Browsing by keyword "Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) Investigators"

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Ensuring vaccine safety

Knipe, David M.; Levy, Ofer; Fitzgerald, Katherine A.; Muhlberger, Elke (2020-12-11)

There is an urgent need for vaccines to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to reduce COVID-19 and stop the current pandemic. Although bureaucratic delays should be reduced to accelerate vaccine availability, there remains the need for extensive safety testing protocols developed by the U.S. Food and Drug Administration (FDA) and other regulatory agencies. COVID-19 vaccines will be safe if regulatory agencies maintain their well-documented safety testing protocols. Safety should be considered at every phase of vaccine discovery, development, and testing. History provides a strong scientific basis for safety evaluation of all vaccine candidates, which must be maintained to realize their enormous potential.