Vaccines and Preventable Diseases:

Hepatitis B (HepB) Vaccine Supply Constraints
Questions and Answers for Infant, Children, and Adult Providers

NOTE: Any delays or shortages of a vaccine can be viewed on the Current Vaccines Delays and Shortages page.

Infants and Children

1. Is the supply of hepatitis B vaccine for pediatric use adequate to meet demand during 2009 in the United States?
   Since February, there have been intermittent pediatric hepatitis B vaccine supply constraints in the United States, with some local areas experiencing delays in shipments.  Despite these supply constraints, current analysis indicates that during the remainder of 2009, sufficient pediatric hepatitis B vaccine will be available to meet demand, if providers continue to order vaccine judiciously.

CDC has worked closely with the two US manufacturers of pediatric hepatitis B vaccines to understand their projections for how much vaccine will be available for the remainder of 2009.  Vaccine supply is anticipated to be tightest during the summer months.

2. How can providers and hospitals help to ensure the supply of monovalent pediatric hepatitis B vaccine is adequate to meet demands during 2009?
   Providers can help to ensure that the supply of monovalent pediatric hepatitis B vaccine will meet demands by doing the following:
   • Maintain a usual ordering pattern; stockpiling vaccine will worsen supply constraints
   • Use supplies of monovalent pediatric hepatitis B vaccine only for infants and children; do not use monovalent pediatric hepatitis B vaccine for adults.
   • Use of DTaP-IPV-HepB (Pediarix®) vaccine will “free-up” additional monovalent pediatric hepatitis B vaccine. There is no supply constraint for Pediarix®.  When providers have a sufficient supply of monovalent Haemophilus influenzae type b (Hib) conjugate vaccine for Hib immunization, they can use (Pediarix®) for 3 doses of DTaP and hepatitis B vaccination (in addition to IPV) at 2, 4 and 6 months of age. In this situation, it is acceptable for an infant who received a birth dose of hepatitis B vaccine to receive a total of 4 doses of hepatitis B vaccine. There is no reason to delay hepatitis B vaccination in these children. Pediarix® is approved for 3 dose use for infants 6 weeks of age and older. 

3. What should I do if I am using DTaP-IPV/Hib (Pentacel) for Hib vaccination and I cannot get monovalent hepatitis B vaccine for an infant whose mother is hepatitis B surface antigen (HBsAg) positive, or HBsAg status unknown?
   You should contact your local or state health department to assist in obtaining monovalent HepB vaccine for the infant to ensure timely administration of each dose and completion of the recommended schedule of vaccination by 6-8 months of age. If monovalent HepB vaccine is not available the HepB series should be completed with whatever HepB-containing product is available.

4. If a provider is using DTaP-IPV/Hib (Pentacel®) vaccine in the office, what are the options for hepatitis B vaccination?
   Providers using DTaP-IPV/Hib (Pentacel®) to protect infants against Hib disease should make every effort to have an adequate supply of monovalent hepatitis B vaccine available for these infants.  If the infant’s mother is hepatitis B surface antigen (HBsAg)-positive or HBsAg status unknown, the infants should receive monovalent hepatitis B vaccine according to the recommended schedule including a birth dose and hepatitis B immune globulin (HBIG) within 12 hours of birth, and 2 additional doses of monovalent hepatitis B vaccine by 6 to 8 months of age to prevent perinatal transmission of hepatitis B virus and the development of chronic hepatitis B infection. If the infant’s birth weight is <2000 grams, the first (birth) dose of hepatitis B vaccine is not counted toward the 3 dose series (See table (PDF 26KB)). Providers who do not have monovalent hepatitis B vaccine for infants whose mothers are HBsAg-positive or HBsAg status unknown should contact their state or local health department for assistance in obtaining monovalent hepatitis B vaccine to ensure the infants are vaccinated on schedule. If monovalent HepB vaccine is not available the HepB series should be completed with whatever HepB-containing product is available.

