emergency use authorization pfizer

“We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”, “Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. Pfizer and BioNTech Receive First U.S. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. Copyright © 2002-2021 Pfizer Inc. All rights reserved. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose. 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. [email protected], Media Relations +49 (0)6131 9084 1074 Pfizer To Seek Emergency Use Authorization For Its COVID Vaccine For Kids Ages 2 To 11 May 5, 2021, 3:15 AM WBZ TV's Anna Meiler reports. The FDA has authorized Pfizer's Covid-19 vaccine for emergency use. The U.S. Food and Drug Administration expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for adolescents 12-15 Monday, according to ABC News. For more than 150 years, we have worked to make a difference for all who rely on us. 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. Moderna announced Thursday that it plans to start the BLA process later in May. FDA expands emergency use authorization for Pfizer's COVID-19 vaccine for children aged 12 to 15 Nearly 17 million people will soon become eligible to get the Pfizer … Authorization for Emergency Use of COVID-19 Vaccine in Adolescents AUTHORIZED USE IN THE U.S.:. For more information, please visit www.BioNTech.de. 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. The Pfizer-BioNTech COVID-19 vaccine is recommended for persons 16 years of age and older in the U.S. population under the FDA’s Emergency Use Authorization. Alex Tin … Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. The official emergency use authorization comes after a daylong FDA meeting on Thursday during which an advisory panel formally recommended the agency authorize the vaccine.. Pfizer… The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. About Pfizer: Breakthroughs That Change Patients’ Lives. Emergency use authorization could come soon for Pfizer vaccine for teens A federal health official tells CBS News the FDA is expected to authorize emergency use of Pfizer… 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. The submission also includes solicited safety data on approximately 100 children 12-15 years of age. This is the first Covid … Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months. NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- From the start of the research program earlier this year, Pfizer and BioNTech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the U.S., as well as Europe, Latin America, and South Africa. Amy Rose [email protected], Investor Relations 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. Currently, individuals 16 and older are eligible to get vaccinated in San Francisco. +1 (212) 733-3901 Pfizer and BioNTech’s combined manufacturing network has the potential to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021 (subject to clinical success, manufacturing capacity, and regulatory approval or authorization). Based on their collective experience, the companies believe in their capability to distribute the vaccine globally upon approval or authorization. The first primary objective analysis was based on 170 confirmed cases of COVID-19. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Once thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2 - 8oC) conditions. The Moderna and Johnson & Johnson COVID-19 vaccines are only authorized … On December 11, 2020, the U.S. Food … Sylke Maas, Ph.D. The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. We routinely post information that may be important to investors on our website at www.Pfizer.com. Federal health officials authorized emergency use of a two-shot COVID-19 vaccine for 12- to 15-year-olds on Monday, opening eligibility to nearly 17 million school-age kids. THE PFIZER -BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID -19) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. This information—including product information—is intended only for residents of the United States. The products discussed herein may have different labeling in different countries. [email protected], Investor Relations View source version on businesswire.com: https://www.businesswire.com/news/home/20201120005370/en/, Media Relations The information contained in this release is as of November 20, 2020. Chuck Triano Doctors could start receiving shots by early next week. 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 or in larger, more diverse populations upon commercialization; 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 any future preclinical and clinical studies; whether and when any other 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; 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 candidate’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 any potential approved vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine candidate 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. ציע בלאט פאר די וועלכע באקומען און פאר הילפער (גבאים), ភាសាអង់គ្លេស (Khmer). The Phase 3 clinical trial of BNT162b2, which is based on BioNTech's proprietary mRNA technology, began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. The Food and Drug Administration authorized the emergency use of Pfizer's COVID-19 vaccine for children ages 12 to 15 on Monday, bolstering chances for full-time in-person school in the fall. (CNN) The US Food and Drug Administration has expanded the emergency use authorization for Pfizer's Covid-19 vaccine to include people ages 12 to 15. Along with Pfizer, Moderna and Johnson & Johnson's COVID-19 vaccines were previously given emergency use authorization. On November 20, 2020, the Sponsor (Pfizer, on behalf of Pfizer and BioNTech) submitted an Emergency Use Authorization(EUA) request to FDA for an investigational COVID-19 vaccine Pfizer today said it is seeking an amended emergency use authorization for its COVID-19 vaccine, requesting that the Food and Drug Administration allow its use for individuals between 12 and 15 years old.. