Pfizer’s recent announcement that its COVID-19 vaccine (which it is developing with its German partner BioNTech) is 95% effective made international headlines.
The apparent success story is the culmination of multiple studies consisting of tens of thousands of participants.
What is it like to participate in a vaccine study — having an unproven drug injected into your body, risking your own health to do a service for humanity?
Hamodia spoke to Pfizer study participant Benjy Spiro of Los Angeles last weekend, as Pfizer was announcing that it would seek emergency authorization from the FDA to begin distribution of its vaccine.
Spiro, 34, works for a Fortune 500 premier infrastructure engineering and design consulting firm. He is also the West Coast Director of Chesed Shel Emes, serves on the White House National Faith Leaders Council, and is a District Staff Officer of Human Resources for the U.S. Coast Guard Auxiliary.
His wife, Leah, 31, a nurse practitioner at Cedars-Sinai Medical Center in Los Angeles, participated in the Pfizer study as well.
How did you come to participate in the Pfizer COVID-19 vaccine study?
I saw an ad on social media, a targeted ad asking if I would be interested in participating in a vaccine study for COVID-19. And I immediately was like, “I really want to do this.”
I saw the ad on August 12. They replied on August 14 asking me to come down to their testing facility.
My appointment was August 25. Pfizer is partnering with 130 testing facilities around the world for this study; I was assigned to a testing facility in Anaheim, which is a 35-minute drive from my house.
So I drove down there. They gave me a physical, asked me all sorts of questions, went through my medical history, asked if I am taking medication, things like that.
When they gave me the physical, they of course gave COVID tests, and also did bloodwork, including a COVID antibody test. They did not give me the results of any of my tests, but I assume that both my COVID test and my antibody test were negative; otherwise, I could not have proceeded in the study.
My wife also replied to the ad, and she entered the study as well. We did it together. We both got our first shots at the end of that first visit, on August 25.
More than 43,000 people participated in this Phase Three study. Some got the vaccine and others got a placebo.
This is a double-blind study — neither the participants nor the doctors who interact with us know who got the vaccine and who got the placebo. Everyone is identified only by a Patient ID number. They don’t want anyone to be biased based on whether we got the vaccine or the placebo.
Why were you and your wife interested in participating in this vaccine study?
One reason is that even though we live in Los Angeles, we’d heard about some negative publicity the Jewish community in New York had gotten during the pandemic, and the clashes with Mayor de Blasio. I thought that participating in this study, and to be able to walk into the testing facility with my yarmulke on, could be a great opportunity for a kiddush Hashem.
Also, I’ve been reading a lot during this pandemic, and I felt that there was so much misinformation going around, particularly about vaccines. And I thought that participating could be a good way to get firsthand knowledge — I could tell people, “I got the vaccine and so should you.”
I also saw this as an extension of my work for the community.
And of course, my wife and I participated because it was a big contribution to science, to humanity. We know that saving one life is like saving the entire world. And particularly with my work in Chesed Shel Emes and my wife’s work in the hospital, we’ve seen an unspeakable amount of tragedy caused by COVID-19, and the fact that we could help bring this pandemic one step closer to an end and that people could start living their lives again was a big incentive to do it.
Were you concerned about being injected with a drug that hasn’t been proven?
No, because when I joined the study, it was already in Phase Three, so it was fairly along in the process.
My wife is a nurse practitioner at Cedars-Sinai, so she talked to some people there. Based on her discussions, we didn’t think there were any downsides. We thought the worst thing that could happen was that it wasn’t going to work.
Some of my friends who are not in the medical field thought that this was risky, dangerous and perhaps even a bit crazy, but I thought that was due to ignorance. No one who was a medical expert advised us against it.
The people your wife spoke to were familiar with this particular vaccine?
No, but they were familiar with the general vaccine-study process and what it means to be in Phase Three. Phase Three means it’s already gone through quite a rigorous process. They don’t put it out into a larger testing pool until it’s proven to be reliably safe.
If it had been Phase One or Phase Two, would you have participated?
I don’t know. I would have asked a lot of questions, I can tell you that.
Did Pfizer discuss possible side effects with you?
Yes, they went over possible side effects. Anyone who’s had a flu vaccine knows that their arm gets sore; that’s a normal side effect. They warned me that would probably happen. And they told me I might feel side effects.
I got two shots roughly three weeks apart. With the first shot, my arm felt pretty sore. It wasn’t like anything terrible; it was like I got punched in the arm. I was able to lift up my 18-month-old child, take out the garbage, lift groceries, no problem. I probably couldn’t have done very strenuous activity. This soreness lasted 24 hours, maybe a little less.
And then came the second shot, on September 17. My wife and I did our joint appointments pretty early, 8 a.m. or 9 a.m. Around 6 p.m. that day, I started feeling so achy and tired and stuff. And my wife said, “I’m pretty sure your body is building antibodies and your immune system is working as it should.”
Pfizer gives participants 24-hour medical care. I called, and the doctor basically said, “Everything you’re telling me — your achiness, your cold, things like that — your body’s building antibodies.” He said, “Just take two Motrin.” I took them; maybe half an hour later they started working, and by the time I went to sleep that night I was totally fine. And again, my arm was sore for about 24 hours.
So you’re pretty sure that you got the real vaccine and not the placebo.
