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.
Women living in states with abortion bans obtained the procedure in the second half of 2023 at about the same rate as before the U.S. Supreme Court overturned Roe v. Wade, according to a report released Tuesday.
Women did so by traveling out of state or by having prescription abortion pills mailed to them, according to the #WeCount report from the Society of Family Planning, which advocates for abortion access. They increasingly used telehealth, the report found, as medical providers in states with laws intended to protection them from prosecution in other states used online appointments to prescribe abortion pills.
“The abortion bans are not eliminating the need for abortion,” said Ushma Upadhyay, a University of California, San Francisco public health social scientist and a co-chair of the #WeCount survey. “People are jumping over these hurdles because they have to.”
Abortion patterns have shifted
The #WeCount report began surveying abortion providers across the country monthly just before Roe was overturned, creating a snapshot of abortion trends. In some states, a portion of the data is estimated. The effort makes data public with less than a six-month lag, giving a picture of trends far faster than the U.S. Centers for Disease Control and Prevention, whose most recent annual report covers abortion in 2021.
The report has chronicled quick shifts since the Supreme Court’s Dobbs v. Jackson Women’s Health Organization ruling that ended the national right to abortion and opened the door to enforcement of state bans.
The number of abortions in states with bans at all stages of pregnancy fell to near zero. It also plummeted in states where bans kick in around six weeks of pregnancy, which is before many women know they’re pregnant.
But the nationwide total has been about the same or above the level from before the ruling. The study estimates 99,000 abortions occurred each month in the first half of 2024, up from the 81,000 monthly from April through December 2022 and 88,000 in 2023.
One reason is telehealth, which got a boost when some Democratic-controlled states last year began implementing laws to protect prescribers. In April 2022, about 1 in 25 abortions were from pills prescribed via telehealth, the report found. In June 2024, it was 1 in 5.
The newest report is the first time #WeCount has broken down state-by-state numbers for abortion pill prescriptions. About half the telehealth abortion pill prescriptions now go to patients in states with abortion bans or restrictions on telehealth abortion prescriptions.
In the second half of last year, the pills were sent to about 2,800 women each month in Texas, more than 1,500 in Mississippi and nearly 800 in Missouri, for instance.
Travel is still the main means of access for women in states with bans
Data from another group, the Guttmacher Institute, shows that women in states with bans still rely mostly on travel to get abortions.
By combining results of the two surveys and comparing them with Guttmacher’s counts of in-person abortions from 2020, #WeCount found women in states with bans throughout pregnancy were getting abortions in similar numbers as they were in 2020. The numbers do not account for pills obtained from outside the medical system in the earlier period, when those prescriptions most often came from abroad. They also do not tally people who received pills but did not use them.
West Virginia women, for example, obtained nearly 220 abortions monthly in the second half of 2023, mostly by traveling — more than in 2020, when they received about 140 a month. For Louisiana residents, the monthly abortion numbers were about the same, with just under 700 from July through December 2023, mostly through shield laws, and 635 in 2020. However, Oklahoma residents obtained fewer abortions in 2023, with the monthly number falling to under 470 from about 690 in 2020.
Telehealth providers emerged quickly
One of the major providers of the telehealth pills is the Massachusetts Abortion Access Project. Cofounder Angel Foster said the group prescribed to about 500 patients a month, mostly in states with bans, from its September 2023 launch through last month.
The group charged $250 per person while allowing people to pay less if they couldn’t afford that. Starting this month, with the help of grant funding that pays operating costs, it’s trying a different approach: Setting the price at $5 but letting patients know they’d appreciate more for those who can pay it. Foster said the group is on track to provide 1,500 to 2,000 abortions monthly with the new model.
Foster called the Supreme Court’s 2020 decision “a human rights and social justice catastrophe” while also saying that “there’s an irony in what’s happened in the post-Dobbs landscape.”
“In some places abortion care is more accessible and affordable than it was,” she said.
There have no major legal challenges of shield laws so far, but abortion opponents have tried to get one of the main pills removed from the market. Earlier this year, the U.S. Supreme Court unanimously preserved access to the drug, mifepristone, while finding that a group of anti-abortion doctors and organizations did not have the legal right to challenge the 2000 federal approval of the drug.
This month, three states asked a judge for permission to file a lawsuit aimed at rolling back federal decisions that allowed easier access to the pill — including through telehealth.
