The daily grind of bad news regarding the COVID-19 pandemic has taken a turn, offering a brighter view with the announcement of the U.S. Food and Drug Administration’s emergency use authorization of the Pfizer and Moderna mRNA vaccines. So why do we need to continue conducting trials of other vaccines?
Our enthusiasm for this good news is tempered by the reality that these two vaccines will not be sufficient to meet the needs of the population because there is a limited supply available and considerable hurdles to wide distribution.
We have received our first allocations and begun vaccinating health care workers, but it is likely we will exhaust our supply and subsequent deliveries long before we can vaccinate the population at large.
If these are to be the only vaccines available to us, it will be months before the vaccine is available to the community and even longer to achieve the goal of broad-scale vaccination.
In short, we need more vaccine options to meet the needs of our state, our country and the world. That is why we persevere with vaccine trials, currently with the Astra-Zeneca vaccine, and soon with Novavax and Janssen vaccines. We need more options and more product to allow for broad vaccination coverage.
And we need more volunteers to participate in these trials.
There are many factors that influence the decision to participate in a clinical trial.
In some cases, individuals are interested because of their own health interests (such as preventing serious COVID illness), or they may believe that they are contributing to the benefits of others.
Some may choose to not participate because of study requirements (e.g. visits are too frequent or take too long) or worries about side effects, especially when there is not a lot of experience with the investigative product.
The highest quality clinical trials are those that enroll subjects who best represent the population for whom the treatment is intended. For the COVID vaccine trials, that is everybody.
Failure to enroll a representative sample limits the knowledge that can be gained about safety and efficacy across gender, age, race and ethnic groups.
We know that safety, efficacy and side effects can differ in various populations. COVID-19 has already exacted a too great a toll worldwide, particularly for minority and medically underserved populations.
In order to be certain that the therapeutic agents developed serve the entire population well, we need all groups represented in the clinical trials.
We celebrate the good news regarding COVID vaccine development, but the work is not done. We appreciate the hardworking teams who are making the vaccine trials successful, but we are particularly grateful for all of the volunteers who are participating in these trials.
We have all taken medicines at some time in our lives, either by prescription or over the counter. We must remember that volunteers participated in the trials that were essential for the approval of those medications.
We owe a debt of gratitude to all of them.
Dr. Patrick Flume is an MUSC professor of medicine and pediatrics and associate provost for research compliance and regulatory affairs. Dr. Kathleen Brady is an MUSC professor of psychiatry and vice president for research, and Dr. Gary Headden works in MUSC's emergency medicine.