By Stella O. Gonzales
In November 2020, I saw a news report that the United Kingdom (UK) government’s health research agency was looking for volunteers for COVID-19 vaccine studies. The report said more volunteers were needed, even though several drug companies had already finished their phase 3 trials elsewhere in the world and were due to report their results very soon. After searching for more information on the internet, I signed up to the UK’s national registry.
It was not as though I badly wanted to be vaccinated – and because it’s a clinical trial, I could even end up having just a placebo. I was not at high risk of contracting COVID: I lived alone in London, worked from home, conformed strictly with the lockdown rules then in place, would only go out for groceries and would wear a face mask even when just walking on the street.
But I wanted to make a small contribution to the fight against SARS-CoV-2, which was killing tens of thousands of people every day globally. Across the world, hundreds of thousands of people volunteered to take part in various COVID vaccine trials.
The UK national registry is where drug companies would select their study participants. You cannot choose which vaccine company you want to sign up with. You can, of course, back out when you are contacted, and you can withdraw from the study at any time. It was made clear that study volunteers were not going to be paid.
I was secretly hoping that, if I would be selected at all, it would be for the Janssen/Johnson & Johnson vaccine clinical trial. I was impressed with J&J’s commitment that it would not earn any profit from its COVID vaccine for emergency pandemic use.
A month later, I received a call from the Barts Health study center. They are one of the research groups doing the Janssen Ensemble 2 study in the U.K. and they asked me whether I was interested in doing the trial. The government had by then already started vaccinating people in the U.K. with the Pfizer or AstraZeneca jab, prioritizing those who needed them most. But I decided I would still like to do the trial.
Up to 30,000 people (6,000 of them in the U.K.) enrolled in the Ensemble 2 study, which would last for two years and three months. We were told we would have two injections of the study vaccine (Ad26.COV2.S) or two injections of the placebo of sterile saltwater two months apart. Ensemble 2 is a study of a two-dose regimen versus the one-dose Janssen jab that was later on given emergency use authorization in many parts of the world, including in the Philippines.
It was a randomized, double-blinded study, meaning neither the study participants nor the doctors would know who was given the study vaccine or the placebo.
Why would anyone want to join a clinical trial where you might not even get the study vaccine? As the study document said: “There is no direct medical benefit to you for participation in this clinical study. Your participation may help future vaccine recipients.”
I was advised by those close to me to think carefully about joining the trial: the Janssen jab was, at the time, an unproven product and it might be best if I instead waited a few more months when it would be my turn to get one of the government-approved jabs. What they said made sense, but I still wanted to join the study.
In early January, I went as scheduled to my vaccine study center at the Bethnal Green library. First, I had to sign a consent form, which explained in detail what the trial was and what I could expect. A copy of this was sent to me in advance so I could study it carefully. I had to put my initials on each page and then sign on the last page; a study doctor also signed the document.
Why would anyone want to join a clinical trial where you might not even get the study vaccine?
Then a nurse took me to one of several cubicles in the main hall for my medical screening. It was very thorough: I was asked about my medical history, family history and all the medication, vitamins and supplements I was taking. The nurse checked my height, weight, blood pressure and temperature, took a nasal swab for a COVID test, drew some blood samples, and asked me to pee in a cup for a pregnancy test.
After I passed the screening, a doctor gave the nurse a prepared syringe containing my jab. I am used to injections but this one was really painful as the liquid went into my arm. Was this the first time the nurse injected someone? Or maybe this was the study vaccine; surely, the saltwater solution would not cause that much pain? (My injection site was sore for three days and I had a slight fever overnight.)
I was given a digital thermometer, oximeter, a nasal swab stick, and a tote bag to put them in. I was to use them should I experience any COVID symptoms.
Then I was escorted to a room where I was to stay for 15 minutes, just to make sure I did not have an adverse reaction to the injection. There was a hospital bed and oxygen tanks in the recovery room; I noted that the bed looked as if it had not been used at all – that’s good news, right?
Most decided to be in the study for purely altruistic reasons.
I was given an appointment for my second injection for March. In the meantime, in case of a medical emergency, I was told I must show to emergency services a card indicating that I was a participant in the Janssen vaccine trial and the study center’s contact numbers. I tucked the card in my mobile phone case and went home.
By March, I had already qualified for a government vaccine. This meant I had to make another decision: I could stay in the Janssen trial and get my second injection with them, or I could leave the trial and get a vaccine (AstraZeneca, Pfizer) from the UK’s National Health Service. Stick with something unproven or go with the safer, already approved option?
I stayed in the trial. I would learn later on social media that thousands of other Janssen Ensemble 2 participants made the same decision. We opted to be test subjects who were not paid to be in the trial nor received any perks. Most decided to be in the study for purely altruistic reasons.
Study participants have to do twice-weekly COVID symptoms check-in through a secure app, and will have to do this for two years, when, hopefully, most of the world would have already coped with the coronavirus. On my second and third visits to the study center, they got blood samples again. I even agreed to let Barts Health draw one extra vial of blood for their other non-vaccine research. Why not, I thought, it’s not as if I would lose anything by giving them that extra sample.
I had my second injection in March; the jab was as painful as the first one. And although I no longer developed a fever, the site of the jab on my left arm was again sore for about three days.
A few weeks later, a doctor from Barts Health phoned me so I could be “unblinded” from the study. She explained that if I received the placebo, I could either get a government-approved jab or the study center could offer me one dose of the vaccine if the UK government approves the Janssen shot. On the other hand, if I received the Janssen vaccine, I would be considered fully vaccinated (because the vaccine had already been approved in the U.S. and Europe) and I had the option of leaving or staying in the study.
After about a minute during which the doctor searched for the information on her computer, she told me what I had been hoping for: I received two doses of the Janssen study vaccine.
I was overwhelmed and was close to tears. I remember thanking the doctor several times. Then she asked me whether I was going to leave or stay in the study. I told her I will stay: “I am in for the long haul.” WWW
(British regulators granted emergency use authorization to Janssen’s one-shot vaccine only in late May, much later than in the U.S. and Europe, and about three months after the company sought approval for use in the U.K. It took just weeks for the Pfizer, AstraZeneca and Moderna vaccines to receive U.K. approval. Results of the Janssen Ensemble 2 trial have not yet been released; study participants continue their twice-weekly COVID symptoms check-in and are still called in for blood tests.)
ABOUT THE AUTHOR:
Stella Gonzales is an editor at the Financial Times in London.