Only days after saying it expects to have key data from its Phase III clinical trial of its COVID-19 vaccine in October, Germany’s BioNTech received a grant of up to €375 million from the German Federal Ministry of Education and Research (BMBF). The goal is to support the accelerated development of COVID-19 vaccines.
BioNTech expects to use the funds to support its contribution to its mRNA BNT162 vaccine program it is developing with Pfizer and Fosun Pharma. The BMBF’s initiative is to expand vaccine development and manufacturing capabilities in Germany, as well as expand the number of people involved in late-stage clinical trials.
“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,” said Ugur Sahin, chief executive officer and co-founder of BioNTech. “The funding is an important contribution to accelerate the development and scaling-up of our COVID-19 vaccine manufacturing capabilities in Germany. It highlights the tremendous importance of our mission to efficiently find a lasting solution to control the pandemic.”
The company plans to use the grant to cover its expenses for the development program. Pfizer will still independently fund its part of development costs without use of this or other government funding.
The grant is milestone-based, so funding is based on preclinical evaluation of the vaccine candidates, the launch and implementation of Phase I and Phase II/III clinical trials, which include four clinical development milestones. It also includes milestones such as upscaling of manufacturing capacities for clinical trials and the general population, if it receives approval, and the submission to regulatory bodies and future marketing. To date, BioNTech has hit five of the eight defined milestones.
Most recently, BioNTech received approval from the German regulatory authority, the Paul-Ehrlich-Institut, to launch the German arm of the global Phase II/III trial. Recruitment had begun on three continents and more than 28,000 participants have already been enrolled in the U.S., Brazil, Argentina and Europe.
On Saturday, September 12, the two companies announced plans to expand the Phase III vaccine trial to up to about 44,000 participants. The original plan was for 30,000 volunteers. They say they expect to reach the 30,000-mark next week. The rationale behind the expansion is to increase the trial’s diversity to include adolescents as young as 16 years old and people with chronic, stable HIV, Hepatitis C, and Hepatitis B, as well as to gather more safety and efficacy data.
Sahin told CNN last week, the vaccine “has an excellent profile and I consider this vaccine … near perfect, and which has a near perfect profile.”
He believes that approval or an Emergency Use Authorization will be granted quickly by regulatory agencies and said that its “understanding of the mode of action, in combination with the safety data coming in from the running trial” gave them “a lot of confidence. … “Yes, we believe that we have a safe product and we believe that we will be able to show efficacy.”
In addition, the Pfizer-BioNTech vaccine, dubbed BNT162, appears to have fewer side effects than some of the competing vaccines, such as the one being developed by Moderna, which uses similar technology to the Pfizer-BioNTech vaccine, and the vaccine being developed by the University of Oxford and AstraZeneca.
Sahin said, “We don’t see frequent fever. So only a minor proportion of participants in this trial have fever. We see also much lower symptoms like headache or like feeling tired. And the symptoms that are observed with such vaccines are temporary, they are usually observed for one or two days and then are gone.”