New recommendation for MenB vaccine?

Patients aged 16 to 23 years now have greater access to meningitis B vaccination, but the Centers for Disease Control and Prevention (CDC) withheld its broadest approval over concerns about the cost and safety of the relatively new drug.

Pediatricians may now offer a vaccination against serogroup B meningococcal disease (MenB) to any teenagers and young adults that want to receive it.

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The vaccine has been designated as a category B vaccination by the CDC’s Advisory Committee on Immunization Practices (ACIP), meaning pediatricians may recommend the vaccine or patients can request it, but it is not offered as a routine vaccination.

The ACIP voted 14-1 in favor of the new recommendation at its June meeting, says the CDC’s Ian Branam. The final recommendation states that preteens, teenagers, and young adults aged 16 through 23 years may be vaccinated with MenB vaccines to provide short-term protection against most strains of MenB.

Vaccines for other meningitis serogroups-A, C, W, and Y-currently have category A recommendation from ACIP, meaning that all children aged 11 and 12 years should receive the vaccine with an additional booster at age 16 years. Vaccination against MenB was recently recommended for all children in the United Kingdom and Scotland.

The committee previously made a recommendation on the MenB vaccine in February 2015, but reserved its approval at that time for high-risk populations between the ages of 10 and 25 years.

High-risk individuals include persons with certain genetic deficiencies, as well as patients taking eculizumab for treatment of atypical hemolytic uremic syndrome or paroxysmal nocturnal hemoglobinuria because the drug binds to C5 and inhibits the terminal complement pathway. Patients with functional or anatomic asplenia also may have a higher risk for meningococcal disease, as well as a higher mortality rate.

Scientists estimate the rate of MenB infection is about 13 per 100,000 persons, according to ACIP, but there is a 200 to 1,400-fold increase in that risk during outbreaks, as seen in data collected at college campuses in recent years.

The new recommendation expands the approval to anyone who wants to receive the vaccine within the recommended age range, and opens the door for insurance companies and other publicly funded health programs, such as the federally funded Vaccines for Children program, to cover the costs.

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Meningitis B is a bacterial infection affecting the lining of the spinal cord and the brain. It causes inflammation and is difficult to diagnose, killing between 5 to 10 afflicted individuals each year. It can be treated with antibiotics, but 10% to 15% of affected persons still die, and 19% of survivors are left with long-term disabilities such as brain damage or limb amputations.

According to data presented at ACIP’s February meeting, there were 564 cases of all meningitis serogroups in 2013 including the B serogroup, which accounts for roughly 55 to 65 cases annually in individuals aged 11 through 23 years.

The CDC’s Jessica MacNeil, MPH, told ACIP at that time that meningococcal infection rates are currently at a historic low in the United States, but a rash of 7 outbreaks on college campuses since 2009 caused CDC to increase surveillance. As a result, CDC found that 65% of cases in 2013 and 2014 were among students, with 2 deaths each year, MacNeil said at the meeting.

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MacNeil also reported that although serious adverse effects didn’t appear to be a concern in clinical trials so far, “theoretical concerns” were raised about autoimmune disorders from a study of animal models.

New MenB vaccines appeared safe in clinical trials, according to reports presented to ACIP, 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 groups. MacNeil reported that between 100,000 and 400,000 vaccinations would be needed to prevent a single case of MenB, and between 1 million and 3 million vaccinations would be needed to prevent a single MenB-related death.

MenB vaccines were licensed by the US Food and Drug Administration (FDA) through an accelerated pathway in response to an urgent need to control outbreaks, Branam says.

“This means we are still waiting on additional data that is needed to inform how best to use these vaccines. However, these vaccines appear to be safe based on currently available data and we want people to have access to them now to help prevent this serious illness,” Branam says. “A category B recommendation provides that access and allows clinicians to weigh the risk of the disease with the risks and benefits of the vaccine.”

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Two versions of the vaccine are available-Pfizer’s Trumenba and Novartis’ Bexsero. Trumenba was approved by the FDA in October 2014 and Bexsero in January 2015. Trumenba is a 3-dose series with the second and third doses given 2 and 6 months after the first dose. Bexsero is a 2-dose series with the doses occurring 1 month apart. Both vaccines were granted Breakthrough Therapy designations for accelerated approval following a series of MenB outbreaks on 2 college campuses in 2013.

The ACIP reviewed data from 7 clinical trials of Bexsero and 9 clinical trials of Trumenba. Adverse events were not widespread during clinical trials of Bexsero, and the most common adverse effects included pain at the injection site, myalgia, erythema, fatigue, headache, induration, nausea, and arthralgia. Similarly, serious adverse events were not reported during trials of Trumenba, and the most common adverse effects occurred within a week of administration and included pain at the injection site, fatigue, headache, myalgia, and chills. Trumenba was also tested for co-administration, and no interference with the effects of other vaccines given at the same time was reported. Co-administration was not studied in the clinical trials for Bexsero, according to ACIP’s report.

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Although no deaths were reported in the trials of either vaccine, 1 case of anaphylaxis was reported with each drug. Bexsero’s cost is $320 for the series, and Trumenba costs $345 for the complete series, according to ACIP.

Jonathan L. Temte, MD, PhD, chair of the Wisconsin Council on Immunization Practices and professor in the department of family medicine and community health at the University of Wisconsin School of Medicine and Public Health, Madison, recently left ACIP but spent 8 years on the committee. Although he didn’t cast a vote at the June meeting, Temte says there were 2 major issues in the MenB vaccine discussions.

“First, the committee felt that there was need for additional assessments of safety prior to expanding to a routine recommendation; second, more information is needed on duration of protection,” Temte says. “Other issues include a very high cost of vaccination, implementation issues with the 2-dose and 3-dose schedules, very low burden of illness, and little information on the effect of vaccination on carriage.”

The committee continually revisits its recommendations, although there is no specific time frame, Temte says. He says he thinks the MenB vaccine is an issue that will garner a lot more attention.

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“I believe that there will be great interest in assessing safety as this vaccine is used in much wider populations,” he predicts. “I suspect that there will be continued interest and efforts by the stakeholder groups to push for a universal recommendation.”

Temte says he thinks that the recommendation from ACIP will result in many colleges and universities endorsing the vaccination prior to entry.

Advocates of broad MenB vaccination testified before ACIP both in February and June, arguing that a category B recommendation could cause confusion and prevent some patients from receiving the vaccine, but the committee determined that the vaccines were simply too new and too costly to warrant a category A designation.

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The National Meningitis Association (NMA) offered its support to ACIP’s decision, saying that whereas the group would have preferred a routine vaccination as for the other serotypes, this action by ACIP will at least increase availability and insurance coverage of the vaccination.

The association also expressed concern that, because other meningitis serotypes are a part of the routine vaccination series, parents and patients might be confused about the new MenB vaccination and mistakenly believe they are covered against the disease through the other vaccinations. The group said in a statement that it plans to launch outreach and education campaigns about the vaccine.

“I think it important for providers of care to adolescents and young adults (aged 16 through 26 years, with preference at age 16 through 18 years) to consider the burden of illness, the devastation of MenB disease on an individual level, the generally good safety profile, and concerns about more rare adverse effects when discussing this vaccine to eligible patients,” Temte says.