On December 11, 2020, the Pfizer and BioNTech COVID-19 vaccine received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). An EUA allows the investigational vaccine to be used during the current COVID-19 public health emergency. The vaccine has not been approved or licensed by the FDA but has been authorized for emergency use by the FDA under an EUA to prevent COVID-19 for use in individuals 16 years of age and older.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of this product unless the declaration is terminated, or authorization revoked sooner. Please see EUA Fact Sheet at http://www.cvdvaccine.com
All participants aged 16 years and older who courageously volunteered to help make a difference during this pandemic have the option to receive the investigational vaccine while continuing to be part of the clinical trial.