Seniors wonder, will a shot protect those who need it most?
Over the past eight months, Claudio Martins’s world has become smaller.
Martins, who is 82 and looks younger, has been careful to follow public health guidelines. He wears a mask, limits the people he sees and restricts his trips to the pharmacy or the bank. The hardest thing is not being able to visit his wife, who lives in a nursing home.
So he reads, listens to music and spends time in the yard of his home in Toronto’s Little Italy. He said he’s long believed that age is just a number and that you have to take care of yourself.
“You have to be patient. You have to accept the situation, you know what I mean?” he says. “But it’s hard. No doubt about that.” There’s no question that seniors have borne the brunt of the coronavirus pandemic. More than 80 per cent of COVID-19 deaths worldwide have been in those older than 65.
Last week, promising test results from Pfizer Inc. ignited new hope for an effective vaccine. And Canada’s National Advisory Committee on Immunization recommended that older adults be at the front of the line when one becomes available.
Yet experts warn that older adults have unique vaccine needs.
As people age, their immune systems get weaker.
Those same experts are calling on the government and potential vaccine manufacturers to make sure that older adults are specifically included in the vaccine development process, lest countries end up with a vaccine that won’t work for those who need it most.
Many companies say they’re rising to the challenge.
Clinical trials, which involve the human testing that all new drugs or vaccines must undergo before being considered for regulatory approval, often rely on younger adult volunteers.
In part, that’s because of the risks that come with participating in a trial. Another reason is that it’s easier for researchers to determine whether their drug works when the people they’re testing it on don’t have other health conditions, as older people tend to do.
A study published in JAMA Internal Medicine in late September looked at the volunteer requirements of 847 COVID-19 clinical trials and found that older adults were “likely” to be excluded from more than half of the trials for things such as treatments and tests, and all of the vaccine trials.
That meant that while seniors weren’t specifically ruled out, the study designs didn’t seem to make any specific attempt to include them, either.
“One thing that we’re often taught to do in medicine, is say, ‘Does my patient look like this?’ ” said Dr. Samir Sinha, the director of geriatrics at Sinai Health and the University Health Network in Toronto.
“So often, I read these trials about a blockbuster cholesterol medication or a blockbuster blood pressure medication, but the oldest person in the trial is in their 70s,” Sinha said.
The average patient age in his practice? Mid-80s.
Once a vaccine clears testing, it will go to Health Canada, whose scientists will decide whether or not to approve it.
Sinha said that if Canada is going to spend upwards of a billion dollars on vaccines, it only makes sense to demand they work for everyone.
The push for a COVID-19 vaccine has been like no other in modern history.
It has the backing of the world — and that’s making a difference in how the research is approached.
One of the companies with which Canada has an advance purchase deal highlights the efforts it’s making to develop a vaccine for “communities that have historically been underrepresented in clinical research.”
Medicago, which is currently developing the only made-inCanada vaccine, is starting its second phase of testing here in this country this week, and says half of its volunteers will be older than 65.
Pfizer’s results released last Monday are still “blinded,” meaning researchers haven’t yet looked at who among its subjects contracted COVID-19, so as not to influence their decisions while the test is ongoing. However, a spokesperson said 41 per cent of their testing to date has been on people aged 56 to 85, a number that rises to 45 per cent when you look at only U.S. testing.
Elsewhere, Massachusettsbased Moderna, which has agreed to supply Canada with 56 million doses of its potential COVID-19 vaccine, is expected to report testing results in the coming weeks.
In late September, it published a study in the New England Journal of Medicine that examined the results of a Phase 1 trial in 40 older adults. The study looked at two dosage levels in two groups of adults, one of which was age 54-70, and another that consisted of people 71 and older.
Both doses triggered an immune response.
It’s an early trial and a small number of people. Still, the results suggested that Moderna’s candidate “can generate neutralizing antibodies in older and elderly adults at levels comparable to those in younger adults,” the company’s chief medical officer, Dr. Tal Zaks, said in a statement at the time.
The company said its third, or final stage of human testing, is being done in the U.S. and was designed with help from the FDA to make sure it included Americans at the highest risk of severe COVID-19.
That study of 30,000 volunteers — which is ongoing — includes 7,000 people over the age of 65 and 5,000 people who are under 65 but who have high-risk chronic diseases, such as diabetes and cardiac disease.
Then, there’s AstraZeneca, the British-Swedish multinational currently working on a vaccine candidate with the University of Oxford.
Its principal investigator has said the company’s Phase 2 results showed a similar immune response in both younger and older adults.
AstraZeneca is testing on adults of a range of ages in multiple countries, but a quarter of the participants in their final stage trial in the U.S. are over the age of 65, a spokesperson said.
That trial is also ongoing, and Canada has a contract for 20 million doses.
Normal vaccine trials are subject to economic constraints. This means they start relatively small with young, healthy adults, and only later, if successful, begin testing on older people or those with other conditions, explains Dr. Wilbur Chen, chief of the adult clinical section at the Centre for Vaccine Development at the University of Maryland School of Medicine.
But think of the COVID-19 trials like accordions, he said. Instead of going step by step, manufacturers have the funding to do a bunch of things at the same time, often running multiple stages simultaneously on volunteers from a much broader spectrum than they would normally start with.
“We can’t just wait for perfect results in perfect studies because it would take that much longer,” he said.
“But what is good about the studies that we’re doing is that we’re trying, as best possible, to have all parts of the population involved, which means that we’re having racial and ethnic diversity built in, we’re having age diversity built in, we are trying to do it all throughout different geographic locations as well.”
He’s optimistic about early studies such as Moderna’s, which suggest its vaccine can still generate antibodies in older people, but says the real test will be the final data from the last phase of human testing.
Shannon MacDonald is an assistant professor of nursing at the University of Alberta who is leading a national survey of people, such as seniors, who are first on Canada’s vaccine prioritization list.
MacDonald, who has a doctorate in addition to being a registered nurse, said that as part of the survey, her team plans to ask seniors how they would feel about a theoretical vaccine that hasn’t been tested on their age group.
She stressed it’s going to be important that when a vaccine is rolled out, the government is very transparent about what research has been done.
There is precedent for this, she says. When the H1N1 first vaccine came out, it hadn’t been trialled on pregnant women, so a lot of women were given clear information about the data and the ability to decide for themselves.
He’s looking forward to a vaccine, but Martins seconds the argument that he wants to see how the first round of doses go before he gets in line himself.
Until then, he worries more about people continuing to follow the public health rules, and wonders how a diverse city such as Toronto will handle making sure everyone continues to get updates on the pandemic and the progress of a vaccine.
He hopes seniors such as himself are still able to get out, get some exercise and do what they can. “You’re going to die when it’s your turn to die, but even if you’re older you can still take care of yourself,” he says.
Meanwhile, Sinha, from Sinai Health, said he’s encouraged by the work being done by some trials to include older adults, but is also looking forward to seeing the data.
He said we have a duty to protect those who have paid the biggest price for COVID-19.
“These are people who built our country. These are the people who raised us; these are our aunts and uncles; these are our parents.”