the system is unused. Instead, the approval for these vaccines is functionally
given to national technical advisory groups like ACIP, a statutory body
established to “develop recommendations on the use of vaccines in the
civilian population of the United States.”
68 ACIP reports to the Director of
69 Its statutory authority is based on the role of the CDC in
preventing communicable diseases.
70 Similarly, professional organizations
like the American Congress of Obstetricians and Gynecologists (“ACOG”)
develop immunization recommendations for practitioners.
71 The FDA
effectively allows these recommendations to substitute for regulatory review
specific to pregnant women.
In 2008, ACIP issued Guiding Principles in Development of ACIP
Recommendations for Vaccination during Pregnancy and Breastfeeding.
Previously, the ACIP did not provide any guidance to its constituent
workgroups to formulate policy for vaccination use during pregnancy.
These workgroups took differing approaches to maternal immunization
issues, which resulted in a diverse number of recommendations that “var[ied]
in clarity and underlying rationale.”
75 Since 2004, both ACIP and ACOG
have recommended yearly vaccinations for all women who are pregnant or
planning to become pregnant during the influenza season, regardless of the
76 Tdap is also recommended, even though neither is licensed
for use during pregnancy.
77 It is through this system that a fairly small
number of vaccinations have been generally accepted for use during
68. 42 U.S. C. § 2l7a; see also CTRS. FOR DISEASE CONTROL & PREVENTION, ABOUT ACIP,
www.cdc.gov/vaccines/acip/about.html (last updated Aug. 16, 2012).
69. See CTRS. FOR DISEASE CONTROL & PREVENTION, ACIP CHARTER,
https://www.cdc.gov/vaccines/acip/committee/charter.html (last updated Apr. 20, 2016).
72. See, e.g., U.S. FOOD & DRUG AMIN., CLINICAL DEVELOPMEN T & REQUIREMENTS FOR
LICENSURE OF VACCINES INTENDED FOR USE DURING PREGNANCY TO PREVENT DISEASE IN THE
73. See CTRS. FOR DISEASE CONTROL & PREVENTION, ACIP: GUIDANCE FOR VACCINE
RECOMMENDATIONS FOR PREGNANT WOMEN,
76. See Geeta K. Swamy & R. Phillips Heine, Vaccinations for Pregnant Women, 125
OBSTETRICS & GYNECOLOGY 1, 4 (2015).
77. See CTRS. FOR DISEASE CONTROL & PREVENTION, MATERNAL VACCINES: PART OF A
HEALTHY PREGNANCY, http://www.cdc.gov/vaccines/pregnancy/pregnant-women/index.html
(recommending use of tetanus toxiod, reduced diphtheria toxoid and acellular pertussis
vaccine (Tdap) in pregnant women).