My AstraZeneca COVID-19 vaccine trial: (leading up to) Day 1

AstraZeneca has gotten quite a bit of (IMHO justified) bad press lately concerning their COVID-19 vaccine candidate, AZD1222. I won’t go into the details here (as they seem to be changing daily), but, I think ironically, because of the mistakes and delays, I was very-quickly able to sign up and get a needle stuck in my arm with a 66% chance that it was the actual vaccine (and a 33% chance that it was the saline solution placebo). With all the bad press, why on earth would I volunteer for such an endeavor?

To make the decision to pull the trigger, I constructed for myself a complex, (but probably) inaccurate mathematical model that guided me. Here are some of the elements of that model in some loose priority:

1. First and foremost, I wanted to get the vaccine sooner than later. I have an immunocompromised member of my family, and the prospect of getting infected and then passing that infection along is not an option. However, according to the New York Times, I’m behind 268.7 million people in line for a vaccine, so the only prospect of getting one in the near future is to sign up for a trial.
2. I thoroughly applaud the cutting edge work of those working on the mRNA vaccines, but I am not ready to take one of these vaccines, either before the end of their Phase III trials or if approved for Emergency Use Authorization (EUA). There’s a reason why Phase III trials are multi-year. I am also not a Phase I or II risk-taker.
3. I’d like to contribute my efforts to vaccine that is globally affordable. Will, for example, the rest of the world be able to afford the mRNA vaccines? Can the infrastructure for their delivery be built for the poorer nations?
4. That leaves AZD1222 since the other candidates have not entered Phase III trials. As stated earlier, participants of the double-blind AZD1222 Phase III trial have a two-thirds chance of receiving the vaccine and a one-third chance of receiving a placebo. That’s a chance (either way!) I’m willing to take.
5. Finally, I am okay with the executive missteps. I believe in the scientists and the science driving the AZD1222 vaccine.
6. However…

I had a few questions before I would let them stick me with a needle. Note: In some cases, the answers to these questions depends on which trial you enter so I will give just ONE of the answers I got:

1. Since I have a 33% chance of getting the placebo, can I get either the AZD1222 vaccine or another when it becomes available? The answer is nothing stops you from getting a COVID-19 vaccine if and when it becomes available. The trial may still want to monitor you.
2. However, if I know that I got the AZD1222 vaccine and not the placebo, at this point in time, I would not want to get a second vaccine. Is there some way that I can be unblinded to make that decision? There are a couple of layers here. At this point in time, if you elect to receive a vaccine other than the AZD1222 vaccine outside the trial, you will not be unblinded. However, usually (and this is the case with Pfizer’s EUA application) trial members will have the option of receiving the vaccine when it becomes available and have priority. There is a nuanced variation to this answer. It is possible that you can get a second round of shots WITHOUT being informed whether you got the vaccine first or the placebo first (so if you got the vaccine, the second round is the placebo, and if you got the placebo, the second round is the vaccine). There are potential ethical issues around this variation, but I am good with the concept.
3. Would we be receiving the accidental half-dose first which seemed to be more effective? (I won’t go into the sample size and make-up of the volunteers here.) The Phase III for which I signed up is for two full doses. There might be a future trial that experiments with the half-dose.

I had heard that you had to be high-risk to be accepted into the trial. I am not, but I decided to start the process anyway. The process I followed was a bit unorthodox, I think:

1. I searched for a suitable trial through ClinicalTrials.gov, answered a few online questions, and to my surprise, I was allowed to go to the next step, namely I got an email saying my selected site would contact me.
2. Impatient, I went ahead and called the site the following day after not being contacted by the site. The site said they had not received my information, so I re-took the evaluation on the phone directly with the site, and again, to my surprise, I was able to go to the next step.
3. Unfortunately the site I chose was unresponsive in the step that would have me come in, so I chose another site that a relative of mine was going through the trial process, and that site also gave me an evaluation on the phone.
4. Again, I was accepted into that study, but this time, I was able to make the clinical appointment for the very next day.

Again, I wonder if circumstances changed due to all the missteps that allowed me, not a high-risk individual, to participate in the trial. I know that at this point it time, they had signed up about half of the desired 30,000 members:

1. Did the delays make them relax the criteria so they could fill up the study more quickly?
2. Were they afraid that the publicizing of the missteps would put their ability to get to 30,000 at risk?

Day 1 begins with the signing of consent and acknowledgement forms. The acknowledgement forms had to do with acknowledging that I had been told of the transverse myelitis cases. I had already heard of these cases, but what I had not heard was that one of the subjects had been given a meningitis vaccine as the placebo, a practice that after it was explained to me makes sense: if the subject has a reaction to the shot in a double-blind situation, the subject might conclude that he or she definitively received the vaccine and not the placebo if the placebo is saline. However, with the introduction of the meningitis vaccine as the placebo, it adds to the “blindness.” Just to be clear, the study that I am in gives saline solution as the placebo.

Following the signing of forms, I was given a physical along with answering some questions about my medical history. No hiccups here for me, but the exam ended with a nasal swabbing, something that I had done a couple of times when receiving a COVID-19 test. This time, however, the swabbing was much more painful than my previous experiences which took me by surprise.

My next stop was blood draw and then the injection. Again, no hiccups here for me as I have no problem with blood draws. The injection was painless as evidently, the vaccine/placebo needle is thinner than vaccine needles that I remember recently (flu, pneumonia). I then made my two follow-up appointments: a phone screening next week and the administration of the second shot on Day 29. After sitting in the waiting area for about 15 minutes, I was allowed to leave.

I will of course not change my behavior because I might have gotten the vaccine and some immunity. Where I live, masks are the norm, and we are experiencing a second “shelter-in-place.”

As I finish this essay, I am not feeling any side effects. I have never felt any side effects from previous vaccines, but I really really wish I got the vaccine and not the placebo and would feel something (even though I know my mind can make that happen with the placebo). Still, I am satisfied that I am contributing to the advancement of this science, and the prospect of having priority for the AZD1222 vaccine when it is given EUA heartens me in the event I received the placebo.