the risk of losing days of work to post-vaccine fever, pain, or malaise. Side effects are a big barrier for COVID-vaccine acceptance. The CDC reported on Monday that, according to a survey conducted in the spring, only about half of adults under the age of 40 have gotten the vaccine or definitely intend to do so, and that, among the rest, 56 percent say they are concerned about side effects. Lower rates of adverse events are likely to be a bigger issue still for parents, when considering vaccination for their children.

Don’t get me wrong—the Pfizer and Moderna vaccines have been extraordinary lifesavers in this pandemic, and we may well be heading into a new golden age of vaccine development. (This week, BioNTech started injections in an early trial for an mRNA vaccine for melanoma.) But even the best experts at predicting which drugs are going to be important get things wrong quite a bit, overestimating some treatments and underestimating others. Pharmaceuticals are generally a gamble.

But here’s what we know today, based on information that we have right now:  Among several wonderful options, the more old-school vaccine from Novavax combines ease of manufacture with high efficacy and lower side effects. For the moment, it’s the best COVID-19 vaccine we have.

https://www.theatlantic.com/health/archive/2021/...19-vaccine/619276/







 

Novavax-developed vaccine called CovovaxTM available in the Philippines Q3 2021

…“Manufacturing for CovovaxTM has started at Serum Institute of India, which is the largest manufacturer of vaccines in the world,” said Dr. Luningning Villa, medical director of Faberco. “The target delivery to the Philippines of the first batch of CovovaxTM vaccines is within the 3rd quarter of this year.”

Serum Institute of India has an exclusive agreement to manufacture CovovaxTM for low- and middle-income countries such as the Philippines, using the latest Covid-19 vaccine technology developed by Novovax.

https://businessmirror.com.ph/2021/06/25/...8R3Vtw66V1XyNiP7VW12Qujzo  

Novavax's COVID-19 vaccine Covovax

Vaccine manufacturer Serum Institute of India (SII) on Friday said it has started the production of first batch of Novavax's COVID-19 vaccine Covovax at its plant in Pune.

Earlier this month, Novavax Inc said its vaccine candidate 'NVX-CoV2373' demonstrated 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall, and met the primary endpoint in phase-III trials.

In a tweet, SII said it has reached a new milestone by beginning the production of Covovax….

https://www.businesstoday.in/current/...ine-covovax/story/442493.html  

WHO expects to give emergency approval to 1-2 more COVID-19 vaccines in coming months

The World Health Organization has received submissions from at least three vaccine makers for emergency approval for additional COVID-19 vaccines and expects to approve at least one or two of them in the next month or two, a top expert said on Friday.

Mariangela Simao, WHO assistant director-general for access to medicines and health products, did not specify which new vaccines were being considered. The WHO has so far given emergency approval to vaccines from Pfizer-BioNTech, AstraZeneca, Johnson & Johnson, Moderna, Sinopharm and Sinovac.

https://www.reuters.com/article/...kXmruY5G2BB8HALHmwgUp6KwMHruCBq2h0  

https://www.nasdaq.com/articles/...ap-stocks-on-the-planet-2021-06-27
"The crème de la crème of fast-growing large-cap companies is biotech stock Novavax (NASDAQ: NVAX). Following a pandemic-ravaged year where it brought in $476 million in sales, Wall Street is looking for Novavax to generate $5.8 billion in annual revenue in 2024. That's your run-of-the-mill sales increase of 1,118% over the coming four years.As you may have rightly guessed, Novavax's core catalyst is a coronavirus disease 2019 (COVID-19) vaccine. The company's candidate, NVX-CoV2373 (these scientific names just roll off the tongue), demonstrated nearly 90% efficacy in a large U.K. study, and recently reported a 90.4% trial efficacy in the United States. Though you'd think this was a cut-and-dried success story, Novavax has delayed its emergency-use authorization filings in Europe, the U.S., and U.K. until the third quarter, and it likely won't be at full production capacity till the fourth quarter....."  

gestartet - starke Daten auch gegen Virus-Varianten
"...Die Produktion hat nun begonnen: Der Kooperationspartner Serum Institute of India hat laut eigenen Angaben mit der Produktion einer ersten Charge des Impfstoffs am Standort in Pune begonnen. In Indien soll dieser unter dem Namen Covovax an den Markt kommen. Wie groß die Charge ist, teilt der indische Novavax-Partner nicht mit.

