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Thank you for making a difference.

We are grateful to the tens of thousands of courageous people who chose to volunteer for The COVID-19 Vaccine Landmark Study.

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Thank You for Making a Difference

To the participants in our COVID-19 vaccine trial around the world: Thank You.

COVID-19 Vaccine Receives EUA Approval

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.

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Vaccine Transition

The Vaccine Transition Option offers all participants 16 years and older the choice to learn whether they received the investigational vaccine or placebo, and for participants who learn they received the placebo, to have the option to receive the investigational vaccine while staying in the study.

Vaccine doses for placebo recipients have been secured, and our aim is that all participants 16 years and older who received the placebo will have the opportunity to receive thier first dose of the investigational vaccine within the study by March 1, 2021, if they choose this option.

How the Vaccine Transition Option works:

  • All participants 16 years and older who received the placebo have two doses of the investigational vaccine reserved for them within the study.
  • The study doctor will follow the latest guidance from the U.S. Centers for Disease Control and Prevention and their local health authorities to offer the Vaccine Transition Option to participants in a prioritized manner.
  • If you choose the Vaccine Transition Option, your study site will schedule a time for you to be unblinded (that is, learn whether you were in the investigational vaccine or placebo group) at the appropriate time in the coming weeks.
  • If you find out that you were in the placebo group and would like to receive the investigational vaccine, you will have an in-person visit where you will be provided with a new informed consent document that the study doctor will review with you before you sign it. Then, you will receive your first dose of the investigational vaccine.
  • You will receive a second dose of the investigational vaccine about 21 days later and follow an updated study schedule that includes follow-up and illness visits.

The Decision To Transition To The Vaccine Group Is Up To You
 

Your continued participation in the trial will provide valuable contributions to the understanding of COVID-19 and the investigational vaccine. The Vaccine Transition Option is completely voluntary, and you can also choose to remain blinded and continue with your planned study activities. If you would like to learn more about the Vaccine Transition Option and how it works, please contact your study site.

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