The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health

The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health

by FDA Commissioner Stephen M. Hahn, MD, and Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research

The U.S. Food and Drug Administration’s mission is to protect and promote the public health, both in the U.S. and globally, by ensuring the safety and effectiveness of the products we regulate. Nowhere is this public health mission more evident than in the FDA’s role in the scientific and regulatory oversight of vaccines. One of the agency’s highest priorities is ensuring the quality, safety and effectiveness of vaccines. This deep and abiding commitment is something that we consider essential to engendering the public’s trust in vaccines. (September 11, 2020)
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FDA and global partners to analyze coronavirus samples

Effort to help inform development of SARS-COV-2 diagnostics, vaccines, and therapeutics

FDA awarded a new research contract to the University of Liverpool and global partners to sequence and analyze samples from humans and animals to create profiles of various coronaviruses, including SARS-CoV-2, which causes COVID-19. The study will also examine in vitro coronavirus models, such as organs-on-chips. This regulatory science project, awarded in collaboration with the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID), will hopefully help inform development and evaluation of medical countermeasures for COVID-19. (September 14, 2020)
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