WASHINGTON (AP) — U.S. regulators say transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to surge.
The late-night announcement Thursday by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations.
It’s harder for vaccines to rev up an immune system suppressed by certain medications and diseases, so those patients don’t always get the same protection as otherwise healthy people — and small studies suggest for at least some, an extra dose may be the solution.
“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a statement.
The FDA determined that transplant recipients and others with a similar level of compromised immunity can receive a third dose of the vaccines from Pfizer and Moderna at least 28 days after getting their second shot. The FDA made no mention of immune-compromised patients who received the single-dose Johnson & Johnson vaccine.
The announcement comes as the extra-contagious delta version of the coronavirus surges through much of the country, pushing new cases, hospitalizations and deaths to heights not seen since last winter.
Importantly, the FDA’s decision only applies to this high-risk group, estimated to be no more than 3% of U.S. adults. It’s not an opening for booster doses for the general population.
Instead, health authorities consider the extra dose part of the initial prescription for the immune-compromised. For example, France since April has encouraged that such patients get a third dose four weeks after their regular second shot. Israel and Germany also recently began recommending a third dose of two-dose vaccines.
Separately, U.S. health officials are continuing to closely monitor if and when average people’s immunity wanes enough to require boosters for everyone — but for now, the vaccines continue to offer robust protection for the general population.
The Centers for Disease Control and Prevention is expected to formally recommend the extra shots for certain immune-compromised groups after a meeting Friday of its outside advisers.
Transplant recipients and others with suppressed immune systems know they’re at more risk than the average American and some have been seeking out extra doses on their own, even if it means lying about their vaccination status. The change means now the high-risk groups can more easily get another shot — but experts caution it’s not yet clear exactly who should.
“This is all going to be very personalized,” cautioned Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who is running a major National Institutes of Health study of extra shots for organ recipients. For some people, a third dose “increases their immune response. Yet for some people it does not seem to. We don’t quite know who’s who yet.”
One recent study of more than 650 transplant recipients found just over half harbored virus-fighting antibodies after two doses of the Pfizer or Moderna vaccines — although generally less than in otherwise healthy vaccinated people. Another study of people with rheumatoid arthritis and similar autoimmune diseases found only those who use particular medications have very poor vaccine responses.
There’s little data on how well a third dose works, and if it causes any safety problems such as an increased risk of organ rejection. Wednesday, Canadian researchers reported that transplant recipients were more likely to have high levels of antibodies if they got a third dose than those given a dummy shot for comparison. Other small studies have similarly found that some transplant recipients respond to a third dose while others still lack enough protection.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Canada Facing Difficult Battle with Mental Health Struggles
Mental health is an important health issue that affects us all, and unfortunately, it’s an issue that is rarely discussed openly. According to the World Health Organization, approximately 20% of Canadians will experience a mental illness.
This makes mental health one of the most pressing issues facing Canadians today. Let’s take a closer look at why mental health is such an important issue in Canada.
The Need for Better Mental Health Care
In Canada, access to quality mental health care can be costly and difficult to obtain. Many Canadians are unaware of what services are available or how to access them due to a lack of public education about mental health.
Additionally, there is still a stigma attached to seeking help for mental illness, which can make it difficult for those who need help to get it. As a result, many people cannot access the care they need in order to live happy and healthy lives.
This deficiency can have severe consequences; untreated mental illness can lead to increased risk for suicidal behavior, substance abuse, homelessness, unemployment, and other serious problems.
Additionally, research shows that early diagnosis and treatment can help prevent long-term complications and reduce the overall costs associated with mental health treatment.
Mental health services are especially important for marginalized populations such as Black Canadians, Latinx individuals, LGBTQ+ individuals, immigrants, and individuals with low incomes who have been underserved when it comes to healthcare access.
These communities often experience higher rates of poverty and discrimination which results in an even greater need for quality mental health services but also fewer resources available to them.
Given these facts, it is clear that there is a great urgency for better access to mental health services. To make meaningful progress towards addressing this issue we must first focus on breaking down barriers such as stigma against seeking help as well as lack of information about available services among vulnerable populations.
Furthermore, a greater investment must be made into training more providers so there are enough qualified professionals available who understand how to provide culturally competent care.
Particularly when working with traditionally underserved communities – while also ensuring accessibility through reduced cost or free options for those with limited insurance coverage or financial resources.
Mental Illness as an Invisible Disease
Unlike physical illnesses, mental illnesses are often invisible and difficult to diagnose. This makes it difficult for those living with a mental illness to get the help they need as well as understand what they are going through.
It also means that many people do not realize the severity of mental illnesses and the impact they have on the lives of those living with them until they experience it firsthand or hear stories from someone who has gone through similar struggles.
