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By Steve Stecklow
LONDON, Nov. 12 (Reuters) – So why did I volunteer to receive an injection of an experimental vaccine against COVID-19? That’s what some of my friends wanted to know when I told them what I was doing.
“Who knows for the long haul,” wrote a former college roommate. “Sounds like a bet.”
It all started in July when the British government announced that it was seeking large numbers of volunteers for large-scale clinical trials of new vaccines. Just a month ago, a good friend of mine had died of COVID-19 after spending weeks on a ventilator.
Curious, I filled out an online form, thinking I wasn’t committing to anything.
At the end of September, an email informed me that I was one of the more than 250,000 “pioneers in the fight against COVID-19” who had joined the cause. On October 1, I was invited to apply for a trial of a vaccine made by a US biotech company called Novavax Inc. At the time, they were looking for up to 10,000 volunteers in the UK for an advanced stage trial. to determine the vaccine. safety and efficiency.
“If you are between the ages of 18 and 84 and in good health, you may be eligible to participate,” the email read. “The study includes six visits over a period of approximately 13 months. Reasonable travel costs will be reimbursed.”
Now it was time to decide. I started to research the Novavax vaccine, which received less attention than several others. On Monday, Pfizer Inc announced that its COVID-19 vaccine candidate appeared to be over 90% effective. In September, late-stage trials of a vaccine developed by the University of Oxford and AstraZeneca Plc were halted after a report of severe neurological disease in a volunteer, although trials were cleared thereafter to resume.
For me, the Novavax vaccine seemed less risky. Although the Maryland-based company has never received approval for a vaccine, it is using the same technology to create its COVID-19 candidate that it used with a promising flu vaccine. I have had the flu shot every year for decades and have never had a single adverse reaction.
The published results of the first phase of testing of the Novavax vaccine also did not show serious side effects in more than 100 participants who had received an injection. The worst case was someone who had a mild fever for a day.
I decided to go there. I figured if life ever got back to normal, the world would need vaccines and volunteers to see if they worked. On a selfish level, I liked the idea of getting the vaccine as soon as possible, given how monotonous my daily routine had become – and sometimes frightening. I became so risk averse that my wife called me her “jailer”.
Another attraction: if I were to catch the virus, researchers would watch me closely. In the UK, where there has been an increase in the number of new COVID-19 cases to over 20,000 per day, those infected are essentially alone unless they require emergency care.
Of course, there was a 50-50 chance that I would get an injection of a placebo – saline solution – which wouldn’t protect me from anything. When testing for vaccines, placebos are used as a control to see if reality is more effective in repelling the virus.
And so, after screening online and over the phone to determine if I had any medical conditions that disqualified me from the study, I made an appointment for the first of two injections.
I showed up one recent morning at the clinical research center at King’s College Hospital in South London – a drab little building that is part of a large medical complex. To my surprise, the receptionist asked me to remove my “Churchill Pro” cycling mask – which costs $ 33 and uses “British military filtration technology” to block “almost 100%” of viruses – and replace it. by a cheap and disposable. I later found out that it was because my super-duper mask could be contaminated.
Several other volunteers were already in a large room to settle down. I met privately with a doctor who asked me if I had any questions. I had a few: “What if the Novavax vaccine was so effective that the trial was stopped? Will I be told if I received the placebo and, if so, the real one? vaccine?” The doctor told me that if I got the placebo I would have to wait a year because the researchers would like to continue monitoring every trial participant. Not what I wanted to hear.
“What if another vaccine is approved first and I’m given the placebo? Would I be allowed to take it?” The doctor suggested it was possible.
After signing a consent form to participate in the trial, she gave me a brief physical exam. Back in the large room, a nurse gave me a COVID-19 test, sticking a long swab down my throat and then into my nostril. Then he prepared to draw my blood. I warned him that my veins were thin and often proved problematic. He failed twice before calling in a more fortunate colleague.
The injection itself went without incident. But when the nurse checked my blood pressure afterwards, it had increased. He asked me to wait a few minutes and calm down. I thought about the meditation exercises I had always laughed at, but recently tried to reduce pandemic-induced anxiety – inhale, exhale. It worked.
So far I have not experienced any side effects and I am waiting for a second injection after three weeks have passed. Curious about my experience, I spoke to James Galloway, a clinical lecturer at King’s College who is the physician responsible for my trial.
He told me that no decision had been made on what to do with the volunteers who were given the placebo if Novavax was found to work or if another vaccine was approved first. He later added: “If we get another vaccine that works, we would want people to get that vaccine if they had the placebo.”
“We don’t want anyone to suffer from their participation in the study,” he said.
A Novavax spokesperson later told me that the volunteers would discuss their options with the clinicians overseeing the trial sites.
Galloway said there was a theoretical risk if someone who had received the Novavax vaccine was injected with another vaccine. “There’s a chance you’ll have a reaction.”
He does not know how the Novavax trial in the UK is going because he does not have access to the data. But overall, he remains optimistic about the arrival of effective vaccines against COVID-19.
In fact, the 42-year-old doctor himself contracted COVID-19 last spring. He said he had a fever for 10 days and was briefly hospitalized after developing a heart rhythm problem. “I wouldn’t wish that on anyone,” he said.
(report by Steve Stecklow, edited by Janet McBride)
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