Issue Number
171
June 29,
2000
CONTENTS OF THIS ISSUE
- Joint statement of AAFP, AAP, ACIP, and PHS concerning
removal of thimerosal from vaccines now available
- Thimerosal Policy Q&A is now available on CDC's website
- Expect delays in influenza vaccine availability for the 2000-2001
season! CDC publishes press release so providers can plan ahead
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(1)
June 22, 2000
JOINT STATEMENT OF AAFP, AAP, ACIP, AND PHS CONCERNING REMOVAL OF THIMEROSAL FROM VACCINES NOW AVAILABLE
Almost one year after a joint statement was released by the American Academy of Pediatrics (AAP) and the United States
Public Health Service (PHS)expressing a commitment to remove the mercury-containing additive
thimerosal from childhood vaccines in the United States, a second joint statement updating the health care community on the
progress toward this effort was released on June 22, 2000, by the Centers for Disease Control and Prevention (CDC).
Now available on CDC's website is an official document titled "Joint Statement
Concerning Removal of Thimerosal from Vaccines." The statement's purpose is twofold: 1) to
provide an update on the process of removing thimerosal from vaccines in the United States, and 2) to discuss the
results of studies that aim to assess any potential relationship between exposure to mercury in
thimerosal-containing vaccines and health effects. The statement combines information and recommendations from the American
Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP), the Advisory
Committee on Immunization Practices (ACIP), and the United States Public Health
Services (PHS).
A link to the full text of the joint statement is located at the end of this article.
The concluding "Summary" statement of the June 22, 2000, document is reprinted
here as follows:
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SUMMARY
In 1999, family physicians, pediatricians, federal health officials, and vaccine
manufacturers stated that because any potential risk from mercury is of concern, and the
elimination of exposure to mercury in the form of thimerosal from vaccines is feasible, thimerosal should be
removed from vaccines as soon as possible. However, there remains no convincing evidence of harm
caused by low levels of thimerosal in vaccines.
Since mid-1999, two new hepatitis B vaccine products have been introduced and one new Hib product will be produced
next month to make the new supply of both hepatitis B and Hib vaccines for infants entirely free of thimerosal as a
preservative. One of the four licensed DTaP vaccines is already thimerosal
free, and at least one other thimerosal free DTaP vaccine is anticipated to be
licensed by early 2001.
Thus, the likely maximum number of micrograms of ethylmercury that an infant
may be exposed to from the routine immunization schedule will have been reduced by
60%. This amount will be reduced even further in early 2001 when at least two vaccine products for hepatitis B, Hib,
and DTaP are expected to be available. Meanwhile, research on the potential health effects of exposure
to thimerosal is continuing, and information will be monitored closely by the
PHS to determine if any changes in policy are needed.
The AAFP, AAP, ACIP, and the PHS recommend continuation of the current policy of moving rapidly to vaccines which are
free of thimerosal as a preservative. Until an adequate supply of each vaccine is available, use of
vaccines which contain thimerosal as a preservative is acceptable.
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To obtain the full text version (HTML format) of this joint statement, visit the
website of CDC's National Immunization Program (NIP) at: http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/joint_statement_00.htm
For a more complete listing of thimerosal-related information, visit CDC's website
at: http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/
or visit the website of the Immunization Action Coalition at: http://www.immunize.org/genr.d/thimer.htm
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(2)
June 29, 2000
THIMEROSAL POLICY Q&A IS NOW AVAILABLE ON CDC'S WEBSITE
A succinct, easy-to-read resource titled "Thimerosal Policy Questions and Answers" is now available on the website of
the National Immunization Program, Centers for Disease Control and Prevention (CDC). Consisting of five questions
and answers, the document highlights the major points of concern over thimerosal
as an additive in childhood vaccines, as well as background on the policy effort to
remove thimerosal from these vaccines.
To obtain the full text version (HTML format) of this Q&A document, go to:
http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/default.htm
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(3)
June 22, 2000
EXPECT DELAYS IN INFLUENZA VACCINE AVAILABILITY FOR THE 2000-2001 SEASON! CDC PUBLISHES PRESS RELEASE SO
PROVIDERS CAN PLAN AHEAD
The Centers for Disease Control and Prevention (CDC) published a press release
on June 22, 2000, titled "Flu Season 2000-01." The purpose of this press release
is to inform providers of immunization services that they should expect delays in flu
vaccine shipments and that it is possible there will be reductions of available
influenza virus vaccine for the 2000-01 season. The full text of the press release is
reprinted here as follows:
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FLU SEASON 2000-01: FLU VACCINE SUPPLY
The Department of Health and Human Services' Food and Drug Administration and
CDC are working closely with vaccine manufacturers to facilitate the availability of
safe and effective influenza vaccine for the upcoming flu season. Influenza
vaccine manufacturers have told FDA and CDC to expect delays in flu vaccine
shipments and that it is possible there will be reductions of available influenza
virus vaccine for the 2000-01 season.
The FDA and CDC today briefed the Advisory Committee on Immunization Practices (ACIP) about the current situation
regarding influenza vaccine supply. The FDA and CDC stressed to the ACIP that the situation is very fluid and
that health care providers should expect periodic updates from them through the
summer and fall.
ACIP, in a consensus recommendation, urged health care providers to begin thinking now about delaying adult mass
influenza vaccination campaigns to November (usually recommended for October through mid-November) based on
supply availability, and to consider ways to ensure their high risk patients receive
vaccination if a severe vaccine shortfall were to occur.
The total amount of vaccine available for the influenza season is uncertain at this
time; however, both FDA and CDC are actively working with manufacturers to
determine how much and when vaccine will be available. The amount of available
flu vaccine will become more clear within the next two months.
Many potential flu vaccine providers, including health care offices, hospitals,
health care organizations, nursing homes and other organizations, who are currently in the
midst of preparing for their fall and winter influenza vaccination efforts, need this information at this time to
adequately prepare for the upcoming season. Persons who normally receive influenza vaccine should not be concerned
and should delay inquiries about flu vaccination until the fall.
- It is important to stress that FDA, CDC and vaccine
manufacturers are confident that vaccine will be available to vaccinate those at highest risk of
complications from influenza, including those over 65, those who are immunosuppressed and
others.
- The amount of vaccine available is complicated by two
important factors: 1) the yield for this year's influenza vaccine A(H3N2) component appears to be
lower than expected which limits the supply that can be developed in time for
this flu season and, 2)other manufacturing issues. Manufacturers are working closely
with the FDA to address these issues.
- If a substantial shortfall of vaccine were to occur, the
ACIP and CDC would provide modified recommendations for the 2000-2001 influenza season that
emphasize vaccinating persons at highest risk of death from influenza (and
the health care workers who take care of them) and then vaccinating, as the
vaccine supply allows, the other groups for whom vaccine is traditionally
recommended.
- Currently, four antiviral drugs are approved by FDA to
treat acute, uncomplicated influenza. These drugs are not a substitute for influenza
vaccine and should not be used as such. The annual use of influenza vaccine is the
primary means for minimizing adverse outcomes from influenza virus infections.
- Over the course of the summer and the influenza season
new information is expected to become available, and CDC and FDA will issue information
updates. If a shortfall does occur, ACIP and CDC request that persons and
organizations administering influenza vaccine join in voluntary efforts to
ensure that influenza vaccine is administered first to the persons most likely
to develop serious and life threatening complications from influenza.
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To access the full text version (HTML format) of this press release as well as
additional Internet links to influenza information for the 2000-01 season, go to:
http://www.cdc.gov/od/oc/media/pressrel/r2k0622a.htm
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