Mental illness affects more people than most realize. It can be difficult to comprehend the depth of mental health disorders, as they are often invisible and misunderstood. Mental illness is a disease, yet it can remain hidden while still having a profound effect on a person’s life.
The Impact on Society
Mental illness has far-reaching effects on society as a whole. Untreated mental illness can lead to substance abuse, homelessness, unemployment, and even suicide in some cases.
All of these have ripple effects throughout our communities, from increased crime rates and lower productivity at work to higher healthcare costs and fewer resources available for those in need, making this an issue that affects us all regardless of our personal situations.
We need to create a friendly environment in which those with invisible diseases feel comfortable sharing their stories and seeking help without fear of judgment or rejection.
Mental illness should not be ignored; rather it should be treated with respect and understanding just like any other type of medical condition.
By recognizing the reality of invisible diseases such as depression, anxiety, PTSD, bipolar disorder, and more we can begin to create a world where everyone gets the help they need regardless of whether or not their condition is visible on the surface.
With understanding comes empathy, and empathy leads us toward meaningful change for ourselves and our communities alike.
Five things to know about health-care talks Tuesday between Trudeau, premiers
OTTAWA — On Tuesday in Ottawa, Canada’s 13 premiers and Prime Minister Justin Trudeau will sit around the same table in person for the first time since COVID-19 hoping to find a path toward a new long-term health-care funding deal.
Both sides are optimistic a deal will emerge but there are some big divides to overcome, including how much more money Ottawa is willing to put on the table, and how much accountability the provinces are willing to put up in return.
The premiers have been asking for a new deal for more than two years. Trudeau kept punting until the COVID-19 crisis was largely over.
That time has come.
Trudeau has been clear a deal is not going to be finished this week. But here’s a snapshot of how we got to this point, and what they’re going to be talking about.
Money, Money, Money, Money
This year Canada expected to transfer almost $88 billion to the provinces and territories for health, education, social supports and equalization. The Canada Health Transfer, or CHT, is $45.2 billion, or 51 per cent of that.
In their 2022-23 budgets, the provinces collectively forecast to spend $203.7 billion on health care. Ottawa’s transfer accounts for 22 per cent of that. The provinces want that increased to 35 per cent, which would mean $26 billion more this year alone.
“There’s been continual demands for an increase in the CHT although I’ve never seen quite as large a demand for an increase as this one,” said Gregory Marchildon, a professor emeritus at the Institute of Health Policy, Management and Evaluation at the University of Toronto.
Trudeau intends to put an offer on the table Tuesday. It will not be an immediate increase of $26 billion, but Ottawa has been silent on where it will land.
While it has existed in its current form only since 2004, some sort of federal health transfer dates from 1957, when Ottawa offered 50-50 funding for health care to provinces that agreed to provide public hospital services based on national standards.
It has evolved and changed at least five times since then, including splitting the federal share between cash and a transfer of tax points — when the federal government cut its income tax rates and the provinces could raise their own in exchange.
In 1995, then-finance minister Paul Martin, desperate to turn around Canada’s debt problems, slashed the health and social transfer by 20 per cent, followed by a 15 per cent cut in 1996. Some provinces have said their health systems have never recovered.
In 2004, a new deal was reached between the premiers and Martin, who by then was prime minister, to see the Canada Health Transfer increased six per cent a year for a decade.
The Conservatives under prime minister Stephen Harper kept that in place, but told the provinces that in 2017-18, the CHT increase would be based on a three-year average of economic growth, but with a minimum increase of at least three per cent.
Trudeau and the Liberals have maintained that.
With economic growth, the annual CHT increase has averaged five per cent since 2017-18.
Over the last 10 years, the CHT has increased 67 per cent, to $45 billion from about $27 billion in 2012-13.
An attempt in 2016 to negotiate a new CHT deal mostly failed, resulting in one-on-one agreements between Ottawa and the provinces and territories to share $11.5 billion over 10 years, beginning in 2017-18, to improve mental-health and home care.
Angling for Accountability
In the split jurisdictional world Canada’s governments live in, provinces are the ones who control health-care delivery. So for the most part, the federal government helps fund it and the provinces get to say how it’s spent.
The Canada Health Act, passed in 1984, sets out the guiding principles for recipients of the Canada Health Transfer, including that health-care systems must be universally accessible. Failing to abide by the principles can, and has, resulted in Ottawa clawing back some transfers.
Trudeau has made clear any increase to federal health transfers must be met with provincial accountability to show results. The federal government has been frustrated at the lack of accountability from provinces over transfers for health care made during COVID-19.
It is adamant that will not be the case with a new funding deal, and is looking at a combination of an annual increase to the CHT and separate deals to target specific problem areas, like health-care worker retention and training, access to family doctors, surgical backlogs, and data collection and sharing.
