changes and improve the quality and utility of the vaccination.
Vaccine approval also requires appropriate product labeling to inform
health care providers about the vaccine’s proper use, including its benefits
and risks, to communicate with patients and parents, and to safely deliver the
59 A product’s package insert, also known as the “label,” is a critical
element of the evaluation of a vaccination.
60 Vaccine labels must include a
section for usage during pregnancy.
The FDA recently revised the regulations for the characterization of a drug
or biologic as it affects pregnancy and issued the Pregnancy and Lactation
Labeling Rule (“PLLR”).
62 The PLLR changed the labeling rule for
pharmaceuticals from categorizing risks into lettered categories ( A, B, C, D,
and X) to providing a narrative summary of the risks of using the drug or
biologic during pregnancy.
63 Under the old system, Category A
pharmaceuticals were those, like folic acid supplements, where adequate and
well-controlled studies did not demonstrate a risk to the fetus in the first
trimester of pregnancy.
64 Category B pharmaceuticals meant that there were
no adequate and well-controlled studies in pregnant women and animal data
were reassuring while Category C pharmaceuticals meant that there were no
adequate and well-controlled studies in pregnant women and also no animal
65 Categories D and X conveyed fetal risk in investigational or
The new rule not only requires that this information be adapted to be given
in narrative form, but also that the labeling include clinical information to
help healthcare providers make prescribing decisions and counsel women
about the use of drugs during pregnancy.
B. Alternative Regulatory Channels for Vaccines Intended for Use
Despite FDA guidance on approval of vaccines through these channels,
59. See Vaccine Product Approval Process, supra note 34.
21 C.F.R. §§ 201. 56—57 (2015).
62. 21 C.F.R. § 201.57 (2015).
63. Marion F. Gruber, The US FDA Pregnancy Lactation and Labeling Rule –
Implications for Maternal Immunization, 33 VACCINE 6499, 6450 (2015).