Real thing or placebo? My odyssey with the COVID-19 vaccine continues

LONDON (Reuters) – The subject line of the email I received last week just said “Test”.

FILE PHOTO: Reuters journalist Steve Stecklow is participating in a clinical trial of the Novavax experimental COVID-19 vaccine at the NIHR / Wellcome King clinical research facility in London on October 28, 2020. REUTERS / Steve Stecklow

It contained the results of a private blood test I had done the day before. I opened the attachment with excitement and a little fear – I thought it would probably show if I had already been vaccinated against COVID-19 or if I was given a placebo.

As a volunteer in a late-stage clinical trial for an experimental vaccine against COVID-19, I had already received two injections. I knew when I signed up there was a 50-50 chance that I would either get a vaccine from an American company called Novavax – or a saline solution that was used as a control to see if the reality worked. A friend joked that he might save me from drowning, but nothing else.

I had no symptoms after the first shot I received in late October. Immediately after the second injection three weeks later, there was a slight swelling where the needle had pierced my right upper arm. A small pink circle quickly formed around him.

A nurse carefully measured the redness and took notes. Two doctors were called to take a look. They eventually sent me home and asked me to contact the clinic if I had any pain or signs of infection. 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 have the right thing,” he said to my surprise. He noted that several other volunteers had similar symptoms, although he added that it was still possible that I had received the placebo.

The UK became the first western country to approve a COVID-19 vaccine that morning. It’s made by Pfizer Inc and German partner BioNTech, who reported it was 95% effective in clinical trials. It has since been approved for use in several other countries, including the United States.

My feelings about the doctor’s comment were mixed. Although the Novavax vaccine is seen as showing great promise based on early results, its effectiveness is not expected to be known until early next year. Does anyone know how effective it will be? However, it seemed like a relief to know that I might already be protected from a potentially fatal virus. For a start, I could finally feel safe enough to visit the wonderful pub behind my house for the first time in nine months – with a mask, of course.

To be honest, part of me was secretly hoping to get the placebo. At the beginning of my study, I asked what would happen if another vaccine was approved first. The doctor in charge had strongly suggested that I tell me what was injected – 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 it could be risky as receiving two vaccines for the same disease could cause a reaction.

An email I received from the UK’s National Health Service – “INFORMATION FOR PARTICIPANTS IN THE LIGHT OF THE NEWS ABOUT PFIZER / BIONTECH COVID-19 VACCINE” – basically confirmed that people who received the placebo would receive the approved vaccine as soon as he was offered you could. Volunteers are not said to be “disadvantaged”.

This appears to be in contrast to some other COVID-19 clinical trials in the US. The New York Times recently reported that some volunteers given a placebo may have to wait up to two years to get a vaccine so as not to compromise long-term results. (A concerned friend emailed me with the article and wrote, “I’m sure it’s far from comforting to learn that you can’t get a real vaccine for 2 years because you were in a trial.” I wrote back, fortunately explaining this, that is not the policy in the UK.) On Saturday, a US Food and Drug Administration official told a news conference that the agency was discussing the placebo problem with vaccine manufacturers.

For the next few days, I debated whether to stop my tension and try to know for sure whether I had received the Novavax vaccine or the placebo – by doing a test to see if there were any COVID-19 antibodies in my blood available. The real vaccine is supposed to produce them to fight the virus. If I received this, my test result should be positive.

I asked two doctors involved in my study whether a private antibody test was allowed. Both said it wasn’t forbidden under the terms of my trial. I thought I would find out at some point if I was already vaccinated as the Pfizer / BioNTech vaccine rollout in the UK has already started although it is not clear when exactly I will be offered.

On December 7th, I crossed the Thames in an almost empty commuter boat to make an appointment at a private medical clinic. Before I took my blood, a nurse asked why I wanted a COVID-19 antibody test. “I want to find out if I was vaccinated or received the placebo in a clinical trial,” I replied. She confirmed that no one had ever given her this reason before.

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 either I received the placebo or the Novavax vaccine didn’t work at all. (I assume the former.) ”

“That’s interesting,” he replied. “As soon as you are offered another vaccine, let me know and I will be able to unblind you and we can find out!”

There was an unexpected twist in the plot this week. I learned that the antibody test I did would not tell whether I had received the real vaccine because it detects antibodies to another COVID-19 protein. A test would be needed to identify antibodies to the spike protein. Who knew?

So I crossed the Thames again to visit another medical clinic that does another COVID-19 antibody test. This time a nurse gave me the result after just a few minutes – again negative.

Looks like I won’t be visiting the pub behind my house any longer.

(Read Steve Stecklow’s previous story here: here)

Letter from Steve Stecklow; Adaptation by Janet McBride