Contract Pharma Staff09.15.20
BioNTech SE will receive a grant of up to $445.4 million) from an initiative by the German Federal Ministry of Education and Research (BMBF) to support the accelerated development of SARS-CoV-2 vaccines.
BioNTech will use the milestone-based BMBF funding to support its contribution to the Company’s mRNA vaccine program BNT162 that is being co-developed with its partners Pfizer Inc. and Fosun Pharma respectively. The goal of the initiative is the expansion of vaccine development and manufacturing capabilities in Germany, as well as the expansion of the number of participants in late-stage clinical trials. The BNT162 vaccine program is one of three programs supported by the BMBF initiative, which will provide a total of up to €750 million ($890.8 million) to its funding recipients.
“We are grateful for the significant support from the BMBF, which is helping us to provide a safe and effective vaccine as soon as possible following regulatory approval. The funding is an important contribution to accelerate the development and scaling-up of our COVID-19 vaccine manufacturing capacities in Germany. It highlights the tremendous importance of our mission to efficiently find a lasting solution to control the pandemic,” said Ugur Sahin, M.D., CEO and co-founder of BioNTech.
BioNTech says it 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 authorization as soon as possible. Pfizer will continue to independently fund its share of development costs for BNT162 without use of this or other government funding.
Milestones
The milestones defined by the BMBF include the preclinical evaluation of the vaccine candidates, the initiation and implementation of clinical Phase 1 and Phase 2/3 trials (which includes four clinical development milestones), the upscaling of production capacities to supply the clinical trials and the general population (pending marketing authorization), and the submission for regulatory approval as well as future marketing authorization of a vaccine.
The Company has already achieved five of the eight defined milestones. Most recently, BioNTech received approval from the German regulatory authority, the Paul-Ehrlich-Institut, to initiate the German arm of the global Phase 2/3 trial. Patient recruitment has commenced on three continents and over 28,000 participants have already been enrolled worldwide with study sites in the United States, Brazil, Argentina and Europe. Potential marketing authorization is dependent on the final outcome of the ongoing late-stage clinical trials.
BioNTech will use the milestone-based BMBF funding to support its contribution to the Company’s mRNA vaccine program BNT162 that is being co-developed with its partners Pfizer Inc. and Fosun Pharma respectively. The goal of the initiative is the expansion of vaccine development and manufacturing capabilities in Germany, as well as the expansion of the number of participants in late-stage clinical trials. The BNT162 vaccine program is one of three programs supported by the BMBF initiative, which will provide a total of up to €750 million ($890.8 million) to its funding recipients.
“We are grateful for the significant support from the BMBF, which is helping us to provide a safe and effective vaccine as soon as possible following regulatory approval. The funding is an important contribution to accelerate the development and scaling-up of our COVID-19 vaccine manufacturing capacities in Germany. It highlights the tremendous importance of our mission to efficiently find a lasting solution to control the pandemic,” said Ugur Sahin, M.D., CEO and co-founder of BioNTech.
BioNTech says it 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 authorization as soon as possible. Pfizer will continue to independently fund its share of development costs for BNT162 without use of this or other government funding.
Milestones
The milestones defined by the BMBF include the preclinical evaluation of the vaccine candidates, the initiation and implementation of clinical Phase 1 and Phase 2/3 trials (which includes four clinical development milestones), the upscaling of production capacities to supply the clinical trials and the general population (pending marketing authorization), and the submission for regulatory approval as well as future marketing authorization of a vaccine.
The Company has already achieved five of the eight defined milestones. Most recently, BioNTech received approval from the German regulatory authority, the Paul-Ehrlich-Institut, to initiate the German arm of the global Phase 2/3 trial. Patient recruitment has commenced on three continents and over 28,000 participants have already been enrolled worldwide with study sites in the United States, Brazil, Argentina and Europe. Potential marketing authorization is dependent on the final outcome of the ongoing late-stage clinical trials.
