FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech Covid-19 Vaccine in Children 5 to
FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech Covid-19 Vaccine in Children 5 to
- Committee reviewed clinical data showing a favorable safety profile and high vaccine efficacy of 90.7% in children 5 to <12 years of age during a period when Delta was the prevalent strain
- 10-µg dose level used in the trial for children 5 to <12 years of age was carefully selected based on safety, tolerability and immunogenicity data
- If Emergency Use Authorization is granted, the Pfizer-BioNTech COVID-19 Vaccine will be the first COVID-19 vaccine authorized in the U.S. for use in this age group
NEW YORK and MAINZ, GERMANY, OCTOBER 26, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 0, with 1 abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the companies' COVID-19 vaccine in children 5 to <12 years of age. VRBPAC is made up of independent experts who advise the FDA on scientific and regulatory matters, including the evaluation of vaccine safety and efficacy.
The committee reviewed the totality of scientific evidence shared by the companies, including results from a Phase 2/3 randomized, controlled trial that included ~4,500 children 5 to <12 years of age (2,268 from the original group and 2,379 from the supplemental safety group). Participants in this age group received a two-dose regimen of 10-µg doses administered 21 days apart, one-third of the 30-µg dose used for people 12 years and older. This dose level was carefully selected for use in the trial based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study. The Phase 2/3 trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine.
"We appreciated the opportunity to present our clinical data demonstrating the safety and high efficacy of our COVID-19 vaccine in children 5 to under 12 years of age," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the U.S., as they remain at risk for this infection. About 10% of all weekly U.S. cases occur in children 5 to under 12 years of age with a potential risk of complications. In addition, immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner. We thank the FDA advisory committee for their review and positive recommendation in support of Emergency Use Authorization to help protect this young population."
"We are committed to support the ongoing efforts to reduce infections and COVID-19 cases around the world by expanding the population of people protected against COVID-19," said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech. "The clinical data reviewed underline that our vaccine induces a strong immune response in children when Delta was the prevalent strain and thus may contribute to help address this public health crisis."
The FDA is expected to make its decision in the coming days. If authorized and subsequently recommended by the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), the Pfizer-BioNTech COVID-19 Vaccine will be the first COVID-19 vaccine available for use in children 5 to <12 years of age in the U.S. The companies expect to then begin shipping pediatric vaccine doses immediately, as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government's commitment to free access to COVID-19 vaccines.
Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency. Initial data from the other two age cohorts in the ongoing Pfizer-BioNTech clinical trial in children – those 2 to <5 years of age and those 6 months to <2 years of age – are expected as soon as fourth quarter 2021 or early first quarter 2022.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned or ongoing.
U.S. INDICATION & AUTHORIZED USE
HOW IS THE VACCINE GIVEN?
The vaccine will be given as an injection into the muscle.
Primary Series: The vaccine is administered as a 2-dose series, 3 weeks apart. A third dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.
Booster Dose:
- A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series to individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
- A single booster dose of the vaccine may be administered to certain individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding eligibility for, and timing of, the booster dose.
WHAT IS THE INDICATION AND AUTHORIZED USE?
The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 primary vaccination series or a booster dose.
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
- It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older.
- It is also authorized under EUA to provide:
-
- a two-dose primary series in individuals 12 through 15 years
- a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
- a single booster dose to the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
- a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series.
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
- a two-dose primary series in individuals 12 years of age and older
- a third primary series dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
- a single booster dose to the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
- a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series.
EUA Statement
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 12 years of age and older. The emergency uses are 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 EUA Fact Sheet at www.cvdvaccine-us.com.
IMPORTANT SAFETY INFORMATION
Individuals should not get the vaccine if they:
- had a severe allergic reaction after a previous dose of this vaccine
- had a severe allergic reaction to any ingredient of this vaccine
Individuals should tell the vaccination provider about all of their medical conditions, including if they:
- have any allergies
- have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects the immune system
- are pregnant, plan to become pregnant, or are breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
The vaccine may not protect everyone.
Side effects reported with the vaccine include:
- There is a remote chance that the vaccine could cause a severe allergic reaction
- A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
- Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
- If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
- Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
- chest pain
- shortness of breath
- feelings of having a fast-beating, fluttering, or pounding heart
- Side effects that have been reported with the vaccine include:
- severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine
- These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away
Data on administration of this vaccine at the same time as other vaccines has not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines, should discuss their options with their healthcare provider.
Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1‐800‐822‐7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Please click here for full Prescribing Information (16+ years of age). Please click here for Fact Sheet for Vaccination Providers (12+ years of age). Please click here for the Recipients and Caregivers Fact Sheet (12+ years of age).
