This is an extract from a letter to our legislative, science and health consultant, Dr. Paul G. King from the FDA. This letter articulates the ACIP recommendations which you can use in formulating the communication instrument emerging from the collaborative effort of Sen. Hartsuch, MD and the Iowa Dept. of Public Health.  It also states the position of the FDA’s opinion of the ACIP’s recommendations.  
         Regards, Eileen Dannemann, Director, NCOW  

National Coalition of Organized Women   

     From Laboring Women to Labor Unions, We Move as One

                                  www.ProgressiveConvergence.com

From the desk of the Director:

Dear Sen. Hartsuch: 

             Please find, for your use, an official communication from David Horowitz, Esq., Asst. Commissioner for Policy, FDA to our legislative, science and health consultant, Dr. Paul G. King.   I have included herein an extract from that document dated Nov. 21, 2008. We trust this official language will help you in your collaboration with the IDPH to issue a balanced communication regarding the flu vaccine for the coming seasons. 

-Regards, Eileen Dannemann, Director NCOW

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

“NOV 21 2008”

Food and Drug Administration [stamped/not typed]

Rockville MD 20852-1448

Paul G. King, Ph.D., and Other Representatives for CoMeD

Coalition for Mercury-free Drugs

33A Hoffman Avenue

Lake Hiawatha, NJ 07034-1922

Re: Docket Number 2007P-0331/CP1

Dear Dr. King and Others:

This letter is in response to your citizen petition dated August 10, 2007, in which you asked the Secretary of Health and Human Services or the Commissioner of the Food and Drug Administration (FDA) to take numerous actions pertaining to vaccines and other FDA-regulated products containing thimerosal or other mercury-based preservatives.

…The general approach taken by the ACIP is that the benefit of vaccination among pregnant women usually outweighs the risk for potential adverse effects in the mother or developing offspring when a) the risk for disease exposure is high, b) infection poses a special risk to mother and fetus, and c) the vaccine is unlikely to cause harm⁴⁶ These are [ACIP] recommendations and are not FDA-approved indications for use of vaccines during pregnancy.

Signature on document:  David Horowitz, Esq, Asst. Commission for Policy

FLU VACCINE RECOMMENDATIONS FOR PREGNANT WOMEN**

 The Advisory Committee on Immunization Practices (ACIP):

Vaccination of pregnant women is recommended by the Centers for Disease Control Advisory Committee on Immunization Practices (ACIP).http://www.cdc.gov/vaccines/pubs/vis/default.htm#flu

FDA approved manufacturers’ package insert: Manufacturer’s warnings

Sanofi Pasteur’s Fluzone® package insert, http://www.vaccinesafety.edu/package_inserts.htm

8.1   Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone vaccine. It is also not known whether Fluzone vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone vaccine should be given to a pregnant woman only if clearly needed.

8.2    Nursing Mothers: It is not known whether Fluzone vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone vaccine is administered to a nursing woman. 

13.1   Carcinogenesis, Mutagenesis, Impairment of Fertility: Fluzone vaccine has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.