Zuletzt hatte Novavax bereits Fortschritte beim Aufbau der Impfstoff-Produktionskapazitäten in Kanada gemeldet. Dort wurde der Bau des neuen Biologics Manufacturing Centre am Standort Royalmount des National Research Council of Canada abgeschlossen. ....
Im dritten Quartal soll der Zulassungsantrag gestellt werden.
Trendwende in Sicht ?
https://www.4investors.de/nachrichten/...?sektion=stock&ID=153982  

https://www.4investors.de/nachrichten/...=stock&ID=154042#ref=rss  

https://www.finanzen.net/nachricht/aktien/...-wirksame-kombi-10250700
Das Medikament NVX-CoV2373 erreichte nach zwei Impfungen demnach eine Wirksamkeit von 90,4 Prozent. Auch in einer Kombination mit einem neuen Grippe-Impfstoff liege die Wirksamkeit bei knapp 90 Prozent. Im Herbst werde es hohen Bedarf an COVID-Impfstoff und zugleich hohe Nachfrage nach einem Schutz gegen Grippe geben, die Impfung könne zeitgleich hochwirksam erfolgen, so Konzernchef Stanley Erck...
Die Aktie stieg nach Bekanntgabe der Daten stark an. Sodann kündigten die Amerikaner eine Emission von Aktien im Umfang von 500 Millionen Dollar an.  

Auszug aus der Mitteilung:

"In einer bisher beispiellosen Studienumgebung mit 15 aufgetretenen Virusstämmen zum Zeitpunkt der finalen Analyse zeigte der Impfstoffkandidat CVnCoV insgesamt eine Wirksamkeit von 48% (83 Fälle in der Impfgruppe, 145 in der Placebogruppe) gegen eine COVID-19-Erkrankung jeglichen Schweregrades, darunter Fälle von moderaten und nicht notwendigerweise atemwegsbetreffenden Symptomen. Eine signifikante Schutzwirkung zeigte sich bei Studienteilnehmern in der Altersgruppe zwischen 18 und 60 Jahren. In dieser Gruppe erzielte der Impfstoffkandidat eine Wirksamkeit von 53% (71 Fälle in der Impfstoffgruppe, 36 in der Placebogruppe) gegen eine Erkrankung jeglichen Schweregrades und über alle Virusvarianten hinweg; es wurde eine Schutzwirkung von 77% (9 Fälle in der Impfstoffgruppe, 36 in der Placebogruppe) vor moderaten und schwerem Krankheitsverlauf errechnet."

Bleibt spannend, wie sich diese Nachricht auf Novavax auswirken wird.  

News von gestern:

Novavax Publishes Results of United Kingdom Phase 3 Clinical Trial in New England Journal of Medicine, Demonstrating High Levels of Efficacy of COVID-19 Vaccine

https://ir.novavax.com/...-Efficacy-of-COVID-19-Vaccine?sf146717139=1  

https://www.livemint.com/science/health/...n-pune-11624615861568.html
Serum Institute of India (SII) CEO Adar Poonawalla had said that clinical trials of the vaccine 'Covovax' have begun in India and the company hopes to launch it by September this year...he said the Novavax vaccine has "great potential to protect our future generations below the age of 18. Trials are ongoing." US-based Novavax Inc has a vaccine manufacturing agreement with Serum Institute of India,  

währenddessen macht der Kurs wieder die Biege Richtung Süden...  

and Biontech
https://seekingalpha.com/article/...split-for-an-inviting-opportunity
seekingalpha fragt, ob jetzt nicht ein Aktiensplit erfolgen sollte

"...The Novavax share price is trading at an irrational discount to the share prices of Moderna and BioNTech.The Novavax share price in the same share ratio to Moderna would trade at around $38 as a vivid demonstration of the irrational discount inherent to the Novavax share price.
Moderna and BioNtech were trading near $100 at the pre-EUA application stage which would indicate a trading range of close to $600 for Novavax to be on par with the trading ranges of BioNtech and Moderna at that same stage...Significant progress has been made since the share price low in early May 2021.....The Big One was the results of the Phase 3 trial in the USA and Mexico which were published on 14 June 2021. The results were exceptional with 100% efficacy against the original virus strain, 93% efficacy against a basket of Variants of Concern and Variants of Interest, 91% efficacy in high-risk populations and zero hospitalizations of vaccinated candidates.."
...2fache Kapitalerhöhung im Juni ohne Bezugsrechte..
Novavax hat auch einen Malaria Impfstoff in der Pipeline
FUJIFILM Diosynth Biotechnologies is manufacturing the Novavax vaccine at scale at its facilities in the UK, USA and Denmark....
 

https://www.godmode-trader.de/analyse/...iterer-kursexplosion,9564911