Emergency meningitis vaccine will be imported to halt Ivy League outbreak

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By JoNel Aleccia

Emergency doses of a meningitis vaccine not approved for use in the U.S. may soon be on the way to Princeton University to halt an outbreak of the potentially deadly infection that has sickened seven students since March.

Government health officials said Friday they have agreed to import Bexsero, a vaccine licensed only in Europe and Australia that protects against meningitis B, a strain not covered by the shots recommended for college students in the U.S.

"This is a bad disease and we know how devastating it is," Dr. Thomas Clark, acting head of the Centers for Disease Control's meningitis and vaccine preventable diseases branch, told NBC News. "A lot of us had a gut feeling that there would be more cases and we should get the ball rolling." 

The unprecedented move could aim to inoculate the nearly 8,000 undergraduate and graduate students at the Ivy League school in hopes of stopping the spread of an illness that kills 10 percent or more of teens and young adults who get it.

"If you're a student at Princeton University right now, your risk is quite high," Clark said. 

Officials at the New Jersey university were mum on the arrangement, providing no details about how or when a vaccination effort would be launched. 

"We are not prepared to confirm anything at this time," said Martin Mbugua, Princeton's director of media relations. "This is a question we have been considering very carefully. We will be discussing it with our trustees this weekend and when we have something to announce, we will make an announcement."

CDC officials asked for an IND, or investigational new drug application, to import the vaccine in early October, after the fifth case was diagnosed. Since then, two more students have fallen ill, including a male student who was hospitalized last weekend. The outbreak began in March, when a female student who left campus for spring break came back with signs of the disease. Since then, six Princeton students and an April visitor to the campus have become ill. 

All of the cases were caused by the B strain of the bacterium Neisseria meningitidis, New Jersey health officials said. Six of the those who were sickened have recovered from the infections; the seventh is recovering. None of the cases is linked to the others, officials said. 

Bexsero will be approved for use only in the Princeton community because of the seriousness of the outbreak, Clark said. Students at other colleges across the country are not in any greater danger of infection than usual, he added. 

"We've identified the population at risk. Right now it's an outbreak at Princeton University," Clark said. 

Bexsero, which is manufactured by drugmaker Novartis, was approved earlier this year for use in Europe and Australia. British health officials initially declined to recommend it for use in the country’s childhood vaccination program mostly because of worries about cost effectiveness, but also concerns about efficacy. Clark estimated that it would be 90 percent to nearly 100 percent effective at preventing infection. Vaccines available in the U.S. also prevent most — but not all — infection.

Novartis has submitted an application to offer the shots in the U.S., but they haven’t yet agreed on a “pathway to licensure” with the FDA, said Julie Masow, a company spokeswoman. 

It's generally regarded as safe, Clark said. He emphasized that an IND does not mean that it's an experimental vaccine or that any study would be done without a student's consent.

Bacterial meningitis is a dangerous infection of the protective membranes that cover the brain and the spinal cord, known as the meninges. It is spread through respiratory droplets or secretions exchanged through close contact such as coughing or kissing. Cases have dropped sharply in the U.S. in recent years, but between 800 and 1,200 are typically reported annually. Last year, only 500 cases were reported in the U.S., Clark said. Most cases in America are caused by the C or Y strains of bacteria, CDC says.

The worry is that between 10 percent and 12 percent of those who get the fast-moving infection die, and about 20 percent of those who recover can wind up with severe side effects including deafness, mental retardation and limb amputations, according to the CDC.

Adolescents are particularly vulnerable to the infection. Health experts recommend that preteens routinely get the vaccine at age 11 or 12, with a booster shot at 16. Kids who don’t get it earlier need a booster shot before going to college. At least 16 states require incoming college students or those who live in dormitories or shared housing to get the vaccine.

Early symptoms can be mild and resemble minor illnesses like a cold or flu: fever, headache, body aches, fatigue. But they can quickly escalate to include stiff neck, nausea, vomiting, confusion and sensitivity to light. After the disease has taken hold, a rash may appear. Death can occur very quickly — within hours or days. 

Four meningitis vaccines are licensed for use in the U.S., including Menveo, made by Novartis and Menactra, made by Sanofi Pasteur. But they protect against only four of the strains that cause illness: A, C, Y and W-135.

Scientists have been working for two decades to make a vaccine to protect against the B strain, but it’s been challenging. There are many types of B bacteria that cause illness and it’s tough to produce a universal vaccine that would cover strains circulating in different parts of the world.

That's a key frustration for U.S. meningitis education advocates, who have long called for a vaccine that could protect better against all strains of the disease. 

"We've been waiting years for a B vaccine," said Lynn Bozof, president of the National Meningitis Association, whose 20-year-old son, Evan, died of meningitis in 1998 after suffering for nearly a month, including having his arms and legs amputated. 

She praised the cooperation of CDC, the FDA, Novartis and Princeton officials. 

"I think this is really wonderful that all these groups have come together to combat this," she said. "Their immediate concern is stopping the outbreak in this contained group."

But for parents across the country whose kids died after contracting meningitis B, the effort at Princeton is anguishing. 

"My Emily was vaccinated. I felt safe," said Alicia Stillman of West Bloomfield, Mich. She lost her 19-year-old daughter on Feb. 2 after the Kalamazoo College sophomore contracted a meningitis B infection that killed her 36 hours after she walked into a hospital with a headache.

She's glad the Princeton families will have more protection against the meningitis outbreak, but she wishes it had come sooner to the U.S. 

"I hope there will come a time it can be used routinely here," said Stillman, who has two other children. "It's a horrible, horrible disease."

JoNel Aleccia is a senior health reporter for NBC News. Reach her on Twitter at @JoNel_Aleccia or send her an email.