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CPHO Sunday Edition: Vaccine safety in Canada: What you should know – Benzinga

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OTTAWA, ON, March 28, 2021

The COVID-19 pandemic continues to create stress and anxiety for many Canadians, particularly those who do not have ready access to their regular support networks. Through the Wellness Together Canada online portal, people of all ages across the country can access immediate, free and confidential mental health and substance use supports, 24 hours a day, seven days a week.

/CNW/ – It has been yet another productive week on the vaccine front in Canada, as close to 1.4 million doses of COVID-19 vaccines arrived in Canada, and roll-out continues to ramp up across the country. It seems fitting that as the first signs of spring emerge around us, and the days get longer, there is more hope and optimism to fill the air. Our vaccination program is moving forward, to a point that the majority of us now have someone close to us who has been vaccinated. It is an incredible feeling to know that a loved one who is at higher risk for COVID-19 is now safer.

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Through this process, we are also learning many new things about vaccines. However, with so much information coming at us, and much of it evolving at a rapid pace, this can also create gaps in our understanding, cause confusion, and even, in some cases, lead to distrust.

I know that many of you are curious to know more about vaccine safety and how adverse events following immunization (AEFIs) are monitored in Canada. That is why, in today’s Sunday Edition, I would like to explore this process by providing you with a bird’s eye view of the vaccine safety monitoring process from vaccine development through to post-marketing surveillance.

Ensuring Vaccine Safety at Every Step of the Vaccine Life Cycle

Vaccine safety assessment and monitoring is not something that takes place in a single, fixed step. Rather, it is an ongoing and continual process that is carried out throughout a vaccine’s life cycle, spanning all phases from development, to market authorization, administration, and post-marketing surveillance.

Here is brief description of how safety (and effectiveness) are evaluated at each step of the vaccine life cycle:

Pre-approval review and approval process

Vaccine testing starts in the lab with preclinical studies, which are carried out using cell cultures (in vitro studies) and animal models (in vivo studies). These studies provide preliminary information on vaccine effectiveness and safety.

If the vaccine is shown to be safe and effective in the lab and in animals, studies in people, known as clinical trials, are conducted next. These assess safety, including safe dose range, and efficacy, starting with a small number of healthy volunteers, and moving up to 1,000 or more participants by phase 3 trials. Importantly, every AEFI noted in these studies is investigated carefully and assessed to determine whether the vaccine is the cause.

In order for a manufacturer to receive regulatory approval for a new vaccine, they are required to submit all preclinical, clinical and manufacturing data to the Biologic and Radiopharmaceutical Drugs Directorate, the group responsible for approving vaccines at Health Canada, for their own independent review. Scientific and medical reviewers from this group then conduct an in-depth assessment of all the data they receive. A vaccine is only authorized for use in Canada if it meets the regulatory requirements for safety, efficacy, and quality set by Health Canada.

Quality Control

The Biologic and Radiopharmaceutical Drugs Directorate will also review detailed chemistry and manufacturing information to ensure consistent quality of the vaccine product, which is another important facet related to safety. This may include an on-site evaluation of the manufacturing process, as well as a lot release program, which tests vaccine samples from different lots. Vaccine manufacturers must also adhere to current Good Manufacturing Practices (GMP), or recognized international quality standards, a process which is ensured by Health Canada’s Regulatory Operations and Enforcement Branch.

Post-approval monitoring

Once a vaccine is approved, it continues to be monitored and any safety signals are investigated. Canada has a strong vaccine safety monitoring system that remains in place for as long as the vaccine is used. Health Canada and the Public Health Agency of Canada (PHAC) share the responsibility for ongoing monitoring in collaboration with provincial, territorial and local public health authorities, health care professionals, vaccine manufacturers, and the public. This ongoing process is important as it alerts public health authorities to changing trends or unusual AEFIs that were not previously reported. These are adverse events that occur too rarely to be detected even in a large clinical trial; they can only be identified once millions of people receive a vaccine. This is why when serious, unusual or unexpected AEFIs occur, they need to be taken very seriously and investigated very carefully, in order to determine whether they are indicative of a safety issue related to the vaccine that has emerged unexpectedly.

Manufacturers are also required to report AEFIs that they become aware of in Canada, or internationally, to the Canada Vigilance Program, Health Canada’s post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada. As part of a “risk management plan”, manufacturers may also be required to provide data on the safety of the vaccine for specific groups of people or conduct additional studies.