The 2017 deals on mental-health and home care will be a bit of a model. Those deals saw Ottawa promise $11.5 billion over 10 years for the two areas, but in exchange provinces had to agree to a common set of principles and goals, and to report results.
The Canadian Institute for Health Information was tapped to help collect and publish data. The most recent report in December is still laden with gaps and incomplete data. The reports note it will take time for the reporting to lead to change, and that provinces need to harmonize their data collection in order to better compare statistics across provincial lines.
Marchildon said one of the biggest problems for the federal government in demanding accountability is that measuring health outcomes is difficult, and hard targets are rare.
It’s all about the numbers
Of course, it’s difficult to measure progress if you’re not keeping track.
Data — or the lack of it — is a long-standing weakness of Canada’s federalized system, with 13 separate health-care systems working alongside one another but not necessarily in tandem.
In his first public overture to open negotiations with provinces on health funding in November, Health Minister Jean-Yves Duclos told provincial health ministers the federal government would increase the Canada Health Transfer if provinces agree to work together on a “world-class health data system for Canada.”
“It is the foundation for understanding what we’re doing, who’s receiving services, whether we’re making improvements,” said Kim McGrail, a professor with the University of British Columbia School of Population and Public Health.
McGrail was one of several experts the federal government tasked with reporting on what a “world-class health data system” would look like in Canada.
Gaps in Canada’s data tripped up the national health responses in dozens of different ways during the pandemic, from tracking the number of COVID-19 cases to reporting adverse effects from vaccines.
The same is true of tracking surgical backlogs and other information about how well, or not, the health system is working.
“Data informs every part of the way we think about health,” McGrail said, which includes the health of individual patients.
Canadians who move from one province to another can’t easily access their records because the technology isn’t compatible.
It’s a problem that exists even within provinces, as incompatible technology makes records inaccessible between hospitals and clinics.
“We need those technology systems to be able to talk to one another, to be able to to move data back and forth or to send messages back and forth in some way,” she said.
It’s an expensive problem to fix. Just last week, Nova Scotia government signed a $365-million contract to bring new electronic health-care records to the province, which may or may not be compatible with other provincial systems.
McGrail said investments will pay off if important information about the health of Canadians stops falling through the cracks.
The expert panel delivered a report last year that will likely serve as a road map for improving data sharing in Canada. It includes 31 recommendations, starting with provinces, territories and the federal government agreeing on a shared national vision for health data.
Ontario and Quebec have indicated a willingness to work with Ottawa on data, though other provinces have been less firm about it.
Provincial leaders have been able to agree with Ottawa on the need to reform Canada’s long-term care homes, though exactly how to accomplish that is still up for debate.
Duclos has said helping Canadians “age with dignity” is one of Ottawa’s priorities for a new health-care deal, and long-term care plays a major role in that.
So does home care, and the 2017 bilateral deals already began to advance improvements on that front.
Long-term care is an entirely different story.
The pandemic cast a glaring light on the dismal conditions in care homes across the country, when COVID-19 outbreaks led to thousands of deaths and inhumane living conditions for seniors. The military and the Red Cross were summoned to help.
In the early months of the pandemic, Canada had the worst record for COVID-19-related deaths in long-term care of the world’s wealthy countries.
Meanwhile, residents were isolated from the outside world and workers struggled to provide basic care and ensure dignity.
Experts and advocates say the problems long predate the pandemic, and have gone largely ignored until now.
“Given the devastation that we’ve seen in the COVID-19 pandemic and the impacts on our health-care system … we’re seeing this unprecedented moment where finally there’s some hope of collaboration,” said Dr. Amit Arya, a palliative care physician and founder of Doctors for Justice in Long-Term Care, which advocates for an overhaul of Ontario’s long-term care system.
Governments are now scrambling to improve the conditions, as the number of people who need specialized care grows every year and the number of workers willing to provide that care dwindles.
Several provinces have already announced plans to increase the number of hours of care residents receive per day and build new spaces for the growing number of seniors who are living longer with more serious cognitive and physical impairments.
The federal government created a $1 billion “safe long-term care fund” during the pandemic to help pay for immediate infection prevention and control measures to stop the spread of the virus.
The government also set aside $3 billion to help provinces bring homes in line with national standards for the design and operation of long-term care, though specific agreements with provinces haven’t yet been signed to deliver that money.
Those standards were publicly released last week but are unlikely to factor into the health-care talks.
Still, there is plenty of work that needs to be done if provinces have a hope of meeting the standards, especially when it comes to the workforce.
“I think we’re stepping into a crisis,” said Dr. Joseph Wong, the founder of Yee Hong Centre for Geriatric Care, the largest non-profit nursing home in the country.
He said Canada will need upwards of 100,000 new personal support workers to provide care over the next 10 to 15 years in order to provide adequate care to residents.