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 170 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 October 26, 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 COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including the potential in children 5 to <12 years of age, a study in children 6 months to 5 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations 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 preclinical and clinical data (including the Phase 2/3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety 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 following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging 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 preclinical and 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 and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in younger pediatric populations, applications for a potential booster dose and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including the submission to request emergency use for children 5 to <12 years of age, potential submissions for younger pediatric populations, a potential booster dose or any other requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program 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 or marketing, 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, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or new variant-specific vaccines; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain 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 as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; 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, 2020 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 including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including the potential in children 5 to <12 years of age and a study in children 6 months to 5 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; 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 market demand, including our production estimates for 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 Annual Report as Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, 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.
CONTACTS
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PfizerMediaRelations@pfizer.com
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BioNTech:
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Media@biontech.de
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- 委员会审查的临床数据显示,在5至5岁的儿童中,疫苗具有良好的安全性和90.7%的高效力
- 试验中用于5至5岁儿童的10微克剂量水平
- 如果授予紧急使用授权,辉瑞-生物科技新冠肺炎疫苗将是美国批准用于治疗的第一种新冠肺炎疫苗这个年龄段
2021年10月26日,德国纽约和美因茨 — 辉瑞。(纽约证券交易所股票代码:PFE)和BioNTech SE(纳斯达克股票代码:BNTX)今天宣布,美国食品和药物管理局(FDA)疫苗及相关生物制品咨询委员会以17票赞成、0票反对、1票弃权的投票结果,建议食品和药物管理局授予这两家公司新冠肺炎疫苗用于5至5岁儿童的紧急使用授权。
该委员会审查了这些公司共享的全部科学证据,包括2/3期随机对照试验的结果,该试验包括约4500名5至5岁的儿童
我们非常感谢有机会展示我们的临床数据,证明我们的新冠肺炎疫苗在5至12岁以下儿童中的安全性和高效性。凯瑟琳·U·詹森(Kathrin U.Jansen)博士,辉瑞公司高级副总裁兼疫苗研发主管。“新冠肺炎对美国这个年龄段的2800多万儿童来说是一个持续的威胁,因为他们仍然处于感染的风险中。美国每周大约10%的病例发生在5岁到12岁以下的儿童中,他们有潜在的并发症风险。此外,给儿童接种疫苗将有助于我们更接近群体免疫力,有可能更快地遏制疫情。我们感谢食品和药物管理局顾问委员会的审查和积极建议,他们支持紧急使用授权,以帮助保护这一年轻群体。”
我们致力于通过扩大新冠肺炎保护者的人数来支持在世界各地减少感染和新冠肺炎病例的持续努力。özlem Türeci,医学博士,BioNTech联合创始人兼首席医疗官。审查的临床数据强调,当Delta是流行毒株时,我们的疫苗在儿童中诱导了强烈的免疫反应,因此可能有助于解决这一公共卫生危机。“
FDA预计将在未来几天做出决定。如果获得美国疾病控制和预防中心免疫实践咨询委员会的授权并随后推荐,辉瑞-生物科技新冠肺炎疫苗将成为第一种可用于5岁至5岁儿童的新冠肺炎疫苗。
辉瑞公司和生物科技公司已经向包括欧洲药品管理局在内的世界各地的其他监管机构提交了他们的新冠肺炎疫苗在这个年龄段的授权请求。来自正在进行的辉瑞-BioNTech儿童临床试验的其他两个年龄段队列的初步数据-这两个年龄段到
辉瑞-生物科技新冠肺炎疫苗是由生物科技和辉瑞共同开发的,它基于生物科技的专有基因技术。BioNTech是美国、欧盟、英国、加拿大的营销授权持有者,也是美国(与辉瑞联合)和其他国家的紧急使用授权或等价物的持有者。在最初获得紧急使用授权或同等许可的国家寻求监管批准的申请正在计划中或正在进行中。
美国的适应症和授权使用
疫苗是如何接种的?
疫苗将作为肌肉注射。
初级系列:疫苗以2剂系列接种,间隔3周。第三次接种可以在第二次接种后至少四周给那些被确定有某些免疫损害的个人。
助推器剂量:
- 单次加强剂量的疫苗可在初级系列结束后至少6个月接种给个人:
- 65岁及以上
- 18至64岁是严重新冠肺炎的高危人群
- 18至64岁,经常接触SARS-CoV-2机构或职业
- 可向使用不同授权新冠肺炎疫苗完成初级接种的某些个人接种单剂加强剂量的疫苗。个人应该咨询他们的医疗保健提供者,了解是否有资格获得加强剂量,以及时间安排。
适应症和授权用途是什么?
