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  • It was January 24 2020, BioNTech CEO Ugur Sahin knew

  • that Covid-19 was likely to become a global pandemic.

  • I did some calculations and calculated how many people were

  • infected. How many weeks how many people could have traveled,

  • how many people could be as symptomatic and every

  • calculation that I made clearly demonstrated. This is not any

  • more original outbreak, but the virus has already spread

  • worldwide.

  • Though it was over a month and a half before the World Health

  • Organization officially declared a pandemic, Sahin met with his

  • wife, BioNTech's co-founder and chief medical officer Özlem

  • reci, and together they agreed to redirect most of the

  • company's resources to developing a vaccine.

  • It was immediately clear to both of us that the technology we

  • had, which we had already clinically developed, could help

  • to ensure a rapid response.

  • Up until that point, BioNTech was primarily focused on

  • developing novel cancer treatments. The company was

  • little known internationally and had never brought a product to

  • market. They were still

  • a small, relatively unknown biotech company really working

  • on this cutting edge science.

  • The founders were confident in the potential of their mRNA

  • technology, which they knew could trigger a powerful immune

  • response. That confidence wasn't necessarily shared by the

  • broader medical community. No mRNA vaccine or treatment had

  • ever been approved before. But the couple's timely breakthrough

  • was actually decades in the making.

  • We understood that we would need to invest some time and it would

  • need innovations on different levels in order to make it

  • really work for vaccines and beyond. But the potential was

  • already clear there.

  • Sahin and Tureci, whose families both immigrated to Germany from

  • Turkey, met in the early 1990s, when they were working in the

  • cancer ward at a hospital in southwest Germany. Neither

  • envisioned a career in business.

  • During my time at medical faculties studying medicine, I

  • also started to do my PhD, which meant work in a laboratory. And

  • that actually caused a clash in my perception.

  • Tureci and Sahin both realized that while there was a little

  • they could offer terminal cancer patients in the ward, in the lab

  • they saw lots of potential for new treatments.

  • I was doing my lab work and understood that the immune

  • system could be a powerful weapon to fight cancer. And at a

  • certain time point, I realized that it's not only laboratory

  • work, but you have really to develop the therapies and you

  • need funding for that.

  • Out of desperation, I become became an entrepreneur and

  • founder companies because I understood that if you want to

  • use innovative research to develop medicines, you have to

  • do it yourself.

  • The couple had been studying messenger RNA or mRNA since the

  • late 1990s. The function of mRNA is essentially to teach

  • ourselves how to make specific proteins. But because mRNA is

  • very unstable and quickly degrades in the body, they knew

  • there was still a long way to go before it was ready for use in a

  • vaccine.

  • And at that time point, mRNA was used by a very small community.

  • So it was like a talent you see a young talent, you know all the

  • weaknesses and you know that you have to invest a lot of years to

  • make the technology mature.

  • So in the meantime, they co-founded their first company

  • Ganymed Pharmaceuticals in 2001. Ganymed used a more established

  • technology, monoclonal antibodies to treat stomach

  • cancer, and the couple sold the company for 1.4 billion in 2016.

  • It was Germany's biggest biotech deal ever. By that point, Sahin

  • and Tureci were already eigh years into their second ventur

  • BioNTech. When they founded th company in 2008, the couple fel

  • that they had improved th stability of mRNA enough t

  • focus on developin individualized cancer vaccine

  • So the biggest challenge in cancer treatment is that every

  • cancer is different, personalized or individualized.

  • Cancer vaccines are based on on getting the tumor off of the

  • patient and analyzing that tumor, then making a vaccine

  • which is tailored to the profile to the genetic profile of the of

  • the patient's tumor.

  • Unlike traditional vaccines, mRNA vaccines don't introduce a

  • weakened version of the virus into your body. Instead, the

  • mRNA instructs the body to make a specific virus protein that

  • will trigger an immune response and produce antibodies, which

  • can be used to fight off a cancer that's already growing,

  • or to protect against future COVID-19 infections. And while

  • traditional vaccines require scientists to collect and grow

  • large quantities of a virus, a process that can take months,

  • mRNA vaccines are much faster to produce. That's because they're

  • made from a DNA template in the lab, the sequence for which can

  • be shared electronically in an instant.

