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California asks to use non-approved meningitis vaccine for college outbreak

By Sharon Bernstein

SACRAMENTO, California (Reuters) - Public health officials in California said on Thursday they had sought permission from the federal government to use a vaccine not approved for use in the United States against an outbreak of meningococcal disease among students in a public university.

The outbreak, which resulted in a student at the University of California, Santa Barbara, having his feet amputated, is similar to one that has stricken eight students at Princeton University in New Jersey, where students began receiving the European and Australian vaccine this week.

California's move comes amid renewed concern about meningococcal disease, which can infect either the brain or the bloodstream and is highly contagious among people who live in close quarters, such as college students.

This week, a staff member at the University of California, Riverside, east of Los Angeles, was hospitalized with a suspected case of bacterial meningitis, prompting officials there to consider implementing a requirement that all students be vaccinated against it.

On Thursday, the dean of the U.C. Riverside medical school called on the broader U.C. system to insist on vaccinations at all of its 10 campuses.

"Let's hope we don't have to wait for every campus to have an outbreak before somebody decides to look at this as a larger issue," said Dr. Richard Olds, the infectious disease specialist who serves as dean.

Most strains of the bacteria that cause the sometimes fatal central nervous system infection meningitis as well as a blood disease can be controlled with a vaccine that is widely available in the United States.

But the vaccine that protects against the type of bacteria causing the infections at Santa Barbara and Princeton, called serotype B, has not been submitted for approval for use in the United States, according to the U.S. Centers for Disease Control and Prevention.

Students at Princeton began receiving that vaccine earlier this week, after the CDC intervened on their behalf.

But when the California outbreak was announced, the CDC said it wanted to wait, in part to see if the disease spread to more students.

WORRIED PARENTS

Worried college parents complained to the university as well as to public health officials in Santa Barbara, wanting to know why the vaccine had not been made available to their children, according to spokesmen for both agencies.

Public health officials and university administrators said they had discussed the possibility of requesting permission to use the vaccine with CDC officials, but had decided to defer to the CDC's judgment about whether it was warranted.

Late on Thursday, a spokesman for the California Department of Public Health said in an email that the state had formally asked the CDC to request permission from U.S. regulators to use Swiss drugmaker Novartis' Bexsero in Santa Barbara.

A CDC spokesman did not have any immediate comment on Thursday night.

But Dr. Tom Clark, the agency's head of meningitis surveillance, said in an earlier interview that the CDC wanted to first make sure that the vaccine worked against the bacteria in the precise form that it was appearing in the Santa Barbara students, and then had wanted to wait to see if more students became infected.

"It's an exceptional thing really to use an unlicensed vaccine in an outbreak like this," Clark said. "So for example in Princeton we took the actual bacteria that caused disease in the cases and tested it against serum in blood of folks that have gotten immunized."

A spokeswoman for Novartis said Bexsero was the only vaccine that covered serotype B of the disease, and that the company was working on a version for the United States that would cover serotype B as well as other strains. She said the company had not yet heard from a university other than Princeton, where it had begun administering thousands of doses to students earlier this week.

(Reporting by Sharon Bernstein; Editing by Dan Whitcomb, Eric M. Johnson and Lisa Shumaker)

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