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September 10, 1999
CONTENTS OF THIS ISSUE
- CDC provides notice of the availability of hepatitis B vaccine which
does not contain thimerosal as a preservative
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September 10, 1999
CDC PROVIDES NOTICE OF THE AVAILABILITY OF HEPATITIS B VACCINE WHICH DOES NOT CONTAIN THIMEROSAL AS A
The Centers for Disease Control and Prevention (CDC) provided a notice to readers, "Availability of Hepatitis
B Vaccine That Does Not Contain Thimerosal as a Preservative," in the September 10, 1999 issue of the
MMWR. The authors state that "the availability of hepatitis B vaccine that does not contain
thimerosal as a preservative should alert medical facilities to review their
policies to ensure the vaccination of newborns as recommended by the Advisory Committee on
Immunization Practices, AAFP, and AAP." "Routine
hepatitis B vaccination policies for all newborn infants should be reintroduced
immediately in hospitals in which these policies and practices have been discontinued."
Because the availability of such vaccine should be of interest to all immunization providers, the entire article
is reprinted below.
On August 27, 1999, Merck Vaccine Division* (Merck & Co., Inc., West Point,
Pennsylvania) received approval from the Food and Drug Administration (FDA) of
a supplement to Merck's license application to include the manufacture of single-antigen preservative-free
hepatitis B vaccine (Recombivax HB, Pediatric); distribution is expected to begin September 13, 1999. In
addition, SmithKline Beecham Biologicals (SmithKline Beecham, Philadelphia, Pennsylvania), expects to make
single-antigen preservative-free hepatitis B vaccine (Engerix-B, Pediatric) available in the near future.
Further product information will be provided when it becomes available. Product packaging and
labels will indicate that these vaccines do not contain preservative.
To prevent shortages because of limited supplies of
single-antigen hepatitis B vaccines that do not contain thimerosal as a preservative and to assure
prevention of perinatal and early childhood hepatitis B virus (HBV) infection
during the transition when both vaccines that contain and do not contain thimerosal as a preservative
are available, the following three steps should be taken:
- Newborn infants. The priority for use of single-antigen
hepatitis B vaccines that do not contain thimerosal as a preservative should be to vaccinate
newborn infants. Routine hepatitis B vaccination policies for all newborn infants
should be reintroduced immediately in hospitals in which these policies and
practices have been discontinued. All hospitals should ensure that newborn
infants of hepatitis B surface antigen (HBsAg)-positive mothers and of mothers
whose HBsAg status is unknown receive their first dose of hepatitis B vaccine
within 12 hours of birth. If hepatitis B vaccine that does not contain thimerosal
as a preservative is not available, then thimerosal preservative-containing
vaccine should be used for these infants.
- Infants aged less than 6 months. When available,
hepatitis B vaccines that do not contain thimerosal as a preservative should be used to vaccinate infants
aged less than 6 months (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, these groups should be
vaccinated with thimerosal preservative-containing vaccine. 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 (1-4). These groups should
complete the three-dose hepatitis B vaccine series by age 18 months.
- Children aged greater than or equal to 6 months,
adolescents, and adults. Thimerosal preservative-containing hepatitis B vaccines can continue
to be used for vaccinating children aged greater than or equal to 6 months,
adolescents, and adults as is recommended (1-6).
Reported by: National Center for Infectious Diseases;
National Immunization Program; Agency for Toxic Substances and Disease Registry; National Center
for Environmental Health, CDC.
Editorial Note: On July 8, 1999, the American Academy of Pediatrics (AAP)
and the Public Health Service (PHS) released a joint statement about thimerosal in vaccines,
and the American Academy of Family Physicians (AAFP) released a comparable statement (1-3). Thimerosal is a
mercury-containing preservative that has been used as an additive to biologics
and vaccines since the 1930s because it is effective in preventing bacterial
and fungal contamination, particularly in open multidose containers. Vaccine
manufacturers, FDA, and other PHS agencies are working together to replace expeditiously thimerosal
preservative-containing vaccines whenever possible with vaccines that do not contain thimerosal as a preservative
while ensuring maintenance of high vaccination coverage levels and prevention of disease.