  • It's the most ancient information technology, which

  • means that the organism is prepared and has all the tools

  • to understand what you want to convey in terms of messages with

  • mRNA.

  • The vision and the scientific know how we're in place, but by

  • the beginning of 2020, BioNTech had still not gotten any of its

  • mRNA cancer vaccines approved for use in humans. The company

  • had never turned a profit. And when it IPO in 2019, it raised

  • about 100 million less than it had hoped for.

  • They were still a small, relatively unknown biotech

  • company, really working on this cutting edge science.

  • But the world was on the verge of changing. On the day when

  • Sahin realized that COVID-19 had already spread around the world,

  • few others were concerned. Europe had just reported its

  • first few Coronavirus cases, and Germany had not reported any

  • yet. But after Sahin and Tureci talked that morning in late

  • January, they immediately jumped into action.

  • On the weekend, we started to decide the vaccine sequences.

  • And on Monday, we met our teams explained them, this could

  • become a global outbreak and that we have the obligation to

  • do the best that we can do to come up with vaccine candidates.

  • And already on Tuesday, we had the full commitment of the whole

  • team to start the development of a new vaccine.

  • We are like in a military operation. The teams were

  • redirected. We never put our cancer programs at hold. So they

  • went on while those parts of our company who could really help

  • with COVID-19 project started step by step to pick up pace and

  • work on a project litespeed.

  • BioNTech knew that to successfully produce tests and

  • manufacture a Covid vaccine on a global scale, it would need a

  • bigger partner. The company had already partnered with Pfizer,

  • having worked with him since 2018, to develop an mRNA based

  • flu vaccine, which is currently in clinical trials. And so

  • naturally BioNTech turn to them.

  • We approach Pfizer in early February, which was very early

  • because no one really believed that there was a pandemic. And

  • as everyone else, our Pfizer colleagues did not really

  • believe that a pandemic vaccine would be needed.

  • And the response to that point from Pfizer was no. And I talked

  • with Pfizer CEO about this. And he was saying essentially at

  • that point early on, he was really focused on Pfizer's

  • operations in China, Pfizer's people in China, and he wasn't

  • yet thinking about developing a vaccine.

  • Undeterred, BioNTech initially went at it alone, developing not

  • just one but for vaccine candidates. The company started

  • preparing for phase one clinical trials in Germany, which would

  • test the vaccine in humans. By this time, others were starting

  • to catch on.

  • COVID-19 can be characterized as a pandemic. Dow is now down more

  • than 1100 points as moments ago, the who has formally declared

  • the Coronavirus, a global pandemic.

  • And now the extreme new measures in the US. Large events banned

  • in Washington State and San Francisco. As U.S. cases rise

  • over 1000. Less

  • than a week after the pandemic was declared Pfizer agreed to

  • work with BioNTech to help them scale up their clinical trials

  • production and distribution.

  • We had our first patient in on on April 23. It was the first

  • volunteer and in July, we started phase three clinical

  • trial. This was already in partnership with Pfizer, which

  • allowed us to move fast from the early stage of clinical

  • development to the to the latest stage of development.

  • So as they were starting phase one they were designing and

  • figuring out phase two as they were getting into phase two,

  • they were figuring out these massive phase three clinical

  • trials that they managed to start in the summer, and the FDA

  • and regulators globally were working on being incredibly

  • flexible.

  • Over 43,000 participants were enrolled in the company's phase

  • three trials, which measured how many vaccinated participants

  • contracted Covid compared to the unvaccinated placebo group.

  • Sahin and Tureci we're by no means certain that the vaccine

  • would work at all.

  • We knew that vaccine is able to activate the immune system, but

  • it didn't know whether the immune system is able to control

  • the virus. So as a scientist, my expectation was it would be

  • great if we have 70% efficacy. But I was also aware that if the

  • immune system is not able to control we might have just a

  • negative result and getting the call on Sunday evening and

  • hearing that we have 95% efficacy. This was

  • extraordinary, of course high much higher than than we had

  • expected.