Climate change may be contributing to thousands more wildfire smoke-related deaths every year than in previous decades, a new study suggests — results a Canadian co-author says underline the urgency of reducing planet-warming emissions.
The international study published Monday is one of the most rigorous yet in determining just how much climate change can be linked to wildfire smoke deaths around the world, said Sian Kou-Giesbrecht, an assistant professor at Dalhousie University.
“What stands out to me is that this proportion is increasing just so much. I think that it really kind of attests to just how much we need to take targeted action to reducing greenhouse-gas emissions,” she said in an interview.
The study estimates, using mathematical modeling, that about 12,566 annual wildfire smoke-related deaths in the 2010s were linked to climate change, up from about 669 in the 1960s, when far less carbon dioxide was concentrated in the atmosphere.
Translated to a proportion of wildfire smoke mortality overall, the study estimates about 13 per cent of estimated excessdeaths in the 2010s were linked to climate change, compared to about 1.2 per cent in the 1960s.
“Adapting to the critical health impacts of fires is required,” read the study, published in the peer-reviewed journal Nature Climate Change.
While wildfires are a natural part of the boreal forest ecosystem, a growing number of studies have documented how climate change, driven by the burning of fossil fuels, is making them larger and more intense — and contributing more to air pollution.
The same research group is behind another study published in the same journal Monday that suggests climate change increased the global area burned by wildfire by about 16 per cent from 2003 to 2019.
Those climate-fuelled fires then churn out more fine particle pollution, known as PM2.5, that’s tiny enough to get deep into the lungs — and in the long run can have serious health effects.
The study that estimated the scale of those effects is based on modeling, not historical data about reported deaths from air pollution.
Researchers used established public-health metrics for when pollution is thought to contribute to mortality, then figured out the extent to which wildfire smoke may have played a role in that overall exposure to arrive at the estimates.
Meanwhile, Health Canada estimates that between 2013 and 2018, up to 240 Canadians died every year due to short-term exposure to wildfire air pollution.
Kou-Giesbrecht said Monday’s study did not find that climate change had a major influence on the number of smoke-related deaths from Canada’s boreal wildfires.
She suggested that’s likely due to the country’s relatively small population size, and how tricky it is to model forest fires in the region, given its unique mix of shrubs and peat.
But she also noted that a stretch of devastating Canadian wildfire seasons over the past several years was not captured in the study, and she expects future research could find a bigger increase in deaths and public-health problems linked to climate change.
The most affected regions in the study were South America, Australia and Europe.
Kou-Giesbrecht said the more studies that uncover the link between climate change and disasters as “tangible” as wildfires, the more the case for “drastic climate action” will be bolstered.
“I think that the more and more evidence that we have to support the role of climate change in shaping the past 100 years, and knowing that it will continue to shape the next 100 years, is really important,” she said.
“And I find that personally interesting, albeit scary.”
The study used three highly complex models to estimate the relationship between climate change, land use and fire.
The models, which each contain thousands upon thousands of equations, compare what wildfires look like in the current climate to what they may have looked like in pre-industrial times, before humans started to burn vast amounts of fossil fuels.
The researchers used the models to calculate gas and aerosol emissions from wildfires between 1960 and 2019, and then make estimates about annual smoke-related deaths.
The type of methodology used by Monday’s studies, known as attribution science, is considered one of the fastest-growing fields of climate science. It is bolstered in part by major strides in computing power.
This report by The Canadian Press was first published Oct. 21, 2024.
Some Ontario doctors have started offering a free shot that can protect babies from respiratory syncytial virus while Quebec will begin its immunization program next month.
The new shot called Nirsevimab gives babies antibodies that provide passive immunity to RSV, a major cause of serious lower respiratory tract infections for infants and seniors, which can cause bronchiolitis or pneumonia.
Ontario’s ministry of health says the shot is already available at some doctor’s offices in Ontario with the province’s remaining supply set to arrive by the end of the month.
Quebec will begin administering the shots on Nov. 4 to babies born in hospitals and delivery centers.
Parents in Quebec with babies under six months or those who are older but more vulnerable to infection can also book immunization appointments online.
The injection will be available in Nunavut and Yukon this fall and winter, though administration start dates have not yet been announced.
This report by The Canadian Press was first published Oct. 21, 2024.
-With files from Nicole Ireland
Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
