Swapna Venugopal Ramaswamy
Rockland/Westchester Journal News
Published 6:00 AM EDT Sep 19, 2019
Kathrin Jansen’s 83-year-old mother is skeptical about getting a flu vaccine.
This puts Jansen at something of a disadvantage: Jansen, 61, is senior vice president and head of vaccines R&D for Pfizer, where she leads a team of over 500 scientists.
“Sometimes, it takes multiple conversations, but at the end she gets the flu vaccine because while they are not perfect, they still prevent a lot of disease and they still prevent hospitalizations,” said Jansen, a microbiologist who played a vital part in the development of two blockbuster vaccines, Gardasil, the world’s first vaccine to prevent human papillomavirus, and Prevnar-13, given to children and adults against life-threatening illnesses like meningitis and pneumonia.
“It is important to remind people of how it was before we had vaccines,” she continued.
“There is no other intervention that can eradicate a disease. We eradicated smallpox. We could eradicate polio, we could eradicate measles, but it takes everyone to be part of this,” Jansen said.
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“Once the disease is gone, you don’t have to vaccinate anymore. Nobody gets smallpox vaccine anymore.”
Vaccines save millions of lives each year by preventing diseases, yet the health care industry has had to increasingly contend with vocal skeptics, or anti-vaxxers, as they have become known, who believe vaccines do more harm than good.
Earlier this year, the World Health Organization added “vaccine hesitancy” to its list of the top 10 threats to global health.
This year, the CDC confirmed 1,203 cases of vaccines-preventable measles in the U.S., the greatest number of cases reported since 1992 and since measles was declared eliminated in 2000.
Rockland County had one of the worst outbreaks of 2019, concentrated in Hasidic and Orthodox communities in Ramapo. A total of 312 measles diagnoses have occurred since the outbreak began in October.
In June, Gov. Andrew Cuomo signed a law that removed non-medical exemptions from school vaccine requirements. This applies to all schools and daycares, whether public or private programs. The ruling continues to face court challenges.
“I don’t know what motivates an individual to ignore scientific facts. As scientists, it is our obligation to rectify misinformation and to provide the facts on what we know and what we don’t know,” said Jansen, as she sat at a conference room in Pfizer’s sprawling 330-acre R&D campus in Pearl River, which employs about 800 people.
She gets it from her mother
A little over a year before the Berlin Wall went up in 1961, Jansen, who was born in Erfurt, a town in East Germany, was smuggled into West Germany by her aunt.
She was 2.
Her mother and father drove across the border from East Germany in separate cars so as not to raise suspicion.
“It was actually my mother who realized that things were not looking good,” said Jansen. “My mother was worried they would close it (the border) down and she was right.”
Good instinct; knowing when to move on and the courage to speak her mind are traits Jansen surely inherited from her mother.
For instance, she briefly contemplated pursuing a medical degree after high school in Germany. What gave her pause was the lack of women role models in the profession and the “authoritarian” attitude of the male doctors who “thought they knew everything,” Jansen said.
“I kind of had the sense that it probably wouldn’t go well with my personality and that if I studied medicine I would probably get in trouble.”
Until 1977, married women in West Germany could not work without permission from their husbands.
“The German medical establishment at the time was very hierarchical. One better did not disagree with whoever was in charge,” said Jansen. “Being a person who was brought up and educated to think critically and do the right thing, this did not sit well with me.”
She recalled a visit as part of her Ph.D. class to a German pharmaceutical company where a male doctor employed by the company asked the women on the tour why they would bother with the visit.
“He claimed it would be a waste of time, that we would become homemakers anyway and never work as Ph.D. scientists,” said Jansen. “I was mad as hell, but too stunned to have an appropriate response at the time.”
Her takeaway from the experience?
“Follow your dreams no matter what people tell you.”
Her dreams led her to look outside Germany; she headed to the U.S. to pursue postdoctoral work at Cornell University.
Mark Yeager, to whom Jansen has been married for more than 30 years, said he isn’t surprised by his wife’s success.
“Kathrin has a very clear vision about what needs to be done,” said Yeager. “She’s very goal-oriented and focuses on making things happen increment by increment.”
The couple met at Cornell where Yeager was pursuing his doctorate in biochemistry and Jansen was attending on the prestigious Humbolt fellowship to do post-doctoral work on a yeast expression system. (A yeast expression platform involves using a strain of yeast to produce large amounts of proteins, sugars or other compounds for research or industrial uses.)
“That was probably one of the most formative experiences of my professional life because it was not easy,” said Jansen.
