Conquering COVID Part 2.4 (aka the 15th Installment in a Finite Series):
“Phase 3 Vaccine Trials are becoming ubiquitous-Time to Score A Touchdown?!” (aka field goals are fine, but touchdowns are better)
November 3, 2020
by Mark A. Moyad, MD, MPH
“I am concerned, of course, but I am also incredibly optimistic.”
(Note: All references are at the end of the column-thank you.)
First, I want to apologize. I am sorry. I was on a fabulous roll and wrote countless pages of COVID-19 updates from March to September and then, for many weeks/months almost nothing, except the sound of crickets. Why have I been silent for the last month or so? Good question. September is Prostate Cancer Awareness Month and October is Breast Cancer Awareness Month. I have a multitude of other good excuses (a "dog ate my homework" kind of thing), but I am back and feeling stronger and more energized than ever, my friends, and through all of this I only rely on “1,3,7-trimethylxanthine” (aka “caffeine”) to keep me awake! Why am I so excited? It is because the ball is now on the two yard line and it is time to punch it in for a touchdown! Yes, time to score because we now have Phase 3 trials everywhere! I do not want a field goal, but a touchdown! Again, I want a touchdown!
I am so greedy for a touchdown because of a plethora (nice SAT word) of Phase 3 trials going on with vaccines and other medications. Phase 3 trials are ubiquitous? Yes! Phase 3 means you are now one step away from demonstrating enough potential data to be approved for widespread utilization. How in the “H-E-double-toothpicks” did the research go from laboratory studies to human Phase 1 and 2, and now Phase 3 within 6 months, and then hopefully and potentially emergency use authorization (EUA) or simply FDA approval? Can you imagine that pace with a cancer prevention or treatment medicine? Countless researchers around the world have been doing their thing since the pandemic started. So, now the ball has been moved from one side of the field to the other, and it is time to score a touchdown, and not a field goal. I wish Michigan football could do that more often (sorry, I needed that personal moment of therapy after this past weekend). Look, a field goal would be nice, but we should score a touchdown! Why? Buckle up, because here we go, and we are going to focus on the bottom line. Here comes a wonderful fact - there are over 150+ vaccines being studied around the globe and nine are now in the final stages (aka moving to, or already in, PHASE 3). So, let us start by reviewing just the two phase 3 clinical trials that are likely to report their initial results in 2020 or in early 2021. My hope is that both of these companies are able to report initial news in 2020. The first company is Moderna (I know the first two letters you have to love…"Mo" as in “Moyad”), and the second company is Pfizer, working with another company from Europe known as “BioNTech.”I decided to address some of the most common questions I have been asked in the following:
The Two Phase-3 COVID-19 Vaccine Clinical Trials Likely to First Report Results in 2020 or Early 2021
Is this company currently in a Phase-3 COVID-19 vaccine trial?
Moderna: Heck Yes! Called the “COVE” (Coronavirus Efficacy) Study. Pfizer/BioNTech: Heck Yes! Just called the Pfizer/BioNTech study.
When was the Phase-3 start date?
Moderna: July 27, 2020 (approximately)
Pfizer/BioNTech: July 27, 2020 (approximately)
What kind of vaccine is it? (note: the approach or “platform” is similar between the two companies and there is absolutely no live virus utilized in the vaccine itself).
Moderna: Known officially as “mRNA-1273” where a genetic blueprint or script of a protein part of COVID-19 is provided to humans to ultimately produce or trigger an immune memory and response to the real virus in the future.
Pfizer/BioNTech: Also, an mRNA vaccine, but known officially as “BNT162b2”. BNT162b2-a nucleoside-modified messenger RNA (mRNA) candidate, which means the vaccine harbors a small amount of the script of COVID-19, which also allows body to go after the real virus in the future.
How many people are they recruiting?
Pfizer/BioNTech: 44,000 (study initial goal was 30,000 participants and then was expanded to 44,000 to increase diversity of participants).
How many people have they recruited up to now?
Moderna: 30,000! Study is fully recruited (more than 25,000 have received both doses)! Approximately 37% of participants are “minorities/have diverse backgrounds” (20% Hispanic/Latinx, 10% Black/AA, 4% Asian, 3% other); 25% of the participants are the age of 65 or older.
Pfizer/BioNTech: Almost 44,000 Study is almost fully recruited-actually 43,249 participants on 11/2/20! (more than 37,000 have received both doses)! Approximately 43% of participants overall or globally (30% in the U.S. trials) are “minorities/have diverse backgrounds” (26% Hispanic/Latinx, 10% Black/AA, 5% Asian, 0.7% Native American); 41% ages 56 to 85 years old.
How many doses or injections do you need?
Moderna: 2-doses or 2-total injections needed and each single injection or dose is separated by a total of 28-days. The placebo arm of this study will receive saline injections.
Pfizer/BioNTech: 2-doses or 2-total injections needed and each single injection or dose is separated by a total of 21-days. The placebo arm of this study will receive saline injections.
What is/are the catches?
Moderna: Vaccine needs to be transported/distributed and stored at a very cold temperature of -20 Celsius (-4 Fahrenheit), and once thawed it can be kept in a refrigerator for 7 days.
Pfizer/BioNTech: Vaccine needs to be transported/distributed and stored at a very cold temperature of -70 Celsius (-94 Fahrenheit) and once thawed it can be kept in a refrigerator for 24 hours or 2 hours at room temperature. The company is working on a way to increase refrigerator time of 7-10 days.
Why is the glass half full already?
Moderna: The independent data/safety monitoring committee has not stopped the trial, so safety has not been a major issue so far.
Pfizer/BioNTech: The independent data/safety monitoring committee has not stopped the trial, so safety has not been a major issue so far.