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.
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First…has this age group been omitted from testing and if so, why?
Second…not every person in long term Healthcare facilities is frail or even elderly.
Third…decisions on offering/administering the vaccine can be made on an individual basis.
Fourth…why didn’t the others on the committee have the level of concern as this writer?
Fifth…the argument that if the staff of the facilities has been vaccinated, then the residents would be protected isn’t valid. Why? Because family members won’t have been vaccinated…certainly not for many months into 2021 since supplies are limited and vaccine won’t be offered to the general population, probably until next summer. That means the residents will be exposed or the current isolation policies will be continued.
Too many unanswered questions.
Please consider the facts as presented by Fauci
Fauci: Early COVID-19 vaccines will only prevent symptoms, not block the virus http://finance.yahoo.com/news/fauci-vaccines-will-only-prevent-symptoms-not-block-the-virus-195051568.html?soc_src=community&soc_trk=ma
If you are genuinely interested in the welfare of people, how can you support a vaccine which only suppresses symptoms being given to health care workers?
If they are vaccinated & become infected, they will only be symptom-free & will unknowingly pass the virus to people in care.
What level of intelligence & due care is being applied here?
Please publicize these facts urgently 🙏
I’m 76years old, healthy and live at home. I believe after the first responders the vaccine should
be given to the working parents.. Get our country back to work..I’m sure all grandparents want to see their kids and grandchildren able to work. I also think those in nursing homes will have more side affects and ruin the confidence of 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.” So, the frail elderly just aren’t that important, eh? The truth is, we are testing this on everyone, because we still don’t fully understand the mutational rate and how any specific mutation responds to the antibodies. But let’s say goodbye to Grandma, because she’s already a statistic anyway.
So my mother that is in long term care in a nursing home will never see the outside world again. But, she gets the flu shot every year without any complications. Thank you for your insensitivity!!!!!
Bernd Ludwig, Blessings to you and your Mom. You are correct , if the elderly in the nursing homes do not get vaccinated they will never be able to safely have visitors in and out of these homes. It’s bad enough that many of us have had to place family members into these homes because they require 24/7 care that most of us cannot provide. Now with all the guilt of placing them into a facility, we can’t even be supportive by visiting them. Even without them catching Covid they still die alone because we can’t visit them in any medical facilities due to the pandemic. This is very sad times… I say give these elderly people the vaccine where their loved ones can at least come in there and give them one last hug and kiss. My father-in-law is close to death in a facility right now and we can’t even go in to hug him and tell him goodbye. If everyone there was vaccinated we could, we’ve never let one of our pets die alone, but we have to let my husbands father die alone. I don’t know about my husband, but I think I will be mentally screwed after this. I’m not sure I ‘ll ever be able to accept the fact of him dying alone.
Although I am past 90 years, and as the saying goes “one foot in the grave and the other on a banana peal,” I believe the caregivers should be vaccinated first. As already stated, the reason being to prevent carrying the virus to the elderly.
I agree with this take. Those in long term care facilities are not out and about getting exposed to the virus. The workers in those facilities, when vaccinated, would create a much safer enviroment. The patients though, it may be a waste on them. And as this article wrote, is incidents occur with this population from the vaccine it could get negative press. I would much rather see teachers get this than people in retirement homes. Teachers are exposed daily unlike many other professions and can transmit the virus among a dozen + families if they get the virus and transmit before symptoms present.
I don’t think the vaccine would be a waste for anyone. The largest subset of deaths occurs in nursing home residents.
Are there very many examples of a vaccine tested the way these have been tested not working well or being harmful in this population?
After health care workers, it seems to me, who to vaccinate is crystal clear if you look at age demographics for deaths from the virus >80 years old ~20%+ (rough) mortality rate, 70-79 ~12%, 60-69 ~7% and so on; under 30 it is almost nil. Please don’t tell me they are going to vaccinate an “essential worker” that is under forty, before they vaccinate my 75 year old parents, are they?
Why do you put essential worker in scare quotes? I would like my 36 yo daughter who is a health care worker with an infant to get vaccinated ASAP. She is exposed to Covid daily, working in a hospital. Do you not consider that “essential”?
Seasonal flu vaccines generally are less effective in older populations. For this reason, the elderly getting flu vaccine generally get a higher dose. This does NOT mean a COVID vaccine will not work well in this population, but it is suggestive; perhaps in time older populations will get a higher dose of this vaccine as well.
I work with this population and Ms Talbot is correct in her thinking. Another consideration-unfortunately by the time we really get enough doses the virus will have gone through a significant portion of this population as well. And any backlash will also result in family refusing the vaccine for their family member in LTC. Independent living, assisted living is different as those folks usually aren’t as frail as the long term care resident.
And the health care worker getting vaccinated so as to NOT bring it in is maybe the priority here.
I’d be interested in learning more about why these arguments weren’t persuasive for all the other panel members. Were there valid counter-arguments? Was the case never really made?
Good points and I’d be interested in those answers too. Unfortunately in today’s hyper political science forum ANY dissenting opinion or different interpretation of data is considered to be “evil” ; witness the absolute trying to silence, fire etc Dr Atlas-yeah he absolutely said stuff that was inflammatory and in a way designed to be inflammatory-but instead of PROFESSIONALS calmly expressing disagreement and providing counterpoints with DATA to back it up everyone just started screaming for his head on a pike. And that has been true for ANY dissenting idea/thought etc.