History in the Making

01-17-2021Nurse's LetterShannon David, RN, NCSN

Friday afternoon, following the release of our students into the beautiful Arizona sunshine, many teachers headed to a regional “POD” (point of distribution) to receive their first dose of the COVID vaccine! Among the greatest medical advances of the past 100 years, vaccines to prevent viral illnesses have had a profound impact on the health of the world’s population. Very early in this pandemic, it was recognized by those in the scientific and medical communities that any return to “normal” would likely involve some type of widespread immunization. To this end, in March 2020, the Federal government embarked on a mission (Operation Warp Speed) to expedite the development of a COVID vaccine.

By late summer, Phase III clinical trials (these involve real people) were underway. In early August, it was announced that Moderna would be conducting Phase III clinical trials in the Phoenix area. The trial was designed as a “double-blind placebo controlled study” of an m-RNA vaccine. In this study, 50% of participants would be given two doses of the Moderna vaccine and 50% would be given two doses of placebo (salt water). In double-blind studies, neither researcher nor participant knows which preparation is being given. Participants would then be monitored for side effects, exposures and development of illness over a three month period, in the short term, and two and a half years through completion of the study. To gather enough data, Moderna needed 30,000 volunteers to conduct the study. After some thought, and clearance from my physician, I volunteered. I was accepted into the study at the end of August. Many may wonder how I came to make this decision, even questioning my soundness of mind, given all the controversy that has surrounded the vaccine development.

First, and foremost, I have a tremendous regard for the integrity of the practice of medicine. Medicine, and it’s associated disciplines, remains a very noble profession. Throughout my years as a nurse, I have been blessed to work alongside physicians and researchers whose sole mission was to improve the lives of the patients they serve. I can in all honesty say I have never met anyone who held nefarious or malicious intent. With the development of the COVID vaccine, we have seen the top researchers in the world come together like never before. Second, I recognize that every medication or therapy we use today at some point had to be tested for safety and effectiveness in people. For example, in the early 1980’s, ibuprofen was only available by prescription. It was not until large clinical trials were done that it was deemed safe to be sold “over-the-counter”. On a more personal level, I recognize that in order for me to receive medications to treat breast cancer in 2012, someone had to have said “yes” long before I was diagnosed. So, maybe this was my time to give back.

In December, because m-RNA vaccines had shown such great effectiveness, Emergency Use Authorization was granted for the Moderna and Pfizer vaccines. At that time, the Research Team for the COVEm-RNA1273 study (Moderna) alerted all study participants that they would be given the opportunity to be “unblinded” to learn whether they had gotten a vaccine or placebo. On Friday, I left school and headed to HOPE Research. After some procedural matters, another nasal swab and blood draw, I learned I was given placebo (good thing I never reported any side effects!!). My disappointment was momentary. As I was given my first dose of real vaccine, I realized I was exactly where I want to be--half vaccinated with a group of people I really love! Please continue to practice those things that keep us “Smart, Healthy & Holy”. And, when your turn comes to get vaccinated, please consider taking the shot--it could be our best shot at ending this pandemic!