An In Vitro Study Shows Pfizer-BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with a Mutation Associated with Rapid Transmission
New York and Mainz, Germany, January 8, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB) that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. The results were published on the preprint server bioRxiv and are available here. Rapidly spreading variants of SARS-CoV-2 have been reported, initially in the United Kingdom and South Africa. These variants have multiple mutations in their spike or S glycoproteins, which are key targets of virus neutralizing antibodies. Though these two rapidly spreading viruses are different, they share the N501Y mutation, which is located in the receptor binding site of the spike protein and results in the virus’s spike protein binding more tightly to its receptor. It has been shown to infect mice more efficiently.iTo determine if sera of people who had received the Pfizer-BioNTech COVID-19 vaccine could neutralize SARS-CoV-2 with the N501Y mutation, a virus with this substitution was generated in UTMB’s laboratory. The sera of 20 participants from the previously reported Phase 3 trial neutralized the virus with the mutation as well as they neutralized virus without the mutation. While the virus tested in this experiment did not include the full set of spike mutations found on the rapidly spreading strains in the U.K. or South Africa, neutralization of virus with the N501Y mutation by the Pfizer-BioNTech vaccine-elicited human sera is consistent with preserved neutralization of a panel of 15 pseudoviruses bearing spikes with other mutations found in circulating SARS-CoV-2 strains. This indicates that the key N501Y mutation, which is found in the emerging U.K and South Africa variants, does not create resistance to the Pfizer-BioNTech vaccine induced immune responses. Pfizer, BioNTech, and UTMB are encouraged by these early, in vitro study findings. Further data are needed to monitor the Pfizer-BioNTech COVID-19 vaccine’s effectiveness in preventing COVID-19 caused by new virus variants. If the virus mutates such that an update to the vaccine is required to continue to confer protection against COVID-19, we believe that the flexibility of BioNTech’s proprietary mRNA vaccine platform is well suited to enable an adjustment to the vaccine.The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com.AUTHORIZED USE IN THE U.S.: The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: * Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine. * Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. * Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/). * Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. * The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. * In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). * Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. * Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. * Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion. * There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series. * Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report. * Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.Pfizer Disclosure Notice The information contained in this release is as of January 8, 2021. 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 COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approval or authorization and anticipated manufacturing, distribution and supply) involving 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 clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations upon commercialization; the ability of BNT162b2 to prevent COVID-19 caused by new virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; 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 additional 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 any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines; whether and when any other applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S.) may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’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; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s ultra-low temperature formulation and attendant storage, distribution and administration requirements, including risks related to handling after delivery by Pfizer; the risk that we may not be able to successfully develop non-frozen formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine 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; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; 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, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.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 collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial and/or in commercial use based on data observations to date; the expected time point for additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; 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: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; 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 Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, 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.Pfizer:Media Relations Amy Rose +1 (212) 733-1226 PfizerMediaRelations@pfizer.com Investor Relations Chuck Triano +1 (212) 733-3901 Charles.E.Triano@Pfizer.com BioNTech:Media Relations Jasmina Alatovic +49 89 62 81 75 46 Media@biontech.de Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074 Investors@biontech.dei Gu H, Chen Q, Yang G, et al. Adaptation of SARS-CoV-2 in BALB/c mice for testing vaccine efficacy. Science 2020;369:1603-7.
Health Canada approves Canadian-made rapid COVID-19 testing system – CBC News
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MPs clash over pandemic response as Parliament resumes Monday – CBC.ca
Members of Parliament continue to clash over the federal government’s COVID-19 response as the House of Commons is set to reconvene on Monday for the first time this year.
In a panel interview on CBC Radio’s The House, Conservative MP Michael Chong and Liberal MP Arif Virani offered duelling analogies to describe Canada’s pandemic response, days before deliveries of the Pfizer-BioNTech vaccine are expected to drop dramatically over the next four weeks.
“It’s like saying that I have negotiated a contract with six fire departments to respond to my fire, but they won’t respond for six hours when I do have a fire. And my neighbour has negotiated one contract with a single fire department to respond in five minutes,” Chong told host Chris Hall.
“Personally, I’ll take the single contract with the fire department that responds in five minutes because that is going to save my house. We are the country that’s negotiated the contract with six fire departments … that’s the problem here.”
