Vaccines that protect against COVID-19 are on the way. What should older adults expect?
The first candidates from Pfizer and Moderna could arrive before Christmas, according to Alex Azar, director of the Department of Health and Human Services.
Both vaccines are particularly effective at preventing diseases caused by the coronavirus, according to the companies, although much of the data from clinical trials is still pending. Both were tested on adults aged 65 and over who showed a strong immune response.
Seniors in nursing homes and assisted living centers will be among the first Americans to be vaccinated after being recommended by a federal advisory council last week. Older adults who live at home will have to wait a while longer.
Many uncertainties remain. Including: What side effects can older adults expect and how often will they occur? Do the vaccines provide useful protection for seniors who are frail or who have multiple chronic diseases?
Here’s a look at what’s known, what’s not, and what’s ahead of us.
Decision making schedule. Pfizer’s vaccine will be assessed Thursday by a 15-member advisory panel to the Food and Drug Administration. Moderna’s vaccine is expected to be available before the December 17th panel.
An analysis by FDA staff is published at least two days before each meeting. This is the first opportunity to gain extensive data on the performance of the vaccines in large Phase 3 clinical trials, including more details on their effects on older adults.
To date, summary results in press releases show that Pfizer’s vaccine, made in partnership with BioNTech, has an overall efficacy rate of 95% and an efficacy of 94% in people aged 65 and over. According to Moncef Slaoui, scientific advisor to Operation Warp Speed, the government’s COVID-19 vaccine development program, the overall effectiveness of Moderna is 94%, with 87% effective in preventing moderate illnesses in older adults.
If the advisory panel gives the green light, the FDA will decide within days or weeks whether to approve the Pfizer and Moderna vaccines for emergency use. The spread of the vaccine has already begun, and healthcare providers are expected to administer it immediately following the FDA’s actions.
Allocation framework. At a December 1 meeting of the Advisory Commission on Immunization Practices (ACIP), which heads the Centers for Vaccine Control and Prevention, experts recommended people living in long-term care (mostly nursing homes and assisted living facilities) and health care workers are the first groups to receive COVID-19 vaccines.
This recognizes the extraordinary burden of COVID-19 in long-term care facilities. Although its residents make up less than 1% of the US population, they are responsible for 40% of COVID deaths – more than 100,000 deaths to date.
The Commission’s decision comes despite the lack of evidence that Pfizer and Moderna’s vaccines are effective and safe for long-term care for frail, vulnerable seniors. Vaccines have not been tested in this population. Federal officials insist that side effects be carefully monitored.
Following the Commission’s deliberations on November 23, which did not result in a formal vote, it is likely that it will be the turn of important workers who cannot work from home, such as the police, fire brigade, teachers and people involved in food processing are employed in the transport sector.
Then there would be adults with high-risk conditions like diabetes, cancer, kidney disease, obesity, heart disease, and autoimmune diseases, as well as all adults aged 65 and over.
For example, although states typically follow ACIP guidelines, some states choose to vaccinate high-risk older adults in front of certain categories of essential workers.
Removed from the list are family carers who provide essential support to vulnerable older adults in the community – an unpaid workforce of tens of millions of people. “If someone offers daily care, it makes sense that they also have access to the vaccine to keep everyone safe,” said Beth Kallmyer, vice president of care and support for the Alzheimer’s Association.
Further prioritization. The priority groups make up nearly half of the US population – 21 million healthcare workers, 3 million long-term care residents, 66 million key workers, more than 100 million adults with high-risk conditions, and 53 million adults 65 and over.
Since the initial supply of vaccines is limited, it will be inevitable to prioritize. In practice, this means that hospitals and doctors may try to identify older adults at highest risk of developing COVID-19 and offer them vaccines before other seniors.
A study of more than 500,000 Medicare beneficiaries aged 65 and over provides new evidence that could influence these assessments. The conditions that increase the chances of older adults dying from COVID-19 have been found to be the most likely to be sickle cell disease, chronic kidney disease, leukemia and lymphoma, heart failure, diabetes, cerebral palsy, obesity, lung cancer, and heart attacks in that order.
“Of all Medicare beneficiaries, we identified just under 2,500 who had no medical problems and who died of COVID-19,” said Dr. Martin Makary, study co-author and professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “We knew that the risk was skewed towards comorbidity [multiple underlying medical conditions], but we didn’t realize it was going so badly wrong. “
Supplies available. Both the Pfizer and Moderna vaccines require two doses three to four weeks apart. The companies have announced that around 40 million doses of their vaccines should be available this year, enough to fully vaccinate around 20 million people.
After that, 50 million doses could be available in January, followed by 60 million doses in February and March, said Dr. Larry Corey, a virologist who heads the COVID-19 Prevention Trials Network.
That means enough vaccine for another 85 million people and should be enough to vaccinate older adults in addition to frontline medical workers and many other people at risk, Corey recently suggested on a panel on COVID-19 sponsored by the National Academy of Medicine and American Public Health Association.
He admitted that these were estimates based on information he had received. Pfizer and Moderna have not yet established how much vaccine will be delivered and when. It is also not clear when other vaccines under study will be available – 13 are in Phase 3 clinical trials – or what their monthly production capacity might be.
Distribution problems. With Pfizer and Moderna vaccines in place, they can be difficult to get for a very vulnerable group: 2 million seniors living in their home country and another 5.3 million with physical impairments who have trouble getting around.
The reason: requirements for handling and cold storage.
Pfizer’s vaccine needs to be stored at minus 70 degrees Celsius, which requires special equipment that is not available in small hospitals, clinics or doctor’s offices. Moderna’s vaccine has to be stored long-term at minus 20 degrees Celsius.
Landmark Health provides home health care to more than 120,000 frail, chronically ill seniors in 15 states. “We are unable to store these vaccines and distribute them to our population,” said Dr. Michael Le, the company’s co-founder and chief medical officer.
Instead, Landmark is working to arrange transportation of its patients to centers that administer COVID-19 vaccines and educate them about the vaccines’ benefits. “Given the trust and connection we have with our patients, we can play a huge role as lawyers,” said Le.
Addressing suspicion. Lawyers have a great job ahead of them. According to a recent survey by the University of Michigan, only 58% of older adults (50 to 80 years old) said they were very or more likely to receive a COVID-19 vaccine. A significant number of older adults, 46%, believed they would get the vaccine at some point but wanted others to go first. Only 20% wanted to get it as soon as possible.
Knowing how well the vaccine is working is important, according to 80% of 1,556 older adults surveyed. A little more than half (52%) said that a recommendation from their doctor would have an impact.
Dr. Sharon Inouye, a geriatrician at Hebrew Senior Life in Boston and a professor of medicine at Harvard Medical School, is one of the doctors eagerly awaiting the release of data from Pfizer and Moderna’s Phase 3 clinical trials.
Among other things, she would like to know: How many older adults with chronic diseases took part? How many participants were 75 years of age and older? Are the side effects different in older adults?
“What worries me the most are the side effects,” she said. “We may not know about serious, but rare, side effects until millions of people take them.”
But this is a gamble she is ready to take. Not only will Inouye be given a vaccine, she has also told her 91-year-old mother, who lives in assisted living, to say “yes” if one is offered.
“My whole family lives in fear that something will happen to them every day,” Inouye said. “While we still don’t know much about these vaccines, it is imperative that we protect people from this overwhelming disease.”
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