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Vaccine Topics

Hepatitis B Vaccine

Update on Supply of Pediatric Hepatitis B Vaccine

March 2, 2009 -- The Bureau of Immunization wishes to bring to your attention information provided by the Centers for Disease Control and Prevention (CDC), concerning the supply of pediatric hepatitis B vaccine. As many of you are aware, providers ordering pediatric hepatitis B vaccine from either manufacturer (GSK or Merck) have recently been experiencing backorders.

CDC has been in discussions with both vaccine manufacturers about the U.S. supply of pediatric hepatitis B vaccine. Based on these discussions, the CDC has released monovalent hepatitis B vaccine doses from its pediatric vaccines stockpiles (which contain both Engerix® and Recombivax®). These doses are made available to the respective manufacturers to fill their public and private sector orders through March.

Beyond March:

  • Merck has communicated to the CDC that its supply of the pediatric/adolescent formulation of Recombivax® is expected to be limited throughout the remainder of 2009, and Merck does not expect to return to full supply until some time in 2010. However, Merck may be able to make some additional doses of the pediatric/adolescent formulation of Recombivax® available for distribution during the second quarter 2009. Merck will communicate to customers and public health authorities as additional information becomes available.
  • GSK expects to be able to meet the U.S. market demand through the end of May in the form of monovalent hepatitis B vaccine, and is working closely with the CDC to determine how much additional hepatitis B product can be supplied for the U.S. market, should the shortage persist. GSK also produces the hepatitis B-containing combination vaccine Pediarix® (DTaP-IPV-HepB), which is in good supply.

The CDC will provide updates on pediatric hepatitis B vaccine supply as they become available, and subsequently, we will ensure that pertinent information is disseminated.

The CDC's web page Current Vaccine Shortages & Delays is updated as needed to provide public information on vaccine shortages and/or delays.

The FDA's web page on Biological Product Shortages provides additional information regarding regulatory issues related to vaccine supply.

Please note: Florida's VFC Program has not experienced a need for backorders and will monitor the vaccine supply and keep everyone updated.

At this time, there is no change in the recommended vaccination schedule for pediatric hepatitis B vaccine.

Food and Drug Administration Approval of an Alternate Dosing Schedule for Twinrix®

April 2007 -- In April 2007, GlaxoSmithKline Vaccine Division (GlaxoSmithKline Biologicals) received approval from the Food and Drug Administration (FDA) for an alternate schedule for Twinrix®, a combined hepatitis A and hepatitis B vaccine. (Twinrix® Schedule)

Important Notice: Merck Recalls Hib Vaccines

December 13, 2007 -- Merck & Co., Inc. ("Merck") has initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, PEDVAXHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)], and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate)]. (Vaccine Recall)

A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States

The Bureau of Immunization is pleased to announce the release of A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP), Part II: Immunization of Adults in the MMWR Recommendations and Reports Volume 55, No. RR-16, December 8, 2006.

This report, the second of a two-part statement from the Advisory Committee on Immunization Practices (ACIP), provides updated recommendations to increase hepatitis B vaccination of adults at risk for HBV infection. The first part of the ACIP statement, which provided recommendations for immunization of infants, children, and adolescents, was published previously (CDC. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices [ACIP]. Part 1: immunization of infants, children, and adolescents. MMWR 2005;54[No. RR-16]:1--33 ).

In settings in which a high proportion of adults have risks for hepatitis b virus (HBV) infection, ACIP recommends universal hepatitis B vaccination for all unvaccinated adults. In other primary care and specialty medical settings in which adults at risk for HBV infection receive care, healthcare providers should inform all patients about the health benefits of vaccination. This information should include risks for HBV infection and persons for whom vaccination is recommended. Healthcare providers should vaccinate adults who report risks for HBV infection and any adults requesting protection from HBV infection. To promote vaccination in all settings, healthcare providers should implement standing orders to identify adults recommended for hepatitis B vaccination and administer vaccination as part of routine clinical services, not require acknowledgment of an HBV infection risk factor for adults to receive vaccine, and use available reimbursement mechanisms to remove financial barriers to hepatitis B vaccination.

Please ensure that the Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection is widely distributed to colleagues, members, coalitions, and partners with an interest in the supply, distribution, management and administration of Hepatitis B vaccine. You may access the document online:

A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP), Part II: Immunization of Adults in the MMWR Recommendations and Reports Volume 55, No. RR-16, December 8, 2006

Additionally, CDC launched a website to promote implementation of revised hepatitis B immunization recommendations for adults. The new website is titled "Hepatitis B Recommendations for Adults." To access the website, go to: http://www.cdc.gov/ncidod/diseases/hepatitis/recs/index.htm

Hepatitis B Immune Globulin Availability

The Florida Department of Health, Bureau of Immunization, is aware of recent concerns regarding spot shortages of 0.5mL syringes of Hepatitis B Immune Globulin (HBIG). The Centers for Disease Control and Prevention (CDC), Division of Viral Hepatitis, has been communicating with the Food and Drug Administration (FDA) about this issue. The FDA notes that Talecris (formerly Bayer) released a quantity of 0.5mL HBIG syringes in November and will be releasing more of this size syringe in January. Talecris also released 5 mL vials of HBIG. Health departments and hospitals should be able to obtain Talecris/Bayer HBIG through their distributors, or through Talecris directly at telephone 800-243-4153.

Please ensure this information is distributed to colleagues, members, coalitions, and partners with an interest in the supply, distribution, management and administration of HBIG. For further information, or if a health department or hospital experiences problems obtaining HBIG, please contact the Bureau of Immunization at (850) 245-4342.