...Poland's Mabion aims to start production of U.S. firm Novavax's coronavirus vaccine for Europe from the third quarter, representatives of the biotechnology company said.
... Mabion would produce the active substance of the COVID-19 vaccine in the form of a recombinant virus protein. The active ingredient will be sent in 10 litre bags to a company in Germany, where the fill and finish will take place.
... "The product will be distributed in Europe," Mabion representatives added.
... Mabion, which will be one of three Novavax's vaccine producers in the European Union, has not revealed the size of the production, but said its 2,500 litre bioreactor is one of the largest in Europe.
Mabion and Novavax have not yet signed a final commercial agreement, but initial financial conditions have been agreed, the Polish company said. (Reporting by Agnieszka Barteczko and Anna Koper; editing by Jason Neely)
EXCLUSIVE-Fauci says U.S. may not need AstraZeneca COVID-19 vaccine
... Asked whether the United States will use the AstraZeneca vaccine doses, he said, "That's still up in the air. My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfill all of our needs without invoking AstraZeneca."
... Also in March, a U.S. health agency said data from the company gave an incomplete picture of its efficacy. Days later AstraZeneca published results showing diminished, though still strong, efficacy.
Fauci said that "If you look at the numbers (of doses) that we're going to be getting, the amount that you can get from J&J, from Novavax from Moderna if we contract for more, it is likely that we can handle any boost that we need, but I can't say definitely for sure."
...We were a small company' Novavax expects to apply for emergency use authorization for its Covid-19 vaccine sometime in the second quarter of this year. But the company is already manufacturing the vaccine at 10 sites in eight countries -- with two sites in the United States: North Carolina and Texas.
"They're all at different stages," Glenn said. "Some are earlier, but all are up and running and working on the vaccine. So, we expect to have a very large capacity."
Novavax's coronavirus vaccine was not among the first authorized in the United States because the company had to build the staff needed to develop such a new vaccine, Glenn said.
"We were a small company," he said, in comparison with some of the larger vaccine makers such as Pfizer and Johnson & Johnson.
"We had to recruit people, and our funding was kind of low," he said. "In addition to all the challenges of developing the vaccine, which is really complicated, we had the challenge to build a company."
But Novavax has "reached a really good point now," Glenn said.
-Crossover allows participants to continue in trials and remain blinded -Ensures that all trial participants receive active vaccine -South Africa and UK crossover arms initiated; US/Mexico PREVENT-19 crossover planned
Novavax to expand COVID-19 vaccine trials to children, teens
Novavax Inc. NVAX, -4.59% said late Monday it plans to expand its COVID-19 vaccine trials to include children and teens by the second quarter. The biotech also said it will start crossover trials in its ongoing trials of the vaccine candidate. The crossover will ensure that all participants in the trials, including U.S. participants, will receive an active vaccine candidate, the company said. The trials will remain blind to preserve the ability to assess their efficacy, Novavax said. Shares of Novavax rose 0.9% in the extended session Monday after closing down 4.6% in the regular session. Novavax said last month it hoped to get an emergency-use authorization from the FDA in May.
... ?The concept here is to allow for the flexibility to provide third-party provided services to the employees, that could also activate the street frontages along Bank Street or Firstfield, if desired,? she said.
Block 3 of the sketch plan covers two existing buildings on Bank Street and expands their uses to include R&D and integrated light manufacturing.
... When Council Member Mike Sesma asked on Monday how many people would work on the campus, Novavax Project Engineer Tarek Kalaaji said it would be more than 1,000, including the expected addition of 400 employees.
The City Council plans to accept public comments until May 14 and hold a policy discussion on June 7. The Planning Commission will accept comments through April 23 and make its recommendation to the council on May 5.
... The vaccine rollout in France has been badly managed, he said,
... ?The French are fed up,? and if the current four-week lockdown doesn?t lift in May as scheduled, he fears ?another revolution.?
... Compounding Europe?s vaccine supply issues is the fact that the AstraZeneca shot ? use of which was temporarily suspended last month by a dozen countries out of fears it might be linked to blood clots ? is once again in limbo.
.., On Wednesday, however, the EMA walked back that news, stressing again that the benefits outweigh the risks.
... AstraZeneca vaccine as of mid-March, the agency said 84 had developed blood clots resulting in 18 deaths. Those numbers were enough, however, to convince the British health agency to issue recommendations Wednesday to stop using the vaccine for those under 30 years of age, and for AstraZeneca to put the brakes on clinical studies of the vaccine on children.
... At the same time, the European Commission, which oversees vaccine purchases for the EU, is dismayed that while AstraZeneca has not delivered its promised shipments to the bloc, some 77 million doses of vaccines manufactured in Europe were being shipped off to other countries, including to Britain, where 48 percent of the population has already received at least one shot of a vaccine. At one point last week, the European Commission threatened to block exports of all AstraZeneca doses until the company made good on its promised deliveries.
