York County Medicine Winter 2020 - 22

YO R K C O M E D S O C . O R G

FEATURE:

Vaccine Product

Approval Process

F

DA's Center for Biologics Evaluation and Research (CBER)
is responsible for regulating vaccines in the United States.
Current authority for the regulation of vaccines resides
primarily in Section 351 of the Public Health Service Act and
specific sections of the Federal Food, Drug and Cosmetic Act.
Vaccine clinical development follows the same general pathway
as for drugs and other biologics. A sponsor who wishes to begin
clinical trials with a vaccine must submit an Investigational New
Drug application (IND) to FDA. The IND describes the vaccine,
its method of manufacture, and quality control tests for release. Also
included are information about the vaccine's safety and ability to
elicit a protective immune response (immunogenicity) in animal
testing, as well as the proposed clinical protocol for studies in
humans.
Pre-marketing (pre-licensure) vaccine clinical trials are typically
done in three phases, as is the case for any drug or biologic. Initial
human studies, referred to as Phase 1, are safety and immunogenicity
studies performed in a small number of closely monitored subjects.
Phase 2 studies are dose-ranging studies and may enroll hundreds
of subjects. Finally, Phase 3 trials typically enroll thousands of
individuals and provide the critical documentation of effectiveness
and important additional safety data required for licensing. At
any stage of the clinical or animal studies, if data raise significant
concerns about either safety or effectiveness, FDA may request
additional information or studies, or may halt ongoing clinical
studies.

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York County Medicine | W I N T E R 2020/2021

If successful, the completion of all three phases of clinical
development can be followed by the submission of a Biologics License
Application (BLA). To be considered, the license application must
provide the multidisciplinary FDA reviewer team (medical officers,
microbiologists, chemists, biostatisticians, etc.) with the efficacy
and safety information necessary to make a risk/benefit assessment
and to recommend or oppose the approval of a vaccine. Also during
this stage, the proposed manufacturing facility undergoes a preapproval inspection during which production of the vaccine as it is
in progress is examined in detail.
Following FDA's review of a license application for a new
indication, the sponsor and the FDA may present their findings
to FDA's Vaccines and Related Biological Products Advisory
Committee (VRBPAC). This non-FDA expert committee (scientists,
physicians, biostatisticians, and a consumer representative) provides
advice to the Agency regarding the safety and efficacy of the vaccine
for the proposed indication.
Vaccine approval also requires the provision of adequate
product labeling to allow health care providers to understand the
vaccine's proper use, including its potential benefits and risks, to
communicate with patients and parents, and to safely deliver the
vaccine to the public.
The FDA continues to oversee the production of vaccines after
the vaccine and the manufacturing processes are approved, in order
to ensure continuing safety. After licensure, monitoring of the
product and of production activities, including periodic facility


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York County Medicine Winter 2020

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