Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015.
MMWR Morb Mortal Wkly Rep
; 64(41): 1171-6, 2015 Oct 23.
Article
in En
| MEDLINE
| ID: mdl-26492381
ABSTRACT
At its June 2015 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended that adolescents and young adults aged 1623 years may be vaccinated with a serogroup B meningococcal (MenB) vaccine to provide short-term protection against most strains of serogroup B meningococcal disease. This report summarizes the deliberations of ACIP, the rationale for its decision, and recommendations for use of MenB vaccines in adolescents and young adults. Two MenB vaccines have recently been licensed by the Food and Drug Administration (FDA) for use in the United States and approved for use in persons aged 1025 years MenB-FHbp (Trumenba, Wyeth Pharmaceuticals, Inc.) and MenB-4C (Bexsero, Novartis Vaccines). Both MenB vaccines were licensed based on statutory regulations for accelerated approval, which enabled FDA to approve the MenB vaccines for serious or life-threatening diseases based on safety and demonstration that vaccine effectiveness, as measured by bactericidal antibody responses with assays using several MenB test strains that were representative of prevalent strains in the United States, is reasonably likely to predict clinical benefit. As a requirement for accelerated approval, confirmatory studies in the postmarketing period will be conducted to verify and further describe the effectiveness of the vaccines against an extended number of MenB strains that represent a broader diversity of endemic disease. Additional postlicensure safety data are also needed and will be reviewed by ACIP as they become available.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Immunization
/
Practice Guidelines as Topic
/
Meningococcal Vaccines
/
Neisseria meningitidis, Serogroup B
/
Meningococcal Infections
Type of study:
Guideline
/
Prognostic_studies
Limits:
Adolescent
/
Adult
/
Child
/
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
MMWR Morb Mortal Wkly Rep
Year:
2015
Document type:
Article