Canada also has several other post-market vaccine safety surveillance systems in place to detect any serious adverse events that may occur following immunization. These include the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS), a federal, provincial and territorial collaborative surveillance system that is supported by PHAC. CAEFISS continuously monitors the safety of vaccines in Canada through various reporting processes. Health care professionals are asked to report all serious adverse reactions, such as those that may require hospitalization, result in persistent or significant disability or incapacity or be life-threatening, to CAEFISS. Anyone who experiences an adverse event is encouraged to inform their healthcare professional so they can report it.

Another component of the vaccine safety surveillance system involves proactively inquiring about adverse events from vaccine recipients or searching adverse events in clinical or administrative records. The Canadian Vaccine Safety Network (CANVAS) is a national network of sites across Canada that conducts vaccine safety surveillance during implementation of immunization campaigns. It can provide rapid information early on in vaccination campaigns, including for COVID-19. CANVAS is currently conducting a large, national, web-based vaccine safety study to monitor health events that may occur after COVID-19 vaccinations.

Approaches used in Canada align with good practices put forward by the World Health Organization in their COVID-19 vaccine Safety Surveillance Manual. If any serious side effects are identified, an investigation will take place and this information will be rapidly communicated to Canadians. The Canadian Immunization Guide provides specific information on management of selected AEFI and/or special populations. AEFI expert assessment is available via several avenues. For example, all serious AEFIs are reviewed by medical specialists at PHAC and Health Canada. Where needed, experts in specific fields of study are consulted. The Canadian Immunization Research Network’s Special Immunization Clinic (SIC) Network, established across Canada in 2013 by infectious disease specialists and allergists, provides expert advice to patients who have experienced adverse events following immunization and those who have medical conditions that may affect their immunizations. For more information on AEFI management, you can refer to the SIC Network’s Managing Adverse Events Following Immunization: Resource for Public Health.

Global Collaboration

It is important to note that post-approval vaccine monitoring is a process that is similarly carried out in many countries around the world, and Canada’s systems are linked with international networks, allowing us to share and access important safety information from other countries where the same vaccine is also in use. These networks include the Global Advisory Committee on Vaccine Safety (GACVS) which was created by the World Health Organization (WHO) and enables quick and efficient responses to vaccine safety issues of global importance.

In the case of COVID-19 vaccine monitoring, we are seeing even greater international collaboration and communication on vaccine safety. Regulatory and public health authorities in Canada are actively collaborating and regularly exchanging information with international partners such as the WHO, in order to detect and discuss any emerging safety signals as well as how any potential risks may be mitigated. Regulators are also working closely together to share information.

Instilling confidence in our vaccination program

I hope that the information that I’ve provided today will help to shed some more light on the vaccine monitoring process we have in place in Canada. Ensuring that all vaccines authorised for use in Canada are safe and effective is a priority for health authorities at every level, who continue to monitor, investigate and report through Canada’s vaccine safety surveillance systems.

For additional information on vaccine safety, you can visit the Government of Canada’s COVID-19 vaccines and treatment portal. You can also keep track of any adverse effects reported in Canada with the COVID-19 Vaccine Safety Report which is updated on a weekly basis.

With fewer infections in those over 80 years of age, along with decreased outbreaks in long-term care settings, we are seeing the real-world benefits of COVID-19 vaccinations. As these vaccines work to protect more and more Canadians, let’s play our part by staying strong and helping each other – follow public health advice, keep up with individual practices, and prepare to take your place in the queue when the time comes for you to be vaccinated.

SOURCE Public Health Agency of Canada

Cision View original content: http://www.newswire.ca/en/releases/archive/March2021/28/c5860.html

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Toronto reports 2 more measles cases. Use our tool to check the spread in Canada – Toronto Star

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April 19, 2024

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Canada has seen a concerning rise in measles cases in the first months of 2024.

By the third week of March, the country had already recorded more than three times the number of cases as all of last year. Canada had just 12 cases of measles in 2023, up from three in 2022.

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Cancer Awareness Month – Métis Nation of Alberta

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April 18, 2024

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Cancer Awareness Month

Posted on: Apr 18, 2024

April is Cancer Awareness Month

As we recognize Cancer Awareness Month, we stand together to raise awareness, support those affected, advocate for prevention, early detection, and continued research towards a cure. Cancer is the leading cause of death for Métis women and the second leading cause of death for Métis men. The Otipemisiwak Métis Government of the Métis Nation Within Alberta is working hard to ensure that available supports for Métis Citizens battling cancer are culturally appropriate, comprehensive, and accessible by Métis Albertans at all stages of their cancer journey.

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Receiving a cancer diagnosis, whether for yourself or a loved one, can feel overwhelming, leaving you unsure of where to turn for support. In June, our government will be launching the Cancer Supports and Navigation Program which will further support Métis Albertans and their families experiencing cancer by connecting them to OMG-specific cancer resources, external resources, and providing navigation support through the health care system. This program will also include Métis-specific peer support groups for those affected by cancer.

With funding from the Canadian Partnership Against Cancer (CPAC) we have also developed the Métis Cancer Care Course to ensure that Métis Albertans have access to culturally safe and appropriate cancer services. This course is available to cancer care professionals across the country and provides an overview of who Métis people are, our culture, our approaches to health and wellbeing, our experiences with cancer care, and our cancer journey.

Together, we can make a difference in the fight against cancer and ensure equitable access to culturally safe and appropriate care for all Métis Albertans. Please click on the links below to learn more about the supports available for Métis Albertans, including our Compassionate Care: Cancer Transportation program.

I wish you all good health and happiness!

Bobbi Paul-Alook
Secretary of Health & Seniors

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Type 2 diabetes is not one-size-fits-all: Subtypes affect complications and treatment options – The Conversation

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April 18, 2024

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You may have heard of Ozempic, the “miracle drug” for weight loss, but did you know that it was actually designed as a new treatment to manage diabetes? In Canada, diabetes affects approximately 10 per cent of the general population. Of those cases, 90 per cent have Type 2 diabetes.

This metabolic disorder is characterized by persistent high blood sugar levels, which can be accompanied by secondary health challenges, including a higher risk of stroke and kidney disease.

Locks and keys

In Type 2 diabetes, the body struggles to maintain blood sugar levels in an acceptable range. Every cell in the body needs sugar as an energy source, but too much sugar can be toxic to cells. This equilibrium needs to be tightly controlled and is regulated by a lock and key system.

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In the body’s attempt to manage blood sugar levels and ensure that cells receive the right amount of energy, the pancreatic hormone, insulin, functions like a key. Cells cover themselves with locks that respond perfectly to insulin keys to facilitate the entry of sugar into cells.

Unfortunately, this lock and key system doesn’t always perform as expected. The body can encounter difficulties producing an adequate number of insulin keys, and/or the locks can become stubborn and unresponsive to insulin.

All forms of diabetes share the challenge of high blood sugar levels; however, diabetes is not a singular condition; it exists as a spectrum. Although diabetes is broadly categorized into two main types, Type 1 and Type 2, each presents a diversity of subtypes, especially Type 2 diabetes.

These subtypes carry their own characteristics and risks, and do not respond uniformly to the same treatments.

To better serve people living with Type 2 diabetes, and to move away from a “one size fits all” approach, it is beneficial to understand which subtype of Type 2 diabetes a person lives with. When someone needs a blood transfusion, the medical team needs to know the patient’s blood type. It should be the same for diabetes so a tailored and effective game plan can be implemented.

This article explores four unique subtypes of Type 2 diabetes, shedding light on their causes, complications and some of their specific treatment avenues.

Severe insulin-deficient diabetes: We’re missing keys!

In severe insulin-deficient diabetes, beta cells limit production of the keys that unlock cells to allow entry of sugar from the blood.
(Lili Grieco-St-Pierre, Jennifer Bruin/Created with BioRender.com)

Insulin is produced by beta cells, which are found in the pancreas. In the severe insulin-deficient diabetes (SIDD) subtype, the key factories — the beta cells — are on strike. Ultimately, there are fewer keys in the body to unlock the cells and allow entry of sugar from the blood.

SIDD primarily affects younger, leaner individuals, and unfortunately, increases the risk of eye disease and blindness, among other complications. Why the beta cells go on strike remains largely unknown, but since there is an insulin deficiency, treatment often involves insulin injections.

Severe insulin-resistant diabetes: But it’s always locked!

A diagram of three closed locks and lots of keys

In severe insulin-resistant diabetes, the locks start ignoring the keys, triggering the beta cells to produce even more keys to compensate.
(Lili Grieco-St-Pierre, Jennifer Bruin/Created with BioRender.com)

In the severe insulin-resistant diabetes (SIRD) subtype, the locks are overstimulated and start ignoring the keys. As a result, the beta cells produce even more keys to compensate. This can be measured as high levels of insulin in the blood, also known as hyperinsulinemia.

This resistance to insulin is particularly prominent in individuals with higher body weight. Patients with SIRD have an increased risk of complications such as fatty liver disease. There are many treatment avenues for these patients but no consensus about the optimal approach; patients often require high doses of insulin.

Mild obesity-related diabetes: The locks are sticky!

Illustration of a lock and key

In mild obesity-related diabetes, the locks are ‘sticky,’ making it difficult for the keys to open the locks.
(Lili Grieco-St-Pierre, Jennifer Bruin/Created with BioRender.com)

Mild obesity-related (MOD) diabetes represents a nuanced aspect of Type 2 diabetes, often observed in individuals with higher body weight. Unlike more severe subtypes, MOD is characterized by a more measured response to insulin. The locks are “sticky,” so it is challenging for the key to click in place and open the lock. While MOD is connected to body weight, the comparatively less severe nature of MOD distinguishes it from other diabetes subtypes.

To minimize complications, treatment should include maintaining a healthy diet, managing body weight, and incorporating as much aerobic exercise as possible. This is where drugs like Ozempic can be prescribed to control the evolution of the disease, in part by managing body weight.

Mild age-related diabetes: I’m tired of controlling blood sugar!

Illustration of a lock and a beta cell

In people with mild age-related diabetes, both the locks and the beta cells that produce keys are tired, resulting in fewer keys and stubborn locks.
(Lili Grieco-St-Pierre, Jennifer Bruin/Created with BioRender.com)

Mild age-related diabetes (MARD) happens more often in older people and typically starts later in life. With time, the key factory is not as productive, and the locks become stubborn. People with MARD find it tricky to manage their blood sugar, but it usually doesn’t lead to severe complications.

Among the different subtypes of diabetes, MARD is the most common.

Unique locks, varied keys

While efforts have been made to classify diabetes subtypes, new subtypes are still being identified, making proper clinical assessment and treatment plans challenging.

In Canada, unique cases of Type 2 diabetes were identified in Indigenous children from Northern Manitoba and Northwestern Ontario by Dr. Heather Dean and colleagues in the 1980s and 90s. Despite initial skepticism from the scientific community, which typically associated Type 2 diabetes with adults rather than children, clinical teams persisted in identifying this as a distinct subtype of Type 2 diabetes, called childhood-onset Type 2 diabetes.



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Indigenous community research partnerships can help address health inequities

Childhood-onset Type 2 diabetes is on the rise across Canada, but disproportionately affects Indigenous youth. It is undoubtedly linked to the intergenerational trauma associated with colonization in these communities. While many factors are likely involved, recent studies have discovered that exposure of a fetus to Type 2 diabetes during pregnancy increases the risk that the baby will develop diabetes later in life.

Acknowledging this distinct subtype of Type 2 diabetes in First Nations communities has led to the implementation of a community-based health action plan aimed at addressing the unique challenges faced by Indigenous Peoples. It is hoped that partnered research between communities and researchers will continue to help us understand childhood-onset Type 2 diabetes and how to effectively prevent and treat it.

A mosaic of conditions

Illustration of different subtypes of Type 2 diabetes

Type 2 diabetes is a mosaic of conditions, each with its own characteristics.
(Lili Grieco-St-Pierre, Jennifer Bruin/Created with BioRender.com)

Type 2 diabetes is not uniform; it’s a mosaic of conditions, each with its own characteristics. Since diabetes presents so uniquely in every patient, even categorizing into subtypes does not guarantee how the disease will evolve. However, understanding these subtypes is a good starting point to help doctors create personalized plans for people living with the condition.

While Indigenous communities, lower-income households and individuals living with obesity already face a higher risk of developing Type 2 diabetes than the general population, tailored solutions may offer hope for better management. This emphasizes the urgent need for more precise assessments of diabetes subtypes to help customize therapeutic strategies and management strategies. This will improve care for all patients, including those from vulnerable and understudied populations.

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