Editing Vaccine (section)

===United States===
Under the FDA, the process of establishing evidence for vaccine clinical safety and efficacy is the same as for [[Drug approval|the approval process for prescription drugs]].<ref name="fda-vacc">{{cite web|date=30 January 2020|title=Vaccine product approval process|url=https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-product-approval-process|archive-url=https://web.archive.org/web/20200927144627/https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-product-approval-process|archive-date=27 September 2020|access-date=17 August 2020|publisher=U.S. [[Food and Drug Administration]] (FDA)}}</ref> If successful through the stages of clinical development, the vaccine licensing process is followed by a [[Biologics License Application]] which must provide a scientific review team (from diverse disciplines, such as physicians, statisticians, microbiologists, chemists) and comprehensive documentation for the vaccine candidate having efficacy and safety throughout its development. Also during this stage, the proposed manufacturing facility is examined by expert reviewers for GMP compliance, and the label must have a compliant description to enable health care providers' definition of vaccine-specific use, including its possible risks, to communicate and deliver the vaccine to the public.<ref name="fda-vacc" /> After licensure, monitoring of the vaccine and its production, including periodic inspections for GMP compliance, continue as long as the manufacturer retains its license, which may include additional submissions to the FDA of tests for potency, safety, and purity for each vaccine manufacturing step.<ref name="fda-vacc" />