By Jen Christensen
Starting Monday, students at the University of California Santa Barbara will be getting an unapproved vaccine scientists hope will stop a meningococcal disease outbreak there, the university said.
The Swiss pharmaceutical company Novartis already has approval for its vaccine Bexsero in Europe, Canada and Australia. It is not approved for use in the United States.
In this case, the Food and Drug Administration had to grant special permission for its use at UCSB. The FDA granted special permission to use the vaccine at Princeton last December to fight an unrelated outbreak there.
Meningitis B outbreaks are rare but deadly, according to the Centers for Disease Control and Prevention. In 2012, there were 480 cases of bacterial meningitis; some 160 of those were group B, the agency said.
There were eight confirmed cases at Princeton and four UCSB students were confirmed as sick with meningococcal disease, which can cause meningitis or blood infections.
One case at UCSB was so advanced, doctors had to remove a student's lower legs in November. Aaron Loy had been a promising lacrosse and soccer player. After his operation his parents asked the FDA to pick up the pace on Bexsero's approval.
"We hope that Aaron's horrific illness brings increased awareness and rapid approval by the FDA of the vaccine" for the type B strain, Mike Loy said.
There are vaccines approved in the United States for other types of meningitis, but group B is the strain that does "pack the most powerful punch," the CDC said.
College students are especially vulnerable. Students who drink a lot of alcohol can be particularly susceptible to catching it. Dorms are the perfect breeding grounds for an outbreak.
Meningitis B spreads through coughing, sneezing, and kissing. It can also spread when people forget to wash their hands or clothes, or among people who drink out of the same cup.
Meningitis B is tricky since students who catch it may first think they have the flu. It starts with flu-like symptoms: fever, headache, stiff necks, vomiting and delirium. If the bacteria spread to the protective tissue around the spinal cord and brain, known as the meninges, patients can suffer hearing loss, permanent neurological damage and even death.
The CDC sent a team of scientists to UCSB to study the outbreak in December. Fortunately, scientists said, a meningitis B outbreak moves slowly than others.
"It smolders," said Dr. Tom Clark, the chief of the CDC's meningitis branch. "You have a bit more time to get everything in place."
Bexsero will be offered to some 20,000 students at UCSB. More than 5,000 were vaccinated at Princeton University and they are currently getting a second dose which is necessary for full immunity.
Novartis says it is seeking U.S. license for the vaccine's use in all adolescents and young adults which they say would "enable immediate response to future outbreaks," according to its press release.
"These recent outbreaks remind us how unpredictable the disease can be," said Andrin Oswald, division head for Novartis Vaccines. His company has submitted successful test results from 8,000 vaccinations of adults, children, adolescents and infants.
That test data was used for vaccine approval in other countries. "We will continue to work with the FDA to pursue a potential license for Bexsero in the U.S. to help fulfill this public health need," Oswald said.
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