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Moderna, Novavax, Inovio, BioNtech, 'RNA vaccin-producenten'

1. [verwijderd] 27 augustus 2020 13:57

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   Novavax CEO expects filing for COVID-19 vaccine approval in December: paper
   AUGUST 27, 2020 / 8:44 AM / UPDATED 4 HOURS AGO
   
   PRAGUE (Reuters) - Novavax Inc expects filing for approval of its COVID-19 vaccine candidate in the United States in December, Chief Executive Stanley Erck said in an interview for Czech daily Hospodarske Noviny, released on Thursday.
   
   The company plans to produce part of the vaccine at its Czech plant, which will give the country access to the product once it is approved, the paper cited Erck as saying.
   
   Novavax said on Monday it had begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020.
   www.reuters.com/article/us-health-cor...
2. MisterBlues 27 augustus 2020 13:58

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   voda schreef op 26 augustus 2020 18:08:

   Moderna tevreden met studieresultaten bij ouderen
   
   FONDS KOERS VERSCHIL VERSCHIL % BEURS
   Moderna Inc
   $ 70,23 3,98 6,01 % NASDAQ
   
   (ABM FN-Dow Jones) Moderna heeft met zijn experimentele coronavaccin een zelfde immuunreactie bij mensen ouder dan 56 jaar gerealiseerd als bij jongere mensen. Dit bleek woensdag uit een presentatie die het biotechbedrijf gaf.
   
   Vooral oudere mensen lopen meer risico om door corona in het ziekenhuis te belanden. En omdat het immuunsysteem zwakker wordt naarmate mensen ouder worden, waren er twijfels of het coronavaccin waaraan Moderna werkt, wel net goed zou werken bij oudere mensen als de relatief kleine studie bij jongere mensen aantoonde.
   
   Na ongeveer 4 weken nadat de proefpersonen ouder dan 56 jaar een tweede toediening met het vaccin kregen, lieten zij zogeheten neutraliserende antilichamen zien. De reactie was daarbij vergelijkbaar als bij die van jongere mensen.
   
   Het aandeel Moderna noteert woensdag 3,5 procent hoger.
   
   Door: ABM Financial News.
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   © Copyright ABM Financial News B.V. All rights reserved.
   

   Het is nog een lange weg van 10 proefpersonen naar duizenden...We wachten op de peer review.
   
   KEY FACTS
   
   Older adults are at higher risk of hospitalization and death from Covid-19 than younger people and, because the immune system usually weakens with age, it can be harder for a vaccine to be effective, according to the U.S. Centers for Disease Control and Prevention.
   
   Moderna, which reported in July that its vaccine induced immune response and was generally safe and well tolerated in adults aged 18 to 55, said during a presentation to medical experts and advisors that it had expanded its study to a small group of older adults.
   
   Moderna tested its vaccine on 10 adults between the ages of 56 and 70 and 10 adults aged 71 and older and found that the older volunteers developed antibodies in a similar range as the younger volunteers; Moderna said the vaccine was well-tolerated with no serious side effects reported.
   
   Moderna presented the data, which has yet to be peer reviewed, Wednesday to a committee of outside experts to advise the U.S. Centers for Disease Control and Prevention on vaccine practices.
   
   Earlier this month, President Trump said the U.S. government will purchase 100 million doses of Moderna’s coronavirus vaccine candidate for $1.5 billion as part of Operation Warp Speed which hopes to find at least one safe, effective vaccine by the end of the year.
   
