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The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.
FDA announced on Oct. 19, 2023 that it had issued the final guidance, Development and Licensure of Vaccines to Prevent COVID-19, to help sponsors with the clinical development and licensure of COVID-19 vaccines. The document does not address every consideration for satisfying requirements because some vaccines may need specific data, according to the agency. The final guidance reflects FDA’s current thinking on the issue.
“Given the need to ensure that sponsors are aware of our current recommendations to facilitate timely development of vaccines to prevent COVID-19, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), (21 U.S.C. 371(h)(1)(C)), and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices,” the agency stated in the document.
The final guidance explains key considerations for chemistry, manufacturing, and controls including facilities and inspections; nonclinical data, such as toxicity studies; clinical trials, such as trial populations and trial design; post-licensure safety evaluations; and diagnostic and serological assays. In addition, the guidance discusses other safety considerations that should be addressed including demonstrating effectiveness, surrogate endpoints, and adequate datasets. “If it is no longer possible to demonstrate vaccine effectiveness by way of conducting clinical disease endpoint efficacy studies, the use of a controlled human infection model to obtain evidence to support vaccine efficacy may be considered. However, many issues, including logistical, human subject protection, ethical, and scientific issues, would need to be satisfactorily addressed,” FDA stated in the guidance.