ABSTRACT

FDA Briefing Document: Development, Authorization and Licensure of Vaccines to Prevent COVID-19   [open pdf - 463KB]

From the Introduction: "The SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] pandemic presents an extraordinary challenge to global health and, as of September 22, 2020, has caused more than 30 million cases of COVID-19 [coronavirus disease 2019] and claimed the lives of more than 900,000 people worldwide. On January 31, 2020, the U.S. Secretary of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. On March 13, 2020, the President declared a national emergency in response to COVID-19. In addition, the WHO [World Health Organization] declared the novel coronavirus a pandemic on March 11, 2020. The rapid spread of SARS-CoV-2 requires expedited timelines to develop COVID-19 vaccine candidates and test them in clinical trials that can provide the data to meet the relevant legal standards for safety and effectiveness. Currently, numerous COVID-19 vaccine candidates intended to prevent COVID-19 are in development globally. These candidates are based on a variety of different vaccine technologies and platforms. Some of these vaccines have entered Phase 3 clinical trials intended to demonstrate their safety and effectiveness. The U.S. Food and Drug Administration (FDA) is committed to facilitating the scientific development and evaluation of safe and effective COVID-19 vaccines and to providing as much transparency as possible to the American public, while adhering to applicable confidentiality requirements."

Publisher:
Date:
2020-10-22
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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