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mRNA BNT162b2

BioNTech + Pfizer + Fosun Pharma + University of Rochester Medical Center (URMC) + Rochester Regional Health (RRH)
(Germany + USA)
vaccine type: RNA-based

distribution (started in December 2020):
Albania, Andorra, Australia, Austria, Bahrain, Belgium, Bermuda, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czechia, Denmark, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Gibraltar, Greece, Greenland, Guernsey, Hungary, Iceland, Ireland, Isle of Man, Israel, Italy, Japan, Jersey, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Luxembourg, Malta, Mexico, Monaco, Netherlands, New Zealand, Northern Cyprus, Norway, Oman, Panama, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turks and Caicos Islands, United Arab Emirates, United Kingdom, United States
Distribution updates
Dec 22Argentina's ANMAT has authorized BioNTech-Pfizer COVID-19 vaccine for emergency use in the country (by
Dec 21EMA has recommended granting a conditional marketing authorisation for the vaccine developed by BioNTech-Pfizer (by
Dec 21EMA authorisation of Pfizer's vaccine follows a thorough assessment for safety, effectiveness and quality (by
Dec 12BioNTech-Pfizer announced that the US CDC ACIP voted today to recommend the use of the company's vaccine in people 16+ years of age (by
Dec 11BioNTech-Pfizer announced today that the US FDA has granted the emergency use of their vaccine in individuals 16 years of age or older (by
Dec 11Mexico's health agency Cofepris approved Pfizer's vaccine for emergency use being the first country In Latin America to do so (by
Dec 11Cofepris began reviewing data on BNT162b2 Nov.26 and a 24-member committee voted unanimously to approve its use (by
Dec 11The FDA's authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic (by
Dec 11BioNTech-Pfizer celebrate historic first authorization in the US of vaccine to prevent COVID-19 (by
Dec 10SFDA approved the registration of BioNTech-Pfizer vaccine in Saudi Arabia after Pfizer submitted a request to approve registering the vaccine (by
Dec 10BioNTech-Pfizer announced that the US' FDA VRBPAC voted 17 to 4 in support of the FDA granting EUA for the company's vaccine (by
Dec 09After a thorough,independent review of the evidence Health Canada has authorized BioNTech-Pfizer vaccine for emergency use (by
Dec 04Bahrain is the second country in the world after the UK to have given approval to BioNTech-Pfizer vaccine for emergency use (by
Dec 02BioNTech-Pfizer announced today that the MHRA in the UK has granted a temporary authorization for emergency use for their mRNA vaccine (by
Dec 02UK medicines regulator has today been given approval to BioNTech-Pfizer vaccine for use after a thorough review carried out by MHRA (by
Nov 20Pfizer-BioNTech announced they'll submit a request today to the US FDA for emergency use authorization of their mRNA vaccine (by
Nov 20Pfizer and BioNTech expect to produce up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021 (by
Oct 06BioNTech-Pfizer have initiated rolling submission to EMA for their companies' vaccine candidate (by
Sep 15Pfizer provided an extensive overview of pipeline advances and shared updates (by
Sep 09Pfizer-BioNTech are working to close a supply deal with the EU for up to 300 million doses (by
Apr 09Pfizer will manufacture hundreds of millions doses of BionNTech vaccine in 2021 (by
Mar 16Fosun will commercialize the BioNTech vaccine in China (by
Human Testing updates (clinical trials)

PHASE 1-2 (Mainz, Ger)


started April 20 2020

with 444 healthy volunteers aged 56-85

trial location: Mainz, Germany

» clinical trial details

PHASE 1-2 (Berlin, Ger)


started April 23 2020

with 456 healthy volunteers aged 18-85

trial location: Berlin and Mannheim, 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)


started September 9 2020

with 120 healthy volunteers aged 18-85

trial location: Berlin, Germany

» clinical trial details

PHASE 1 (Japan)


started October 21 2020

with 160 healthy volunteers aged 20-85

trial location: Japan

» clinical trial details

PHASE 2 (China)


