Taking One for the Team: My COVID-19 Vaccine Trial
Many months ago, I heard AstraZeneca was looking for volunteers for their Covid-19 Phase 3 Clinical Trial and I signed up. At the beginning of October, someone from the A-Z Trial called to see if I was still interested but he warned that the USA trial had been temporarily halted. He asked about my age, health record, ethnicity, and availability for a two-year study and determined that I qualified.
«Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less.» Marie Curie
By the end of October, the trial had resumed and my initial appointment (the Shot) was set for November 1, 2020. That first appointment took about 3 hours and included signing a 20+ page consent form, drawing 4 vials of blood, testing for Covid, virus antibodies, an exam by a doctor, and of course, an inoculation of the vaccine.
The trial was “double blind”, meaning neither I nor the people who work at the trial knew whether I got the vaccine or not.
The trial was double blind, meaning neither I nor the people who work at the trial knew whether I got the vaccine or not. Also, it’s a 2-year study so they can test the vaccine’s efficacy and effectiveness, that is, if the vaccine will protect over the long haul. Think polio vaccine, one series and done, compared to the flu vaccine, a shot you’ll need every year. In the USA, the A-Z trial has a cohort of 40,000 subjects in 90 test centers. The trial in Phoenix is looking for 1,500 participants and as of December 7, they had about 800. Every infection movie I ever saw was running through my head. Would my hair fall out or would I grow horns?? Would it make me sick as a dog or kill me?
One third of the participants received a placebo and the other two thirds got the actual vaccine. In order for the vaccine to be proven effective, they needed to give me Covid!
In fact, none of those things happened. In Phoenix, I was participant number 114 and because I was enrolled in the early grouping, I was placed in a sub-study that tracks all of my symptoms for the subjects who come later. I downloaded an app called the IQVIATM Study Hub. It contained an “E-diary” where I daily recorded my temp and any symptoms for the first week, then weekly after that. It asked about 15 questions relating to side-effects. A day after the shot, I ran a fever and felt like I had the flu. It was a long day of temperature taking, napping, and wondering how bad it might get. Next day, I ran a slight fever but resumed my usual activities. After that, I felt no side effects except a little tenderness at the injection site. On the whole, my symptoms were uneventful.
They seemed to think that because I had symptoms, I had received the FULL DOSE of vaccine and not the placebo…
Thirty days later, I received a vaccine “booster” shot. This time, there was no fever and the only side-effect was soreness at the injection site that felt like Mike Tyson had punched my arm. Again, I E-diaryed for a week. While I waited the required 15 minutes to be sure I didn’t pass out from the shot, I asked more questions. They seemed to think that because I had symptoms, I had received the FULL DOSE of vaccine and not the placebo…
It was not strictly altruism on my part. I felt that by Phase 3, A-Z was pretty sure they had a viable vaccine. If I got IT rather than the placebo, I would be one of the first people in the world to be vaccinated against Covid-19.
In the middle of November, Pfizer announced a vaccine that was 90-95% effective. However, if approved, the A-Z vaccine had a huge benefit over the others; it can be held and shipped at a refrigerated temperature rather than stored in a deep freeze of -94F. Buy stock in dry ice if you think the Pfizer vaccine is going to be the winner here. BUT, the refrigeration method of A-Z makes it more practical for world-wide distribution. Now that other companies had been approved for distributing a vaccine, where did that leave me?
I consented to being in a study so not only could I not get a Pfizer vaccine but neither could prove I had received A-Z’s. In fact, people in other studies who believed they received a placebo, dropped out in order to get an approved vaccine. I was told that after A-Z had their vaccine approved, they would “un-blind” the study and I would know my results. In order to resume a normal life and all that offers, how to show proof of the Covid vaccination will be up for debate. Maybe a “V” stamp on an ID or Passport?
I was lucky enough to get the polio vaccine that someone else tested.
People often ask my reasons for taking part in a study that might harm me. It was not strictly altruism on my part. I felt that by Phase 3, A-Z was pretty sure they had a viable vaccine. If I got IT rather than the placebo, I would be one of the first people in the world to be vaccinated against Covid-19. Another reason for taking part in the trial was that I grew up in the 1950’s during the height of the polio epidemic. Polio, like Covid, infected most in its path, including Franklin D. Roosevelt and my aunt, Rita. She got polio as a young adult and had a deformed foot as a result. I was a child during those scary times when people were afraid to let their kids swim in the local pool or hang out with friends. I was lucky enough to get the polio vaccine that someone else tested.
Polio Headlines: “Safe, Effective, Potent!”
The Covid pandemic reminds me of those times. Another aunt, Doris, lives in a nursing home in Massachusetts and sadly saw over half of her fellow residents pass away from Covid. We got through the polio epidemic and we will get through this one with a safe and effective vaccine. All my life, I have taken vaccines; polio, smallpox, pneumonia, and shingles, to name a few. Plus, I’ve gotten a flu shot every year since they became available. I have always tolerated vaccines well, with little or no side effects. Someone had to step up and be willing to test the Covid vaccine, why not me?
Just what is efficacy and how does it differ from effectiveness?
Efficacy remains to be seen in this trial as it has been reported that A-Z’s is only 70% effective while two other vaccines claim 90 to 95%. Just what is efficacy and how does it differ from effectiveness? “Vaccine effectiveness shows how well a vaccine works when used in bigger populations whereas vaccine efficacy shows how well a vaccine works in certain, often controlled, conditions.” (Wikipedia) Ethical questions remain; will it be effective world-wide? is it safe? how long will it last in a human? who gets it first? will its use be mandatory? can the demand for it be met? who will pay for it?
Vaccine effectiveness shows how well a vaccine works when used in bigger populations whereas vaccine efficacy shows how well a vaccine works in certain, often controlled, conditions.
There are many questions and only time will tell the answers. For the next two years I will keep going to the clinic and have my blood tested because I’ve signed on for the long haul. I long for the day when the world will be safe from this devastating virus and I will know that I played a small part in making that happen. I overcame my fear to understand and fear less…