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WWhen a Centers for Disease Control and Prevention advisory committee voted on Tuesday to recommend that residents of long-term care facilities be on the front line – along with health care providers – for Covid-19 vaccines, the only dissenting voice came from a researcher who studies vaccines in the elderly.
Helen Keipp Talbot – known by her middle name – raised serious concerns at the Immunization Practices Advisory Committee meeting regarding the use of vaccines in frail elderly people, noting that there are no data suggesting that vaccines work in this population.
All Phase 3 trials of Covid vaccines in the United States must include people 65 years of age and older. But none have specifically tested vaccines in people in long-term care. It cannot be assumed that the results in people over 65 who are healthy enough to be accepted for a clinical trial are indicative of everyone in this demographic, she said.
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At a previous ACIP meeting, Talbot warned that vaccinating this population early in the vaccine rollout was risky, as residents of long-term care facilities have a high rate of medical events that could be confused as side effects of vaccination and undermine confidence in vaccines. . “And I think you’re going to have a very striking reaction of ‘My grandmother got the vaccine and she passed away,’” she said at the time.
STAT spoke to Talbot, associate professor of infectious diseases at Vanderbilt University, about Zoom, asking her why she voted against placing residents of long-term care facilities in “Phase 1a” to gain access. to Covid-19 vaccines, which will likely begin to be deployed in the second half of December.
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The conversation has been edited slightly for clarity and length.
It was a bit unusual to see ACIP – which is an evidence-based decision-making group – making a recommendation on the assumption that vaccines would work in frail elderly people.
I think they based it on data. It was just the data on the number of deaths in that population. The number of deaths in this population is far out of proportion with the number of infected people. And that was the main reason for this vote.
You are studying vaccines in the elderly. Tell me why you think vaccinating long-term care residents first is not the right approach.
I think this is the right approach if we have data.
It’s the kicker. We have routinely, and for almost all of our adult vaccinations until recently, tested them in college-aged children and army recruits and found that they worked and used them in older adults. .
The first example is the flu. In 1960 the Surgeon General said, well, it works in healthy young adults, so it should at least partially work in older adults. Since 1960, it has been “because it can partially work”.
We need to stop assuming these vaccines work and design and test them in this population and use them appropriately.
Are you worried that these doses will be wasted?
I wouldn’t say wasted. But not used as effectively as they could be.
If I know it works in a healthy healthcare worker, I would prefer to have all healthcare workers vaccinated so that when they are near frail elderly people they don’t get sick.
We do not yet have enough vaccines for all healthcare workers. We’ll do it eventually, but we’re not doing it yet.
Do you have any concerns about the safety of vaccine use in residents of long-term care facilities?
More than anyone? No. But I think what we have for the general adult population is a randomized controlled trial to look at the safety data.
What do you mean?
If something happened to me after the vaccine, we could go back to the data from the randomized controlled trials and see if it happened in both groups? Occurred or not in the placebo group. We can’t do that for the long-term care facility because there was no trial in the long-term care facility.
And you can’t extrapolate from the general phase 3 trial?
We can try. But this is not final. Because it’s a different population with different co-morbidities and frailty.
And the chances of something like a stroke or even death occurring within 30, 60 days, or any other day after vaccination is much higher among residents of long-term care facilities …
[Talbot nods vigorously.]
Here is the deal. All the events will be temporarily associated. But how do you explain this to the caregiver who takes care of this patient and loves her like her own grandmother? Who then decides she won’t get the shot and tells everyone not to get the shot?
In the general population, the way you determine whether a health event observed after vaccination is caused by it or simply related to it over time – it happened at about the same time – is to know the base rates of this type of event so you can say: This is in the range of the number of hits we would expect to see in this population during this time.
Are these event rates not known for residents of long-term care facilities?
I wentogle the nursing home death rate and couldn’t find anything. Now I had a call with a group of geriatricians and asked for this. A few of them – not all – knew of this data. I don’t know how common this knowledge is.
What is your fear? How do you see it playing out?
I fear a loss of confidence in the vaccine. That the vaccine will be really safe, but there will be temporary events associated with it and people will be afraid to use the vaccine. And we won’t be able to get our kids back to school and people back to work – the things that are important.
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