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 it 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 temporally 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 temporally 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.
About the Author Reprints
The bottom line is that Dr Talbot’s only committed concern is her fear of a chimera not yet -or sure to materialize – the possibility that Joe Dokes might think the vaccine is bad because his grandmother died some time after vaccination. The rest of her reasoning is a whack-a-mole bouncy ballgame of why she agrees with the outcome, had no definitive reason to vote against it, but simply felt like it. This equivocation and whimsy and should fill none of us who all depend on sober deliberation with an unbridled sense of confidence in her decision making skills. One would hope someone of more fully formed judgement, a Dr Janet Knabl, UNTHS perhaps, would have greater depth, more fact based decision making skills and a greater experiential maturity to offer the ACIP in future.
But, of course, it is Dr Talbot’s own legacy she has cast. Fortunately, it need concern none but her…this time.
How do we even know that the vaccine will work in the long term care population? It hasn’t been tested in them. They may be too old and sick to mount an immune response to the vaccine. It is their weak immune systems which make Covid-19 so fatal in them. I don’t want to sound cruel, but it seems the science isn’t there yet for the nursing home population. Better to vaccinate health care workers, first responders, military, and essential workers like grocery clerks and teachers. Getting teachers vaccinated early will help get schools back open which is essential for children and their parents. We can protect the long term care patients by masking, social distancing, hand washing, and good ventilation. We know that works. It’s not easy.
On the other hand, given the absolutely sky high COVID mortality rate in nursing homes, it seems pretty cruel not to at least offer the vaccine to residents. Explain that it might help, and also might cause side effects. These people (or their families in the case of diminished mental capacity) are adults. Stop condescending. Let them make their own informed decisions. Another major issue in nursing homes is the loneliness and isolation these people are experiencing. Many are unable to see their families. That, in itself, can prove fatal. The idea of waiting another 6 months or a year while trials can be carried out seems wrong, and would be making their life or death decision for them.
Is it really up for debate that healthcare workers should be the first immunized? How is this not the obvious choice? They should also have their student debt erased. They are on the battleground of this war between reason and madness as they fight to protect people that curse at them as they are being intubated because they do not believe they have covid. We are rapidly becoming a third world country run by an authoritarian theocratic state. If Trump manages to pull off his joke of a coup it will be the end of America as we know it.
Once you forgive that student debt will I no longer be billed 80K for a 4 hour surgery or have to pay 2 to 3 hundred dollars for five minutes of time with my doctor?
I very much agree with Helen Talbot ‘s vote and reason for it. All health care providers should be immunized first. As a retired nurse and one who has worked in a nursing home, I worry about resident fragility and ability to tolerate Covid vaccine side effects. Until the vaccine is studied for nursing home residents, please refrain from them being top of the list for receiving it.
With the annual flu vaccine a more potent dose is given for those over 65. I wonder if this will be necessary with the COVID vaccine.
It would be difficult to get testing done on seniors in care facilities ,most of which are legally bound to provide a safe haven for their clients.
Many elders are in such places because they no longer can make choices about simple daily tasks. They certainly could not make an
Educated choice about the Covid vaccine. Even with a legal Health POA, this raises legal and moral
Issues.
Please notify me of any other comments. I’m over 80, reasonably healthy (except for peripheral neuropathy) and hope to be here long enough to have to decide whether to get the vaccine (which I lean to doing ASAP now).
Peripheral neuropathy is no small thing. There is one type, Guillain Barre syndrome, that is associated with the annual influenza vaccine and most likely will be associated with the Covid-19 vaccine. I have PN also (caused by Metronidazle/flagyl prescription.) Mine has also led to vascular problems that lead me to be very careful about considering either vaccine. See this:
https://www.thedailybeast.com/feds-very-concerned-about-astrazeneca-covid-19-vaccine-side-effect
Kudos to Dr. Talbot for staying true to her convictions on this issue. She raises important questions about widely exposing what would be considered a “vulnerable population” that would be handled with extreme caution in clinical trials. Until the detailed data are reviewed, we will not know whether there is enough evidence to support ACIP’s recommendation.
Very interesting. Do we know how many over-80s, 90s + with/without dementia, if any, were in testing cohorts?