1 ACIP hepatitis B vaccine recommendations can be found at: 

https://www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF. 2

 Recommended Immunization Schedule for Children and Adolescents Aged 18 

Years or Younger can be found at: 

https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-childcombined-schedule.pdf. 

Pediatric Hepatitis B Vaccination Guidance during the Supply Shortage 

Merck’s supply of pediatric hepatitis B vaccine (Recombivax HB®) will continue to be limited through mid-2020. GSK 

will continue to be able to address supply gaps for pediatric hepatitis B vaccine during this period, using a combination 

of monovalent pediatric hepatitis B vaccine and its DTaP-HepB-IPV pediatric combination vaccine (Pediarix).

This increase is sufficient to address the gap in supply related to Merck’s manufacturing issue so that infants and young 

children can continue to receive their recommended hepatitis B vaccine series on time. Importantly, sufficient singlecomponent hepatitis B vaccine will be available to continue to deliver the birth dose of hepatitis B vaccine for infants. 

CDC has provided general guidance for pediatric hepatitis B vaccine and an implementation plan that provides options 

for giving vaccine during this time. 

Pediatric hepatitis B vaccine general guidance: 

The recommendations for hepatitis B vaccination of infants have not changed.

Providers should continue with the recommendations as written in the Advisory Committee on Immunization Practices

(ACIP) hepatitis B vaccine recommendations. 

• Only single-component hepatitis B vaccine should be used for any dose given before 6 weeks of age, including

the birth dose.

• During this time, providers should prioritize birth dose vaccination and infant series completion over child and

adolescent catch-up vaccination. However, children and adolescents who are at risk for infection as described in

the ACIP hepatitis B vaccine recommendations1 should be vaccinated.

For infants whose mothers are hepatitis B surface antigen (HBsAG)-negative: 

• Administer single-component hepatitis B vaccine to infants:

⋅ Weighing 2,000 grams (4 pounds, 6.5 ounces) or more at birth, within 24 hours of birth

⋅ Weighing less than 2,000 grams (4 pounds, 6.5 ounces) at birth, at 1 month of age or when discharged from

the hospital

• The third HepB dose can be administered at 6–18 months.

• In populations with high rates of childhood HBV infection (e.g., Alaska Natives, Pacific Islanders, and immigrant

families from Asia, Africa, and countries with intermediate or high endemic rates of infection), the first dose of

HepB vaccine should be administered at birth and the final dose at age 6–12 months.

For infants whose mothers are HBsAg-positive or hepatitis B status unknown:

• Administer single-component hepatitis B vaccine to infants within 12 hours of birth. Complete the series within

6 months using available single-component or combination vaccine.

⋅ For infants weighing less than 2,000 grams (4 pounds, 6.5 ounces) at birth, the birth dose should not be

counted as part of the vaccine series. Three additional doses (for a total of 4 doses) should be administered 

beginning when the infant reaches age 1 month. 

For considerations of serology testing prior to vaccination, refer to the guidance on persons recommended to receive 

serologic testing prior to vaccination in the ACIP hepatitis B vaccine recommendations. 

For additional information, see the Recommended Immunization Schedule for Children and Adolescents Aged 18 Years 

or Younger2. 
1

For infants weighing less than 2,000 grams (4 pounds, 6.5 ounces) at birth, vaccine given at birth should NOT be counted as part of 

the vaccine series. Three additional doses (for a total of 4 doses) should be administered beginning when the infant reaches 1 month

of age. Complete the series within 6 months. 2

For infants weighing 2,000 grams (4 pounds, 6.5 ounces) or more at birth, vaccine given at birth DOES count as part of the vaccine 

series. Two additional doses (for a total of 3 doses) should be administered. A series that includes 4 doses is acceptable, but not 

required. Complete the series within 6 months. 3

The 4th dose of DTaP may be administered as early as age 12 months, provided at least 6 months have elapsed since the 3rd dose. 4

If using PedvaxHIB a dose at 6 months is not needed. 

These sample immunization schedules apply to infants born to

hepatitis B surface antigen-negative mothers

1. Using Pediarix for all doses after the birth dose

2. Using Pediarix and single-component DTaP and IPV

3. Using Pentacel® and single-component HepB vaccine

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB HepB HepB

Pentacel

DTaP-IPV/Hib

Pentacel

DTaP-IPV/Hib

Pentacel

DTaP-IPV/Hib

DTaP3

Hib

4. Completing the hepatitis B series using all single-component vaccines

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB HepB HepB

DTaP DTaP DTaP DTaP3

IPV IPV IPV

Hib Hib Hib4 Hib

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB Pediarix

DTaP-HepB-IPV

Pediarix

DTaP-HepB-IPV

Pediarix

DTaP-HepB-IPV DTaP3

Hib Hib Hib4 Hib

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB Pediarix

DTaP-HepB-IPV

Pediarix

DTaP-HepB-IPV DTaP DTaP3

IPV

Hib Hib4 Hib
1

For infants weighing less than 2,000 grams (4 pounds, 6.5 ounces) at birth, vaccine given at birth should NOT be counted as part of 

the vaccine series. Three additional doses (for a total of 4 doses) should be administered beginning when the infant reaches 1 month

of age. Complete the series within 6 months. 2

For infants weighing 2,000 grams (4 pounds, 6.5 ounces) or more at birth, vaccine given at birth DOES count as part of the vaccine 

series. Two additional doses (for a total of 3 doses) should be administered. A series that includes 4 doses is acceptable, but not 

required. Complete the series within 6 months. 3

The 4th dose of DTaP may be administered as early as age 12 months, provided at least 6 months have elapsed since the 3rd dose. 4

If using PedvaxHIB a dose at 6 months is not needed. 

These sample immunization schedules apply to infants born to 

hepatitis B surface antigen-positive or unknown status mothers

1. Completing the hepatitis B series using Pediarix for all doses after the birth dose

2. Completing the hepatitis B series using Pentacel

Birth1 2 months 4 months2 6 months 12–15 months 15–18 months

HepB HepB HepB HepB

Pentacel

DTaP-IPV/Hib

Pentacel

DTaP-IPV/Hib

Pentacel

DTaP-IPV/Hib

DTaP3

Hib

3. Completing the hepatitis B series using all single-component vaccines

Birth1 2 months 4 months2 6 months 12–15 months 15–18 months

HepB HepB HepB HepB

DTaP DTaP DTaP DTaP3

IPV IPV IPV

Hib Hib Hib4 Hib

Birth1 2 months 4 months2 6 months 12–15 months 15–18 months

HepB Pediarix

DTaP-HepB-IPV

Pediarix

DTaP-HepB-IPV

Pediarix

DTaP-HepB-IPV DTaP3

Hib Hib Hib4 Hib