The US Food and Drug Administration (FDA) took action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations related to licensure for those developing COVID-19 vaccines.
The guidance, titled “Development and Licensure of Vaccines to Prevent COVID-19,” describes the agency’s current recommendations regarding the data needed to facilitate the manufacturing, clinical development, and approval of a COVID-19 vaccine. The FDA has the scientific expertise to evaluate any potential COVID-19 vaccine candidate regardless of the technology (e.g., DNA, RNA, protein and viral vector) to produce or administer the vaccine.
The guidance provides an overview of key considerations to satisfy requirements for chemistry, manufacturing and control, nonclinical and clinical data through development and licensure, and post-licensure safety evaluation. Given the current understanding of SARS-CoV-2 immunology, the goal of development programs at this time should be to support traditional FDA approval by conducting studies to directly evaluate the ability of the vaccine to protect humans from SARS-CoV-2 infection and/or disease. The guidance also notes that, as more is learned about SARS-CoV-2 immunology and vaccine immune responses, consideration may be given to the FDA’s Accelerated Approval pathway for vaccine licensure.
The guidance also addresses considerations regarding Emergency Use Authorization (EUA) of an investigational vaccine, making clear that an assessment regarding any potential EUA for a COVID-19 vaccine would be made on a case-by-case basis considering the target population, the characteristics of the product, and the totality of the relevant available scientific evidence including preclinical and human clinical study data on the product’s safety and effectiveness.
In the second FDA Insight podcast, titled "All About COVID-19 Testing," host Dr. Anand Shah, FDA’s deputy commissioner for Medical and Scientific Affairs, is joined by Toby Lowe, associate director for FDA’s In Vitro Diagnostics Program in the Center for Devices and Radiological Health, discussing “all things” COVID-19 testing.
