Novavax: Reasons To Believe Company Will Deliver Best-In-Class COVID-19 Vaccine (Seeking Alpha - Edmund Ingham)
Summary:
Novavax's share price has risen from $4, to $181 in 2020, and is now in decline, trading at $99.7 at the time of writing.
The company's promising SARS-Cov-2 vaccine has produced some of the most positive data to date, and Novavax has secured ~$2bn in development funding.
I put the share price decline down to the recent progress of treatments developed by pharmas GSK, AZN, and PFE, plus less favourable treatment from Operation Warp Speed.
I believe Novavax can secure approval for its COVID-19 vaccine, given its learnings from developing 2 late-stage vaccines for RSV and Flu, and expect to see its shares trade above $160 before the end of the year.
The longer-term downside case is severe, despite the RSV and flu opportunities, but I would not expect to see NVAX drop below $80 in 2020.
Novavax Stock Is Jumping Again on Positive New Data on Its Covid-19 Vaccine
... The Novavax vaccine is a relatively more proven approach compared with the more cutting-edge approaches employed by vaccines already in U.S. Phase 3 trials from AstraZeneca (AZN), Moderna (MRNA), and Pfizer (PFE). A flu vaccine under development by Novavax that uses the same technology succeeded in a Phase 3 trial in March.
GlaxoSmithKline (GSK) and Sanofi (SNY) are using an approach similar to that of Novavax in the Covid-19 vaccine they are jointly developing, but the companies aren’t as far along. They announced Thursday the start of their first in-human Phase 1 trial...
Banani
: FDA Commissioner Stephen Hahn and Novavax,
FDA Commissioner Stephen Hahn and Novavax, Inc.'s Stanley Erck
The Economic Club of Washington, D.C. will host a virtual Signature Event on Thursday, September 10, 2020 from 12:00 p.m. to 1:00 p.m. EDT. David Rubenstein will interview The Honorable Stephen M. Hahn, M.D., Commissioner of Food and Drugs of the Food and Drug Administration and Stanley C. Erck, President and Chief Executive Officer of Novavax, Inc. to discuss, among other things, the overall effects of the pandemic, the progression of vaccines and therapeutics, and the way forward.
The European Commission is in discussions with Novavax to add the company's COVID-19 vaccine candidate to its shopping list, Politico's Sarah Wheaton reports. Novavax's potential vaccine would be the 7th candidate for procurement from the EU, Wheaton notes.
A Coronavirus Vaccine, or Three, Could Be Available by Year-End
... Overall, we see probabilities of approval of 50%-70% for the leading programs--from Moderna, Pfizer/BioNTech, Astra/Oxford, and Novavax (NVAX)--with variation due to neutralizing antibody efficacy. Novavax’s efficacy looks the strongest, in our opinion, while Astra’s weaker preclinical data and tougher comparisons to convalescent sera in phase 1 could give it a slightly weaker probability of reaching efficacy thresholds in phase 3. Importantly, these four vaccines represent three different platforms, which we think should reduce any correlation between failure or success...
... Novavax phase 1 data was strong, and the very low dosage required could give the firm the ability to produce large supply of an antigen-based vaccine. This could be the first vaccine approved that uses a more established vaccine technology (as opposed to mRNA and viral vector technologies with other leading vaccine programs)...
Banani
: Biopharma Leaders Unite to Stand with Science
-- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines --
Novavax recently purchased the Prague Vaccines production plant in Bohumil in the Prague-East district. He intends to produce the coronavirus vaccine he is currently developing here. We asked Stanley Erck, CEO and President of Novavax, for details.
In addition to the already announced production of coronavirus vaccines, is the production of vaccines against other diseases planned in the Czech Republic?
The coronavirus vaccine is currently a priority for us in Czech production. We are working so that it can be prepared and approved as soon as possible. Our main goal now is to supply a functional vaccine to the market in an adequate amount, which is up to 1 billion doses of NVX-CoV2373, our COVID-19 vaccine, per year during the full operation of our Czech plant.
Of course, Novavax is also working on the development of other vaccines, and we are currently furthest with the development of NanoFlu, our influenza vaccine, which has shown positive results in the third phase of testing. After overcoming the current pandemic, we also plan to fully return to the production of a seasonal flu vaccine, which we will fully devote to the Czech plant near Prague. In other branches of Novavax, we also work on, for example, a vaccine against respiratory syncytial virus, Ebola or malaria.
How many employees does Novavax employ in its plant near Prague? Does it plan to hire more employees in the future?
Currently, the Czech production plant for Novavax employs 150 vaccine experts, but we plan to expand their team in the future. We are currently ready to put another 100 or more new employees into operation, both in the area of the production of the vaccine itself and in the area of disinfection of the plant premises or maintenance of production equipment.
The European Union is now negotiating agreements with potential manufacturers of coronavirus vaccine candidates, to be acceded to by the Member States. Is Novavax involved in these negotiations and how far are they?
As can be seen from some of the recent agreements, Novavax is already working with a number of countries to obtain vaccines for their people. We will continue to report on our further negotiations.
Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax’ Global Production Capacity to Over 2 Billion Doses Annually
-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
Cvirus.- Biofabri (Grupo Zendal) producirá en Europa la vacuna contra el Covid-19 de Novavax
... El grupo biofarmacéutico Zendal, a través de su filial Biofabri, ha sido el elegido por la compañía americana Novavax para la producción industrial de su vacuna contra el Covid-19, la enfermedad que provoca el nuevo coronavirus, en la Unión Europea....
... Der biopharmazeutische Konzern Zendal wurde über seine Tochtergesellschaft Biofabri von der amerikanischen Firma Novavax für die industrielle Herstellung seines Impfstoffs gegen Covid-19, die Krankheit, die das neue Coronavirus verursacht, in der Europäischen Union ausgewählt....
Die globale Produktionskapazität in großem Maßstab zu erweitern und das von Beginn an ist ein sehr wichtiger strategischer Schachzug, nur meine Meinung.
UN-Generalsekretär Guterres für 'Volksimpfstoff' gegen Corona
Wenige Tage vor der Generaldebatte der diesjährigen UN-Vollversammlung hat Generalsekretär António Guterres zum gemeinsamen Vorgehen bei der Entwicklung eines Impfstoffs gegen Covid-19 aufgerufen. "Wir brauchen einen Impfstoff, der erschwinglich und für alle verfügbar ist - einen Volksimpfstoff", sagte Guterres am Mittwoch in New York. Ein funktionierender Wirkstoff sei öffentliches Gut und dürfe nicht "nationalisiert" werden.
Guterres warb für die Initiative Covax der Weltgesundheitsorganisation WHO, die zu internationaler Zusammenarbeit bei der Herstellung eines Impfstoffs und gerechter Verteilung beitragen soll. Mehr als 170 Länder haben an dem Vorstoß UN-Angaben zufolge Interesse. Vor allem aber die USA gehen einen eigenen Weg.
India seeks up to 500 million coronavirus vaccine doses by July
... Serum Institute of India and private companies have been teaming up with organizations from the Bill & Melinda Gates Foundation to U.S. drug developer Novavax Inc in a scramble to secure vaccines for the country of 1.3 billion people...
With the supply pact, officials in Europe have lined up more than 1 billion potential coronavirus vaccine doses. Under the German EU presidency, the bloc has also finalised talks with Moderna, CureVac, Novavax and Pfizer/BioNTech partnership for additional doses.
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