   The goal of the federal government’s Operation Warp Speed initiative is to spur the production of promising vaccine candidates and to buy initial batches so they can be distributed as soon as a candidate is approved.
   tangent
   
   The White House has made similar deals over the last few months with other companies developing vaccines, including Johnson & Johnson, Pfizer, Novavax, AstraZeneca and GlaxoSmithKline and Sanofi. The U.S. had already given $955 million to help Moderna research develop its vaccine through the Biomedical Advanced Research and Development Authority.
   what to watch for
   
   Although a vaccine might be proven safe and effective by early next year, Dr. Anthony Fauci said last month he doesn’t anticipate widespread availability with hundreds of millions of doses until “several months” into 2021.
   big number
   
   $2.1 billion. That’s Moderna CEO Stéphane Bancel’s net worth, according to Forbes estimates. He became a billionaire in April as Moderna stock jumped after announcing it expected to begin Phase 2 human trials for its Covid-19 vaccine.
3. MisterBlues 27 augustus 2020 18:51

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   quote:

   hosternokke schreef op 27 augustus 2020 13:57:

   Novavax CEO expects filing for COVID-19 vaccine approval in December: paper
   AUGUST 27, 2020 / 8:44 AM / UPDATED 4 HOURS AGO
   
   PRAGUE (Reuters) - Novavax Inc expects filing for approval of its COVID-19 vaccine candidate in the United States in December, Chief Executive Stanley Erck said in an interview for Czech daily Hospodarske Noviny, released on Thursday.
   
   The company plans to produce part of the vaccine at its Czech plant, which will give the country access to the product once it is approved, the paper cited Erck as saying.
   
   Novavax said on Monday it had begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020.
   www.reuters.com/article/us-health-cor...
   

   @Hosterrrnokke, het ligt voor de hand dat goede berichten van de concurrenten zullen leiden tot winstneming bij Novavax dat in een paar maanden groeide met 3000%. Je zou dan ook wel gek zijn om geen winst te nemen of in ieder geval ten delen. Ik denk dat Novavax nog veel gaat verliezen als de berichten rond Moderna, Oxford etc positief blijven.
   
   VBIV is overigens weer omhoog geschoten...
   
   Ben jij je goed aan het inlezen rond Novavax? Hoor graag van je...
4. MisterBlues 28 augustus 2020 11:10

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   MisterBlues schreef op 27 augustus 2020 18:51:

   [...]
   
   VBIV is overigens weer omhoog geschoten...
   
   

   Raymond James upgraded VBI Vaccines to "strong buy" from "outperform" and raised price target to $9 saying VBI's COVID-19 vaccine "looks like it could be the best vaccine of them all"
   * VBIV's enveloped virus-like particle vaccine leads to a relatively greater neutralizing antibody titer in rodents vs a recombinant pre-fusion spike protein-based vaccine, the brokerage added
   * VBIV on Wednesday had selected two vaccine candidates for COVID-19 for early- to mid-stage trial that is expected to begin around the year-end...
   * Raymond James also suggested that VBI may now get a serious look from Operation Warp Speed regarding funding
   * All four brokerages covering VBIV rate the stock "buy" or higher.
   
   Investors shouldn't have to wait for too long to know how VBI's COVID-19 vaccine fares in clinical testing. The company has selected two vaccine candidates to advance into a phase 1/2 clinical study. Assuming VBI receives a green light from the FDA, the study will likely begin in late 2020.
   
   Other companies like Moderna and Pfizer are all ready in phase3 testing. There won’t be any interest in their vaccine once the market is saturated with others.
5. voda 28 augustus 2020 13:46

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   Moderna in gesprek met Japan over coronavaccin
   
   FONDS KOERS VERSCHIL VERSCHIL % BEURS
   Moderna Inc
   $ 68,03 0,00 0,00 % NASDAQ
   Takeda Pharmaceutical Company Ltd
   --- --- --- Handmatige afwikkeling
   
   (ABM FN-Dow Jones) Het Amerikaanse biotechbedrijf Moderna is in gesprek met het Japanse ministerie van volksgezondheid over de levering van 40 miljoen coronavaccins. Dit bevestigde het bedrijf vrijdagmiddag nadat de Japanse minister Kato Katsunobu daarover communiceerde in nationale media.
   
   Het vaccin zal door Moderna geleverde worden, terwijl Takeda Pharmaceutical verantwoordelijk zal zijn voor de distributie.
   
   Moderna zou de vaccins vanaf de eerste helft van 2021 leveren, als het vaccin de goedkeuring van de regelgevende instanties krijgt.
   
