SATURDAY, OCTOBER 1, 2016

CDC committee votes to allow meningococcal group B vaccine

Newly available vaccinations to combat the “B” strain of meningitis should only be considered for use by individuals and their physicians, recommends the Advisory Committee on Immunization Practices, a committee of the U.S. Centers for Disease Control and Prevention.

Meningococcal disease is a rare but serious bacterial infection that may be difficult to diagnose within 24 hours of symptom onset, and it may leave those affected with lifelong disabilities, according to the CDC, which reports that there are 800 to 1,200 cases each year of all serogroups of meningococcal disease across all ages.

Five serogroups of Neisseria meningitidis [A, B, C, W-135 and Y] cause the majority of cases of meningococcal disease in the United States and the CDC currently recommends routine vaccination against four of the five major strains of the disease (A, C, W and Y). Meningococcal group B is one of the most prevalent serogroups, accounting for 32 percent of all reported U.S. cases in all age groups during 2013, the most recent year the CDC provided data. The new serogroup B vaccine is separate from the routine vaccine.

“This recommendation means that those who know enough to request the vaccination from their doctors will get it,” Neal Raisman, Global Healthy Living Foundation Ambassador, told the committee during its June 24 meeting. “This is an incremental step forward in protecting our population from this deadly disease.”

GHLF, a nonprofit organization that advocates to improve the quality of life for people living with chronic illnesses, had asked that the new vaccine be added to the current vaccination recommendations for college-aged students, who are more susceptible to meningitis because of the way it is spread -- through close personal contact including dorm living.

Currently, a vaccine that covers four strains of the disease is recommended for college-age youth and many states and colleges require the vaccination. During the past few years, outbreaks of the “B” strains have occurred at colleges across the country, including Princeton University, the University of California at Santa Barbara, and Georgetown University. In the last several weeks, a seventh case was diagnosed at the University of Oregon, where one student died from the disease.

Specifically, the center’s ACIP recommendation determines states’ action to add vaccines to their immunization schedule. ACIP voted for a Category B recommendation for meningococcal group B vaccination in individuals aged 16 to 23 (with a preferred age of 16-18), which means that the decision to vaccinate against meningococcal group B will be made by qualified healthcare professionals, based on an individual’s patient risk assessment.

The ACIP recommendation also paves the way for coverage of the vaccine by private and public health insurance providers, including the federal Vaccines for Children program.

ACIP also voted last week to include BEXSERO® in the CDC’s VFC program for ages 16-18, a vaccine produced by GlaxoSmithKline, a major research-based pharmaceutical and healthcare company.

The committee’s vote “is the latest milestone on a 20-year journey to develop a vaccine in order to help protect individuals from this devastating condition," said Patrick Desbiens, GSK’s senior vice president for U.S. vaccines. "Meningococcal disease is fast-moving, unpredictable and can cause irreversible damage, so vaccination is the best tool to help prevent it.”

GSK is currently evaluating the safety and immune response of a pentavalent meningococcal vaccine for all five serogroups that is now in Phase 2 research, Desbiens said, and the company plans to continue to invest in vaccines against this disease as a key part of its growth strategy.

Meanwhile, the ACIP voted in February to allow the meningococcal group B vaccines to be used in people older than 10 who are at increased risk for meningococcal group B disease. The final ruling was published June 12. The committee’s new recommendation will become final once it’s published in an upcoming Morbidity and Mortality Weekly Report.