... Unhappy with the amount of vaccine allotted to Austria, that country?s Chancellor Sebastian Kurz last week threatened to block the European Commission from buying an additional 100 million doses of the Pfizer-BioNTech vaccine ? ultimately dropping that idea and announcing that he was instead negotiating the purchase of a million doses of the Russian vaccine that hasn?t been approved for use in the EU.
... French President Emmanuel Macron and German Chancellor Angela Merkel also placed a joint call last week to Russian President Vladimir Putin during which they discussed the possibility of purchasing his shot.
... But Russia?s Sputnik V vaccine, which is currently employed in several Eastern European immunization programs despite not yet being green-lit by the European Medicines Agency,
... The Lancet, the highly respected medical journal, reported in February that the Sputnik inoculation has efficacy rates of 91 percent, but Slovakia?s national health agency is currently refusing to authorize Sputnik?s use there, saying that the vaccine delivered this week is not the same vaccine studied by the Lancet.
... What?s more, as he told Le Parisien, he expects Europe "will become the world's leading vaccine producer by the end of the year, with a volume that could reach 3 billion doses per year, compared to 2 billion for the US."
... This is a propaganda coup for Russia in trying to split the EU ? by demonstrating that the EU is not able to take care of its population,? said Jamie Shea, senior fellow at the Brussels-based think tank Friends of Europe and a former deputy assistant secretary general for emerging security challenges of NATO. He added that given the relatively small production of the Sputnik vaccine and its limited use in Europe, that ?the coup is disproportionate to the actual role that it?s really playing.?
Dänemark will die Impfung mit AstraZeneca vollständig einstellen:
Denmark to ditch AstraZeneca shot, delaying vaccine rollout - media
...Denmark on Wednesday will become the first country to entirely cease administering AstraZeneca?s COVID-19 vaccine following its possible link to very rare cases of blood clots, several Danish media outlets reported on Wednesday, citing unnamed sources.
AstraZeneca and J&J vaccine contracts at expiry: paper
The EU Commission has decided not to renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson (J&J), Italian daily La Stampa reported on Wednesday, citing a source from the Italian health ministry.
?The European Commission, in agreement with the leaders of many (EU) countries, has decided that the contracts with the companies that produce (viral vector) vaccines that are valid for the current year will not be renewed at their expiry,? the newspaper reported.....
Results could allow more flexibility in giving second shots
...A major U.K. trial looking at whether COVID-19 vaccines can be safely mixed has been expanded to include shots made by Moderna and Novavax, researchers announced on Wednesday.
...The expanded study will look to recruit adults aged over 50 who have received their first vaccination in the past eight to 12 weeks.
... The six new ?arms? of the trial will each involve 175 people, bringing the total number of participants in the trial to 1,050.
Working across eight sites in the U.K., researchers will monitor the immune system responses, as well as any adverse reactions, such as fever, to these new combinations of vaccines. The trial is designed as a so-called ?non-inferiority? study, which means its intent is to demonstrate that mixing isn?t substantially worse than not mixing.
?If we can show that these mixed schedules generate an immune response that is as good as the standard schedules, and without a significant increase in the vaccine reactions, this will potentially allow more people to complete their COVID-19 immunization course more rapidly,? said Matthew Snape, associate professor in pediatrics and vaccinology at the University of Oxford and chief investigator on the trial, in a statement.
?This would also create resilience within the system in the event of a shortfall in availability of any of the vaccines,? Snape added.
with Pfizer and Moderna vaccine as with AstraZeneca's: study
A study by Oxford University found the number of people who receive blood clots after getting vaccinated with a coronavirus vaccine are about the same for those who get Pfizer PFE, +1.16% and Moderna MRNA, -0.10% vaccines as they are for the AstraZeneca AZN, +1.99% vaccine that was produced with the university's help. According to the study, 4 in 1 million people experience cerebral venous thrombosis after getting the Pfizer or Moderna vaccine, versus 5 in 1 million people for the AstraZeneca vaccine. The risk of getting CVT is much higher for those who get COVID-19 -- 39 in a million patients -- than it is for those for get vaccinated. AstraZeneca's vaccine use has been halted or limited in many countries on blood clot concerns.
Impfstoffe: EU, Verhandlungen für Novavax werden fortgesetzt
ANSA) - BRÜSSEL, 16. APRIL - "Die Verhandlungen mit der Novavax-Impfstofffirma werden fortgesetzt. Wir werden Sie über den Abschluss eines Vertrags auf dem Laufenden halten." Dies erklärte einer der Sprecher der Europäischen Kommission. (GRIFF).
Covid: EU, Verhandlungen mit NovaVax über den angestrebten Impfstoffkauf von 100 Millionen Dosen des Impfstoffs Nvx-CoV2373 auf der Grundlage der Verwendung von Proteinen werden fortgesetzt.
