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
Dannemann, Director, NCOW
National Coalition of Organized
Laboring Women to Labor Unions, We Move as One
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
OF HEALTH & HUMAN SERVICES Public Health
“NOV 21 2008”
Food and Drug Administration
Rockville MD 20852-1448
Paul G. King, Ph.D., and Other Representatives
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
Signature on document: David
Horowitz, Esq, Asst. Commission for Policy
VACCINE RECOMMENDATIONS FOR PREGNANT WOMEN**
Advisory Committee on Immunization Practices (ACIP):
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
approved manufacturers’ package insert: Manufacturer’s
package insert, http://www.vaccinesafety.edu/package_inserts.htm
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.
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.
Impairment of Fertility: Fluzone
vaccine has not been evaluated for carcinogenic or mutagenic potential,
or for impairment of fertility.