As a Pittsburgh family prepares to bury a 19-year-old Drexel University student who died suddenly of a fast-moving infection, a drugmaker says it will seek U.S. approval for a meningitis vaccine that may have saved her.
Officials with Novartis confirmed Friday that they plan to submit a license application to the Food and Drug Administration "as early as" the second quarter of this year for Bexsero, a vaccine that protects against the B strain of meningitis that killed Stephanie Lynn Ross.
It's the same vaccine recently given to Princeton students and those at University of California, Santa Barbara after outbreaks there. Julie Masow, a Novartis spokeswoman, said its exact timing "will depend on guidance from the FDA."
Ross, a Drexel sophomore who played softball, loved the color purple and planned a career in mechanical engineering, will be remembered at a service set for Monday at a Pittsburgh church. She died March 10 of a bloodstream infection caused by the B strain, which is not covered by existing meningitis vaccines recommended for U.S. college students.
Her father, Stephen Ross, speaking briefly to NBC News, said that the family may be interested in helping “champion” ways to get the vaccine to other college students.
Courtesy of Ross family
Drexel University student Stephanie Ross, 19, of Pittsburgh, died March 10 from a sudden meningococcal strain B infection.
Health officials at the Centers for Disease Control and Prevention, along with those in Philadelphia and New Jersey, said they are cooperating with a Pennsylvania state investigation into how Ross may have contracted the infection.
CDC officials said they’re waiting for tests to see whether the genetic type of the meningitis B bacteria is the same as that responsible for a Princeton University outbreak last year that sickened eight people — or the type that caused an outbreak at the UCSB, where at least four people fell ill.
Drexel University and Princeton University are about 45 miles apart. College students are at high risk for bacterial meningitis because the infection is spread through respiratory droplets and oral secretions from close personal contact, such as kissing.
Meanwhile, some health experts are calling for Bexsero to be offered more widely much sooner.
“With mengingococcal disease in general, that’s the scary thing about it, it can cause very significant disease very quickly,” said Dr. Kristen A. Feemster, a pediatrician and infectious disease expert at Children’s Hospital of Philadelphia. “The question is: If we have a tool that could effectively prevent it, does it change our conversation about making this tool available?”
Dr. Paul Offit, a vaccine expert also with CHOP, told NBC News the same compassionate use criteria that made vaccines available to healthy students after outbreaks at Princeton and UCSB could perhaps be used for others at risk elsewhere in the U.S.
“If my child were on that campus, I’d want to be able to get it,” said Offit, who co-authored a paper with Feemster in December calling for wider use of the vaccine.
“Our ability to mobilize resources in response to this situation should compel us to take measures to ensure access to this prevention tool with proven safety and efficacy to all who are at risk,” they wrote.
Sally Pipes, president of the Pacific Research Institute for Public Policy, a conservative think-tank group, has been critical of what she says is the FDA's excessive caution and regulatory hurdles in approving Bexsero.
"I think it should be available," she said. "There's one case at Drexel now, but who's to say there won't be more cases?"
Bacterial meningitis is a dangerous infection of protective membranes that cover the brain and spinal cord. There are about 500 cases of bacterial meningitis in the U.S. each year, with more than a third caused by meningitis B. About 1 in 10 people who contract it die and another 20 percent are left with permanent disabilities.
First published March 15 2014, 5:06 AM