COVID-19 Vaccine: mRNA BNT162 by BioNTech, Pfizer, Fosun Pharma, University of Rochester Medical Center (URMC), Rochester Regional Health (RRH)

Distribution updates

Sep 09	Pfizer-BioNTech are working to close a supply deal with the EU for up to 300 million doses (by fiercepharma.com)
Apr 09	Pfizer will manufacture hundreds of millions doses of BionNTech vaccine in 2021 (by pfizer.com)
Mar 16	Fosun 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 14	Safety 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 14	BioNTech-Pfizer announced NEJM publication of Phase 1 data of their ongoing U.S.study of their vaccine (by biontech.de)
Sep 30	BioNTech-Pfizer announced that peer-reviewed data from their German Phase 1/2 study were published online in Nature (by biontech.de)
Sep 15	Pfizer said on Tuesday participants were showing mild to moderate side effects in late-stage study (by reuters.com)
Sep 15	BNT162 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 12	Pfizer-BioNTech have proposed to expand their Phase 3 trial to 44000 participants to U.S.FDA (by businesswire.com)
Sep 08	Pfizer-BioNTech received approval from the Paul Ehrlich Institut in Germany to conduct a Phase 2/3 trial (by clinicaltrialsarena.com)
Aug 20	Pfizer-BioNTech shared additional Phase 1 safety and immunogenicity data from ongoing US study (by businesswire.com)
Aug 13	Peer-reviewed preliminary data from BNT162b1's Phase 1/2 trials confirmed findings already released (by fdanews.com)
Jul 27	BioNTech-Pfizer started a global Phase 2/3 safety and efficacy clinical study for its vaccine (by biontech.de)
Jul 20	BioNTech and Pfizer announced initial data from their German ongoing Phase 1/2 (by businesswire.com)
Jul 14	Fosun Pharma's vaccine candidate received acceptance notice of clinical trial application by NMPA (by fosunpharma.com)
Jul 13	Pfizer and BioNTech two out of four vaccine candidates received Fast Track designation from FDA (by businesswire.com)
Jul 01	Preliminary data from Phase 1/2 showed BNT162 was well tolerated and gave immunogenicity (by biontech.de)
Jul 01	BNT162 gave immune responses in healthy patients but at higher doses gave some side effects (by statnews.com)
May 12	BNT162's vaccine first clinical data from the trial is expected end of June or July 2020 (by gcs-web.com)
May 05	BioNTech-Pfizer's vaccine started Phase 1/2 clinical trials also in USA with 360 volunteers (by pfizer.com)
Apr 24	BioNTech-Pfizer started Phase 1/2 clinical trials in Germany with 200 volunteers (by selectscience.net)
Apr 22	German government has given approval to Pfizer to start with a phase 2 test (by fiercebiotech.com)
Mar 17	BioNTech'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 09	Pfizer-BioNTech today announced preliminary preclinical data in mouse and non-human primates models from their vaccine (by businesswire.com)
Sep 08	Pfizer-BioNTech's vaccine is highly immunogenic and prevents lung infection in non-human primates (by biorxiv.org)

early development updates

Oct 08	BioNTech-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 06	BioNTech-Pfizer have initiated rolling submission to EMA for their companies' vaccine candidate (by biontech.de)
Sep 15	Pfizer provided an extensive overview of pipeline advances and shared updates (by pfizer.com)

funding:

Operation Warp Speed by Trump administration

Sep 15	BioNTech will receive up to 375 million Euro from BMBF to support BNT162 vaccine program (by biontech.de)
Jun 03	Trump Administration has selected BioNTech vaccine among top 5 most likely to be produced (by nytimes.com)

partnerships:

Jul 28	URMC and RRH are joining a phase 3 clinical trial for the vaccine developed by Pfizer/BioNTech (by rochester.edu)
Jul 22	BioNTech-Pfizer announced agreement with U.S Government for up to 600M doses of their vaccine (by businesswire.com)
Apr 09	Pfizer will fund 100% of the vaccine development costs and pay BioNtech $185M (by businesswire.com)
Mar 16	Fosun is set to pay BioNTech up to $135M to share profits of the vaccine in China (by fiercebiotech.com)