Development and Licensure of Vaccines to Prevent COVID-19 | FDA

Development and Licensure of Vaccines to Prevent COVID-19 | FDA

Coronavirus (COVID-19) Update: Daily Roundup June 30, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

• Today, 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.

• FDA issued an Emergency Use Authorization to LifeHope Labs for its molecular-based LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel.
• 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.
• Testing updates:
• To date, the FDA has authorized 157 tests under EUAs; these include 132 molecular tests, 24 antibody tests, and 1 antigen test.