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

To the 12-15 year old participants in our covid-19 vaccine trial: Thank You.

COVID-19 VACCINE RECEIVES EMERGENCY USE AUTHORIZATION

On May 10, 2021, the Pfizer & BioNTech COVID-19 vaccine received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for 12-15 year-olds. The FDA previously granted EUA for the Pfizer & BioNTech COVID-19 vaccine for individuals 16 and older on December 11, 2020. An EUA allows the study vaccine to be used during the current COVID-19 public health emergency. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 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 the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet at https://www.fda.gov/media/144413/download?linkId=118393561

All participants 12 years and older who courageously volunteered to help make a difference during this pandemic have the option to receive the study vaccine while continuing to be part of the clinical trial. All participants 16 and older have already been offered the Vaccine Transition Option, and we are now expanding it.

Now available to all participants 12 and older

The Vaccine Transition Option offers all participants 12 years and older the choice to learn whether they received the study vaccine or placebo, and for those who received the placebo, to have the option to receive the study vaccine while staying in the study.

How the Vaccine Transition Option works:

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 study vaccine or placebo group) in the coming weeks.
If you find out that you were in the placebo group and would like to receive the study 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 and your parent or guardian before you sign it. Then, you will receive your first dose of the study vaccine.
You will receive a second dose of the study 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 study 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.