In the JournalsPerspective

AAP issues meningococcal B vaccine guidelines for adolescents

Trumenba and Bexsero have both been approved for the prevention of serogroup B meningococcal disease in individuals aged 10 through 25 years by the American Academy of Pediatrics Committee on Infectious Diseases.

Their guidelines on the newly-licensed vaccines align with previous recommendations issued by the CDC's Advisory Committee on Immunization Practices.

The committee issued a category A recommendation stating that either Trumenba (MenB-FHbp, Wyeth Pharmaceuticals) or Bexsero (MenB-4C, Novartis Vaccines) can be used routinely for individuals at increased risk for serogroup B meningococcal disease. Those individuals include: "persons with persistent complement component deficiencies, including inherited or chronic deficiencies in C3, C5–C9, properdin, factor D, or factor H or those receiving eculizumab; persons with anatomic or functional asplenia, including sickle cell disease; and healthy persons identified to be at increased risk because of a serogroup B meningococcal disease outbreak (defined by local health department on the basis of CDC criteria); these persons should receive an MenB vaccine series if their treating health care providers, in consultation with their local health or state departments, determine they are appropriate candidates on the basis of CDC criteria."

The vaccines may be administered, though not routinely, to adolescents and young adults aged 16 through 23 to provide short-term protection. This recommendation received a category B recommendation.

Trumenba should be issued as a three-dose series, while Bexsero should be administered as a two-dose series.

The committee noted that the two-dose series of Trumenba was recently licensed by the FDA and more formal recommendations regarding this dosing series will be made when more data is available. This series should be administered on day 0 and then again at least 6 months later, but should not be used in individuals who need immediate protection.

The three-dose series of Trumenba should be administered on day 0, then at 1-2 months and lastly at 6 months. The two-dose series of Bexsero should be administered on day 0 and then at least 1 month later.

Either vaccine is safe to be administered with other recommended vaccines, but should be administered at a different anatomic site.

The committee urged physicians to check the package insert with the vaccines for a full list of contraindications and warnings.

"Pregnancy and breastfeeding are precautions, because neither vaccine has been evaluated in these situations," they wrote. "A severe allergic reaction to a previous dose of MenB vaccine or any of its components is a contraindication. Adverse events occurring after the administration of any vaccine should be reported to the Vaccine Adverse Event Reporting System (VAERS)." – by Chelsea Frajerman Pardes

Disclosures: The researchers report no relevant financial disclosures.

Trumenba and Bexsero have both been approved for the prevention of serogroup B meningococcal disease in individuals aged 10 through 25 years by the American Academy of Pediatrics Committee on Infectious Diseases.

Their guidelines on the newly-licensed vaccines align with previous recommendations issued by the CDC's Advisory Committee on Immunization Practices.

The committee issued a category A recommendation stating that either Trumenba (MenB-FHbp, Wyeth Pharmaceuticals) or Bexsero (MenB-4C, Novartis Vaccines) can be used routinely for individuals at increased risk for serogroup B meningococcal disease. Those individuals include: "persons with persistent complement component deficiencies, including inherited or chronic deficiencies in C3, C5–C9, properdin, factor D, or factor H or those receiving eculizumab; persons with anatomic or functional asplenia, including sickle cell disease; and healthy persons identified to be at increased risk because of a serogroup B meningococcal disease outbreak (defined by local health department on the basis of CDC criteria); these persons should receive an MenB vaccine series if their treating health care providers, in consultation with their local health or state departments, determine they are appropriate candidates on the basis of CDC criteria."

The vaccines may be administered, though not routinely, to adolescents and young adults aged 16 through 23 to provide short-term protection. This recommendation received a category B recommendation.

Trumenba should be issued as a three-dose series, while Bexsero should be administered as a two-dose series.

The committee noted that the two-dose series of Trumenba was recently licensed by the FDA and more formal recommendations regarding this dosing series will be made when more data is available. This series should be administered on day 0 and then again at least 6 months later, but should not be used in individuals who need immediate protection.

The three-dose series of Trumenba should be administered on day 0, then at 1-2 months and lastly at 6 months. The two-dose series of Bexsero should be administered on day 0 and then at least 1 month later.

Either vaccine is safe to be administered with other recommended vaccines, but should be administered at a different anatomic site.

The committee urged physicians to check the package insert with the vaccines for a full list of contraindications and warnings.

"Pregnancy and breastfeeding are precautions, because neither vaccine has been evaluated in these situations," they wrote. "A severe allergic reaction to a previous dose of MenB vaccine or any of its components is a contraindication. Adverse events occurring after the administration of any vaccine should be reported to the Vaccine Adverse Event Reporting System (VAERS)." – by Chelsea Frajerman Pardes

Disclosures: The researchers report no relevant financial disclosures.

    Perspective

    Jessica MacNeil

    The available data suggest that the MenB vaccines might be an important step forward for controlling serogroup B meningococcal disease; however, much remains to be learned about these new vaccines.

    Although current data suggest the MenB vaccines will protect against the majority of currently circulating serogroup B strains, these vaccines are not expected to provide protection against disease caused by all serogroup B strains circulating in the United States. Additional studies assessing breadth of strain coverage are ongoing. Vaccine licensure was based on immune response after completion of the primary immunization series, but no U.S. data are available on vaccine effectiveness against clinical disease endpoints or duration of protection against clinical disease.

    On the basis of the available data, no concerning patterns of serious adverse events have been reported for MenB vaccines. In addition, initial data suggests the MenB vaccines will not impact nasopharyngeal carriage and herd protection, and the potential impact vaccine introduction might have on the population of Neisseria meningitidis is unknown.

    • Jessica MacNeil, MPH
    • Epidemiologist
      Meningitis and Vaccine Preventable Diseases Branch
      Centers for Disease Control and Prevention

    Disclosures: MacNeil reported no relevant financial disclosures.