   Door: ABM Financial News.
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6. [verwijderd] 29 augustus 2020 18:46

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   quote:

   MisterBlues schreef op 27 augustus 2020 18:51:

   [...]
   
   @Hosterrrnokke, het ligt voor de hand dat goede berichten van de concurrenten zullen leiden tot winstneming bij Novavax dat in een paar maanden groeide met 3000%. Je zou dan ook wel gek zijn om geen winst te nemen of in ieder geval ten delen. Ik denk dat Novavax nog veel gaat verliezen als de berichten rond Moderna, Oxford etc positief blijven.
   
   VBIV is overigens weer omhoog geschoten...
   
   Ben jij je goed aan het inlezen rond Novavax? Hoor graag van je...
   

   Zoals eerder vermeld volg ik vooral de mening van Dirk Haussecker @RNAiAnalyst en gelijken. Rationeel gezien lijkt NVAX de betere papieren te hebben. Ben klein ingestapt, bij goed nieuws koop ik pas bij. Dit gaat nog even duren. Moderna en Oxford hebben zo hun issues begrijp ik maar wel een politieke de wind in de rug.
   
7. MisterBlues 30 augustus 2020 14:08

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   hosternokke schreef op 29 augustus 2020 18:46:

   [...]
   Zoals eerder vermeld volg ik vooral de mening van Dirk Haussecker @RNAiAnalyst en gelijken. Rationeel gezien lijkt NVAX de betere papieren te hebben. Ben klein ingestapt, bij goed nieuws koop ik pas bij. Dit gaat nog even duren. Moderna en Oxford hebben zo hun issues begrijp ik maar wel een politieke de wind in de rug.
   
   

   Ik heb zijn artikeltje gedownload. Bij goed nieuws ben je te laat, vrees ik.
   
   Als ze zakken beneden 100 koop ik een plukje bij in de wetenschap dat ze het antistof-rijkste vaccin hebben, bovendien meer pijlen op hun boog.
8. MisterBlues 31 augustus 2020 15:47

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   Novavax and Canada Reach Agreement in Principle to Acquire Novavax’ COVID-19 Vaccine
   Aug 31, 2020 at 8:55 AM EDT
   Download PDF
   
   • Canadian government to purchase up to 76 million doses of NVX-CoV2373
   
   GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine.
   
   “We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world.”
   
   “We are pleased to announce this agreement with Novavax, which will give Canadians access to a promising COVID-19 vaccine candidate. This is an important step in our government’s efforts to secure a vaccine to keep Canadians safe and healthy, as the global pandemic evolves,” said The Honourable Anita Anand, Minister of Public Services and Procurement, Government of Canada.
   
   Novavax and Canada expect to finalize an advance purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning as early as the second quarter of 2021. This purchase arrangement will be subject to licensure of the Novavax vaccine by Health Canada.
   
   NVX-CoV2373 is currently in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August in the United States and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial population. Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy began in South Africa in August.
9. MisterBlues 31 augustus 2020 17:06

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   COULD VBIV VACCINE CANDIDATES BE A GAME CHANGER..?
   
   VBI Vaccines (VBIV) is an almost-$1 billion company with less than $2 million in annual sales. It also might be the creator of the best vaccine of all for preventing coronavirus. At least, that's what investment firm Raymond James thinks.
   
   On Wednesday, 5-star Raymond James analyst Steven Seedhouse upgraded VBI Vaccines stock to "strong buy" on the strength of the company's enveloped virus-like particle (eVLP) vaccine against COVID-19, saying it "might" be "the best" COVID vaccine out there -- and sparking a 32% price rally in VBI's stock Thursday.
   
   As Seedhouse explains, when you're gauging the effectiveness of a vaccine, it's essential to focus on the production of "neutralizing antibodies" (NAb), which are "the only reliable correlate of protection in primate SARS-CoV-2 challenge experiments." Which is to say, higher NAb numbers translate directly into both "greater vaccine effectiveness" and "potentially greater durability of protection" over time.
   
