When a Centers for Disease Control and Prevention advisory committee voted Tuesday to recommend residents of long-term care facilities should be at the front of the line — with health care providers — for Covid-19 vaccines, the lone dissenting voice came from a researcher who studies vaccines in older adults.
Helen Keipp Talbot — who is known by her middle name — raised serious concerns during the meeting of the Advisory Committee on Immunization Practices about using the vaccines in the frail elderly, noting there are no data yet to suggest the vaccines work in this population.
All the U.S.-based Phase 3 trials of Covid vaccines have to include people 65 and older. But none has specifically tested the vaccines in people who are in long-term care. One can’t assume findings in people over age 65 who are healthy enough to be accepted for a clinical trial are indicative of everyone in that demographic, she said.
At an earlier ACIP meeting, Talbot warned that vaccinating this population at the start of the vaccine rollout is risky, because long-term care residents have a high rate of medical events that could be confused as side effects of vaccination and undermine confidence in the vaccines. “And I think you’re going to have a very striking backlash of, ‘My grandmother got the vaccine and she passed away,’” she said at the time.
STAT spoke to Talbot, an associate professor of infectious diseases at Vanderbilt University, over Zoom, asking why she voted against putting long-term care residents into “Phase 1a” for access to Covid-19 vaccines, which will likely begin to be rolled out in the second half of December.
The conversation has been lightly edited for clarity and length.
It was a bit unusual to see ACIP — which is an evidence-based decision-making group — make a recommendation on the assumption the vaccines would work in the frail elderly.
I think that they did base it on data. It was just the data of the number of deaths in that population. The number of deaths in that population is far out of proportion to the number infected. And that was the driving reason for that vote.
You study vaccines in the elderly. Tell me why you think vaccinating long-term care residents first isn’t the right approach.
I think it is the right approach if we have data.
That’s the kicker. We routinely, and for almost all of our adult vaccinations until recently, tested them in college-aged kids and Army recruits and saw that they’ve worked and use them an older adults.
The first example is flu. In 1960, the surgeon general said, well, it works in young, healthy adults, so it should at least partially work in older adults. Since 1960 it’s been, “Because it might partially work.”
We need to quit assuming that these vaccines work and actually design them and test them in this population and use them appropriately.
Are you concerned that these are doses that are going to be wasted?
I wouldn’t say wasted. But not used as efficiently as they could be.
If I know it works in a healthy health care worker, I’d rather get all the health care workers vaccinated, so that when they are around the frail elderly, they don’t get the frail elderly sick.
We don’t have enough vaccine yet for all health care workers. We will eventually, but we don’t yet.
Do you have any safety concerns about use of the vaccine in long-term care residents?
Any more than anyone else? No. But I think what we have for the adult population in general is a randomized control trial to look at the safety data.
What do you mean?
If something happened to me following the vaccine, we could go back to the randomized control trial data and look at did this happen in both groups? Did happen in the placebo group or not. We can’t do that for the long-term care facility because there wasn’t a trial done in the long-term care facility.
And you can’t extrapolate from the general Phase 3 trial?
We can try. But it’s not definitive. Because it’s a different population with different comorbidities and frailty.
And the chances of something like a stroke or even death happening in the 30, 60, or whatever days after vaccination is so much higher among long-term care residents …[Talbot nods vigorously.]
Here’s the deal. All of the events are going to be temporarily associated. But how do you explain that to the nurse’s aide who’s been taking care of that patient and loves her like her own grandmother? Who then decides that she’s not going to get vaccinated and tells everyone else not to get vaccinated?
In the general population, the way you tease out whether a health event seen after vaccination is caused by it or merely linked to it temporally — it happened around the same time — is by knowing the baseline rates of these kind of events so you can say: This is within the range of the number of strokes we’d expect to see in this population over this amount of time.
Are those rates of events not known for long-term care residents?
I Googled the mortality rate in nursing homes and could find nothing. Now, I had a call with a group of geriatricians and I asked that. A few of them — not all of them — knew that data. I don’t know how common that knowledge is.
What’s your fear? How do you see this playing out?
I fear a loss of confidence in the vaccine. That the vaccine will actually truly be safe, but there will be temporarily associated events and people will be scared to use the vaccine. And we won’t be able to get our kids back in school and people back at work — the things that are important.