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Issue Number 112            September 21, 1999

CONTENTS OF THIS ISSUE

  1. CDC distributes "Dear Colleague" letter on guidance for use of hepatitis B vaccine that does not contain thimerosal as a preservative

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(1)
September 16, 1999
CDC DISTRIBUTES "DEAR COLLEAGUE" LETTER ON GUIDANCE FOR  USE OF HEPATITIS B VACCINE THAT DOES NOT CONTAIN THIMEROSAL  AS A PRESERVATIVE

Reprinted below is the complete text of the "Dear Colleague" letter dated September 16, 1999, from Walter A. Orenstein, MD, MPH, Assistant Surgeon General, Director, National Immunization Program, Centers for Disease Control and Prevention (CDC). The letter provides updated guidance and recommendations to state health department program managers and hepatitis coordinators regarding hepatitis B vaccination policies in light of the recent approval by the Food and Drug Administration (FDA) of a hepatitis B vaccine that does not contain thimerosal as a preservative.

Primarily, Dr. Orenstein stresses that with the introduction of hepatitis B vaccine that does not contain thimerosal as a preservative, "routine hepatitis B  vaccination policies for all newborns should be reintroduced immediately in hospitals in which these policies and practices were discontinued. In addition, opportunities to initiate hepatitis B vaccination at birth in all other hospitals should be considered." Other recommendations highlighted in the letter are intended to assist those who are responsible for the distribution and  monitoring of hepatitis B vaccine in settings in which babies are delivered and in which hepatitis B vaccine is given.

The letter in its entirety reads as follows:

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Dear Colleague: 

The purpose of this letter is to inform you about the recent approval by the Food and Drug Administration (FDA) of a hepatitis B vaccine that does not contain thimerosal as a preservative, and to provide updated guidance and  recommendations regarding hepatitis B vaccination. As public health professionals and health care providers, you continue to play a critical role in assuring that the transition to vaccines that do not contain thimerosal as a preservative takes place as expeditiously as possible, while at the same time ensuring maintenance of high vaccination coverage levels and prevention of disease.

On July 8, 1999, the American Academy of Pediatrics (AAP) and the U.S. Public Health Service (PHS) released a joint statement regarding thimerosal in vaccines and a comparable statement was released by the American Academy of Family Physicians (AAFP). Both statements provided specific  recommendations related to hepatitis B vaccination, encouraging continued administration of a birth dose of the currently available thimerosal preservative-containing vaccine to infants at high risk for perinatal and early  childhood hepatitis B virus (HBV) transmission, with flexibility to delay the first dose of vaccine until 2-6 months of age for infants born to hepatitis B surface  antigen (HBsAg) negative mothers. Results of a recent survey conducted by state and territorial health department hepatitis coordinators, however, indicated that a large number of hospitals discontinued routine vaccination of  infants at birth, regardless of the HBsAg status of the mother. Anecdotal reports were received by the Centers for Disease Control and Prevention (CDC) that some infants were not vaccinated at birth even when their mother's status was documented as HBsAg positive.

On August 27, 1999, Merck Vaccine Division received approval of a supplement to its license from the FDA to include manufacture of a single-antigen hepatitis B vaccine that does not contain thimerosal as a preservative (Recombivax HB, Pediatric). This vaccine is expected to be available for purchase on the private retail market beginning September 13,  1999. A federal contract for purchase of this vaccine with public funds provided through the Vaccines for Children (VFC) 317 grant, and State/local programs is expected in late September, 1999. In both the public and private health care sectors, the initial supply of this product will be limited.  Appropriate vaccine management will require prioritization for usage and close monitoring of vaccine orders and distribution. Distribution of hepatitis B vaccine that does not contain thimerosal as a preservative to birthing  hospitals, or other settings where babies are delivered, should be of highest priority.

Increased supplies are expected as similar products from other vaccine manufacturers are licensed. An application for a single-antigen hepatitis B vaccine that does not contain thimerosal as a preservative (Engerix-B Pediatric) has been submitted by SmithKline Beecham Biologicals (SKB) and is currently under review by the FDA. 