started December 2 2020

with 960 healthy volunteers aged 18-85

trial location: China

» clinical trial details



started April 29 2020

with 43998 healthy volunteers aged 18-85

trial location: USA

» clinical trial details



started January 28 2021

with 1280 healthy volunteers aged 18-55

» clinical trial details

Dec 10The safety profile of BNT162b2 was marked by short term mild to moderate pain at the injection site,fatigue and headache (by
Dec 10BioNTech-Pfizer announced that the New England Journal of Medicine has published results regarding safety and efficacy of the company's vaccine Phase 3 trial (by
Nov 18BioNTech-Pfizer announced that after conducting the final analysis of their ongoing Phase 3 study their vaccine met all primary efficacy endpoints (by
Nov 09BNT162b2 was found to be more than 90% effective in preventing COVID-19 after enrolling 43538 participants (by
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
Oct 14BioNTech-Pfizer announced NEJM publication of Phase 1 data of their ongoing of their vaccine (by
Sep 30BioNTech-Pfizer announced that peer-reviewed data from their German Phase 1/2 study were published online in Nature (by
Sep 15Pfizer said on Tuesday participants were showing mild to moderate side effects in late-stage study (by
Sep 15BNT162 RNA's Phase 1/2/3 study is to evaluate the safety,tolerability and efficacy against COVID-19 in healthy individuals (by
Sep 12Pfizer-BioNTech have proposed to expand their Phase 3 trial to 44000 participants to U.S.FDA (by
Sep 08Pfizer-BioNTech received approval from the Paul Ehrlich Institut in Germany to conduct a Phase 2/3 trial (by
Aug 20Pfizer-BioNTech shared additional Phase 1 safety and immunogenicity data from ongoing US study (by
Aug 13Peer-reviewed preliminary data from BNT162b1's Phase 1/2 trials confirmed findings already released (by
Jul 27BioNTech-Pfizer started a global Phase 2/3 safety and efficacy clinical study for its vaccine (by
Jul 20BioNTech and Pfizer announced initial data from their German ongoing Phase 1/2 (by
Jul 14Fosun Pharma's vaccine candidate received acceptance notice of clinical trial application by NMPA (by
Jul 13Pfizer and BioNTech two out of four vaccine candidates received Fast Track designation from FDA (by
Jul 01Preliminary data from Phase 1/2 showed BNT162 was well tolerated and gave immunogenicity (by
Jul 01BNT162 gave immune responses in healthy patients but at higher doses gave some side effects (by
May 12BNT162's vaccine first clinical data from the trial is expected end of June or July 2020 (by
May 05BioNTech-Pfizer's vaccine started Phase 1/2 clinical trials also in USA with 360 volunteers (by
Apr 24BioNTech-Pfizer started Phase 1/2 clinical trials in Germany with 200 volunteers (by
Apr 22German government has given approval to Pfizer to start with a phase 2 test (by
Mar 17BioNTech's mRNA vaccine expected to enter clinical testing by the end of April 2020 (by
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
Sep 08Pfizer-BioNTech's vaccine is highly immunogenic and prevents lung infection in non-human primates (by
early development updates
Jan 20BioNTech-Pfizer published results of study showing that their vaccine can neutralize UK strain of the virus (by
Jan 08An In Vitro study conducted by Pfizer and UTMB showed that the company's vaccine elicits antibodies that neutralize SARS-CoV-2 with a mutation (by

Operation Warp Speed by Trump administration
Sep 15BioNTech will receive up to 375 million Euro from BMBF to support BNT162 vaccine program (by
Jun 03Trump Administration has selected BioNTech vaccine among top 5 most likely to be produced (by
Oct 08BioNTech-Pfizer reached a deal with Rentschler Biopharma to handle the purification process for the pair's mRNA-based COVID 19 vaccine (by
Jul 28URMC and RRH are joining a phase 3 clinical trial for the vaccine developed by Pfizer/BioNTech (by
Jul 22BioNTech-Pfizer announced agreement with U.S Government for up to 600M doses of their vaccine (by
Apr 09Pfizer will fund 100% of the vaccine development costs and pay BioNtech $185M (by
Mar 16Fosun is set to pay BioNTech up to $135M to share profits of the vaccine in China (by

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