Mystery continues in reporter’s vaccine trial
There are a lot of things I have wanted in life, but being “unblinded” never made it to my short list.
After getting my second shot as a volunteer in the AstraZeneca COVID-19 vaccine clinical trial, I am no closer to knowing if I got the real thing or a placebo than I was when I got my first shot more than a month ago.
Of course, that is the way it’s supposed to work. People who take part in medical research often are given placebos, and both they and the health care professionals who conduct the trials are not told — or “blinded” to — who got what.
But the coronavirus pandemic, as it has in so many other ways, has upended societal norms. There now are likely tens of thousands of people like me wanting to know what they got because at some time in the near future they will have a chance to get an approved vaccine.
So the buzz in vaccine research now is about how and when to unblind them.
Some of those volunteers already may have a pretty good idea if they got the vaccine because they had discernible reactions shortly after getting the shot, such as a mild temperature, fatigue or pain in the arm.
In the AstraZeneca trial, which is being conducted at UW Hospital in Madison and other sites around the country, for every two people who got the actual vaccine, one got a saline injection — the placebo.
I really didn’t have any of those reactions after my first shot in November. After my second shot this past week, I might have been a little warm, and there was a barely perceptible pain in my arm. But those sensations probably were well within the margin of error for being psychosomatic. There’s even a term for when a placebo makes you feel worse rather than better: the “nocebo effect.”
“Your brain can do all sorts of tricks,” said Eli Perencevich, a professor of internal medicine and epidemiology at the University of Iowa, who was a volunteer in the trial for the already-approved Pfizer vaccine.
Perencevich said he was pretty sure he received the real thing when he got his first shot in August because of the pain in his arm and the slight fever he experienced.
In recent days, the Pfizer vaccine has been reaching hospitals and frontline workers have been getting inoculated.
Because Perencevich is a health care worker, he was unblinded so he could be given the actual Pfizer vaccine, but, as it turned out, that wasn’t necessary.
Like me, Kris Pfeiffer, another volunteer in AstraZeneca trial in Madison, recently had his second shot. He had no reaction to it just like with his first shot.
“Absolutely no reaction whatsoever — not even a sore arm,” said Pfeiffer, 49, who lives in Waukesha County. “The typical flu vaccine makes my arm sore. My guess is I received the placebo.”
Pfeiffer said he plans to ask to be unblinded, but he is not sure when.
Unblinding already is occurring among UW health care workers who volunteered for the AstraZeneca trial and now are eligible for an approved vaccine, said William Hartman, principal investigator for the UW arm of the AstraZeneca trial. Hartman said he can’t reveal how many of them are finding out they got a placebo.
He also cautioned that just because a volunteer did not have a reaction to the vaccine it does not mean they got a placebo injection.
Allowing people to be unblinded will make it more difficult for AstraZeneca to obtain valuable data, but the company is doing the ethical thing by letting people find out so they can get vaccinated, Hartman said.
But the company, he said, should be able to obtain enough data in the next month or two so that it will be able to know the initial effectiveness of its U.S. vaccine trial.
He said researchers generally don’t like to unblind data while a trial still is going on because it can result in people leaving the trial before longer-term data is accumulated, “but that is the world we are in.”
At some point, I’ll ask to be unblinded, maybe in a couple of months. For the moment it is a nonissue because the approved vaccines are first going to health care workers and nursing homes.