   In that regard, Seedhouse notes that VBI's vaccine produces "an order of magnitude greater" number of NAb versus recombinant pre-fusion spike protein-based vaccines, a difference that the analyst calls "striking." More than that, Seedhouse hypothesizes that as VBI experiments with "adjuvant optimization" (i.e. using alternative molecules, compounds, or macromolecular complexes to boost the effectiveness of a vaccine), it's possible that the company's vaccine could end up being either: (a) "2 orders of magnitude more potent at driving NAb titers than leading vaccines" from Moderna, Pfizer, or AstraZeneca (i.e. 100x more effective at producing neutralizing antibodies) or (b) strong enough that a single dose of the vaccine could prove more effective than two doses of one of the alternatives, administered weeks apart.
   
   Seedhouse even notes that VBI is working on a trivalent vaccine that might protect patients from both the novel coronavirus SARS-CoV-2 and the original SARS coronavirus and the MERS coronavirus as well!
   
   Now, before we get too excited, a few caveats may be in order. First and foremost, VBI's vaccine is a long way away from undergoing Phase 3 clinical trials. In fact, so far it's apparently only been tested on rats -- although Phase 1/2 clinical trials may begin before 2020 is over. And while Seedhouse titles his report "Warp Speed Take Note, This Might Be the Best COVID Vaccine," the analyst later concedes that the government's Operation Warp Speed hasn't actually taken note just yet, although he hopes that VBI will soon be "getting a serious look from OWS at this point given the data."
   
   Overall, Seedhouse is enthused about VBI's prospects, and says the stock could be worth $9, if everything goes as planned. (To watch Seedhouse's track record, click here)
   
   It’s not often that the analysts all agree on a stock, so when it does happen, take note. VBIV’s Strong Buy consensus rating is based on a unanimous 4 Buys. The stock’s $6.75 average price target suggests a 59% upside from the current share price of $4.25. (See VBIV stock analysis on TipRanks)
   
   May be wishful thinking, but considering the rally Thursday... and subsequent "EXPOSURE" this company has received since then, I suspect we're on "everyone's radar" screen, and may very well see some serious buying come Monday... Watch the volume... The current share price is attractive, and the upside is, well, you decide for yourself...
   
   POINT OF REFERENCE: On 3/16/20 Novavax (NVAX)...as an illustration, was a $5.00 stock... On 8/10/20 it hit an unprecedented high of $181.70... What has NVAX accomplished, other than a Phase I/II study...? My point being is that this market is trading on volatility....and not on fundamentals... I personally feel that VBIV's vaccine candidates VBI-2901 and VBI-2902 surpass what NVAX has accomplished to date.
   
   Not 2 weeks ago the President introduced "Convalescent Plasma", the antibody rich blood plasma taken from those individuals who have recovered from Covid-19... Is there a correlation between antibody rich blood plasma, and... VBI-2901 and VBI-2902...???? Hmmmmm
   
   At any rate, you'll note that shortly after that announcement, ALL BIOTECH BIT THE DUST...
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   jase
   
   11 hours ago
   @Bob Smith you very quickly escalate trials. It’s not like there’s a shortage of patients. I think what a lot of people don’t understand that jumped on the COVID band wagon, is that the early vaccines flying along are non living vectors and there was zero risk of viral enhancement. We just got lucky because it wasn’t killing at a 10+ % rate, or higher god forbid. IF we seen a 30% kill rate of SARS COV 2 you woulda had those non living vector vaccines even pumped out faster than they have been. INO, MRNA, they won’t be even at mid pack for efficacy more like low end. NVAX had 80% grade 3 AE’s, that’s not great. We will be better than NVAX for sure.
   Jay
   15 hours ago
10. voda 4 september 2020 18:07

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    Kleine vertraging patientenwerving Moderna - media
    
    FONDS KOERS VERSCHIL VERSCHIL % BEURS
    Moderna Inc
    $ 62,22 -2,62 -4,04 % NASDAQ
    
    (ABM FN-Dow Jones) De onderzoeksstudie van Moderna om een mogelijk coronavaccin te testen loopt een kleine vertraging op omdat het Amerikaanse farmabedrijf ook voldoende minderheden wil laten deelnemen aan het onderzoek. Dit meldde CNBC vrijdag.
    
