Vaxelis Dosing Guidelines for Infants

Standard Dosing Schedule

• The Centers for Disease Control and Prevention recommends that infants receive 3 doses of Vaxelis vaccine administered at 2, 4, and 6 months of age 1, 2
• The primary vaccination series consists of exactly 3 doses given at ages 2, 4, and 6 months, as recommended by the FDA and the Advisory Committee on Immunization Practices (ACIP) 1, 2, 3

Key Timing Requirements

• The minimum age for the first dose of Vaxelis is 6 weeks, with a minimum interval of 4 weeks between doses 1 and 2, as recommended by the CDC 2, 3
• The minimum age for dose 2 is 10 weeks, with a minimum interval of 4 weeks between doses 2 and 3, as recommended by the CDC 2, 3
• The minimum age for dose 3 is 24 weeks (approximately 6 months), as recommended by the CDC 1, 2, 3

Critical Hepatitis B Consideration

• The CDC recommends that Vaxelis is NOT licensed for the birth dose of hepatitis B vaccine, and infants must receive a separate monovalent hepatitis B vaccine at birth 2, 3
• 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, as recommended by the CDC 1, 2, 3

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), as recommended by the CDC 2, 3
• 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, as recommended by the CDC 2, 3

Important Limitations

• The CDC recommends that Vaxelis should NOT be used for booster doses, and a separate DTaP vaccine is needed for the fourth dose at 15-18 months 4
• A separate Hib conjugate vaccine is needed for the booster at 12-15 months, and a separate IPV vaccine is needed for the fourth dose at 4-6 years, as recommended by the CDC 3, 4

Special Population: American Indian/Alaska Native Infants

• The CDC does not have a preferential recommendation for Vaxelis in American Indian/Alaska Native infants at this time, due to limited data on antibody response after the first dose in this population 1

Common Pitfalls to Avoid

• The CDC recommends avoiding the use of Vaxelis for the birth dose, as this would leave the infant without timely hepatitis B protection 2, 3
• The CDC also recommends avoiding the administration of the third dose before 24 weeks of age, unless an additional hepatitis B vaccine dose is planned at ≥24 weeks 1, 2, 3

Vaxelis Primary Series Dosing Guidelines

Schedule Overview

• The primary vaccination series for Vaxelis consists of exactly three doses administered at ages 2 months, 4 months, and 6 months when the series is initiated at 2 months, as recommended by the FDA and the Advisory Committee on Immunization Practices (ACIP)【5】【6】.
• The first dose may be given as early as 6 weeks of age, although the standard schedule begins at 2 months【5】【6】.
• A minimum interval of 4 weeks is required between each successive dose【5】【6】.

Timing Requirements for Individual Doses

• Dose 1: Administered at 2 months of age (minimum age 6 weeks)【5】.
• Dose 2: Administered at 4 months of age (minimum age 10 weeks) and must be given at least 4 weeks after Dose 1【5】【6】.
• Dose 3: Administered at 6 months of age (minimum age 24 weeks) and must be given at least 4 weeks after Dose 2【5】【6】.

Hepatitis B Considerations

• Vaxelis is not licensed for the birth dose of hepatitis B vaccine; infants must receive a separate monovalent hepatitis B vaccine at birth before initiating the Vaxelis series【5】【6】.
• If the third Vaxelis dose is inadvertently administered before the infant reaches 24 weeks of age, an additional hepatitis B vaccine dose must be given at age ≥ 24 weeks to ensure an adequate immune response【5】【6】.

Age Limits

• No dose of Vaxelis should be administered on or after the child’s fifth birthday; the maximum permissible age for any dose is 4 years, 364 days【5】【6】.