Bexsero is Not Approved for 1-Year-Old Children in the United States
Bexsero (MenB-4C) is FDA-licensed only for persons aged 10-25 years in the United States, and therefore should not be administered to a 1-year-old child. 1, 2, 3
Critical Licensing and Age Restrictions
- The FDA has authorized Bexsero exclusively for individuals aged 10 to 25 years, as confirmed by the CDC. 1
- The Advisory Committee on Immunization Practices (ACIP) explicitly states there are no recommendations for the use of MenB vaccines, including Bexsero, in children under 10 years of age. 1, 2
- Any use of Bexsero outside the 10-25 year age range is considered off-label and should only occur in exceptional research protocols. 1
What This Means for Your 1-Year-Old Patient
- A fourth dose at 1 year of age is not indicated because no doses should have been given in the first place (unless this was part of an approved research study). 1, 2
- If this child has already received three doses of Bexsero, this represents off-label use that falls outside current FDA approval and ACIP guidelines. 1, 3
Important Distinction: MenACWY vs. MenB Vaccines
Common pitfall: Confusion between meningococcal vaccine types is frequent and potentially dangerous. 3
- MenACWY-CRM vaccines (covering serogroups A, C, W, and Y) are the appropriate meningococcal vaccines for infants starting at 2 months of age, given as a 4-dose series at 2,4,6, and 12 months for high-risk infants. 2
- MenB vaccines (Bexsero and Trumenba) are only licensed for persons ≥10 years of age in the United States. 1, 2, 3
- Verify whether this child truly needs meningococcal B vaccination versus meningococcal ACWY vaccination based on their specific risk factors. 2
When Bexsero Can Be Administered
If this child has high-risk conditions (complement deficiency, anatomical or functional asplenia, complement inhibitor use, or microbiologist exposure risk):
- Wait until the child reaches 10 years of age to begin the Bexsero series. 1, 3
- At age ≥10 years with high-risk conditions, administer a 3-dose series at 0,1-2, and 6 months. 3, 4
- For healthy adolescents aged 16-23 years (based on shared clinical decision-making), use a 2-dose series at 0 and 6 months. 4
International Context (Not Applicable to US Practice)
While the United Kingdom introduced Bexsero into their national infant immunization program in 2015 with a reduced schedule (2 doses at 2 and 4 months plus a booster at 12 months), this does not apply to US practice where FDA licensing restricts use to ages 10-25 years. 5, 6