The following article relates to the Pfizer COVID Vaccine Protocol#C4591001: All participants 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.
The Vaccine Transition Option
The Vaccine Transition Option is a voluntary process that offers all participants 16 years and older in the placebo group an option to transition to the active vaccine group. Interested participants can transition at two-time points:
FREQUENTLY ASKED QUESTIONS
I think I am in one of the groups prioritized to receive the investigational vaccine. What happens now?
At this time, groups that are eligible after the outcome of VRBPAC & CDC ACIP recommendations>, and wish to take part in the Vaccine Transition Option, contact your study doctor who will confirm your eligibility and whether you originally received the investigational vaccine or placebo. The Vaccine Transition Option is voluntary. The decision to participate is up to you.
Who is eligible to participate in the Vaccine Transition Option?
All participants are eligible for the Vaccine Transition Option. However, interested participants can transition at two-time points. Participants in the study who are <insert groups that are eligible after the outcome of VRBPAC & CDC ACIP recommendations> and wish to take part in the Vaccine Transition Option, can contact their study doctor now. For all other participants, your study doctor will discuss an option for you to transition from the placebo group to the active vaccine group at your 4th visit, approximately 6 months after you received your second vaccination. In either case, the choice to move from the placebo group to the active vaccine group is completely up to you.
What is an Emergency Use Authorization (EUA)?
An Emergency Use Authorization, or EUA, allows an unapproved medical product (like an investigational vaccine) to be used in a public health emergency such as the current COVID-19 pandemic when there are no adequate, approved, and available alternatives. Vaccines authorized for emergency use are still considered investigational and are not FDA-approved.
When will the investigational vaccine be approved for general use?
Each country’s regulatory agency has its own timing and process for vaccine approvals. It is important that all individuals in Phase 3 clinical trial continue to participate, even if they have received the investigational vaccine.
If I receive the investigational vaccine through the Vaccine Transition Option, am I still in the clinical trial?
Yes. If you choose to transition into the vaccine group, the study team will review an updated visit schedule with you that includes follow-up and illness visits and will answer any other questions you have about continuing in the clinical trial.
Once I get the vaccine, should I still follow social distancing and other guidelines against COVID-19?
Yes. You still need to follow local recommendations about how to avoid COVID-19 (for example, social distancing and mask use).
Can my friends and family members get the vaccine through the study as well?
Only study participants can receive the investigational vaccine through the clinical trial. Your country or state’s health department will be able to provide more information about how and when the investigational vaccine will be offered to people who are not in the clinical trial.