    Moderna wil het vaccin onder 30.000 deelnemers in de Verenigde Staten testen op werkzaamheid en veiligheid. Eind augustus had men ruim 17.000 deelnemers geworven.
    
    Volgens CEO Stephane Bancel is het van belang dat ouderen, gekleurde gemeenschappen en mensen met onderliggende medische problemen goed zijn vertegenwoordigd in de studie.
    
    Het aandeel Moderna noteerde vrijdag bijna 6 procent in de min.
    
    Door: ABM Financial News.
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12. MisterBlues 4 september 2020 20:01

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    voda schreef op 4 september 2020 18:07:

    Kleine vertraging patientenwerving Moderna - media
    
    FONDS KOERS VERSCHIL VERSCHIL % BEURS
    Moderna Inc
    $ 62,22 -2,62 -4,04 % NASDAQ
    
    (ABM FN-Dow Jones) De onderzoeksstudie van Moderna om een mogelijk coronavaccin te testen loopt een kleine vertraging op omdat het Amerikaanse farmabedrijf ook voldoende minderheden wil laten deelnemen aan het onderzoek. Dit meldde CNBC vrijdag.
    
    Moderna wil het vaccin onder 30.000 deelnemers in de Verenigde Staten testen op werkzaamheid en veiligheid. Eind augustus had men ruim 17.000 deelnemers geworven.
    
    Volgens CEO Stephane Bancel is het van belang dat ouderen, gekleurde gemeenschappen en mensen met onderliggende medische problemen goed zijn vertegenwoordigd in de studie.
    
    Het aandeel Moderna noteerde vrijdag bijna 6 procent in de min.
    
    Door: ABM Financial News.
    info@abmfn.nl
    Redactie: +31(0)20 26 28 999
    
    © Copyright ABM Financial News B.V. All rights reserved.
    

    Yesterday, the CDC told states to prepare for distribution of a Covid-19 vaccine as soon as November. While this may seem like good news, many experts sounded the alarm that vaccine safety and efficacy trials might not be complete by that date. Some also wondered if it was a coincidence that the White House was pushing for a vaccine to come out right before the Presidential election on November 3rd. Today, Health and Human Services Secretary Alex Azar denied that the move was politically motivated and said that any vaccine that comes out will meet rigorous FDA standards.
    
    Meanwhile Dr. Anthony Fauci said that it is “conceivable” that a vaccine could be ready for production by next month, though that timeframe is unlikely. He says that November or December is a more realistic time to expect a vaccine.
13. MisterBlues 7 september 2020 12:24

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    The trust in Vaccines may take a big hit the coming Weeks / Months. A Vaccine induced Polio outbreak just started in Africa. Yes you did read that right, the outbreak was caused by the very Vaccine which should have protected them against Polio.
    
    www.who.int/csr/don/01-september-2020...
    
    4 minutes ago
    amp.theguardian.com/commentisfree/202...
14. MisterBlues 9 september 2020 08:33

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    BioNtech wordt winnaar
    
    BNTX reportedly escalated an approximately 5.9% to $62.03 in pre-market trading after the company and Pfizer said to have received approval for German part of global Phase 2/3 study with Covid-19 vaccine candidate BNT162B. Bulls seems to be finding its groove in here!
    
    psce.pw/insanestockalerts
    
    
15. MisterBlues 10 september 2020 11:41

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    Novavax and the catalysts
    