Die Verhandlungen zwischen der Europäischen Kommission und dem US-amerikanischen Unternehmen NovaVax über den Abschluss eines Vertrags über den Kauf des Anti-Covid-Impfstoffs Nvx-CoV2373 "sind im Gange", und ein Update wird "nach Abschluss eines Vertrags" bereitgestellt. Der Sprecher der Gesundheitskommission, Stefan de Keersmaecker, berichtete dies während einer Pressekonferenz in Brüssel. Die Kommission schloss am 17. Dezember 2020 Sondierungsgespräche mit NovaVax mit der Absicht, einen Vertrag über den Kauf von 100 Millionen Dosen des Impfstoffs Nvx-CoV2373 abzuschließen, der auf der Verwendung von Proteinen basiert (eine andere Technologie als Serum zu m-Rna) von Pfizer / BioNTech, Moderna und CureVac bis zu solchen, die Adenoviren als Vektor verwenden (wie AstraZeneca und Johnson & Johnson), mit der Option auf weitere 100 Millionen. Seitdem sind jedoch vier Monate vergangen, und der Vertrag zur Versorgung der EU mit dem sechsten Impfstoff wurde noch nicht unterzeichnet, nachdem Pfizer / BioNTech, Moderna, AstraZeneca und Johnson & Johnson bereits von der EMA genehmigt wurden und wahrscheinlich danach CureVac, der als nächstes unterwegs sein sollte.
Dann gibt es noch einen anderen Produzenten, mit dem Gespräche geschlossen wurden, das französische Biotech-Unternehmen Valneva. Selbst mit dem letztgenannten Unternehmen, mit dem die Gespräche am 12. Januar geschlossen wurden, wurde noch kein Vertrag unterzeichnet (es verfügt über zwei Produktionsstätten, eine in Schweden und eine in Schottland). Der Impfstoff von Valneva, Vla2001, basiert auf einer vierten Technologie: Er verwendet inaktivierte Partikel des Sars-CoV-2-Coronavirus. Der mit Valneva diskutierte Vertrag sieht 30 Millionen Dosen vor, mit einer Option auf weitere 30 Millionen. Bisher hat die EU Verträge mit Pfizer / BionTech geschlossen, dem ersten EU-Lieferanten, der von der Kommission als "Rückgrat" der Impfungen in Europa definiert wurde, AstraZeneca, der die in den Abkommen mit der EU, Moderna und Johnson & Johnson. Alle vier Impfstoffe wurden von der EMA und der Kommission zugelassen. Vorabkaufverträge wurden von der EU im Namen der Mitgliedstaaten auch mit Sanofi / Gsk und CureVac unterzeichnet, deren Impfstoffe in der EU noch nicht zugelassen sind (der von CureVac wird derzeit geprüft und könnte bis zum Sommer zugelassen werden ; das von Sanofi ist nicht bekannt). -
Hier ein einige Informationen aus der Präsentation:
Novavaxat-a-Glance: 800 Employees Globally 10+ years of Nanoparticle Vaccine Development 2+ billionDoses of Annual Manufacturing Capacity* $2+ billionin Funding Secured to Date 50,000+Participants Enrolled in COVID-19 Clinical Trials 96%Efficacy DemonstratedAgainst Original COVID-19 Strain
Recent Progress Leading to Significant Opportunity: ...Secured supply agreements worldwide, bolstering Novavax? financial position heading into 2021, with potential for several billion dollars of revenue
Key Takeaways from Clinical Trials: ?96%VE against original COVID-19 ?86%VE against B.1.1.7 variant (first described in UK) ?51%VE against B.1.351 variant* (first described in South Africa) ?Favorablepreliminary safety profile
Pathway to Regulatory Approvals: ?Rolling reviews in various markets ?Ongoing discussions with FDA through submissions to open IND ?Filings for authorization in UK and US expected in 2Q 2021 US Food and Drug Administration UK Medicines and Healthcare products Regulatory Agency Australian Therapeutic Goods Administration European Medicines Agency New Zealand Medsafe
Variant Vaccines Already Under DevelopmentAgainst Emerging COVID-19 Variants: Optimal vaccine for all regions may need to address / contain alternate strains Development underway for new constructs against emerging strains, using both variant and bivalent approaches (Ongoing evaluation in animal models) Expect to initiate clinical trials in mid-2021
NanoFlu Program: ?Committed to NanoFluregulatory approval ?Exploring combinations with NVX-CoV2373 and/or RSV
30novavax.comSignificant Milestones in 2021: ?Further establish NVX-CoV2373?s unique profile: additional efficacy/safety data and populations anticipated from ongoing clinical trials ?Execute on global manufacturing and distribution plans, transitioning into profitable commercial-scale organization ?Seek authorization of NVX-CoV2373 from regulatory authorities worldwide ?Advance respiratory vaccine pipeline: variant booster / bivalent COVID-19 vaccine candidates and NanoFlu
Bei J&J wird genauso interpretiert wie bei AstraZeneca. 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.