Right. And we managed to find out another way: My wife and I regularly donate blood and platelets to Cedars-Sinai. I did a blood donation on October 1, around two weeks after I received the second shot from Pfizer. Cedars-Sinai automatically tested for COVID antibodies, and on Oct. 4, Cedars-Sinai emailed to let me know that I had antibodies. And my antibody count turned out to be really high — they said it was almost four times as much as someone who had COVID, and they wondered if it was a mistake. And I said, “No, I actually got the vaccine!”
My wife, on the other hand, never got the arm soreness, never had side effects, and when she donated blood, around the same time I did, her antibody test was negative. So we figured that I got the vaccine and my wife got the placebo.
Once they give all participants the shots, they tell you to just live your life regularly, without any restrictions, and to continue to observe local COVID laws pertaining to mask wearing, social distancing, etc.
By the way, I actually read about a different study that is being planned in the U.K. for next January, where they give participants the vaccine and then actually infect them with COVID, but that’s a scary risk to take on.
How do they measure the effectiveness of the vaccine?
Every week, the participants have to fill out a “COVID diary” which is a survey to check whether we have any COVID symptoms: fever, coughing, etc. They also give us a home kit, which includes thermometers and a COVID test we can give ourselves if necessary.
Shortly after I got my second shot, I got a cold. I filled out the form every week, saying I didn’t have any symptoms, but that week I clicked that yes, I have a cold and sinus headache and things like that.
They called me back within about an hour, and they instructed me on how to self-administer that COVID test, and then had a medical courier pick it up. Well, it turned out that I just had a cold.
I also went back a few weeks ago and they gave me an antibody test — which of course I assume was positive, because my previous test at Cedars-Sinai was positive. But Pfizer does not give us any test results. I presume that if I had ever gotten a positive COVID test, they would have had to tell us. But otherwise, Pfizer gave us no test results at all.
Also, because of that one time when I said I was sick, although it was just a cold, I had to do another follow-up visit a few weeks later. And again, they did a whole round of tests there, including an antibody test, but again did not give me any results.
My wife actually also wasn’t feeling well one day a few weeks ago, so she also had to do a self-administered COVID test and one extra visit to the testing facility. So we’ve both had a total of four visits to that testing facility in Anaheim.
We asked the lead doctor at the Anaheim testing facility a lot of questions — particularly my wife did, because she is in the medical field. The doctor said that when the vaccine gets approved, this study will likely become “unblinded,” which means they will tell each of the participants whether they received the vaccine or a placebo, and that those who received the placebo will go to the front of the line for the vaccine.
My wife would likely anyway get to the front of the line because she is a health care worker.
Do you happen to know anyone else who participated in this study?
Our child’s pediatrician actually was in this study. But she was assigned to a different testing facility than we were.
So now that you have antibodies, do you still wear a mask?
Yes. Because I don’t want to cause a chillul Hashem.
It’s the law in Los Angeles that we have to wear masks. When I walk in the street with a yarmulke, why should I cause a chillul Hashem?
Besides those who received the placebo possibly going to the front of the line for the vaccine, was there any benefit given to those who joined in the study?
We got paid. But it was not a lot of money.
We get paid $125 per visit to the testing facility. We also get $5 for every weekly “COVID diary” we fill out. And if people get COVID symptoms and have to self-administer that test like I did, they get $50. The study will follow participants for two years, which means filling out a COVID diary every week and around three more mandatory visits to the testing facility for a full round of tests. And if I were to ever report COVID symptoms, that means another follow-up visit.
But I can tell you that our participation had nothing to do with money.
So they’ll be monitoring you for two years. What is this monitoring like? Is it obtrusive or annoying?
No, it’s not annoying or inconvenient at all. We just get a notification on our phones weekly to remind us to check in with the COVID diary and report if we have any symptoms or not. One day I didn’t do it, because it was a Yom Tov, so they called me the next day to remind me. That’s all. Nothing obtrusive.
And as I mentioned, I’ll need to do three more mandatory visits to the testing facility for a full round of tests.
So you have figured out that you likely got the vaccine while your wife got the placebo. Have you noticed them following up with one of you more than the other?
No, it’s been exactly the same.
Any final thoughts?
It’s been a good experience. I am proud to go with my yarmulke to the testing facility as a study participant, and make a kiddush Hashem. And I feel like I can positively educate people and combat disinformation. I tell people, “I’m living proof of this vaccine’s effectiveness. I got the vaccine. I don’t look weird, nothing bad happened to me, I got antibodies and feel fine with no side effects except for not well on the day of the shot.”
There’s so much misinformation out there. Have you heard the one about the COVID vaccines being a way for the government to track you using 5G technology? That’s one of the many rumors floating around online.
Also, the Biale Rebbe from Bnei Brak, shlita, comes to Los Angeles every year around this time of year to fundraise for his organizations. I’ve become close with him the past few years. I keep in touch with his gabba’im on an almost weekly basis. This past Friday night, I spoke to the Rebbe at length about this vaccine, how it was made quickly, with a new methodology, and how I participated in the study, and that I did it to make a kiddush Hashem, and to help bring a refuah to the world. The Rebbe was very pleased to hear this — he said we can see the Yad Hashem in this, that this will bring an end to the pandemic, and that this brings a kiddush Hashem.
And the Rebbe called me a tzaddik, which was a great feeling.