Immunization Action Coalition and the Hepatitis B Coalition

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Issue Number 171            June 29, 2000

CONTENTS OF THIS ISSUE

  1. Joint statement of AAFP, AAP, ACIP, and PHS concerning removal of thimerosal from vaccines now available
  2. Thimerosal Policy Q&A is now available on CDC's website
  3. 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

 

Immunization Action Coalition1573 Selby AvenueSt. Paul MN 55104
E-mail: admin@immunize.org Web: http://www.immunize.org/
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This page was updated on February 15, 2002