The Guidance includes all the manufacturing, clinical studies, non-clinical studies and post-licensure requirements. This guidance is intended to remain in effect for the duration of the public health emergency related to COVID-19. The recommendations described in the guidance are expected to assist the Agency and sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19 and reflect the Agency’s current thinking on this issue.
Guidance Key Points:
An overview of key considerations to satisfy regulatory requirements set forth in the investigational new drug application (IND) regulations for chemistry, manufacturing, and controls (CMC), and nonclinical and clinical data through development and license, and for post-license safety evaluation of COVID-19 preventive vaccines.
- CMC – specific recommendations for drug substance and drug product along with process validation, quality control and stability and expiry of the vaccine.
- Clinical data – recommending the design of the clinical trial, where FDA stresses that the design of the trial in the later phase should be randomized, double-blinded and placebo-controlled. To determine the vaccine efficacy, the “1:1 randomization between vaccine and placebo” is helpful.
- Non-clinical data – Sponsors should conduct Developmental and Reproductive Toxicity (DART) studies before enrolling pregnant women in clinical trials. The type and extent of nonclinical data required to advance to first-in-human (FIH) trials will vary from candidate to candidate
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