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Pfizer says pandemic could extend to 2024, vaccine data for younger children delayed

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Pfizer Inc on Friday forecast that the COVID-19 pandemic would not be behind us until 2024 and said a lower-dose version of its vaccine for 2- to 4-year-olds generated a weaker immune response than expected, potentially delaying authorization.

Pfizer Chief Scientific Officer Mikael Dolsten said in a presentation to investors that the company expects some regions to continue to see pandemic levels of COVID-19 cases over the next year or two. Other countries will transition to “endemic” with low, manageable caseloads during that same time period.

By 2024, the disease should be endemic around the globe, the company projected.

“When and how exactly this happens will depend on evolution of the disease, how effectively society deploys vaccines and treatments, and equitable distribution to places where vaccination rates are low,” Dolsten said. “The emergence of new variants could also impact how the pandemic continues to play out.”

Pfizer developed its COVID-19 vaccine with Germany’s BioNTech SE, and currently expects it to generate revenue of $31 billion next year. It plans to make 4 billion shots next year.

The drugmaker also has an experimental antiviral pill called Paxlovid which reduced hospitalizations and deaths in high-risk individuals by nearly 90% in a clinical trial. Three analysts estimate sales of $15 billion to $25 billion for it next year, according to IBES data from Refinitiv.

Pfizer’s forecast came after the emergence of the Omicron variant last month, which has more than 50 mutations compared with the original version of the virus. That has reduced the effectiveness of two doses of the vaccine against infection, and spurred fear of rapid spread around the globe.

Prior to the Omicron variant, top U.S. disease doctor Anthony Fauci forecast the pandemic would end in 2022 in the United States.

PEDIATRIC VACCINE

The Pfizer vaccine is authorized in the United States for people age 5 and older. But it said on Friday that its study in children between the ages of 2 and 4 who were given two 3-microgram doses of the vaccine found it did not create the same immune response that a larger dose of the vaccine had in older children.

The 3-microgram dose did generate a similar immune response in children aged 6 to 24 months, the company said.

The company said it will now test a three-dose course in both age groups, as well as in older children. It had previously expected data from 2- to 4-year-olds this year, but said it did not expect the delay would meaningfully change plans to file for emergency use authorization in the second quarter of 2022.

Pfizer and BioNTech have also been developing a version of their vaccine tailored to combat the quick-spreading Omicron variant, although they have not decided whether it will be needed. They expect to start a clinical trial for the updated vaccine in January, Pfizer executives said.

Variant-specific shots, if needed, could boost sales in 2022.

The highly-transmissible Omicron variant of the coronavirus has been detected in over 77 countries and has spread to about one-third of U.S. states.

The vaccine was around 95% effective in the adult clinical trial, but Pfizer has said that immunity wanes some months after the second dose. Early data suggests that three doses of the shot may be necessary to protect against the Omicron variant.

 

(Reporting by Michael Erman in New Jersey and Mrinalika Roy and Leroy Leo in Bengaluru; Editing by Dan Grebler and Rosalba O’Brien)

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Older patients, non-English speakers more likely to be harmed in hospital: report

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Patients who are older, don’t speak English, and don’t have a high school education are more likely to experience harm during a hospital stay in Canada, according to new research.

The Canadian Institute for Health Information measured preventableharmful events from 2023 to 2024, such as bed sores and medication errors,experienced by patients who received acute care in hospital.

The research published Thursday shows patients who don’t speak English or French are 30 per cent more likely to experience harm. Patients without a high school education are 20 per cent more likely to endure harm compared to those with higher education levels.

The report also found that patients 85 and older are five times more likely to experience harm during a hospital stay compared to those under 20.

“The goal of this report is to get folks thinking about equity as being a key dimension of the patient safety effort within a hospital,” says Dana Riley, an author of the report and a program lead on CIHI’s population health team.

When a health-care provider and a patient don’t speak the same language, that can result in the administration of a wrong test or procedure, research shows. Similarly, Riley says a lower level of education is associated with a lower level of health literacy, which can result in increased vulnerability to communication errors.

“It’s fairly costly to the patient and it’s costly to the system,” says Riley, noting the average hospital stay for a patient who experiences harm is four times more expensive than the cost of a hospital stay without a harmful event – $42,558 compared to $9,072.

“I think there are a variety of different reasons why we might start to think about patient safety, think about equity, as key interconnected dimensions of health-care quality,” says Riley.

The analysis doesn’t include data on racialized patients because Riley says pan-Canadian data was not available for their research. Data from Quebec and some mental health patients was also excluded due to differences in data collection.

Efforts to reduce patient injuries at one Ontario hospital network appears to have resulted in less harm. Patient falls at Mackenzie Health causing injury are down 40 per cent, pressure injuries have decreased 51 per cent, and central line-associated bloodstream infections, such as IV therapy, have been reduced 34 per cent.

The hospital created a “zero harm” plan in 2019 to reduce errors after a hospital survey revealed low safety scores. They integrated principles used in aviation and nuclear industries, which prioritize safety in complex high-risk environments.

“The premise is first driven by a cultural shift where people feel comfortable actually calling out these events,” says Mackenzie Health President and Chief Executive Officer Altaf Stationwala.

They introduced harm reduction training and daily meetings to discuss risks in the hospital. Mackenzie partnered with virtual interpreters that speak 240 languages and understand medical jargon. Geriatric care nurses serve the nearly 70 per cent of patients over the age of 75, and staff are encouraged to communicate as frequently as possible, and in plain language, says Stationwala.

“What we do in health care is we take control away from patients and families, and what we know is we need to empower patients and families and that ultimately results in better health care.”

This report by The Canadian Press was first published Oct. 17, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

The Canadian Press. All rights reserved.

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Alberta to launch new primary care agency by next month in health overhaul

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CALGARY – Alberta’s health minister says a new agency responsible for primary health care should be up and running by next month.

Adriana LaGrange says Primary Care Alberta will work to improve Albertans’ access to primary care providers like family doctors or nurse practitioners, create new models of primary care and increase access to after-hours care through virtual means.

Her announcement comes as the provincial government continues to divide Alberta Health Services into four new agencies.

LaGrange says Alberta Health Services hasn’t been able to focus on primary health care, and has been missing system oversight.

The Alberta government’s dismantling of the health agency is expected to include two more organizations responsible for hospital care and continuing care.

Another new agency, Recovery Alberta, recently took over the mental health and addictions portfolio of Alberta Health Services.

This report by The Canadian Press was first published Oct. 15, 2024.

The Canadian Press. All rights reserved.

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Experts urge streamlined, more compassionate miscarriage care in Canada

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Rana Van Tuyl was about 12 weeks pregnant when she got devastating news at her ultrasound appointment in December 2020.

Her fetus’s heartbeat had stopped.

“We were both shattered,” says Van Tuyl, who lives in Nanaimo, B.C., with her partner. Her doctor said she could surgically or medically pass the pregnancy and she chose the medical option, a combination of two drugs taken at home.

“That was the last I heard from our maternity physician, with no further followup,” she says.

But complications followed. She bled for a month and required a surgical procedure to remove pregnancy tissue her body had retained.

Looking back, Van Tuyl says she wishes she had followup care and mental health support as the couple grieved.

Her story is not an anomaly. Miscarriages affect one in five pregnancies in Canada, yet there is often a disconnect between the medical view of early pregnancy loss as something that is easily managed and the reality of the patients’ own traumatizing experiences, according to a paper published Tuesday in the Canadian Medical Association Journal.

An accompanying editorial says it’s time to invest in early pregnancy assessment clinics that can provide proper care during and after a miscarriage, which can have devastating effects.

The editorial and a review of medical literature on early pregnancy loss say patients seeking help in emergency departments often receive “suboptimal” care. Non-critical miscarriage cases drop to the bottom of the triage list, resulting in longer wait times that make patients feel like they are “wasting” health-care providers’ time. Many of those patients are discharged without a followup plan, the editorial says.

But not all miscarriages need to be treated in the emergency room, says Dr. Modupe Tunde-Byass, one of the authors of the literature review and an obstetrician/gynecologist at Toronto’s North York General Hospital.

She says patients should be referred to early pregnancy assessment clinics, which provide compassionate care that accounts for the psychological impact of pregnancy loss – including grief, guilt, anxiety and post-traumatic stress.

But while North York General Hospital and a patchwork of other health-care providers in the country have clinics dedicated to miscarriage care, Tunde-Byass says that’s not widely adopted – and it should be.

She’s been thinking about this gap in the Canadian health-care system for a long time, ever since her medical training almost four decades ago in the United Kingdom, where she says early pregnancy assessment centres are common.

“One of the things that we did at North York was to have a clinic to provide care for our patients, and also to try to bridge that gap,” says Tunde-Byass.

Provincial agency Health Quality Ontario acknowledged in 2019 the need for these services in a list of ways to better manage early pregnancy complications and loss.

“Five years on, little if any progress has been made toward achieving this goal,” Dr. Catherine Varner, an emergency physician, wrote in the CMAJ editorial. “Early pregnancy assessment services remain a pipe dream for many, especially in rural Canada.”

The quality standard released in Ontario did, however, prompt a registered nurse to apply for funding to open an early pregnancy assessment clinic at St. Joseph’s Healthcare Hamilton in 2021.

Jessica Desjardins says that after taking patient referrals from the hospital’s emergency room, the team quickly realized that they would need a bigger space and more people to provide care. The clinic now operates five days a week.

“We’ve been often hearing from our patients that early pregnancy loss and experiencing early pregnancy complications is a really confusing, overwhelming, isolating time for them, and (it) often felt really difficult to know where to go for care and where to get comprehensive, well-rounded care,” she says.

At the Hamilton clinic, Desjardins says patients are brought into a quiet area to talk and make decisions with providers – “not only (from) a physical perspective, but also keeping in mind the psychosocial piece that comes along with loss and the grief that’s a piece of that.”

Ashley Hilliard says attending an early pregnancy assessment clinic at The Ottawa Hospital was the “best case scenario” after the worst case scenario.

In 2020, she was about eight weeks pregnant when her fetus died and she hemorrhaged after taking medication to pass the pregnancy at home.

Shortly after Hilliard was rushed to the emergency room, she was assigned an OB-GYN at an early pregnancy assessment clinic who directed and monitored her care, calling her with blood test results and sending her for ultrasounds when bleeding and cramping persisted.

“That was super helpful to have somebody to go through just that, somebody who does this all the time,” says Hilliard.

“It was really validating.”

This report by The Canadian Press was first published Oct. 15, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

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