BioNTech Demonstrates German Capacity for Innovation to the World with Development of COVID-19 Vaccine

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July 01, 2021

[by Toru Kumagai]

BioNTech is an example of one of Germany’s most successful start-up companies, with a record that will go down in history. The company was the first in the world to receive approval for its COVID-19 vaccine, and it is saving millions of lives. BioNTech is a shining example of what in German is known as a Mittelstand, or a medium-sized enterprise. It illustrates how long years of medical research at a university can come to fruition in a venture start-up that will produces a product of vital importance for humanity.

Deep Knowledge of Immunotherapy Treatments for Cancer

BioNTech was founded in Mainz in 2008 by the Turko-German scientist Uğur Şahin and his partner Özlem Türeci, in collaboration with Austrian immunologist Christoph Huber. BioNTech was originally founded with the goal of developing immunotherapy medicines for cancer.
Chief Executive Officer (CEO) Şahin studied medicine at the universities of Cologne and Saarland, with his research focused on immunotherapy for cancer. Şahin worked at both University Hospital Cologne and Saarland University Medical Center from 1991 to 2001 and while at these institutions continued pursuing his research on malignant tumours. In 1999, he received his doctorate in molecular medicine and immunology.
His primary goal was to develop a vaccine for cancer using ribonucleic acid (RNA). Such a vaccine would stimulate the immune functions in the human body required to suppress and reduce the propagation of cancer cells. In short, the goal was to combat cancer by inducing and encouraging the immune functions inherent in the human body to function without the use of chemical substances that would have strong side effects and cause damage to the patient.
In 2003, Şahin became the head of the Tumor Vaccine Center at the University Medical Center, Johannes Gutenberg University Mainz. Then, in 2006, he became an associate professor in the University Medical Center’s Division of Experimental and Translational Oncology. In 2010, Şahin founded Translational Oncology (TRON) at Johannes Gutenberg University Mainz’s Medical Center. TRON’s objectives have been to develop new diagnostics and drugs for the treatment of cancer and other severe diseases with high medical need. Şahin focused specifically on research geared toward immunotherapy treatments for cancer. After cofounding Ganymed Pharmaceuticals AG in 2001, he set about developing pharmaceuticals that would be used for treating oesophageal and stomach cancer.
Şahin ‘s partner Türeci earned her medical degree from Saarland University in 1992. Her research focused on identifying molecules unique to cancer and on developing immunotherapeutic treatments. In 2002, she became a professor of molecular medicine at Johannes Gutenberg University Mainz. She has also engaged in research on immunotherapy for cancer at the same university’s medical centre.
Dr. Türeci has also served as chair of the German Top Research Cluster for Individualized Immune Intervention (Ci3) of the German Federal Ministry of Education and Research since 2011. She has also been serving as president of the Association for Cancer Immunotherapy (CIMT), Europe’s largest association for cancer immunotherapy.
Ever since her time at Mainz engaging in cancer research, Türeci hoped to put the fruits of her own work to better use in helping cancer patients in a clinical setting. This desire led her to found BioNTech with her partner and workmate Şahin. Put simply, Türeci does not see science and technology as some sort of ivory tower. Rather, she wants to focus on how they can be used to produce concrete results that can help to overcome illnesses and alleviate symptoms.
BioNTech is a company that was created with funding from the Federal Ministry of Education and Research’s “GO-Bio” initiative launched in 2005. With founding capital of USD$180 million, this start-up got off the ground with the objective of developing a cancer medicine that would stimulate an immune response in patients using RNA-based technologies. Since 2014, BioNTech researchers have published articles on the results of their work in such science journals as Nature and acquired patents related to cancer treatments. BioNTech was also listed on the NASDAQ Global Select Market in the US in October 2019. This made it one of eight German companies to be listed on this exchange.

Throwing All Research Resources into Developing a COVID-19 Vaccine

However, the greatest turning point for BioNTech was the spread of the novel coronavirus COVID-19 in China in January 2021. Directly seeing how the outbreak from Wuhan spread around the world and became a pandemic, Şahin and his colleagues decided to throw all of BioNTech’s R&D resources into developing a vaccine for the new coronavirus. Over breakfast one day, Şahin and Türeci came up with the name “Lightspeed” for this research project.
From the start, BioNTech carried out this research and development project on a global scale. In March 2020, BioNTech linked up with Fosun Pharmaceutical Group (based in Shanghai) for research in China and with the New York-based Pfizer for the rest of the world.
It was Şahin’s team at BioNTech that developed the techniques that would be central to creating the BioNTech vaccine. The vaccine, which the company named BNT162b2, uses messenger RNA (mRNA), a technology that was already well established at the time.
COVID-19 uses a spike-shaped protein on its surface to infect human cells. BNT162b2 prevents infections by the new coronavirus by manufacturing antibodies that attenuate the workings of these spike proteins.
In April, BioNTech received permission to conduct research on a COVID-19 vaccine from the Paul Ehrlich Institute (part of the Robert Koch Institute)—which was charged with screening and approving vaccines—and the State Medical Chamber of Baden-Württemberg’s Ethics Committee. BioNTech began conducting studies in the United States, China, South America, and South Africa, and from April to November 2020 treated some 43,500 people aged 16 or older worldwide. Around 40% of the people who were treated were aged 55 or older.

