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CDC's Meningitis B Vax Recommendation Faces Criticism

— Lack of universal recommendation deemed "confusing for parents"

Ƶ MedicalToday

ATLANTA -- Vaccines against meningitis B can be offered to adolescents and young adults, a CDC committee has urged.

The so-called category B recommendation means the vaccines can be offered and will be paid for by insurers, according to the CDC's , which is holding a meeting this week.

The committee voted 14-1 to make the recommendation, despite a parade of people advocating, often tearfully, the stronger category A recommendation, which would have made meningitis B vaccines part of the routine package of vaccinations.

The decision is "really confusing to parents," commented Frankie Milley, the founder of Houston-based . Milley's son, Ryan, died of meningitis B.

Milley said a category A recommendation would make it easier for parents and patients to understand the benefits and risks of the vaccines and for doctors to offer informed counsel.

Quadrivalent vaccines against currently have a category A recommendation, for all children 11 and 12, with a booster at 16.

The stronger recommendation for the meningitis B vaccines would be "less confusing for all concerned," commented , speaking for the Immunization Action Coalition of St. Paul, Minn.

"You have the power to prevent a devastating disease," she said. "A routine recommendation is quite simply the right thing to do."

Several other parents and relatives of adolescents who died of the disease, as well as survivors, gave emotional presentations urging the committee to give stronger support to the vaccines.

On the other hand, the , a nonprofit group that is concerned about vaccine safety, argued in a letter that universal coverage with the vaccine is not yet warranted.

Two vaccines against the relatively rare serogroup B of Neisseria meningitides are currently licensed in the U.S. They are MenB-4C (Bexsero) and MenB-FHbp (Trumenba).

But they were approved following an accelerated pathway and data on immunogenicity and safety is limited, the committee was told.

Currently, the vaccines are recommended for people at high risk of meningitis infection, including those in an outbreak, such as those seen recently in major universities.

The new recommendation would simply add a line saying that people ages 16 through 23 "may be vaccinated" with a preferred age for vaccination of 16 through 18.

The recommendation doesn't become official health policy until it is approved by the director of the CDC and published in .

author of "Worth the Pain: How Meningitis Nearly Killed Me," told the committee he was interested by the level of fear caused by Ebola when "meningococcal B infections are far more prevalent in the United States."

"They're more contagious, they have a similar fatality rate in the U.S., and generally speaking, they kill people faster than Ebola," he continued. If more people understood the gravity of the disease, Marso added, they would also urge the committee to adopt a recommendation for universal vaccination.

"You can put this vaccine in every health plan and every pediatrician's office in America," he concluded, thereby ensuring others do not go through the same debridements and amputations he did.

The rate of meningococcal disease is currently at a historic low in the U.S., noted Jessica MacNeil, MPH, of the CDC, who presented the case for the recommendation developed by the committee's working group on meningitis.

In 2013, she said, there were just 564 reported cases caused by all serotypes of the bacterium, including B. The CDC estimates that serogroup B causes about 55 to 65 cases among those 11 through 23 every year, MacNeil said, with most of the disease seen in those 16 or older.

The CDC had estimated about 40% of the cases among 18- through 23-year-olds were among college students, MacNeil reported.

But in the wake of seven outbreaks on college campuses since 2009, the agency increased surveillance in 2013 and found that in 2013 and 2014 about 65% of cases were among students, with two deaths each year, she said.

MacNeil said the available data suggest that both vaccines offer similar short-term protection, but evidence suggest waning antibody levels for the FHbp vaccine within 6 months of the final dose and within 24 months of the last dose of the 4C vaccine.

One implication is that universal vaccination would not necessarily prevent all cases of the disease, she said.

Both vaccines appeared safe, with the major adverse events being injection site pain, fever, myalgia, fatigue, and headache. Serious adverse events in clinical trials were similar between vaccine and control arms.

"No concerning patterns of adverse events have been seen," she said, although "theoretical concerns" about autoimmune disorders have been raised from study of animal models.

Cost-effectiveness analysis suggested that between 100,000 and 400,000 would need to be vaccinated to prevent a single case; the comparable number to prevent a death was between 1 and 3 million vaccinations.