Canada has signed agreements to receive the vaccine from seven companies, including Pfizer and Moderna. Candidates from the remaining suppliers have yet to receive the regulatory green light from Health Canada, though Virani said the AstraZeneca and Johnson & Johnson products are “on the precipice of hopeful approvals.”
“A different analogy would be, with respect to firefighting, about … how much water do you use on the fire? And we’ve been criticized, including by [Chong’s] party, for putting too much water on the fires in terms of the spending that we’ve been doing,” Virani said.
“But our position is clear. We will remain constant in having Canadians’ backs for as long as it takes to weather this pandemic, including running deficits to do so.”
CBC News: The House12:33The pandemic, Parliament and a possible election
Looking ahead to federal budget
In December, the House of Commons rose for a six-week break without deciding how Parliament should safely resume in the new year. It remains to be seen whether MPs will meet virtually with no members physically present in the Commons or whether they’ll continue to follow the hybrid model put in place last year.
“We have been having discussions with the other parties about the return of Parliament on Monday. Those discussions have been constructive,” read a statement from the office of Government House Leader Pablo Rodriguez.
But when Parliament does resume — amid soaring COVID-19 caseloads in parts of the country — it also comes as Ottawa prepares for its first federal budget in two years.
“We need to see some action from this government,” NDP deputy House leader Heather McPherson told The House in the same interview. “I mean, we have seen things like child care, we have seen things like pharmacare, over and over and over again in these Liberal throne speeches. But we haven’t seen the action taken.”
McPherson said a child-care strategy will be critical for economic recovery from the pandemic, on top of additional support for small businesses. When Parliament returns, she said the NDP will also be pushing the Liberal government on ending clawbacks of the Canada emergency response benefit and calling for expanded access to paid sick leave.
“If [the Liberals] continue to help deliver for Canadians, then we’ll continue to work with them,” she said.
Conservatives, Liberals lay out priorities
Chong said that the Opposition will be zeroing in on vaccine procurement and improving the pace of Canada’s rollout, among other priorities.
“We’re looking for two measures in the upcoming budget that we believe are really important, one of which the government has indicated it’s supportive of, and that is the changes to the Canada Child Benefit that would help Canadian families, particularly working women and single mothers,” the Conservative foreign affairs critic said.
The party is also looking for additional measures to help small businesses buffeted by a second wave of pandemic restrictions.
Virani said he was “keen” to hear the ideas proposed by his colleagues and laid out some priorities of his own, including immediately working to close a loophole in the federal sickness benefit that allows Canadians quarantining after personal travel to claim sick pay.
Virani, who is also the parliamentary secretary to the minister of justice, said the new Biden administration in the United States also changes what’s on the government’s to-do list.
“We’ve now got a co-operative administration that understands the importance of greening the planet,” Virani said, “as well as working on issues that are germane to both of our nations.”
That includes a rise in systemic discrimination and online hate — the latter of which Virani says he’s been tackling with Justice Minister David Lametti.
“We’re looking for progress on a number of files, but it starts with the pandemic and addressing the pandemic,” he said.
China rescues first person from Shandong gold mine: state media – TheChronicleHerald.ca
BEIJING (Reuters) – A miner was rescued from a gold mine in northern China on Sunday morning and rushed to hospital for treatment, state broadcaster CCTV said, after being trapped 14 days below ground by an explosion.
The miner was “extremely weak”, according to a post on CCTV’s Weibo microblog site. TV footage showed the exhausted miner, a black blindfold across his eyes, being lifted out of the mine shaft and covered in a blanket before being carried away by rescue workers.
Twenty-two workers were trapped in the Hushan mine by the Jan. 10 blast in Qixia, a major gold-producing region under the administration of Yantai in coastal Shandong province.
One miner has died and 11 have not been in contact with rescue teams, according to a Xinhua report from last week.
The rescued miner was found in a different section of the mine from a group of 10 men who have been receiving supplies of food.
Officials said on Thursday it could take another two weeks to clear “severe blockages” before they could drill shafts to reach the 10 men.
(Reporting by Dominique Patton; Editing by Tom Hogue)
Health Canada approves Canadian-made rapid COVID-19 testing system – CBC News
MPs clash over pandemic response as Parliament resumes Monday – CBC.ca
China rescues first person from Shandong gold mine: state media – TheChronicleHerald.ca
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