  • And it brought this just amazing hope that we would be able to

  • start fighting back against this virus. And I think everybody who

  • got that news felt like their lives changed.

  • Over 1.75 billion doses of the Pfizer-BioNTech vaccine have

  • been delivered worldwide. And perhaps obviously BioNTech is

  • finally making money. With a market cap of nearly 60 billion,

  • the company made over $4.5 billion in profit in the first

  • two quarters of 2021. As the United States and European

  • Commission governments have entered into massive contracts

  • to buy hundreds of millions of doses. And BioNTech's stock has

  • seen a rise of over 500% since January of 2020.

  • In the second quarter alone, they brought in more than 5

  • billion euros in revenue. That compares to just about 40

  • million that they took it in the second quarter of last year. So

  • this has been a transformative year for BioNTech.

  • In August, the Pfizer-b vaccine became the first to gain full

  • FDA-approval, helping pave the way for a return to normal life.

  • But there's still a long way to go. Over half of the world

  • remains unvaccinated. And the virus is mutating into new, more

  • infectious variants like the Delta strain, which is ripping

  • through communities worldwide.

  • Our work on Covid is still a large part of our activities in

  • the company, obviously, because there is still a long path to go

  • until we have manufactured sufficient supply to ensure that

  • all those who want to be vaccinated and need to be

  • vaccinated get the vaccine.

  • In September, Pfizer submitted data to the FDA demonstrating

  • that a booster given six months after the second shot restores

  • immunity to 95%. Currently, the FDA has authorized boosters of

  • the Pfizer-BioNTech vaccine for certain vulnerable populations

  • such as those over 65.

  • My personal opinion is that we can't control the pandemic. And

  • we can't control this virus, if we don't enable that, that the

  • vast majority of the population stays immune.

  • And then there's the issue of kids. Currently, the

  • Pfizer-BioNTech vaccine is the only one authorized by the FDA

  • for use in children 12 and over though the two companies have

  • requested emergency authorization for ages five

  • through 11, after clinical trials showed positive results

  • when kids were given 1/3 of the normal dosage. But amidst their

  • ongoing Covid efforts, biontech has still found the time to

  • advance its oncology work.

  • Even during the pandemic, we have been able to initiate

  • multiple phase one clinical trials which meant bringing new

  • concepts, not only mRNA vaccines, but also other immune

  • therapies for the first time in human testing in cancer

  • patients. And we have also initiated advanced trials with

  • our cancer vaccines where we compare against standard of care

  • treatments.

  • We are of course excited to get the data and it could be as

  • exciting as COVID-19 efficacy data.

  • Sahin and Tureci emphasize that developing therapeutic cancer

  • vaccines which are administered after a patient has already been

  • diagnosed, are bound to be a much lengthier process and

  • developing the Covid vaccine. That's because of the time it

  • takes to recruit cancer patients for clinical trials and monitor

  • their condition over a number of years. Still, though they say

  • there's much to be learned from the rapid response to the

  • coronavirus pandemic.

  • Namely that it's important also on the regulator side to have

  • sufficient resources in order to enable very efficient work on

  • receivers for clinical trials approvals of drug approvals

  • processes, which could be much leaner and much faster.

  • The question is can be can we use that model also for other

  • severe diseases, and I believe we have to consider how to use

  • it. Because if you take for example cancer in the in the

  • time between 2020 beginning 2020 and now more patients die with

  • this cancer patients died by by COVID-19. So it is not a

  • pandemic, but it's an endemic.

  • Sahin and Tureci are modest about their success. They ride

  • their bikes to work and don't own a car or TV. And while their

  • company has grown from about 1300 employees at the beginning

  • of 2020 to around 2500 today, it's still minuscule compared to

  • the likes of Pfizer, which employs about 78,000 people

  • worldwide. But what the influx of money and attention will

  • change is the level to which BioNTech can invest in and

  • accelerate its other endeavors.

  • We have now the chance to invest to accelerate our cancer