Thank you for your interest in participating in a COVID-19 vaccine clinical trial.
The availability of new COVID-19 vaccines authorized for emergency use is thanks to so many volunteers such as yourself and shows the importance of voluntary participation in vaccine research.
Can I get COVID-19 from the vaccines?
No, you can not get COVID-19 from the COVID-19 vaccines. The vaccines do not contain the live virus.
Are more COVID-19 vaccine trials needed?
Yes. Additional vaccines will be necessary to meet the global needs to combat COVID-19. No single vaccine will be right for everyone, and no single company has the means to supply sufficient vaccine doses for global needs.
I am considering a study and not in a priority group for EUA vaccination. What does this trial mean for me?
Not being in a “priority group” does not mean you’re not “at-risk” for COVID-19. In early 2021, the pandemic is spreading widely throughout the nation by community transmission, and many people who are not identified as “high risk” are nevertheless becoming ill.
It is not anticipated that EUA vaccine doses will be available for the broad population in the US for several months. Thus, you may still want to participate in this trial, in which you have a 2 out of 3 chance to receive an active vaccine immediately.
If I am in a COVID-19 vaccine trial, and that vaccine shows protective efficacy, what happens?
Because vaccines have been able to demonstrate efficacy in only 2-3 months, sponsors have proposed to FDA a modification to the trial design to provide the alternate study injections to all study participants after efficacy has been confirmed. This would be accomplished in what is called a “blinded crossover,” meaning that study participants who initially received placebo would receive active study vaccine, and those who initially received active vaccine would receive placebo.
The advantage of this approach is that all study participants will receive the active vaccine, either at the beginning or after a few months. Over the course of the subsequent months of follow-up, the trial will be better able to demonstrate how long protection lasts after initial vaccination. The duration of protection afforded by a vaccine is important information that is otherwise difficult to acquire
Continued follow-up in the trial will also allow more detailed information to be learned about the safety and efficacy of the vaccine in specific groups of people and with respect to different clinical manifestations of COVID-19.
What if an EUA vaccine becomes available to me and I want to leave the study to obtain it?
People on the study are free to leave at any time as their participation is purely voluntary. We ask that people who do choose to obtain an EUA vaccine continue to attend study appointments and share data on their health and any infection with COVID-19 for as long as possible so that the study can complete as early as possible.