During this transition period when both thimerosal preservative-containing hepatitis B vaccines and hepatitis B vaccines that do not contain thimerosal as a preservative remain available, the following guidelines should be used to assure prevention of perinatal and early childhood HBV transmission and to prevent shortages of single-antigen hepatitis B vaccines that do not contain thimerosal as a preservative.

  1. Newborn infants.
    Priority must be given to using single-antigen hepatitis B vaccine that does not contain thimerosal as a preservative for the routine vaccination of newborns, especially in the hospital setting. Routine hepatitis B vaccination policies for all newborns should be reintroduced immediately in hospitals in which these policies and practices were discontinued. In addition, opportunities to initiate hepatitis B vaccination at birth in all other hospitals should be considered.
            
  2. Infants aged less than 6 months.
    When available, hepatitis B vaccines that do not contain thimerosal as a preservative should be used for vaccination of infants less than 6 months of age (single-antigen hepatitis B vaccine for infants aged less than 6 weeks and either single antigen or combination products for infants  aged greater than or equal to 6 weeks). Infants in groups at high risk for perinatal and early childhood HBV infections should complete the three-dose hepatitis B vaccine series by age 6 months. When vaccines that do not contain thimerosal as a preservative are not available for vaccination of infants at high risk of perinatal and early childhood infection, these infants should be vaccinated with thimerosal  preservative-containing hepatitis B vaccines. For infants born to HBsAg-negative mothers and who are not in high-risk groups, existing recommendations should be used for administering thimerosal preservative-containing hepatitis B vaccines if vaccine that does not contain thimerosal as a preservative is not available (see Internet links to the MMWR "Notice to Readers" that follow this letter). These groups should complete the three-dose hepatitis B vaccine series by age 18 months.
              
  3. Children aged greater than or equal to 6 months.
    Thimerosal preservative-containing hepatitis B vaccines should continue to be used for vaccination of older children (greater than or equal to 6 months of age), adolescents and adults as is currently recommended.

State and local immunization program staff should alert medical facilities to review their policies to assure the vaccination of newborns as recommended by the Advisory Committee on Immunization Practices, AAFP, and AAP.  Strategies to prioritize distribution of the hepatitis B vaccine that does not contain thimerosal as a preservative to birthing hospitals and then to providers for administration to infants less than 6 months of age should be communicated to birthing hospitals or other settings where babies are  delivered and all public and private VFC-enrolled providers. Systems to closely monitor orders and target distribution of this vaccine should be established and enforced by the State or project area. 

For more information, please reference the "Notice to Readers" in the Morbidity and Mortality Weekly Report, September 10, 1999, Vol. 48/No. 35 (see Internet links that follow this letter below). 

We appreciate your efforts to communicate this information to hospitals and providers and prioritize and place limitations on the initial supplies of the hepatitis B (Pediatric) vaccine that does not contain thimerosal as a  preservative and your recognition that other products are fully acceptable depending on the age of the vaccinee. Please direct any questions regarding this matter to the Hepatitis Branch, National Center for Infectious Diseases, (404) 639-3048, VFC Program Consultant at (404) 639-8222 or Immunization Program Consultant at (404) 639-8215.

Sincerely,

Walter A. Orenstein, M.D.
Director
Assistant Surgeon General
National Immunization Program

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For more information on hepatitis B vaccine that does not contain thimerosal as a preservative, please refer to the phone numbers provided in the last paragraph of the letter above.

To read the text version of the "Notice to Readers" entitled "Availability of Hepatitis B Vaccine That Does Not Contain Thimerosal as a Preservative" which appeared in the September 10, 1999, issue of the MMWR, click here: http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/mm4835a3.htm

To obtain a camera-ready copy (PDF format) of the "Notice to Readers," click here: ftp://ftp.cdc.gov/pub/Publications/mmwr/wk/mm4835.pdf

 

Immunization Action Coalition1573 Selby AvenueSt. Paul MN 55104
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This page was updated on September 21, 1999