unfolded between 2014 and 2016.31
What has not changed, despite the unique threat Zika poses to pregnant
women, is the exclusion of pregnant women during the potential vaccine’s
research and development process.
32 Even though Congress, in 1974, added
specific requirements for undertaking research involving pregnant women
(thus implicitly authorizing such research), vaccine and other medical
therapy developers have rarely engaged in that kind of research.
discussion below outlines approval recommendations to the FDA for
vaccines intended for use during pregnancy and the alternative regulatory
channels that actually authorize such use.
III. THE REGULATORY PATHWAY(S) FOR VACCINES INTENDED FOR USE
A. The FDA Approval Process
The Food and Drug Administration’s Center for Biologics Evaluation and
Research (“CBER”) is responsible for regulating vaccines in the United
States. CBER’s approval facilitates the use of vaccines in countries that lack
34 Although clinical vaccine development follows the
same general pathway as for drugs and other biologics, the process in place
for vaccines intended for use during pregnancy, is not used.
1. All Vaccines
As researchers understand and isolate the Zika virus, they seek to map, to
the greatest extent possible, the biological mechanism or mechanisms that
lead to disease.
36 While some candidate vaccines occur naturally, most
31. Ana Maria Henao-Restrepo et al., Efficacy and Effectiveness of an rVSV-vectored
Vaccine in Preventing Ebola Virus Disease: Final Results from the Guinea Ring Vaccination,
Open-Label, Cluster-Randomised Trial, 389 THE LANCET 505, 511 (2017).
32. Saad B. Omer & Richard H. Beigi, Pregnancy in the Time of Zika: Addressing
Barriers for Developing Vaccines and Other Measures for Pregnant Women, 315 JAMA
1227, 1227 (2016).
33. Blehar et al., supra note 2, at e40.
34. Vaccine Product Approval Process, U.S. FOOD & DRUG ADMIN.,
plicationsblaprocess/ ucm133096.htm (last updated Aug. 24, 2015); U.S. FOOD & DRUG
ADMIN., CBER INTERIM STRATEGIC PLAN FY 2017-2019 9 (2017),
35. Vaccine Product Approval Process, supra note 34; Omer & Beigi, supra note 32, at
A. GROISMAN, PRINCIPLES OF BACTERIAL PATHOGENESIS 134 (2001)
(“Essential to the establishment of a complete understanding of the host-pathogen interactions
that are necessary for the manifestation of disease is the identification and detailed
characterization of virulence factors produced by pathogens at each stage of the infection