I have the opportunity to participate next week in the AstraZeneca Covid-19 vaccine trial. I am a healthy, middle-aged, nonessential, gainfully employed New Yorker. I want to participate in the two-year trial for a number of reasons: the desire to contribute to science, (potentially); have early access to the vaccine; and simply do something other than sit horror-struck watching what is happening in health care settings.
In New York, however, maybe as early as this summer, middle-aged, nonessential people could potentially be vaccinated. Is it OK to sign up for a two-year double-blind Covid-19 trial — in which I will not know if I have been given the placebo or the vaccine — and then, without telling the trial administrators, get an antibody test to unblind my status?
If I find that I do not have Covid-19 antibodies, then it means I was likely given the placebo, and if an opportunity arises to get Pfizer/Moderna’s vaccine, I would drop out of the AstraZeneca trial. (The trial follow-up is a two-year commitment, but study enrollees can drop out at any time.) I would stay in the AstraZeneca trial if the antibody test comes back positive, indicating exposure and some presumed immunity. (I currently don’t have the antibodies.)
Is it ethical to participate in the two-year AstraZeneca trial when I know I may drop out after six or 12 months? Amy, New York
A medical trial typically has two arms; my answer has two hands. Here goes.
On the one hand: No, it’s not ethical to enroll in a trial when you’ve already formed an intention not to comply with its rules. If everybody in the trial broke the agreement and had themselves tested for antibodies, the trial would no longer be blind, and if people decided that they received the placebo and dropped out in order to receive an authorized vaccine, the study would give us less information about how safe and effective the vaccine under trial is.
Why does it matter that a trial is genuinely double blind? One reason is that knowing you’re vaccinated could itself change your behavior — by making you take bigger medical risks. Another is that an accurate assessment of “adverse events” relies on blinded comparisons; we may see worrisome side effects that turn out to be just as common in the control arm as in the treatment arm, which is the sort of thing we would never know without doing the comparison. There’s a reason that randomized controlled trials are the gold standard in medical research.
On the other hand, the availability of effective treatments poses a complication for ethical trial design. If you’re eligible for vaccination outside the trial, remaining in the trial as a placebo recipient would, medically speaking, put you at a disadvantage. A trial sponsor must not discourage participants from receiving the “standard of care” that would otherwise be their due and that they would otherwise be accorded. A trial is not a form of therapy, and participants are not patients, but a properly conducted trial does not depart from this standard of care in a way that puts participants at serious risk of harm.
As more vaccines that are already in advanced stages of their trials come on the market, there will be challenges for studying newer vaccines — vaccines that could, in theory, be safer, more protective, cheaper and easier to make or store than the ones that crossed the F.D.A. finish line earlier. Increasingly, we may be testing promising new vaccine candidates against already authorized ones, rather than against placebos. But such trials, experts have warned, will have to be of greater size and duration, raising serious financial and logistical obstacles.
Your participation would probably be of more value if you take the antibody test only when your turn approaches for receiving an authorized vaccine. Should you test positive and, as you plan, remain in the trial, researchers will be able to track (for instance) your antibody levels over time; your membership in the treatment arm can help confirm that the antibodies provide protection, especially if the control arm hasn’t dissolved. Should you test negative and drop out, there could be some usable data points from the period in which you (blindly) participated.
But given your risk profile — you are not elderly and have, I gather, a job that allows you to practice social distancing and all the rest — you could reasonably decide to enroll in the study and abide by its rules. At the very least, you should tell the researchers what you plan to do and let them decide if they still want to enroll you in the trial. Right now, what you’re doing is getting a good chance of protection under false pretenses.
My elderly parents are still living in their home. They go to restaurants a couple of times a week; visit friends’ and relatives’ houses; have friends and relatives over for meals and visits, etc. They do not wear masks in their home.
I expressed my concerns about their behavior, but they say that we all have to choose the risks we are willing to take. Their feeling is that if they catch the coronavirus, they have had long and productive lives.
My concern is that they have home health aides who come in a few hours every day. I do not know if they know about my parents’ activities outside the home. I am worried that they are putting these people at risk. Do I have a moral responsibility to notify the company that provides this service? Name Withheld
Oh, dear. Your elderly parents seem to be running a trial of their own — a deeply misbegotten one and blind in all the wrong ways. According to estimates published in Nature last year, Covid-19 kills nearly one in nine of the men over 80 who gets it, and one in 17 of the women. Some of those who survive may never regain their health. Try as hard as you can to get your parents to focus on the gravity of the risks. You might relay some accounts of what being very sick with Covid-19 is like. You could point out that if one or the other of them does get sick, the last time they’ll be able to hold hands may be waiting for the ambulance.
Still, they are taking these risks knowingly; their caretakers, by contrast, may be unaware of your parents’ reckless ways, even as it increases their chances of exposure. What would be most respectful is to ask your parents to tell the people at the agency what’s happening — unless you’re the person who normally communicates with the agency, in which case you should tell your parents that this is what you plan to do.
For the sake of everyone involved, I dearly hope that they will be able to be properly vaccinated before long. Vaccine-induced immunity can take some time to develop, and if your parents were sensible, they would continue to take precautions even after they were immunized; we’re still awaiting empirical confirmation that vaccinated people won’t — at least at any significant rate — continue to spread the virus. But whatever happens, these home aides are entitled to have a clear picture of what risks they face when they are in your parents’ home.