It’s urgent that we expedite approval of the vaccine for a campus killer, meningitis B.
Andy Marso was a college kid with a bright future. He left Minnesota to study journalism at the University of Kansas. He was three weeks away from graduating and had a job waiting as a sportswriter for the local paper. Then one day he literally felt a shiver up his spine.
Andy thought it was just the flu. What started as a fever and shivers quickly turned into numbness throughout his body, a parched throat and ugly purple blotches on his arms. Within fewer than 24 hours, he was unable to walk and was rushed to the university health center, then to the hospital.
At 22, Andy never had suffered a major illness or injury. He didn’t smoke and generally was in good health. Yet that didn’t stop him from getting a meningitis B (MenB) infection. Andy eventually developed sepsis and pneumonia, his lungs failed, and blisters that would burst and cause additional infections covered his skin. Andy spent 141 days in the hospital, during which he suffered painful sessions to remove decaying skin, and doctors amputated all of his digits except his right thumb.
While it is not known how Andy got sick, it is possible that something as simple as using a dirty plastic cup in a bacteria-rich college dorm room combined with a weakened immune system from lack of sleep could have resulted in the infection. College campuses are a focus of prevention efforts for meningococcal disease because of the increased incidence of the disease during adolescence and young adulthood, as well as transmission from crowded living conditions and social behaviors common among college students.
Andy contracted MenB in 2004 and made it through this horrific experience with his life. Unfortunately, Emily Stillman wasn’t so lucky.
A sophomore at Kalamazoo College in Michigan, Emily called her mom one Friday in February 2013 to tell her she had a terrible headache and was tired. By Sunday, Emily had died from MenB.
The circumstances surrounding Emily’s death are particularly devastating and infuriating, because her death was preventable. Today, the U.S. has an approved vaccine for every type of meningitis except type B. One MenB vaccine, Bexsero, has been approved by regulators in 34 other countries, including the European Union, Australia and Canada. Yet, the vaccine hasn’t been approved here.
This is a failure of leadership and the result of an outdated regulatory process.
More than a dozen students have been infected with MenB across the U.S. during the last year and a half at four colleges, including Princeton, the University of California, Santa Barbara (UCSB), Kalamazoo and Drexel. Two died. Another had to have both feet amputated.
While the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention eventually distributed a limited supply of imported Bexsero to Princeton and UCSB, the vaccine is not available for wider use in the U.S.
This has led parents like Alicia Stillman, Emily’s mother, to seek the vaccine outside of the U.S. Alicia has taken multiple trips with hundreds of parents, children and doctors to Canada to get the vaccination. Her youngest son, Zachary, accompanied her on one of these trips. I had the privilege of meeting Alicia Stillman, who told me she would not risk her son facing the same fate as his sister while waiting for the FDA to approve the drug.
“It’s a no-brainer [to go to Canada for the vaccine],” Alicia told me. “Emily didn’t have to die. This was preventable. How many more students have to die before we do something?”
The FDA recently gave “breakthrough therapy designation” to two companies — including the manufacturer of Bexsero — seeking approval for a vaccine in the U.S. This designation allows for the expedited consideration of their vaccine applications, which they submitted last month. Unfortunately, even with the expedited process, it could take another six to 12 months for the FDA to approve the applications.
The slow approval process means our students will return to school this fall with no defense against MenB. As the father of four girls, including two in college, I am fearful of the consequences of inaction. That’s why I sent a bipartisan letter with my colleagues to the FDA asking that it take immediate action to prevent additional MenB outbreaks. I also called FDA Commissioner Margaret Hamburg to personally urge her to act quickly on the vaccine.
We also must enact reforms to prevent another similar situation in the future.
The U.S. House Energy and Commerce Committee recently launched a comprehensive look at ways we can accelerate the pace of cures in America. This includes expediting the FDA approval process, exploring reciprocity agreements with other countries, and incentivizing the research and development of new and innovative technologies.
While an expeditious FDA approval of a MenB vaccine won’t bring Emily Stillman back or reverse the effects of Andy Marso’s life-altering experience, more enlightened public policy will save other children from a similar fate, and now is the time to take action.
Erik Paulsen, R-Minn., is a member of the U.S. House.
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