    I have dry powder now, (so I'm not speaking to you longs who only hold and only pump, ok?) so the question on my mind is where and when are the news catalysts?
    1. EU funding appears to be in play BUT IT ISN'T SOLID INFORMATION. We have a tweet from Sarah Wheaton of Politico that NVAX MAY have entered into negotiations with the EU on Friday. I feel that an announcement could come suddenly and unexpectedly anyday (like the agreement with Pfizer did today). The problem is it probably won't have a dollar sign attached (like the Canada announcement), so we'll likely see a pop and a drop.
    2. Covax: Won't be announced until between Sept 18 to Oct 9 as previously published. At last report they had 1.6 of a 2.4 B goal to be allocated between 9 to possibly 18 countries. We don't know if they've met their funding goal or whether they're waiting for clinical trials. But keep those dates on your calendar.
    3. P2 results: I remember reading somewhere about Erck or Glenn talking about maybe releasing interim results, but I don't have my hopes resting on that at all. We didn't get that from P1. I was surprised to read the news story from S.Africa about no side effects after the first dose (I consider that a bonus). Releasing interim results from a double-blinded placebo-controlled study would be a breach of protocol imho.
    4. Other Nations: There's always a chance that some country we haven't thought of yet will sign a deal with NVAX. Argentina? UAE? Australia? ...you get the point.
    5. Competition: Astra Zeneca is the eg. Didn't see that one coming.
    6. Miscellaneous: Any and all things which skip my mind at the moment or things nobody can foresee. Feel free to add your opinion.
    Until we get news, I'm of the opinion we're range-bound and going to drift around here at the mercy of the big boys with these 10 to 15 point intraday swings. Even with news (before P2) it's unlikely (unless a $ amount is attached) that the SP will hold.
    I think as so many have tried to tell us that using a portion to day trade or swing trade is a really wise decision. So often this thing has dipped into the high 80's/low 90's. If you can afford it, you could make a nice hunk of change every few days flipping it based on the patterns. If you get caught, and you're in it for the long haul anyways, what do have to lose?
    
16. MisterBlues 10 september 2020 11:42

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    Novavax and the catalysts 2
    
    J&J is using the same platform as AstraZeneca.
    
    Operation Warp Speed Platforms- RNA platform (MRNA, PFE/BNTX), live vector platform (AZN, JNJ), protein-based (NVAX, SNY/GSK), and attenuated live vector platform (Merck)
    
    Novavax has a proven platform via the NanoFlu trial.
    
    Nvax is going to be a major player in vaccines in the future, after licensing and distributing Cvx2373 for Covid on a massive scale, and then NanoFlu, and subsequently a host of vaccines on its exceptional platform. Visit the Novavax website to read more about their platform and pipeline.
    
    After Covid infectious disease companies, especially one which produced a vaccine for Covid are going to be hot companies for years to come. No government will want to see a repeat of this type of devastation.
    
    If phase goes as planned and based on stable platform for a phase 3 then NVAX most probably going for a quick EU.
    
17. MisterBlues 10 september 2020 11:43

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    @hosterrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrnokke, koop je bij?
18. [verwijderd] 10 september 2020 15:23

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    Misschien. Misschien ook niet.
    ;-)
19. MisterBlues 14 september 2020 11:16

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    Oxford’s COVID-19 vaccine trial resumes in UK
    
    A UK regulatory body has recommended Oxford's COVID-19 vaccine trial recommence
    A UK regulatory body has recommended Oxford's COVID-19 vaccine trial recommence
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    Following a swift independent investigation by the Medicines Health Regulatory Authority (MHRA), large-scale Phase 3 trials for a COVID-19 vaccine developed by scientists at the University of Oxford, are recommencing across the United Kingdom after a suspected adverse reaction triggered a global halt to trials last week.
    
    This COVID-19 vaccine, dubbed AZD1222, aka ChAdOx1 nCoV-19, is being developed in association with biopharmaceutical company AstraZeneca and is one of several currently in late-stage Phase 3 trials. The voluntary pause was triggered on September 6 after a standard review identified an adverse reaction in one subject.
    
    “Globally some 18,000 individuals have received study vaccines as part of the trial,” the University of Oxford said in a recent statement. “In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.”
    
    The details of the adverse reaction are still unclear but StatNews has reported the CEO of AstraZeneca said to investors privately the subject was experiencing neurological symptoms consistent with an inflammatory spinal condition called transverse myelitis.
    