Developing Gardasil, Prevnar vaccines
When Jansen arrived at Merck Research Laboratories in 1992, she was hired to work on the development of new vaccines as well as on improvements of vaccines that had already been licensed.
However, she said she knew within the first six months that the project she was assigned to would not yield results.
“Sometimes you need to know when to move on,” she said.
She wanted Merck to invest resources to begin a project to make a vaccine against the human papillomavirus (HPV), based on promising work being done in the area by Australian company CSL.
In 1995, after CSL gave Merck & Co an exclusive license to commercialize the technology, she initiated and led the development of Gardasil, which helps prevent certain kinds of cancers in men and women including HPV, the most common sexually transmitted infection in the United States, according the U.S. Centers for Disease Control, which recommends children get the initial dose of vaccine between the ages of 11-12 to protect them before they are ever exposed to cancer-causing infections.
As the scientific leader of the HPV product development team, she led efforts to complete Phase III testing of a prophylactic HPV vaccine and developed a second-generation HPV vaccine.
In all, Jansen had spent almost 11 years on the development of the HPV vaccine.
Along the way, Jansen rose through the ranks from research scientist to senior director to ultimately becoming the executive director and department head of Microbial Vaccine Research at Merck.
“These things take time. But it was just so much fun. The dedication of everyone working on this program and really being involved from the beginning to the end,” said Jansen, who left Merck in 2004, before licensure, to take on a broader position at VaxGen, a biotech company which had won a large government contract to develop an anthrax vaccine.
Things didn’t go as Jansen had expected. The anthrax vaccine the company developed was unstable, breaking down too quickly for the government to allow it to be tested in clinical trials.
But running into stability issues was normal in development, she said.
She left the company to join the drug maker Wyeth.
At Wyeth, and later at Pfizer (which bought Wyeth in 2009), she was responsible for all infectious disease vaccine discovery and early development activities, including Prevnar-13, which brought in $5.8 billion in revenue in 2018 for Pfizer.
For the past few years, her team had been working on developing a vaccine to prevent staph infection in patients undergoing elective spinal surgery.
After the shot failed a Phase 2 trial, Pfizer decided in December to pull the plug on the vaccine, which was estimated by industry experts to bring in $489 million in sales by 2022.
Jansen said her team was hoping to do a “post-mortem analysis” to get an idea of what may have happened and if there’s a way to reconfigure the vaccine.
A practical approach
In a field where working on a product from start to finish can take a decade or more, it is easy to see how scientists can get disheartened when a program is terminated.
“Sometimes you just have to let it go. I give that advice to other scientists too,” said Jansen. “And sometimes, I’m actually not giving them the choice. So I just have to say ‘we are done.’”
In her organization, Jansen said she tells scientists well in advance what it would take to move a program forward.
“We say ahead of time, if we can demonstrate ABC, then we move forward. If you don’t demonstrate, the program is dead,” said Jansen. “You could see the anxiety on the researchers when you lay it out like that and then you say, look, it doesn’t matter what happens. It would be nice if it works. But if it doesn’t work, we’ll put you on the next project.”
Making the tough call doesn’t mean Jansen is not sensitive to the scientists’ feelings or a believer in their abilities.
“If you do your science well, it can be a success, or you do it well and you can demonstrate that this is the wrong path, in which case you need to say, I did this well, but this is not the right path,” she said. “Science is so big. There are so many things that scientists can do. It doesn’t have to be one thing, you have to keep an open mind.”
Dr. Phil Dormitzer, vice president and chief scientific officer, viral vaccines at Pfizer, said he decided to join the company four years ago because he wanted to work with Jansen.
“She is highly motivated by the desire to get vaccines out there that really have an impact on public health,” he said.
Dormitzer, who described Jansen’s management style as “forceful,” said one of the things that has characterized what she has done is “very strict prioritization.”
“We pick a limited number of targets and focus on research and development,” he said. “So there’s really very little dabbling that goes on here. It’s all very focused.”
One of the areas Jansen is most excited about these days is maternal vaccinations.
Vaccination of pregnant women, also called maternal immunization, has the potential to protect pregnant women, fetuses and infants from vaccine-preventable diseases.
Pfizer is currently working on developing vaccines against respiratory syncytial virus (RSV) and Group B Strep (GBS) that could help protect infants.
“It can really protect the most vulnerable, newly born infants when they are susceptible to infectious diseases,” said Jansen. “I call maternal vaccines the next frontier of vaccinology.”
Swapna Venugopal Ramaswamy covers women and power for the USA Today Network Northeast. Write to her at email@example.com