Vaxelis Dosing for Infants
Infants should receive 3 doses of Vaxelis vaccine administered at 2,4, and 6 months of age. 1
Standard Dosing Schedule
The primary vaccination series consists of exactly 3 doses given at ages 2,4, and 6 months. 1 This is the FDA-approved and ACIP-recommended schedule for routine infant immunization with Vaxelis (DTaP-IPV-Hib-HepB). 1
Key Timing Requirements
- Minimum age for first dose: 6 weeks 1
- Minimum interval between doses 1 and 2: 4 weeks 1
- Minimum age for dose 2: 10 weeks 1
- Minimum interval between doses 2 and 3: 4 weeks 1
- Minimum age for dose 3: 24 weeks (approximately 6 months) 1
- Maximum age for any dose: 4 years, 364 days (do not administer on or after the fifth birthday) 1
Critical Hepatitis B Consideration
Vaxelis is NOT licensed for the birth dose of hepatitis B vaccine. 1 Infants must receive a separate monovalent hepatitis B vaccine at birth, then Vaxelis can be used for subsequent doses starting at 6 weeks of age. 1
If the third dose of Vaxelis is inadvertently given before 24 weeks of age, an additional dose of hepatitis B vaccine must be given at age ≥24 weeks to complete the hepatitis B series. 1 This is because adequate immune response to hepatitis B requires the last dose to be administered at or after 24 weeks of age. 1
Maternal Hepatitis B Status Considerations
For infants born to HBsAg-negative mothers: Vaxelis can be used for the standard 3-dose series at 2,4, and 6 months (after birth dose of monovalent HepB). 1
For infants born to HBsAg-positive or unknown status mothers: Vaxelis can still be used for the 3-dose series, but these infants require monovalent hepatitis B vaccine plus HBIG within 12 hours of birth. 1 The third dose of Vaxelis should not be given before 24 weeks of age in these infants. 1
Important Limitations
Vaxelis should NOT be used for booster doses. 1 After completing the 3-dose primary series:
- A separate DTaP vaccine is needed for the fourth dose at 15-18 months 1
- A separate Hib conjugate vaccine is needed for the booster at 12-15 months 1
- A separate IPV vaccine is needed for the fourth dose at 4-6 years 1
If Vaxelis is inadvertently given for a booster dose, the dose does not need to be repeated with another vaccine when proper spacing of previous doses is maintained. 1
Special Population: American Indian/Alaska Native Infants
Vaxelis does not have a preferential recommendation for AI/AN infants at this time. 1 This is because data on antibody response after the first dose in AI/AN infants are not currently available, and these infants historically benefit from early protection provided by PRP-OMP-containing Hib vaccines. 1
Common Pitfalls to Avoid
- Do not use Vaxelis for the birth dose - this is a critical error that would leave the infant without timely hepatitis B protection. 1
- Do not give the third dose before 24 weeks of age unless you plan to administer an additional hepatitis B vaccine dose at ≥24 weeks. 1
- Do not use Vaxelis for catch-up schedules with accelerated 4-week intervals for the third dose, as this would violate the 24-week minimum age requirement. 1
- Do not continue using Vaxelis beyond the primary series - switch to appropriate monovalent or combination vaccines for booster doses. 1