Biontech & MRNA: Revolution in der Pharmaindustrie

Pfizer and BioNTech Submitted Application for Conditional Marketing Authorization for COVID-19 Vaccine to the EMA


   EMA confirms successful application for Conditional Marketing Authorization for BNT162b2, which Pfizer and BioNTech submitted yesterday
   In addition to submission to EMA, FDA and U.K. MHRA, the companies have also initiated additional rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world
   Data from the Phase 3 clinical study demonstrated a vaccine efficacy rate for BNT162b2 of 95% against COVID-19, with no safety concerns observed to date

NEW YORK and MAINZ, GERMANY, December 1, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have submitted on Monday, November 30, 2020, a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their mRNA vaccine candidate, BNT162b2, against COVID-19. This submission completes the rolling review process initiated on October 6, 2020, with nonclinical data and partial Chemistry, Manufacturing, and Controls (CMC) data, followed by emerging clinical data submitted by Pfizer and BioNTech. If EMA concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID‑19, it will recommend granting a CMA that could potentially enable use of BNT162b2 in Europe before the end of 2020.

The submitted clinical data demonstrated a vaccine efficacy rate of 95% (p<0.0001) in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%. The first primary objective analysis was based on 170 confirmed cases of COVID-19. In the trial, BNT162b2 also showed an overall favorable tolerability with no safety concerns reported by the Data Monitoring Committee to date. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age.

“Today’s announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us.”

“As a company located in the heart of Europe, today’s milestone is important to us as we continue to seek to enable a worldwide supply upon potential approval of BNT162b2,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We will continue to work with regulatory agencies around the world to enable the rapid distribution, should the vaccine receive the approval, contributing to the joint efforts to let the world heal and regain its normal pace of life.”

The vaccine candidate will be assessed according to EMA’s normal stringent standards for quality, safety and efficacy. The BNT162b2 vaccine candidate is currently not approved for distribution anywhere in the world.  

In addition to submission to EMA, U.S. Food and Drug Administration (FDA) and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), the companies have initiated rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.  

Eintrag eingerichtet (n-tv)  

Pfizer / BioNTech EU Zulassung beantragt  

lukrativ, daher wird man sowas auf der Reise noch öfter sehen die Monate, man weiß halt nie wann. Große wollen rein und das nicht mit wenig Stücken.  

...., dass heute noch was kommt!  

https://www.tagesschau.de/wirtschaft/...ona-impfstoff-antrag-101.html  

https://www.spiegel.de/wissenschaft/medizin/...mp;utm_medium=referral  

Wieso zeigt dir das dass was kommt?  

 Da liegen die Daten schon vor und müssen nicht auch noch eingereicht und neu kontrolliert werden.
Das kann dann ganz schnell gehen!
siehe oben:
In addition to submission to EMA, FDA and U.K. MHRA, the companies have also initiated additional rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world

 

Vermutlich wurde kurz vorher die Leerverkaufswelle gestartet und kräftig aufgesammelt, was andere haben fallen lassen. Unter Hundert konnte man nachkaufen. Prima!  

25% plus.
Bin gespannt wo BNTX heute abend steht...  

ob biontech nun auch einen 20% anstieg hinlegt oder ob das nur moderna macht.
verstehen tu ich das schon lange nicht mehr.  

und lassen den Hund um 15.30 Uhr frei, oder wir landen heute sogar noch im Minus...
Das versteht wirklich kein Mensch...  

Machen und verkünden, nicht ankündigen und dann evtl. machen.
Japan, Austrslian und Canada werden auch erwähnt.  

https://biontechse.gcs-web.com/news-releases/...conditional-marketing  

Ja hier der Satz

"...In addition to submission to EMA, U.S. Food and Drug Administration (FDA) and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), the companies have initiated rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world...."

 

Hat dieses Jahr wegen der Corona Geschichte einen Sprung von 100€ auf 500€ gemacht, KGV aktuell 4211 !

Und ich rechne hier brav mit KGV 15 vor was passieren kann mit dem Kurs. Dann bin ich ja mal gespannt auf 2021 :)  

Hier zeigt sich wieder dass eine Rallye immer eher aus USA kommt.
In Deutschland verhaltene Reaktion auf so eine Meldung.
Schauen wir mal was passiert, wenn die Amis öffnen
Allen viel Glück
Alle die die Nerven behalten werden am Ende belohnt. Da bin ich mir sicher
 

da stimme ich voll mit dir überein. Gegen Zoom sind wir hier noch weit weg und deine Berechnungen finde ich übrigens super realistisch und konservativ gerechnet, schönen Dank übrigens mal an dieser Stelle von mir....  

als um 11 verkündet wurde, dass bereits gestern die Zulassung für Europa bekannt wurde...

Glaub schon, dass jetz die 100 nicht mehr anbrennen.
Moderna läuft allerdings viel besser, da der Michel im Gegensatz zum Ami aktienscheu ist.
Müssen also hauptsächlich Ausländer unsere BionTech weiter hochkaufen....


 

 

Hätte ich doch moderna gekauft. Hier tut sich ja nichts. Schneckentempo  

Moderna 50Mrd€ Wert
Curevac 15 Mrd€ Wert
Biontech 25 Mrd€ Wert
Ich weiss nicht warum Biontech nicht beim Anleger beliebt ist. Liegt nur an der PR Arbeit der Firmen, an der Kühlungsthematik oder was anderes!  

https://www.zdf.de/nachrichten/wirtschaft/...rag-100.html#xtor=CS5-62  

und geh rüber zu den Ami's wenn du dich da besser fühlst.
In 3 Monaten können wir nochmal sprechen.