Corona Vaccine Successfully Developed in Just 11 Months

The German federal government in September 2020 provided BioNTech with 375 million euros (48.8 billion yen) in financial support for the vaccine’s development. The European Investment Bank also provided BioNTech with 100 million euros (13 billion yen).
These investments paid off with BioNTech’s November 2020 announcement that the BNT162b2 vaccine it had developed in partnership with Pfizer Inc. was at least 95% effective in preventing infections of COVID-19. This 95% efficacy rate means that the chances of a group of vaccinated individuals becoming infected are 95% lower than those of an unvaccinated group.
BioNTech’s BNT162b2 became the world’s first approved vaccine for COVID-19 after the British government’s medical product authorities gave it emergency authorization for use on December 2, 2020. The British government had been struggling to cope with increases in the numbers of fatalities and seriously-ill persons due to the pandemic, and so it began offering vaccinations on January 2, 2021. Meanwhile, the US Food and Drug Administration (FDA) followed up on December 11, 2020, with its own emergency approval. The European Medicines Agency (EMA) likewise authorized the BioNTech vaccine on December 21, and vaccinations among European Union countries began on December 27. BNT162b2 would become the first product to be added to the World Health Organization’s list of vaccines.
Israel has been the most aggressive and fastest country in the world to deploy the Pfizer-BioNTech vaccine. Then-Prime Minister Benjamin Netanyahu spoke directly by phone with Pfizer CEO Alber Bourla around 30 times in 2020. As a result of those discussions, Israel agreed to provide Pfizer with health data on the people who would be vaccinated and—in exchange for paying about double what the EU was paying per dose—Pfizer would prioritize providing Israel with enough doses to quickly vaccinate around 93% of its population.
As a result, Israel became the most-vaccinated country in the world, and it succeeded in dramatically reducing the number of deaths due to COVID-19. Israel began its vaccination program on December 19, 2020. The number of deaths in the country was 60 on February 25, 2021, but since then the number of deaths has dropped dramatically to 1 on June 1. As of June 9, 59.4% of Israel’s population has been vaccinated, and its people are now largely living their lives as they had been before the pandemic.
The Pfizer-BioNTech vaccine has been at least partially approved by some 65 countries now. Between August 2020 and May 2021, European Union countries placed orders with pharmaceutical companies for around 4.365 billion doses of COVID-19 vaccines, and approximately 2.4 billion or 55% of those orders were for the Pfizer-BioNTech product. In Germany, 74.1% of the 28.77 million doses given between December 27, 2020, and April 29, 2021, were from Pfizer-BioNTech. BioNTech plans to put a system in place by the end of this year that will allow it to produce around 3 billion doses of the vaccine annually.
BioNTech sales for the first quarter of 2021 were 73 times higher than those of the same quarter the previous fiscal year at 2.0484 billion euros (266.2 billion yen).
The company expects sales based on orders for the vaccine to reach 12.4 billion euros (1.6120 trillion yen) by the end of 2021.
For their work on developing the COVID-19 vaccine, German President Frank-Walter Steinmeier presented the Knight Commander’s Cross of the Federal Order of Merit to Şahin and Türeci in March 2021.

Basic Research by Ingmar Hoerr behind BioNTech’s Success

Prior to the COVID-19 outbreak, the conventional wisdom was that vaccine development took years. A project like BioNTech’s that went from proposal to regulatory approval in only 11 months marks a world first.
There are some in the medical community who argue that this speedy development had been made possible by the years of basic research that had already been done in Germany, and in that light it was no surprise that a COVID-19 could be produced in 11 months. It is true that Şahin, for example, already had considerable relevant knowledge from his prior work on immunotherapy treatments for cancer, and that research had been done in Germany from an early stage using this for developing mRNA-based pharmaceuticals.
When it comes to technologies for using mRNA to create antibodies that are useful for treating illnesses, the most patents in the world are held by University of Tübingen biologist Ingmar Hoerr. In 1999, he received his Ph.D. from the university’s Institute of Immunology and Cell Biology for his doctoral thesis on treating illnesses with mRNA vaccines.
Hoerr received a patent in 1999 for a technology that uses mRNA to create antibodies that can reduce the number of cancer cells. He conducted clinical trials in 2008 and 2009 using this to develop a vaccine for cancer.
In 2000, together with other researchers, Hoerr founded the biotechnology company Curevac in Tübingen. Hoerr served as the company’s CEO for a period of time and starting in spring 2020 set to work on developing a COVID-19 vaccine. In March he became seriously ill due to a cerebral infarction and stepped down from active work, but Curevac is continuing its efforts aimed at developing a vaccine that will be authorized by the EMA. Some commentators have said that Hoerr is worthy of a Nobel Prize for medicine for his success in basic research on the use of mRNA in medicine 21 years before the outbreak of the COVID-19 pandemic.
Without Hoerr’s basic research on mRNA , it probably would have been difficult for Şahin to have developed his COVID-19 vaccine in just 11 months. Steady basic research, unnoticed by the public and the media, has brought success to BioNTech. This fact also demonstrates the breadth of German scientific research.
In the past, it has been pointed out that the high level of basic research in the German scientific community did not lead to actual business. BioNTech’s success has shattered this preconception. Sparked by the success of Şahin and Türeci, other scientists are sure to follow in their footsteps.

Click here to read the full article on “Toru Kumagai’s report on R&D trends in Germany”.

About Toru Kumagai

Born in Tokyo in 1959, Kumagai graduated from the Department of Political Science and Economics at Waseda University in 1982 and joined Japan Broadcasting Corporation (NHK), where he gained a wealth of experience in domestic reporting and overseas assignments. After NHK, he has lived and worked as a journalist in Munich, Germany, since 1990. He has published more than 20 books on Germany and Germany-Japan relations, as well as been to numerous media outlets to report on the situation in Germany.