Prevention’s Advisory Committee for Immunization Practices (“ACIP”), the
World Health Organization’s Strategic Advisory Group of Experts on
Immunization, and other national immunization technical advisory groups.
Where those organizations recommend specific immunizations for pregnant
women, the FDA does not consider the use inconsistent with the product’s
labeling or “off-label”.
This article situates the Zika threat in the context of the regulatory
approval process for vaccines intended for use during pregnancy. In doing
so, it suggests that the discrepancy between the review process overseen by
the FDA and the alternative (but prevailing) process managed by national
immunization technical advisory groups (ACIP, physician organizations,
etc.) must be resolved as emerging viral threats pose specialized risks to
pregnant women and their unborn children.
Part II provides a brief history of Zika and its emergence as a viral threat
uniquely dangerous to pregnant women. Part III explains the regulatory
complexities surrounding the licensing of vaccines intended for pregnancy.
Lastly, part IV analyzes the disruptions the current regulatory system causes
to the research, development, and approval process for vaccines intended for
II. THE ZIKA THREAT
A. The Zika Disease Profile
The Zika virus is a flavivirus related to yellow fever, dengue, West Nile,
and Japanese encephalitis viruses.
7 It was discovered in Uganda in 1947
during the course of mosquito and primate surveillance.
8 The virus has
historically circulated in wild primates and arboreal mosquitoes and rarely
caused “recognized spillover” infections in humans.
9 However, between
2008 and 2016, both the number of geographic locations affected by Zika and
the prevalence in those locations have increased, showing the worldwide
spread of the virus.
10 By 2008, the virus had affected populations
5. The Advisory Committee on Immunization Practices (ACIP), Questions and Answers,
ACIP, https://www.cdc.gov/vaccines/hcp/conversations/downloads/vacsafe-acip-color-office.pdf pdf (last reviewed Apr. 15, 2016).
6. Roberts & Gruber, supra note 4, at 966− 67.
7. Edward B. Hayes, Zika Virus Outside Africa,
15 EMERGING INFECTIOUS DISEASES
1347, 1347 (2009).
8. G. W. A. Dick, S.F. Kitchen & A.J. Haddow, Zika Virus (I). Isolations and Serological
46 TRANSACTIONS ROYAL SOC’Y TROPICAL MED. & HYGIENE 509, 509− 11 (1952).
9. Anthony S. Fauci & David M. Morens, Zika Virus in the Americas – Yet Another
Arbovirus Threat, 374 NEW ENG. J. MED. 601, 601 (2016).
10. Charleen McNeill et al., Zika: What Providers Need to Know, 12 J. NURSE PRAC. 359,