Supply to be provided over the course of 2021, subject to Health Canada approval
Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic
Pfizer and BioNTech began a Phase 2b/3 safety and efficacy trial and remain on track to seek regulatory review as early as October 2020, and to manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021
KIRKLAND, Quebec and MAINZ, Germany, Aug. 05, 2020 (GLOBE NEWSWIRE) — Pfizer Canada and BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced an agreement with the Government of Canada to supply their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and Health Canada approval.
Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses. As requested by the Government of Canada, deliveries of the vaccine candidate are planned for over the course of 2021.
“We continue to be committed to partnering with the Canadian government to help fight this pandemic and are pleased with their collaborative approach to addressing a national COVID-19 immunization strategy with public health officials,” said Cole C. Pinnow, President, Pfizer Canada. “With our combined efforts, we know there is no health challenge that we cannot address.”
“As the development of effective COVID-19 vaccines continues around the world, we commend the work of Pfizer and BioNTech, which will provide Canadians access to a vaccine candidate for the virus. This agreement is another critical step in our government’s efforts to keep Canadians safe and healthy as the pandemic continues to evolve,” said The Honourable Anita Anand, Minister of Public Services and Procurement, Government of Canada.
“In the face of this global health crisis, Pfizer’s purpose – breakthroughs that change patients’ lives – has taken on an even greater urgency,” said Albert Bourla, Chairman and CEO, Pfizer. “We’re harnessing our scientific expertise, and we’re marshaling our manufacturing resources in an effort to ensure that the vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”
“This agreement is part of our commitment to address the pandemic by supporting global supply of our vaccine candidate. Our teams are working diligently to advance the lead product candidate through clinical development in order to seek regulatory review as early as October. At the same time, Pfizer and BioNTech continue to scale up manufacturing capacities to be able to produce up to 100 million doses in 2020 and more than one billion doses in 2021. Since we initiated Project Lightspeed our aim has always been clear: Making a potential vaccine available to the public as quickly as possible – worldwide. This agreement is yet another step in that direction,” said Sean Marett, Chief Business and Chief Commercial Officer at BioNTech.
The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The vaccine development program is evaluating at least four experimental vaccine candidates, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.
Recently, two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 – received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies.
On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study. BNT162b2 encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies. In the late-stage trial, the companies will study a 30 µg dose level in a 2-dose-regimen among up to 30,000 participants aged 18 to 85 years. It is expected to include approximately 120 sites globally including in regions with significant expected SARS-CoV-2 transmission. BNT162b2 has received Fast Track designation from the U.S. FDA.
Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that aims to provide governments, including those in the emerging markets, with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world.
About Pfizer Canada Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world’s leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world’s best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube.
Pfizer Disclosure Notice The information contained in this release is as of August 5, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, an agreement with the government of Canada to supply BNT162 and other potential agreements, the BNT162 mRNA vaccine program, and modRNA candidates BNT162b2 and BNT162b1 (including qualitative assessments of available data, potential benefits, expectations for clinical trials and timing of regulatory submissions, anticipated manufacturing, supply and distribution), that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data that may be inconsistent with the data used for selection of the BNT162b2 vaccine candidate and dose level for the Phase 2/3 study; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for BNT162b2 or any other potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
About BioNTech Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer.
BioNTech Forward-looking Statements This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the timing to initiate clinical trials of BNT162 and anticipated publication of data from these clinical trials; the timing for any potential emergency use authorizations or approvals; the potential to enter into additional supply agreements with other jurisdictions or the COVAX Facility; the potential safety and efficacy of BNT162; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
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.
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.
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.