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. The FDA has authorized the emergency use of the Pfizer-BioNTechCOVID-19 Vaccine to prevent COVID-19in individuals12years of age and older under an Emergency Use Authorization (EUA). For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. [email protected]. Pfizer-BioNTech COVID-19 Vaccine. View the full release here: https://www.businesswire.com/news/home/20201120005370/en/. Jasmina Alatovic *Overall efficacy was calculated at >7 days after the second dose among persons without evidence of prior SARS-CoV-2 infection 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 timepoint 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; the timing for submission of manufacturing data to the FDA; our contemplated shipping and storage plan, including our estimated product shelflife 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. An emergency use authorization means what its name suggests: a medical product gets special authorization by the FDA to be used during an emergency -- but it is short of a full approval. Both collaborators are committed to developing this novel vaccine with preclinical and clinical data at the forefront of all their decision making. Pfizer has also asked the FDA for full approval of its vaccine, which means it would no longer be distributed under an emergency use authorization. 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. Sorry, you need to enable JavaScript to visit this website. An emergency use authorization, or EUA, isn’t the same as a full approval, which can typically take months. “Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. 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. The FDA is expanding its emergency use authorization for the Pfizer coronavirus vaccine to include children ages 12 through 15. Pfizer is bringing its leading in-house manufacturing capabilities to this effort, with the ability and experience to quickly scale, manufacture and distribute large quantities of vaccine at high quality, leveraging multiple sites in the U.S. and Europe, and complementing the mRNA manufacturing expertise of BioNTech, gained over almost a decade. This submission also is supported by solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. The decision will allow nearly 17 million more Americans to have the vaccine if they want it. 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, the BNT162 mRNA vaccine program and modRNA candidate BNT162b2 (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the submission of a request for Emergency Use Authorization and other regulatory submissions, the anticipated timing of regulatory submissions, regulatory approval or authorization and anticipated manufacturing, distribution and supply), that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed. After a highly anticipated meeting of its vaccine advisory committee this week, the U.S. Food and Drug Administration (FDA) announced today that it is issuing an emergency use authorization (EUA) for the COVID-19 vaccine developed by Pfizer and BioNTech. 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. Today, the Food and Drug Administration granted Emergency Use Authorization of the Pfizer COVID-19 vaccine for individuals 12 to 15 years old. 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. EMERGENCY USE AUTHORIZATION (EUA) OF . This press release features multimedia. The BNT162b2 vaccine candidate is not currently approved for distribution anywhere in the world. As providers work to distribute vaccines, Pfizer has requested Emergency Use Authorization for its vaccine to be used on 12 to 15-year-olds. While Pfizer and BioNTech await potential authorization or approval from regulatory agencies, the companies continue to work in collaboration with governments and Ministries of Health around the world that will distribute the vaccine, subject to authorization or approval, to help ensure it can reach those most in need as quickly as possible. Pfizer has only submitted two months … Pfizer says its vaccine is 100% effective in preventing illness among those in that age group. The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA). 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. In some cases, governments may have regulatory pathways similar to an EUA. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. The agency is holding another meeting Dec. 17 to determine whether they will issue one for the vaccine candidate from Moderna. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”. Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine, Therapeutic Modalities and Technology Platforms, Small Molecule Product & Process Development, Maintaining Emotional Well-Being During COVID-19, Meet our new Chief Patient Officer, Dr. Dara Richardson-Heron, Reducing Health Disparities in Latino Communities, Creating Cures Through Facility Investments, https://www.businesswire.com/news/home/20201120005370/en/. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic. The Pfizer vaccine is now the only COVID-19 vaccine given emergency use authorization for people that young. Companies were always expected to formally submit for approval, rather than emergency authorization, once they hit the six-month safety requirement. The companieshave already initiated rolling submissions with several regulatory agencies around the world, including the EMA and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days. +49 (0)6131 9084 1513 or +49 (0)151 1978 1385 Pfizer said last week it expects to submit for emergency use authorization for its COVID-19 vaccine for children ages 2 to 11 years old in September. The request follows last week’s release of late-trial data affirming the vaccine’s safety for that age group, along with 100% effectiveness in preventing COVID-19. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine. +1 (212) 733-7410 A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina. This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. 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.

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