FROM AN ACIP MEETING
A recommendation to expand serogroup B meningococcal vaccination to include adolescents and young adults, including college students, was supported by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, at a meeting on June 24.
The panel voted 14-1 in favor of the following recommendation proposed by ACIP’s meningococcal work group: The serogroup B meningococcal (MenB) vaccine series “may be administered to adolescents and young adults 16 through 23 years of age to provide short-term protection against most strains of serogroup B meningococcal disease,” specifying that 16-18 years is “the preferred age for MenB vaccination.” In reference to the two MenB vaccines now licensed in the United States, the proposal also states that the vaccine be administered as a two- or three-dose series, using the same vaccine product for all doses, with no preference of one product over the other. “Based on available data and expert opinion,” the MenB vaccine used “may be administered concomitantly with other vaccines, indicated for this age, but at a different anatomic site, if feasible.”
The two vaccines licensed by the Food and Drug Administration are Trumenba , a three-dose series marketed by Pfizer, and Bexsero , a two-dose series marketed by GlaxoSmithKline; they are indicated for preventing meningococcal disease caused by Neisseria meningitidis serogroup B in people aged 10-25 years.
The work group’s recommendation is a category B recommendation, so whether the vaccine is recommended is subject to individualized clinical decisions. A university may choose to recommend vaccination for students. In contrast, under a “category A” recommendation, all people in an age- or risk factor–based group would be candidates for immunization. During the discussion before the vote, several panelists raised concerns that while they would not support a category A recommendation at this time, the category B recommendation could create confusion among clinicians and parents about who should get the vaccine and could result in unequal access to the vaccine. One panelist noted that in the past, pediatric practices have not stocked vaccines with a category B recommendation in their offices.
The reasons for choosing the category B recommendation include the current low burden of disease, and the high number of individuals needed to vaccinate to prevent one case or one death of serogroup B disease, explained Jessica MacNeil, an epidemiologist and member of the work group, who is with the CDC’s National Center for Immunization and Respiratory Diseases. Another reason is that the number of cases prevented “may be comparable to the number of serious adverse events” associated with the vaccine, she said.
At the meeting, the panel also voted 15-0 for the statement that children aged 16 though 18 years “without high risk conditions may also be vaccinated” be added to the groups eligible or MenB vaccination in the Vaccines for Children program. The eligible groups currently listed are those aged 10-18 years at increased risk for meningococcal disease “attributable to serogroup B,” which includes those at increased risk because of an outbreak attributed to serogroup B meningococcal disease. These groups were recommended at the last ACIP meeting in February, when the panel recommended MenB vaccination for several groups at increased risk for serogroup B disease, including students during outbreaks at college campuses.
Vaccines with a category B recommendation are covered under Vaccines for Children and the Affordable Care Act.
There was an unprecedented number of public speakers and letters sent to the panel, overwhelmingly in support of broadening the recommendation for vaccination. Many letters were sent from universities or college. Speakers included parents and siblings of young people who had died of meningococcal serogroup B disease, as recently as the fall of 2014, including both college and high school students, and one 20-year-old who was not a college student. One college student whose sister died of meningococcal B disease said it took 6 months for her to get vaccinated, and she eventually was able to get immunized through a travel vaccine clinic. Other said they have gone to Canada to get the vaccine.
Since 2009, there have been seven outbreaks or clusters of serogroup B meningococcal disease reported to the CDC, including two in 2015, for a total of 41 cases. The outbreak at the University of Oregon, Eugene, which started in mid-January, included six cases in students, with one death from meningococcemia in February. In May, the Oregon public health department announced that a 52-year-old man had developed meningococcal disease after visiting his daughter at the university – the seventh confirmed case linked to the outbreak.
ACIP is composed of medical and public health experts who develop recommendations on how to use vaccines to control diseases in the United States.