    It is standard procedure to pause clinical trials when abnormal conditions appear. Subsequent investigations then consider whether the drug, or vaccine, being tested can be linked to the negative health condition.
    
    In this instance, a rapid review by the MHRA led to a recommendation the trials be restarted. As the MHRA only regulate activities in the UK, the vaccine trials halted in other parts of the world are still on pause until their respective regulatory bodies complete investigations.
    
    “AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information,” AstraZeneca said in a statement. “All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.”
20. MisterBlues 15 september 2020 13:10

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    Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax’ Global Production Capacity to Over 2 Billion Doses Annually
    Sep 15, 2020 at 7:00 AM EDT
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    Serum Institute of India to manufacture ~1 billion doses of NVX-CoV2373 in 2021
    
    Increases global manufacturing capacity for NVX-CoV2373 to over 2 billion annualized doses when at full capacity in 2021
    
    Agreement expands Novavax partnership with world’s largest vaccine developer to increase global delivery of NVX-CoV2373
    
    GAITHERSBURG, Md., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. With this agreement, Novavax increases its manufacturing capacity of NVX-CoV2373 to over two billion doses annually, when all planned capacity has been brought online by mid-2021. NVX-CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix-M™ adjuvant.
    
    “Today’s agreement with Serum Institute enhances Novavax’ commitment to equitable global delivery of our COVID-19 vaccine. With this arrangement, we have now put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling production on three continents,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We continue to work with extraordinary urgency to develop our vaccine, now in Phase 2 clinical trials, and for which we anticipate starting Phase 3 efficacy trials around the world in the coming weeks.”
    
    The agreement with SIIPL augments a global supply chain that will deliver over two billion doses of NVX-CoV2373 annually as of 2021.
    
    The antigen component of NVX-CoV2373 is being manufactured at Novavax CZ in Bohumil, Czech Republic (formerly Praha Vaccines), as well as at the following partnered manufacturing sites:
    
    Biofabri in Spain
    FUJIFILM Diosynth Biotechnologies (FDB) in both North Carolina and Texas in the United States
    FDB in the United Kingdom
    SIIPL in India
    SK Bioscience in the Republic of Korea
    Takeda Pharmaceutical Company Limited in Japan
    
    Novavax’ Matrix-M adjuvant is now being manufactured at Novavax AB in Uppsala, Sweden and the following partnered manufacturing sites:
    
    AGC Biologics in the United States and Denmark
    PolyPeptide Group will manufacture two key intermediaries used in Matrix-M in the United States and Sweden
    
    “Signing of the manufacturing agreement with Novavax for NVX-CoV2373 is another great milestone for both companies, which will further strengthen our existing relationship. SIIPL expertise to scale-up and manufacture NVX-CoV2373 will help ensure the supply of this most-needed vaccine,” said Adar Poonawalla, Chief Executive Officer of Serum Institute of India.
    
    About NVX-CoV2373
    
    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX-CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August 2020. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
    
    About Matrix-M™
    
    Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
21. voda 17 september 2020 07:33

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    Moderna werkt samen met Vertex tegen taaislijmziekte
    
    FONDS KOERS VERSCHIL VERSCHIL % BEURS
    Moderna Inc
    $ 68,80 1,92 2,87 % NASDAQ
    
    (ABM FN-Dow Jones) Moderna is een samenwerking aangegaan met Vertex voor de behandeling van taaislijmziekte met behulp van genmanipulatie. Dit maakte Moderna woensdagavond laat bekend.
    
    Moderna en Vertex werkten al samen aan Moderna's mRNA en LNP-technologie. Moderna ontvangt van Vertex een vooruitbetaling van 75 miljoen dollar, waarna extra betalingen volgen mits bepaalde doelstellingen worden gehaald.
    
    In een separaat persbericht kondigde Moderna ook de samenwerking aan met Chiesi Group om mRNA-therapieën te onderzoeken en te ontwikkelen tegen de zeldzame, progressieve longziekte pulmonale hypertensie.
    
    Door: ABM Financial News.
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