BNT162c2 / BioNTech, Fosun Pharma, Pfizer - LARVOL DELTA

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults (clinicaltrials.gov) - P1/2 | N=512 | Completed | Sponsor: BioNTech SE | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults (clinicaltrials.gov) - P1/2; N=512; Active, not recruiting; Sponsor: BioNTech SE; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults (clinicaltrials.gov) - P1/2; N=456; Recruiting; Sponsor: BioNTech SE; Trial completion date: Nov 2020 ➔ Apr 2023; Trial primary completion date: Nov 2020 ➔ Apr 2023

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

BioNTech to Receive up to €375M in Funding from German Federal Ministry of Education and Research to Support COVID-19 Vaccine Program BNT162 (GlobeNewswire) - "Five out of eight milestones defined in the BMBF funding for the BNT162 vaccine program have already been achieved; More than 28,000 participants have already been enrolled in the Phase 3 clinical trial currently being conducted in the United States, Brazil, Argentina and Europe; BioNTech SE...today announced that it will receive a grant of up to 375 million Euro....BioNTech will use the grant funding to cover its expenses related to its COVID-19 vaccine program BNT162 within the funded project in order to advance the clinical evaluation and potential marketing authorisation as soon as possible."

Enrollment status • Grant • Infectious Disease • Novel Coronavirus Disease

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy Adults (clinicaltrials.gov) - P1/2; N=200; Recruiting; Sponsor: Biontech RNA Pharmaceuticals GmbH

Clinical • New P1/2 trial • Novel Coronavirus Disease

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy Adults (clinicaltrials.gov) - P1/2; N=456; Recruiting; Sponsor: BioNTech RNA Pharmaceuticals GmbH; N=200 ➔ 456; Trial completion date: Aug 2020 ➔ Nov 2020; Trial primary completion date: Aug 2020 ➔ Nov 2020

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

BioNTech, China's Fosun to potentially supply 10 million doses of COVID-19 vaccine (Reuters) - "German drug developer BioNTech SE on Thursday announced a potential deal with Shanghai Fosun Pharmaceutical Group Co Ltd to supply 10 million doses of their COVID-19 vaccine candidate to Hong Kong and Macau. The two companies are also jointly working on the development and marketing of potential COVID-19 vaccine products based on BioNTech's mRNA technology platform in Mainland China, Hong Kong and Macau..."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2 (Businesswire) - "Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021; Pfizer Inc....and BioNTech SE...today announced the execution of an agreement with the U.S. Department of Health and Human Services...to begin delivering 300 million doses of a vaccine for COVID-19 in 2021....The U.S. government will pay the companies $1.95 billion upon the receipt of the first 100 million doses..."

Licensing / partnership • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Pfizer and BioNTech Announce Agreement with the United Kingdom for 30 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2 (GlobeNewswire) - "Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, currently in development, subject to clinical success and regulatory approval....Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility...that aims to provide governments with early access to a large portfolio of COVID-19 candidate vaccines..."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

BioNTech announces first quarter 2020 financial results and corporate progress (GlobeNewswire) - "COVID-19 Vaccine Program....BNT162 (Europe) - The first cohort of BioNTech’s Phase 1/2 clinical trial was dosed....First clinical data from the trial is expected end of June or in July 2020....BNT162 (U.S) – The first cohort has been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program....The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age)....BioNTech will provide clinical supply of the BNT162 vaccine from its GMP-certified mRNA manufacturing facilities in Europe."

P1/2 data • Trial status • Infectious Disease • Novel Coronavirus Disease