COVID-19 Vaccines | FDA

COVID-19 Vaccines | FDA

Coronavirus Disease 2019 (COVID-19) Updates Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last email update include: October 6, 2020: Daily Roundup including a new COVID-19 vaccine web page and guidance with recommendations for vaccine sponsors October 6, 2020: FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines October 6, 2020: FDA leadership remarks at the Food and Drug Law Institute annual conference, including FDA Commissioner Dr. Stephen M. Hahn September 29, 2020: Dr. Hahn's remarks to the National Consumer League on the vaccine review process - also see a video of this event Bookmark www.fda.gov/coronavirus for the latest.

COVID-19 Vaccines

“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.” --Stephen M. Hahn, M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness, and quality of COVID-19 vaccines. Learn more and bookmark our new web page at: www.fda.gov/covid19vaccines. (October 6, 2020)

Cellular signaling and immune correlates for SARS-CoV-2 infection FDA awarded a new research contract to the Stanford University School of Medicine to perform an in-depth analysis of tissue samples to learn more about how SARS-CoV-2—the virus that causes COVID-19—affects different systems in the body, and identify immune correlates. This regulatory science project could potentially help inform development and evaluation of medical countermeasures for COVID-19. (October 5, 2020)

Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter.