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Until then, developing a vaccine had usually taken many years. Research, trials, approval and production followed one another. In 2020, BioNTech was a midsize company that had never brought a drug to market. Yet it was this company, of all companies, that delivered the Western world’s first approved COVID-19 vaccine. How it managed that shows how speed comes about: from an early decision, from groundwork, from working in parallel and from a willingness to put money at risk.
A Friday evening in January
Situation
On a Friday evening in January 2020, Uğur Şahin, co-founder and CEO of BioNTech, reads about the new coronavirus in Wuhan in a medical journal. He and his wife Özlem Türeci, a physician and co-founder, conclude that the virus will spread around the world. In Europe, the disease is still considered a distant problem at this point.
Link to the principle
Speed begins with the decision, not only with the execution. If you wait until all the facts are settled, you have already lost your lead. Şahin and Türeci acted on a well-founded assessment, not on certainty.
Project Lightspeed
Situation
The project is given the name “Lightspeed.” Instead of testing one candidate after another, the team develops around 20 vaccine candidates at the same time and selects the most promising. It builds on mRNA technology, which the couple has been researching for many years for use in cancer treatment.
Link to the principle
The speed did not come out of nowhere. It rested on years of slow groundwork. Speed at the decisive moment often depends on thorough work done beforehand. And it comes about when you test variants in parallel instead of waiting for results one after another.
Partners instead of going it alone
Situation
In the spring of 2020, BioNTech enters into partnerships with the U.S. company Pfizer and the Chinese pharmaceutical company Fosun. Pfizer brings experience with large trials and global production. In April 2020, the Paul Ehrlich Institute, Germany’s federal vaccine regulator, and the ethics committee of the Baden-Württemberg State Chamber of Physicians approve the first trial in humans in Germany. The large efficacy trial later includes almost 43,500 participants.
Link to the principle
A company of this size would have been too slow on its own. Speed can mean using the strengths of others instead of building everything yourself. If you want to be fast, ask: what do I have to do myself, and what can others do faster?
Producing before the result is in
Situation
While the trials are still running, BioNTech expands production to over a billion doses, contracts manufacturers in Europe and takes over a Novartis plant in Marburg. In November 2020, the data show an efficacy of 95%. On December 2, 2020, the British medicines regulator, the MHRA, grants a temporary emergency authorization. By then, the first roughly 800,000 doses for the United Kingdom are already waiting in Puurs, Belgium. On December 21, 2020, conditional authorization in the EU follows.
Link to the principle
The greatest gain in time comes when steps that would otherwise follow one another overlap. That costs money and involves risk. Had the vaccine failed, the investments would have been lost. Here speed was a deliberate bet: a lost month would have cost more than a lost investment.
Fast, but no shortcuts
Situation
The clinical phases were not skipped. Some of them overlapped. Starting in October 2020, the European Medicines Agency reviewed the data continuously in what is called a rolling review instead of assessing everything at once at the end. Efficacy was measured in tens of thousands of people before the first authorization came.
Link to the principle
This is where the line between speed and haste lies. Speed takes out waiting times. Haste takes out checks. If you confuse the two, you are fast and wrong, as the counterexample of the Hitler diaries shows.
Key takeaways
Key lessons
- Decide on the basis of a well-founded assessment, not only once you have certainty.
- Test several paths at the same time instead of one after another.
- Bring in partners for what others can do faster.
- Let steps overlap and accept the risk deliberately.
- Cut waiting times, never checks.
Summary
In January 2020, Uğur Şahin and Özlem Türeci recognized earlier than many others what the world was facing. They refocused their company, developed around 20 candidates in parallel, brought in Pfizer and Fosun as partners and built up production before the result was in. That is how a vaccine came about in some 324 days. Their example shows: speed is not hurry but cutting waiting time wisely while keeping every check.
Sources
- Joe Miller with Özlem Türeci and Uğur Şahin: Projekt Lightspeed. Der Weg zum BioNTech-Impfstoff – und zu einer Medizin von morgen (in German). Hamburg: Rowohlt 2021.