   If the infants’ mothers are confirmed to be HBsAg-negative, the infants should receive a birth dose of monovalent hepatitis B vaccine and a second dose of monovalent hepatitis B vaccine at 1-2 months of age. Monovalent hepatitis B vaccine should be used for doses administered before 6 weeks of age. These doses should not be delayed. A third dose of hepatitis B vaccine is recommended for these infants at 6 - 18 months of age. Providers should maintain a list of infants and children with delayed or incomplete hepatitis B vaccination and recall these children to complete the hepatitis B vaccination series when monovalent hepatitis B vaccine becomes available.  Providers should administer the third dose of monovalent hepatitis B vaccine as soon as possible, but no later than 18 months of age (See table (PDF 26KB)).

5. How important is it to give a birth dose of hepatitis B vaccine?
   The birth dose of hepatitis B vaccine is a critical component of post-exposure prophylaxis to prevent perinatal transmission of hepatitis B virus infection to infants from women who are HBsAg-positive (who have chronic hepatitis B infection). The birth dose provides a safety net for those infants exposed to household or other persons who may have unrecognized chronic hepatitis B infection. Most infants and children who acquire hepatitis B infection before age 5 years develop chronic hepatitis B infection; these infants and children have a 15% - 25% risk of liver cirrhosis and/or hepatocellular carcinoma.

6. Can monovalent hepatitis B vaccine from either United States manufacturer be used for the birth dose of hepatitis B vaccine?
   Yes. Two monovalent pediatric hepatitis B vaccines (Recombivax HB®, Merck & Co. Inc, and Energix B®, GlaxoSmithKline) are FDA approved for use in newborns and infants. There is no thimerosal in either product.  The ACIP considers the vaccines equivalent for immunizing neonates, infants and children against hepatitis B virus infection.

7. Where can a hospital find monovalent hepatitis B vaccine for the birth dose of hepatitis B vaccination?
   Hospitals should make every effort to maintain a universal birth dose policy. Hospitals unable to obtain sufficient monovalent pediatric hepatitis B vaccine should contact GlaxoSmithKline directly to obtain this vaccine, or contact their state or local health department if they are a Vaccines for Children provider.  

8. If a provider does not have monovalent hepatitis B virus (HBV) vaccine or monovalent Haemophilus influenzae b (Hib) vaccine, can both Pediarix® and Pentacel® be used to immunize against Hib and HBV infection, in addition to diphtheria, tetanus, pertussis (DTaP) and poliovirus (IPV)?
   Under most circumstances providers using combination vaccines containing DTaP should avoid administering Pediarix® and Pentacel® simultaneously or sequentially. There are insufficient data to conclude whether or not providing twice the recommended dose of DTaP antigens increases the rates or severity of potential adverse reactions.  

Adults

1. Is the supply of hepatitis B vaccine for adult use adequate to meet demand during 2009 in the United States?
   Yes. GSK has informed CDC that it has adequate supplies of adult hepatitis B vaccine for the entire United States market through 2009. Merck's adult and dialysis formulations of their hepatitis B vaccine, Recombivax HB® will not be available in 2009. Merck expects to return to full supply some time in 2010.

2. If a dialysis unit is accustomed to using the Merck hepatitis B vaccine dialysis product, but the product is not currently available, what vaccine should they use?
   Dialysis units should use the GSK adult hepatitis B vaccine which is in sufficient supply to meet all national adult vaccine needs. Dialysis patients receive 2 adult 20 mcg (40mcg) doses for each dialysis patient dose. Vaccine is administered as one or 2 injections intramuscularly (IM) in the deltoid at 0, 1, 2, and 6 months (4-doses total), Care must be taken to avoid intravenous administration.  

3. How can providers and hospitals serving adults help to ensure the supply of monovalent pediatric hepatitis B vaccine is adequate to meet demands during 2009?
   Providers can help to ensure that the supply of monovalent pediatric hepatitis B vaccine will meet demands by doing the following:
   • Use supplies of monovalent pediatric hepatitis B vaccine only for infants and children; do not use monovalent pediatric hepatitis B vaccine for adults.
   • Use hepatitis A/hepatitis B (Twinrix®) combination vaccine for adolescents and adults 18 years or older, or providers can use monovalent adult hepatitis B vaccine for adults 20 years and older.

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