“It is a time bomb,” he said.
The same could be said of the health system at large.
None of the lofty goals of the federal or provincial politicians will be possible if they don’t find a way to persuade workers to stay in hospitals, clinics and long-term care centres across Canada, said Linda Silas, president of the Canadian Federation of Nurses Unions.
“They don’t have the staff to do the job,” she said.
Staff shortages have been the common theme among some of the most serious issues underlying the public-health crisis in Canada.
Dozens of emergency rooms have been forced to close temporarily or reduce hours because there weren’t enough staff to treat urgent injuries and illnesses. The Canadian Medical Association estimates nearly five million Canadians don’t have a family doctor. And hundreds of thousands of Canadians are sitting on wait-lists for backlogged surgeries and diagnostic tests.
Health unions and professional associations want a national strategy to keep doctors, nurses and personal support workers in their jobs as well as train new staff to bolster their ranks.
Silas said after years of burnout and moral distress over not being able to care for their patients properly, nurses in particular have said, “I’ve had enough.”
Nurses in Ontario have also balked at a law limiting pay increases to one per cent a year.
Data from the Canadian Institute for Health Information shows that because of new graduates, the supply of nurses is still growing. However, many have chosen not to take full-time positions, and existing staff are increasingly eyeing early retirement, Silas said.
The heavier demands of the job since the pandemic, combined with fewer and fewer people to do the work, has created what even the federal health minister calls a crisis.
“We need to stop the bleed,” Silas said.
This report by The Canadian Press was first published Feb. 5, 2023.
Mia Rabson and Laura Osman, The Canadian Press
Governments seek buyer as Quebec COVID-19 vaccine manufacturer Medicago set to close
Quebec Economy Minister Pierre Fitzgibbon said Friday the province has had preliminary talks with potential buyers in the pharmaceutical sector to keep Medicago’s expertise and skilled workforce in Quebec. He said both the Quebec and federal governments would be willing to put in money to secure a deal.
“We can’t operate it ourselves; the government will not be the main shareholder,” Fitzgibbon said. “But if there is a pharmaceutical company that considers it’s worth continuing, we’re ready to help.”
Mitsubishi Chemical said Thursday it would stop marketing the Medicago-produced Covifenz vaccine, which is plant-based and was approved by Health Canada one year ago for adults aged 18 to 64.
The Japanese chemical company said it had been preparing to commercially produce the Covifenz vaccine but decided against doing so because of the “significant changes” in the COVID-19 vaccine environment. The company said it would dissolve Medicago because it is no longer “viable” to continue marketing its products.
“In light of significant changes to the COVID-19 vaccine landscape since the approval of Covifenz, and after a comprehensive review of the current global demand and market environment for COVID-19 vaccines and Medicago’s challenges in transitioning to commercial-scale production, the (company) has determined that it will not pursue the commercialization of Covifenz,” Mitsubishi Chemical said in a statement.
Following the announcement, Medicago issued a statement thanking its employees. “The Medicago team has pushed scientific boundaries and we know that they will continue to make incredible contributions to innovation and biopharmaceutical’s sector.”
Canada invested $173 million in Medicago in 2020 to support development of the Covifenz vaccine and help Medicago expand its production facility in Quebec City.
On Thursday, Innovation, Science and Industry Minister François-Philippe Champagne told reporters the federal government is in “solution mode.”
“Our first order of business is really to try to find a partner who can help us preserve the jobs, preserve the technology and the intellectual property,” Champagne said.
The minister acknowledged that mRNA vaccine technology for COVID-19 became dominant as it “seemed to be most effective.”
But Medicago’s plant-based vaccine was still “promising,” Champagne said.
“Everyone agreed that the plant-based vaccine could very well help in a future pandemic,” Champagne said.
Speaking to reporters on Montreal’s South Shore Friday, Fitzgibbon said the company informed the province at the end of December it intended to pull the plug on Medicago.
In May 2015, Quebec and Ottawa announced loans of $60 million and $8 million, respectively, for the construction of a complex in the Quebec City region to house Medicago’s activities.
“The challenge is not (getting the loan repaid), it’s how we can save the jobs, save this company,” Fitzgibbon said.
While Canada authorized Medicago’s vaccine in February 2022, it was rejected for emergency use by the World Health Organization in March because tobacco company Philip Morris was a minority shareholder in the company, contravening a policy adopted in 2005 by the United Nations agency.
Quebec City Mayor Bruno Marchand said on Twitter he was saddened by the closure of the company.
“My thoughts are with the families who learned some very sad news,” Marchand said Thursday evening. “We have to roll up our sleeves to keep all this expertise in the field of health innovation in Quebec City.”
This report by The Canadian Press was first published Feb. 3, 2023.
Sidhartha Banerjee, The Canadian Press
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