ACIP endorses individual choice on meningitis B vaccine

The Advisory Committee on Immunization Practices (ACIP) today stopped short of recommending routine use of serogroup B meningococcal vaccine in young people, instead leaving the decision to doctors and their patients.

The committee voted 14-1 for individual choice on use of the vaccine in adolescents and young adults ages 16 through 23, with 16- to 18-year-olds as the preferred age-group. The move came in the wake of several meningitis B outbreaks and a number of sporadic cases on college campuses in the past 2 years.

Some safety, efficacy concerns

Representatives of various organizations and several relatives of meningitis B victims urged the panel to endorse routine immunization against the disease. But some level of uncertainty about vaccine safety caused reluctance to vote for routine use.

The approved recommendation states, "A 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. The preferred age for MenB vaccination is 16 through 18 years of age."

The recommendation is labeled as "Category B," meaning that individual clinical decision-making is recommended. A Category A recommendation means a vaccine is recommended for everyone in an age-group or risk factor group.

"There are some red flags on the safety of this vaccine," one ACIP member commented before the vote. He said the panel would review the possibility of a Category A recommendation when more safety data become available.

The ACIP's recommendations are routinely adopted by the Centers for Disease Control and Prevention (CDC), making them official policy.

Two meningoccal B vaccines were approved by the Food and Drug Administration in recent months—Pfizer's Trumenba last October and Novartis's Bexsero in January. Current quadrivalent vaccines for meningococcal disease in the United States don't include the B serotype. The CDC currently recommends routine vaccination against four of the five major meningococcal serotypes: A, C, W, and Y.

Jessica MacNeil, MPH, of the CDC National Center for Immunization and Respiratory Diseases, in discussing the recommendation at today's meeting, said the available meningitis B vaccines may not provide long-term protection and may not prevent all cases.

Groups welcome decision

The National Meningitis Association (NMA) welcomed the ACIP action today, while noting that a routine recommendation would have been preferable.

In a statement, the NMA said the step allows young people and their parents to decide if they want the vaccine and also "paves the way for coverage of the vaccine by private and public health insurance, including the Vaccines for Children Program (VFC)."

"Today's decision will help parents and healthcare professionals protect our children from all forms of meningitis by providing access to the vaccines," NMA President Lynn Bozof said in the statement. "While we would have preferred a routine recommendation, the permissive recommendation, if accepted by CDC, will ensure these vaccines are covered by private and public insurance, including the VFC program, and medical practices will be more likely to stock and administer them."

The ACIP vote was also welcomed today by Pfizer, manufacturer of Trumenba.

"Healthcare providers should understand the importance of today's ACIP recommendation to help protect adolescents and young adults," Laura York, PhD, global medical lead for meningococcal vaccines at Pfizer Vaccines, said in a statement.

At the meeting, Deborah Wexler, MD, executive director of the Immunization Action Coalition, urged the ACIP to endorse routine immunization of young people against meningitis B.

"Having a routine recommendation for one meningitis vaccine and a permissive recommendation for another is unnecessarily confusing for parents and providers," she said.

"There are still concerns that private insurance and HMOs may not cover the vaccine if it's a permissive recommendation. If it's not on the CDC recommended schedule, the vaccine may not even be discussed," she added.

A representative of America's Health Insurance Plans (AHIP), a trade group, commented, "AHIP does value vaccines, and many health plans already cover this vaccine. . . . Health plans would cover [Category] A and B recommendations when provided in-network."

At its previous meeting, in February, the ACIP voted to recommended meningitis B vaccine for people age 10 and older in certain specific risk groups: those with persistent complement component deficiencies, those with anatomical or functional asplenia, microbiologists exposed to Neisseria meningitidis, and people thought to be at risk during meningitis B outbreaks.

See also:

Jun 24 NMA news release

Jun 24 Pfizer statement

ACIP homepage

Jun 12 CIDRAP News item, "Risk groups recommended for meningitis B vaccine"

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