Previous recommendations for using thimerosal-containing vaccines indicated that clinicians and parents could take
advantage of the flexibility in the immunization schedule to delay hepatitis B vaccination from birth until age 2-6
months for infants born to mothers who are HBsAg negative (1-4). No changes were made in recommendations for
immunization at birth of infants of HBsAg-positive mothers or infants of mothers with an unknown HBsAg status.
After the joint AAP/PHS statement on thimerosal, the AAP and CDC provided additional implementation guidance (3,4).
CDC guidance included hepatitis B vaccination should be continued at birth for infants born to HBsAg-negative
mothers belonging to populations or groups that have a high risk for early childhood HBV infection, including
Asian/Pacific Islanders, immigrant populations from countries in which HBV infection is of high or
intermediate endemicity (7), and households with persons with chronic HBV infection. To
ensure the prevention of perinatal HBV transmission, hospitals should continue
policies to vaccinate all infants at birth until procedures are in place to guarantee that 1) the HBsAg
status of every pregnant woman is reviewed at delivery, 2) appropriate passive-active immunoprophylaxis
(hepatitis B immune globulin and hepatitis B vaccine) is provided for infants of HBsAg-positive women
within 12 hours of birth, and 3) appropriate active immunoprophylaxis (hepatitis B vaccine) is provided
for infants of women with an unknown HBsAg status.
After the statements on thimerosal in vaccines were published, changes occurred in newborn hepatitis B
vaccination policies and practices in some hospitals, including unintended changes affecting immunization of
infants at risk for perinatal HBV transmission. In August 1999, state and territorial health
department hepatitis coordinators conducted surveys of selected birthing
hospitals in their project areas. Of 977 hospitals surveyed in 48 project areas,
773 (79%) were aware of the joint AAP/PHS statement on thimerosal. Of 574
hospitals that were aware of the statement and had existing policies or standing
orders to vaccinate all newborns, 262 (46%) reported a policy change to no longer
routinely vaccinate newborns of HBsAg-negative mothers. In addition, 52 (9%) reported they no longer routinely
vaccinate any newborn (CDC, unpublished data, 1999). Such a policy usually requires a physician's order to
vaccinate infants of HBsAg-positive mothers and infants of mothers whose HBsAg status is unknown. CDC also has received
anecdotal reports of hospitals in which policies were changed, and infants born to HBsAg-positive
mothers and infants born to mothers with unknown HBsAg status were not vaccinated within 12 hours of birth (CDC, unpublished data,
1999). Chronic HBV infection develops in approximately 90% of infants infected perinatally;
among chronically infected infants, the risk for premature death from HBV-related
liver cancer or cirrhosis is approximately 25% (8). The availability of hepatitis B vaccine that does not contain
thimerosal as a preservative should alert medical facilities to review their policies to ensure the vaccination of
newborns as recommended by the Advisory Committee on Immunization Practices, AAFP, and AAP.
- CDC. Thimerosal in vaccines: a joint statement of the
American Academy of Pediatrics and the Public Health Service. MMWR 1999;48:563-5.
- American Academy of Pediatrics. Thimerosal in vaccines:
an interim report to clinicians. AAP News 1999;15:10-2.
- American Academy of Family Physicians. Policy statement
of the American Academy of Family Physicians on thimerosal in vaccines, July
8, 1999. Available at http://www.aafp.org/policy/camp/20.html
Accessed September 3, 1999.
- CDC. Implementation guidance for immunization grantees
during the transition period to vaccines without thimerosal, July 14, 1999. Available
Accessed September 3, 1999.
- Advisory Committee on Immunization Practices. Hepatitis
B virus: a comprehensive strategy for eliminating transmission in the United States through universal
childhood vaccination. MMWR 1991;40(no. RR-13).
- CDC. Update: recommendations to prevent hepatitis B
virus transmission--United States. MMWR 1999;48:33-4.
- CDC. Health information for international travel
1999-2000. Atlanta, Georgia: US Department of Health and Human Services, 1999:98-102.
- Margolis HS, Coleman PJ, Brown RE, Mast EE, Sheingold
SH, Arevalo JA. Prevention of hepatitis B virus transmission by immunization: an
economic analysis of current recommendations. JAMA 1995;274:1201-8.
* Use of trade names and commercial sources is for
identification only and does not imply endorsement by CDC or the U.S. Department of Health and
END OF NOTICE TO READERS
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