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 It contained the results of a private blood test I had undergone the
day before. I opened the attachment with excitement and some
trepidation - I believed it would likely reveal whether I am already
vaccinated against COVID-19, or if I received a placebo.
As a volunteer in a late-stage clinical trial for an experimental
vaccine for COVID-19, I had already received two injections. I knew
when I signed up there was a 50-50 chance I'd either get a vaccine
made by an American company called Novavax – or a salt-water
solution used as a control to see if the real thing works. A friend
joked that might protect me against drowning, but nothing else.
I experienced no symptoms after the first shot, which I received in
late October. But immediately following the second injection three
weeks later, there was mild swelling where the needle had pierced my
upper right arm. A small, pink circle quickly formed around it.
A nurse carefully measured the redness and took notes. Two doctors
were called in to take a look. They eventually sent me home and
asked me to contact the clinic if I experienced any pain or signs
that it had become infected. That didn't happen.
Two weeks later, I returned to the clinical research facility at
King's College Hospital in south London for a scheduled blood test.
I showed a doctor how the skin around the injection site was still
black and blue.
"Looks like you got the real thing," he said, to my surprise. He
noted that several other volunteers had experienced similar
symptoms, although he added it was still possible I had received the
placebo.
As it happened, that morning the United Kingdom became the first
western country to approve a COVID-19 vaccine. It is made by Pfizer
Inc and German partner BioNTech, which have reported that it was 95%
effective in clinical trials. It has since been authorized for use
in several other countries, including the United States.
My feelings about the doctor's comment were mixed. While the Novavax
vaccine is considered very promising based on early results, its
efficacy isn't expected to be known until early next year. Who knows
how effective it'll be? Yet knowing I might already be protected
against a potentially deadly virus seemed a relief. For starters, I
might finally feel safe enough to visit the wonderful pub behind my
house for the first time in nine months - wearing a mask, of course.
To be honest, part of me had been secretly hoping that I had
received the placebo. I had asked when my trial started what would
happen if another vaccine was approved first. The doctor in charge
had strongly suggested that I'd be told what I'd been injected with
- a process known as "unblinding." I could then get the approved
vaccine – provided I had received the placebo. But if I had received
the actual Novavax vaccine, he said, it could be risky because
receiving two vaccines targeting the same disease could cause a
reaction.
An email I received from the UK's National Health Service –
"INFORMATION FOR PARTICIPANTS IN LIGHT OF NEWS ABOUT PFIZER/BIONTECH
COVID-19 VACCINE" – basically confirmed that people who received the
placebo would be able to get the approved vaccine once it was
offered to them. Volunteers will not be "disadvantaged," it stated.
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 This appears to contrast with
some other COVID-19 clinical trials in the
United States. The New York Times recently
reported that some volunteers receiving a
placebo might have to wait up to two years to
get a vaccine so as not to tarnish long-term
results. (A concerned friend emailed me the
article, writing, "I'm sure it is anything but
comforting to be told you can't get the real
vaccine for 2 years because you were in a
trial." I wrote back, explaining that
fortunately, that's not the policy in the UK.)
On Saturday, an official with the U.S. Food and
Drug Administration told a press conference that
the agency is in discussions with vaccine
manufacturers about the placebo issue.
I spent the next few days debating whether I should end my suspense
and try to learn for sure whether I had received the Novavax vaccine
or the placebo – by taking a test to see if COVID-19 antibodies are
present in my blood. The real vaccine is supposed to produce them to
fight the virus so if that's what I received, my test result should
come back positive.
I had asked two doctors involved in my trial whether taking a
private antibody test was permissible. They both said it wasn't
prohibited under the terms of my trial. I figured I would eventually
find out if I'm already immunized, given that the U.K. rollout of
the Pfizer/BioNTech vaccine has already begun, although exactly when
I'll be offered it isn't clear. On December 7, I
crossed the Thames on a nearly empty commuter boat for an
appointment at a private medical clinic. Before drawing my blood, a
nurse asked why I wanted a COVID-19 antibody test. "I want to find
out if I've been vaccinated or got the placebo in a clinical trial,"
I replied. She confirmed that no one before had ever given her that
reason.
The test result arrived in an email the next morning. I assumed it
would be positive.
"Negative," it said.
I emailed the result to a doctor at the research clinic: "I'm
assuming I either received the placebo or the Novavax vaccine
doesn't work at all. (I'm assuming the former.)"
"That is interesting," he replied. "As soon as you get offered
another vaccine, let me know and I will be able to unblind you and
we can find out!"
This week, there was an unexpected plot twist. I learned that the
antibody test I had taken wouldn't reveal if I'd gotten the real
vaccine because it detects antibodies to a different COVID-19
protein. One would need a test that identifies antibodies to the
spike protein. Who knew?
So I crossed the Thames again to visit another medical clinic that
offers a different COVID-19 antibody test. This time, a nurse gave
me the result after just a few minutes - negative again.
Looks like I won't be visiting the pub behind my house anytime soon.
(read Steve Stecklow's previous story here: https://www.reuters.com/article/us-health-coronavirus-vaccine-volunteer/why-i-volunteered-for-a-covid-19-vaccine-trial-idUKKBN27S0YL)
(writing by Steve Stecklow; editing by Janet McBride)
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