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COVID-19 VACCINE:

mRNA BNT162

researcher:
BioNTech + Pfizer + Fosun Pharma + University of Rochester Medical Center (URMC) + Rochester Regional Health (RRH)
https://biontech.de/
https://www.pfizer.com/health/coronaviru...
(Germany + USA)
vaccine type: RNA-based
Distribution updates
Sep 09Pfizer-BioNTech are working to close a supply deal with the EU for up to 300 million doses (by fiercepharma.com)
Apr 09Pfizer will manufacture hundreds of millions doses of BionNTech vaccine in 2021 (by pfizer.com)
Mar 16Fosun will commercialize the BioNTech vaccine in China (by endpts.com)
Human Testing updates (clinical trials)

PHASE 1-2 (Germany)

 

started April 20 2020

with 444 healthy volunteers aged 56-85

trial location: Mainz, Germany

» clinical trial details

PHASE 1-2 (China)

 

started July 21 2020

with 144 healthy volunteers aged 18+

trial location: China

» clinical trial details

PHASE 1-2 (Germany)

 

starting soon (September 2020)

with 120 healthy volunteers aged 18-85

trial location: Berlin, Germany

» clinical trial details

PHASE 2-3 (USA)

 

started April 29 2020

with 29481 healthy volunteers aged 18-85

trial location: USA

» clinical trial details

Oct 14Safety and immunogenicity data in younger adults from several trials support the selection of BNT162 for advancement to phase 2/3 safety evaluation (by nejm.org)
Oct 14BioNTech-Pfizer announced NEJM publication of Phase 1 data of their ongoing U.S.study of their vaccine (by biontech.de)
Sep 30BioNTech-Pfizer announced that peer-reviewed data from their German Phase 1/2 study were published online in Nature (by biontech.de)
Sep 15Pfizer said on Tuesday participants were showing mild to moderate side effects in late-stage study (by reuters.com)
Sep 15BNT162 RNA's Phase 1/2/3 study is to evaluate the safety,tolerability and efficacy against COVID-19 in healthy individuals (by amazonaws.com)
Sep 12Pfizer-BioNTech have proposed to expand their Phase 3 trial to 44000 participants to U.S.FDA (by businesswire.com)
Sep 08Pfizer-BioNTech received approval from the Paul Ehrlich Institut in Germany to conduct a Phase 2/3 trial (by clinicaltrialsarena.com)
Aug 20Pfizer-BioNTech shared additional Phase 1 safety and immunogenicity data from ongoing US study (by businesswire.com)
Aug 13Peer-reviewed preliminary data from BNT162b1's Phase 1/2 trials confirmed findings already released (by fdanews.com)
Jul 27BioNTech-Pfizer started a global Phase 2/3 safety and efficacy clinical study for its vaccine (by biontech.de)
Jul 20BioNTech and Pfizer announced initial data from their German ongoing Phase 1/2 (by businesswire.com)
Jul 14Fosun Pharma's vaccine candidate received acceptance notice of clinical trial application by NMPA (by fosunpharma.com)
Jul 13Pfizer and BioNTech two out of four vaccine candidates received Fast Track designation from FDA (by businesswire.com)
Jul 01Preliminary data from Phase 1/2 showed BNT162 was well tolerated and gave immunogenicity (by biontech.de)
Jul 01BNT162 gave immune responses in healthy patients but at higher doses gave some side effects (by statnews.com)
May 12BNT162's vaccine first clinical data from the trial is expected end of June or July 2020 (by gcs-web.com)
May 05BioNTech-Pfizer's vaccine started Phase 1/2 clinical trials also in USA with 360 volunteers (by pfizer.com)
Apr 24BioNTech-Pfizer started Phase 1/2 clinical trials in Germany with 200 volunteers (by selectscience.net)
Apr 22German government has given approval to Pfizer to start with a phase 2 test (by fiercebiotech.com)
Mar 17BioNTech's mRNA vaccine expected to enter clinical testing by the end of April 2020 (by pfizer.com)
Animal Testing updates (pre-clinical trials)
start date: April 2020
developed 4 vaccine candidates
Sep 09Pfizer-BioNTech today announced preliminary preclinical data in mouse and non-human primates models from their vaccine (by businesswire.com)
Sep 08Pfizer-BioNTech's vaccine is highly immunogenic and prevents lung infection in non-human primates (by biorxiv.org)
early development updates
Oct 08BioNTech-Pfizer reached a deal with Rentschler Biopharma to handle the purification process for the pair's mRNA-based COVID 19 vaccine (by fiercepharma.com)
Oct 06BioNTech-Pfizer have initiated rolling submission to EMA for their companies' vaccine candidate (by biontech.de)
Sep 15Pfizer provided an extensive overview of pipeline advances and shared updates (by pfizer.com)



funding:
Operation Warp Speed by Trump administration
Sep 15BioNTech will receive up to 375 million Euro from BMBF to support BNT162 vaccine program (by biontech.de)
Jun 03Trump Administration has selected BioNTech vaccine among top 5 most likely to be produced (by nytimes.com)
partnerships:
Jul 28URMC and RRH are joining a phase 3 clinical trial for the vaccine developed by Pfizer/BioNTech (by rochester.edu)
Jul 22BioNTech-Pfizer announced agreement with U.S Government for up to 600M doses of their vaccine (by businesswire.com)
Apr 09Pfizer will fund 100% of the vaccine development costs and pay BioNtech $185M (by businesswire.com)
Mar 16Fosun is set to pay BioNTech up to $135M to share profits of the vaccine in China (by fiercebiotech.com)



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