Earlier this week, pharmaceutical company AstraZeneca announced that its vaccine was highly effective against COVID-19. This is great news for the company. We now have three vaccines against the disease that are closing in on approval.
It was also good news for me. I think. May be. I hope.
At some point in my adult life, I developed an obsession with numbers – especially those that could reveal the odds of something happening, like who will win the presidential election. Or if the Packers should go fourth and third.
Or what are my chances of dying from COVID-19.
It was the latter that led me to read a story about coronavirus vaccine development a few months ago and then clicked on a link for those interested in a clinical trial of the AstraZeneca vaccine through the University of Wisconsin School of Medicine and Public Health. .
I signed up, but at the time I thought my chances of being selected weren’t much better than winning $1,000 in a scratch off lottery ticket.
Until I got a call on October 15 from a woman in the university’s clinical trials office.
I had been selected, even if there was a catch. The study had suspended in September because one of the people who got vaccinated in the UK had developed a serious complication that could have been caused by the vaccine.
When the trial resumed, she said, I could participate.
From what I could tell, this serious side effect was on thousands of people who had already received the vaccine when the trial was halted in early September.
As an unvaccinated 69-year-old man, I figured my odds of dying from COVID-19 – if infected – were around 1.5 to 3 in 100, maybe a bit better since I don’t have any of those unwanted things that doctors often call comorbidities, such as obesity, diabetes, high blood pressure, asthma, or known heart disease.
I plugged all this data into my tangled brain of numbers and it quickly spat out an answer: Take the vaccine, you idiot.
So there I sat on the morning of November 16, in the cafe at UW Hospital and Clinics in Madison, wearing a mask and waiting to meet someone who would take me to the sixth floor and into some aspect of the Medicine I’ve Often Written But Never Experienced First-Hand: The World of Clinical Trials.
Over the next two hours, I would go through a 27-page consent form; answer many questions about my health; provide a blood sample and nasal swab; and receive a $100 note in a locked box for my participation, which I then donated to the Hunger Task Force. The visit ended with a painless injection in my left arm – either the vaccine or a placebo.
The AstraZeneca vaccine is manufactured differently from the Pfizer and Moderna vaccines, the first two vaccines to report impressive efficacy results that bring them closer to approval.
The AstraZeneca vaccine starts with an adenovirus that causes colds in chimpanzees but is weakened so it cannot in humans. Added to this is genetic material from the coronavirus for the so-called spike protein. It is the protein on the surface of the virus that allows it to penetrate inside cells and replicate.
With the vaccine, a person’s immune system is ready to quickly recognize when it has been infected with the real coronavirus and mount an attack that includes producing antibodies against the virus.
Vaccine or placebo?
COVID-19 vaccines are coming to us fast and furiously these days.
First, drugmaker Pfizer announced earlier this month that its vaccine was over 90% effective, then boosted it to 95% a few days later when more data came in. A week later, Moderna announced that its vaccine was 94.5% effective.
Monday, AstraZeneca announced that interim results showed his vaccine to be either 62% or 90% effective, depending on the dose.
It was this last caveat that caught my attention. If I didn’t get the placebo, the dose I got is the least effective, the one that’s been used so far at UW. The good news is that, regardless of dose, there were no hospitalizations or serious cases among all vaccinated participants.
Considering all the anguish the pandemic has caused for me, my family and the world, I suspect many people would be happy to get the protection offered by the AstraZeneca vaccine. I certainly would.
But the problem is that I don’t know if I received the real vaccine or a placebo.
In the AstraZeneca lawsuit, for every two people who get the real thing, you get a fake. Even the researchers don’t know who got what. This is done to prevent any bias from affecting the results.
F. Perry Wilson, associate professor of medicine at the Yale School of Medicine, who was not part of the essay, attempted to explain what all of this might mean to me.
Since I’m in the trial arm which is 62% effective and there was a 67% chance of getting the real one, I’m 41% less likely to get COVID-19 than the general public, said Wilson, who teaches a course at Yale on how to understand medical research.
Of course, it’s 0% protection if I got the placebo and 62% protection if I got the real shot.
The problem, he said, is that when you try to apply data from a large population to an individual, “the brain starts to hurt. It’s like a scratch off lottery ticket. Either you win or you lose.”
As new data comes in, it can only become more nuanced for the 800 to 1,000 people the UW wants to enroll in its study. UW is a site for the AstraZeneca lawsuitwhich will eventually involve up to 30,000 to 40,000 people in the United States
The company will share its latest data with the US Food and Drug Administration, though it may need the results of its US trial before the agency approves its vaccine in the US.
By January, the company could have results from its US trial that could confirm or change efficacy numbers, said William Hartman, principal investigator of the trial’s UW arm.
He said he knows that based on those numbers, people could decide whether to stay in the trial or drop out so they can get a more effective approved vaccine once it becomes available, which will likely be in the first quarter of 2021.
“They should do what is in their best interest and that of their family,” he said.