Gov. Andrew Cuomo watches ICU nurse in New York City be among the first people to receive the first dose of the Pfizer/BioNTech COVID-19 vaccine. Storyful
Özlem Türeci feels like she’s been running a marathon since January.
She’s not at the finish line yet, although millions of doses of the vaccine she helped develop are now being delivered across the United States and Britain.
Türeci co-founded BioNTech, a German company that partnered with pharmaceutical giant Pfizer to develop the first U.S.-authorized COVID-19 vaccine.
As the company’s chief medical officer, she’s spent more than a decade, along with her husband and co-founder, Dr. Uğur Şahin, developing vaccines based on mRNA technology. The approach takes advantage of the natural process cells use to translate the underlying DNA blueprint into the proteins that perform all the functions of life.
Their primary aim has been to battle cancer.
They’ve developed two kinds of cancer vaccines using mRNA technology. In the first, a standard approach that can be used by melanoma patients, the mRNA targets antigens common to 95% of all melanomas, turning the immune system against them.
In the second, BioNTech takes the genetics of a person’s tumor and designs a personal mRNA vaccine to train their immune system to fight it it. About a month after sequencing biopsied tissue, BioNTech can provide a completed vaccine, intended to be used in connection with other immunotherapyapproaches.
While developing these therapies, she and others at BioNTech learned how to manipulate the mRNA to get the immune system to do what they wanted. “mRNA is for us a way to modulate the immune system,” said Türeci, an immunologist. “The immune system originally developed over millions of years of evolution to defend us against pathogens, against viruses.”
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Although BioNTech focused on cancer, because the immune system was designed against viruses, they’d learned a lot about how to attack viruses, too, she said.
When Türeci first heard about the new coronavirus in January, she knew the company would have to work on a vaccine against it.
“We saw this as a duty,” Türeci said in deeply accented but precise English. “We have technologies and capabilities and skills in the company … which make us think that we can contribute.”
She said she entered the fray not to be the first to make a COVID-19 vaccine – though she was, at least in the U.S. – but because she thought her company could develop a vaccine quickly.
Inside ‘Project Light Speed’ at BioNTech
Their technology is very similar to Moderna’s, a Cambridge, Massachusetts, mRNA company likely to be the second company to win FDA authorization later this week.
Türeci declined to compare the two vaccines in detail, saying that was the stuff of corporate secrets. The vaccines are very similar in safety and effectiveness, but perhaps are a bit different in terms of side effects, she said. More data will be published highlighting the differences.
“I know which one I would get,” she said, smiling on a recent Zoom call.
From the Jan. 11 publication of the genetic sequence of the virus that causes COVID-19, Türeci and everyone at her company in Mainz, Germany, has been working full tilt.
“For me, the entire year is a blur,” she said.
They started the effort they dubbed “Project Light Speed” with 20 different mRNAs, experimenting in test tubes and mice to see which provoked the best immune response with the fewest side effects.
“Because RNA is so versatile, we could manage them all in parallel,” she said. “The best of the best of our candidates” were chosen for small human trials in Germany.
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That’s about the time the company partnered with Pfizer, a long-time collaborator, to test the best two vaccine candidates in more people, eventually choosing what the companies call BNT162b2.
Pfizer had the expertise and capital to finance the huge investment it takes to bring any vaccine or drug to market. Albert Bourla, Pfizer’s CEO, has estimated his company spent $2 billion on the development effort.
To ease their way, the U.S. government in July promised to pay the companies nearly $2 billion to buy 100 million doses of their vaccine.
Their giant, Phase 3 trial, launched at the end of July and had enough data by the second week of November to meet the FDA’s criteria for authorization.
Until Nov. 15, a Sunday, neither company knew how their vaccine had fared.
During a trial, no one knows which volunteers receive the active vaccine and which the placebo until a predetermined interval, whenan independent data safety monitoring board looks at the safety and effectiveness information.
Türeci spent that Sunday with her family. “We were at home, but not really relaxed, because we knew that data would come in,” she said.
Eventually, the phone rang, and Bourla, the Pfizer CEO, conveyed the good news.
“It was a great moment for us. This was our dream, to have a really high efficacy,” she said. “There was a lot of cheering and jumping up and down. No champagne, but oolong tea.”
Herd immunity is ‘the only way to get back to normal
Despite their success, the marathon isn’t over yet.
“The aim is to contribute until we have herd immunity of 60% to 70%, because this is the only way to get back to normal, not only for all of us personally, but also with our businesses,” Türeci said. “This will keep us on our toes at least the first half of next year.”
Although the vaccine has exceeded everyone’s expectations for effectiveness, there’s still more to be done.
BioNTech and Pfizer are in discussions with more than 30 countries to authorize the vaccine and help make it available.
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Clinical trials will continue, she said, to make sure the vaccine is safe for people with cancer or other immunocompromising conditions, as well as children.
And the company hopes the vaccine can eventually be maintained without being kept at below-freezing temperatures. “You need stability studies and so on,” she said. Mostly, they need time to conduct the experiments.
Plus, she and others at BioNTech are still pursuing their true passion: those cancer vaccines.
Work on them has slowed during the pandemic, and may come to a standstill for a few weeks as Germany remains shuttered through the Christmas holiday season. “We hope that after the unpreventable lockdown over winter, we will be able to accelerate them again, back to normal conditions,” Türeci said.
Türeci said she understands why some people might be concerned about getting the vaccine, but as a scientist, she stands by the data.
“Our data that shows that across ethnicities, across age groups, across different populations at risk … the vaccine is efficacious with a very high efficacy and has a comparable safety profile,” she said.
“Everyone has to decide for themselves. We cannot force anyone who does not want to get vaccinated.”
Contact Karen Weintraub at [email protected]
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