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

Distribution updates

limited distribution: December 2020 (45 million doses)
mass distribution: Q4 2021 (1.3 billion doses)

Dec 22	Argentina's ANMAT has authorized BioNTech-Pfizer COVID-19 vaccine for emergency use in the country (by argentina.gob.ar)
Dec 21	EMA has recommended granting a conditional marketing authorisation for the vaccine developed by BioNTech-Pfizer (by europa.eu)
Dec 21	EMA authorisation of Pfizer's vaccine follows a thorough assessment for safety, effectiveness and quality (by europa.eu)
Dec 12	BioNTech-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 pfizer.com)
Dec 11	BioNTech-Pfizer announced today that the US FDA has granted the emergency use of their vaccine in individuals 16 years of age or older (by pfizer.com)
Dec 11	Mexico's health agency Cofepris approved Pfizer's vaccine for emergency use being the first country In Latin America to do so (by bloomberg.com)
Dec 11	Cofepris began reviewing data on BNT162b2 Nov.26 and a 24-member committee voted unanimously to approve its use (by gob.mx)
Dec 11	The FDA's authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic (by fda.gov)
Dec 11	BioNTech-Pfizer celebrate historic first authorization in the US of vaccine to prevent COVID-19 (by pfizer.com)
Dec 10	SFDA approved the registration of BioNTech-Pfizer vaccine in Saudi Arabia after Pfizer submitted a request to approve registering the vaccine (by spa.gov.sa)
Dec 10	BioNTech-Pfizer announced that the US' FDA VRBPAC voted 17 to 4 in support of the FDA granting EUA for the company's vaccine (by pfizer.com)
Dec 09	After a thorough,independent review of the evidence Health Canada has authorized BioNTech-Pfizer vaccine for emergency use (by canada.ca)
Dec 04	Bahrain is the second country in the world after the UK to have given approval to BioNTech-Pfizer vaccine for emergency use (by bna.bh)
Dec 02	BioNTech-Pfizer announced today that the MHRA in the UK has granted a temporary authorization for emergency use for their mRNA vaccine (by businesswire.com)
Dec 02	UK medicines regulator has today been given approval to BioNTech-Pfizer vaccine for use after a thorough review carried out by MHRA (by gov.uk)
Nov 20	Pfizer-BioNTech announced they'll submit a request today to the US FDA for emergency use authorization of their mRNA vaccine (by businesswire.com)
Nov 20	Pfizer 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 businesswire.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)
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 (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

PHASE 2-3 (USA)

started April 29 2020

with 43998 healthy volunteers aged 18-85

trial location: USA

» clinical trial details

Dec 10	The safety profile of BNT162b2 was marked by short term mild to moderate pain at the injection site,fatigue and headache (by nejm.org)
Dec 10	BioNTech-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 pfizer.com)
Nov 18	BioNTech-Pfizer announced that after conducting the final analysis of their ongoing Phase 3 study their vaccine met all primary efficacy endpoints (by businesswire.com)
Nov 09	BNT162b2 was found to be more than 90% effective in preventing COVID-19 after enrolling 43538 participants (by pfizer.com)
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

currently no early development info

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:

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)
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)

mRNA BNT162b2