Issue Number
112
September 21, 1999
CONTENTS OF THIS ISSUE
- 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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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.
- 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.
- 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.
- 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 |
