COVID-19 Participant Enrollment Question and Answer Guidance
INFORMATION FOR POTENTIAL PARTICIPANTS:
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 a tribute to many volunteers such as yourself and shows the importance of voluntary participation in vaccine research. As these newly authorized vaccines are rolled out to the public, the following information may help answer some questions you have about what this means for you and the clinical trial you are considering.
The vaccines that have been granted Emergency Use Authorization (EUA) by FDA (2 so far, others likely on the way) have been determined by FDA to offer a degree of benefit of protection against COVID-19 disease that outweighs anticipated risks of the vaccines. It is important to note that EUA is not the same as FDA “approval,” as additional data (usually longer-term safety data) are required for full regulatory approval.
Because the vaccines are in limited supply at this time, they are recommended by the US Centers for Disease Control and Prevention initially for individuals who are at particularly high risk of acquiring or developing complications of COVID-19; that is, healthcare workers and residents and staff of long-term care facilities. Some states’ governors have expanded the availability to broader populations to speed their statewide vaccination programs. You should talk with your healthcare provider or the study staff to determine whether and when an EUA vaccine is likely to be available to you in your location.
The simple answer is Yes. Additional vaccines will be required to meet the global needs to combat the SARS CoV-2 virus (coronavirus) because no single vaccine is right for everyone, no single company can supply sufficient vaccine doses for global needs and differences among the vaccines lead to different needs with respect to storage, shelf-life, distribution requirements, etc.
Each vaccine needs to be evaluated to learn the level of protection from disease it provides – termed “absolute efficacy” — which is determined by comparing the vaccine to no vaccine (or placebo). Only with this sort of information in hand can regulators and healthcare providers assess which vaccines work best for which people and how they should be used.
The Novavax trial is a placebo-controlled trial, so enrollment will be focused on at-risk individuals who are not included in the “first waves” of distribution of EUA vaccines; that is, non-healthcare essential workers and older adults who do not live or work in long-term care facilities. We are committed to ensuring participation of people of color and adults with underlying high-risk conditions in the Novavax study.
To ensure that adequate follow-up of study volunteers can be achieved to characterize the absolute vaccine efficacy, study participants should be willing to not receive one of the EUA vaccines for up to 3-6 months. Based on the current situation with “roll-out” of EUA vaccines, that is not an unreasonable period for the general population to expect to wait for an EUA vaccine.
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 active vaccine immediately.
Because vaccines have been able to demonstrate efficacy in only 2-3 months, Novavax has proposed to FDA a modification to this 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.
If you decide to volunteer for this trial, you will be notified as soon as FDA agrees to this proposal and will be asked to provide your consent to participate in the modified trial.
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.
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.
As a participant in this study, you had a 2 in 3 chance of receiving the active vaccine at the time of enrollment. There is therefore a good chance you have already received a product that may provide you with protection against COVID-19.
If the “blinded crossover” is approved by FDA, all study participants who initially received placebo will receive an active vaccine after efficacy is confirmed. Therefore, staying in the study will allow you to continue to contribute to the important information that will help everyone know the best way to use this vaccine.
Nevertheless, being unblinded to decide if you want to get a EUA vaccine is up to you and doing so will not affect your medical care or follow-up in the study. Unblinding will remove you from the study population that will contribute to determining how well the vaccine works, which initially prompted your voluntary participation. Demonstrating the vaccine is effective and safe could become more difficult if people choose to unblind in favor of receiving a EUA vaccine.
No, this type of vaccine uses genetically engineered RNA or DNA that has instructions for making copies of the S protein. These copies prompt an immune response to the virus. With this approach, no infectious virus needs to be handled. While genetically engineered vaccines are in the works, none has been licensed for human use.