FDA批准的COMIRNATY®新冠肺炎疫苗和美国食品及药物管理局授权的辉瑞-生物技术新冠肺炎疫苗具有相同的配方,可互换用于提供新冠肺炎初级疫苗系列或加强剂量。
公益性®新冠肺炎疫苗是美国食品和药物管理局批准的新冠肺炎疫苗,由辉瑞公司为生物技术公司生产。
- 它被批准为两剂系列,用于16岁及以上的个人预防新冠肺炎。
- 根据欧盟协议,它还被授权提供:
-
- 在12至15岁的个体中进行的两剂初级系列试验
- 第三种初级系列剂量适用于12岁及以上已被确定为有某些免疫损害的个人
- 向以下已完成辉瑞-生物科技新冠肺炎疫苗或COMIRNATY®初级系列疫苗的个人提供单次加强剂:
- 65岁及以上
- 18至64岁是严重新冠肺炎的高危人群
- 18至64岁,经常接触SARS-CoV-2机构或职业
- 向使用不同授权新冠肺炎疫苗完成初级疫苗接种的合格个人提供单剂加强剂。加强剂资格和时间表基于用于初级系列的疫苗的标签信息。
辉瑞-生物科技新冠肺炎疫苗已获得美国食品和药物管理局的欧盟批准,将提供:
- 一项针对12岁及以上人群的双剂初级系列研究
- 第三个初级系列剂量适用于12岁及12岁以上已被确定为有某些免疫损害的个人
- 向以下已完成辉瑞-生物科技新冠肺炎疫苗或COMIRNATY®初级系列疫苗的个人提供单次加强剂:
- 65岁及以上
- 18至64岁是严重新冠肺炎的高危人群
- 18至64岁,经常接触SARS-CoV-2机构或职业
- 向使用不同授权新冠肺炎疫苗完成初级疫苗接种的合格个人提供单剂加强剂。加强剂资格和时间表基于用于初级系列的疫苗的标签信息。
EUA声明
疫苗的紧急使用尚未获得美国食品和药物管理局的批准或许可,但已获得美国食品和药物管理局的授权,根据紧急使用授权,在12岁及以上的个人中预防2019年冠状病毒病(新冠肺炎)。紧急使用仅在根据FD&C法案第564(B)(1)条存在有理由授权紧急使用医疗产品的情况的声明期间获得授权,除非声明被终止或授权被更早撤销。请访问www.cvdaccumon-us.com查看EUA情况说明书。
重要安全信息
个人应该不如果他们:
- 在前一剂疫苗后出现严重过敏反应
- 对这种疫苗的任何成分都有严重的过敏反应
个人应告知疫苗接种提供者他们的所有健康状况,包括他们是否:
- 有任何过敏症吗?
- 有过心肌炎(心肌发炎)或心包炎(心外膜发炎)
- 发烧了
- 有出血性疾病或正在服用血液稀释剂
- 免疫功能受损或正在服用影响免疫系统的药物
- 怀孕、计划怀孕或正在哺乳
- 已经接种了另一种新冠肺炎疫苗
- 曾因打针而晕倒过吗?
疫苗可能不会保护所有人。
据报道,疫苗的副作用包括:
- 疫苗引起严重过敏反应的可能性很小。
- 严重的过敏反应通常会在接种疫苗后的几分钟到一小时内发生。因此,疫苗接种提供者可以要求个人在接种疫苗后留在接种疫苗的地方进行监测。
- 严重过敏反应的症状包括呼吸困难、面部和喉咙肿胀、心跳加快、全身出现严重皮疹、头晕和虚弱。
- 如果一个人有严重的过敏反应,他们应该拨打9-1-1或去最近的医院。
- 一些接种疫苗的人出现了心肌炎(心肌炎症)和心包炎(心脏外衬里的炎症)。在这些人中,大多数人在接种第二剂疫苗后几天内开始出现症状。发生这种情况的可能性非常低。个别人士在接种疫苗后,如有下列任何病征,应立即求医:
- 胸痛
- 气短
- 心跳加速、扑腾或跳动的感觉
- 据报道,该疫苗的副作用包括:
- 严重过敏反应;非严重过敏反应,如皮疹、瘙痒、麻疹或面部肿胀;心肌炎(心肌炎症);心包炎(心脏外衬里炎症);注射部位疼痛;疲倦;头痛;肌肉疼痛;寒战;关节疼痛;发烧;注射部位肿胀;注射部位发红;恶心;感觉不适;淋巴结肿大(淋巴结病变);食欲减退;腹泻;呕吐;手臂疼痛;注射相关晕厥
- 这些可能不是疫苗所有可能的副作用。可能会出现严重且意想不到的副作用。该疫苗可能的副作用仍在临床试验中研究。打电话给疫苗接种提供者或医疗保健提供者,询问令人烦恼的副作用或持续不去的副作用
有关与其他疫苗同时接种该疫苗的数据尚未提交给FDA。考虑与其他疫苗一起接种这种疫苗的个人,应该与他们的医疗保健提供者讨论他们的选择。
患者应该总是向他们的医疗保健提供者寻求关于不良事件的医疗建议。鼓励个人向美国食品和药物管理局(FDA)和疾病控制和预防中心(CDC)报告疫苗的负面副作用。请访问http://www.vaers.hhs.gov或致电1-8008227967。此外,副作用可通过www.pfizerSafetyreporting.com或致电1-800-438-1985向辉瑞公司报告。
请点击此处查看完整的预售信息(16岁以上)。请单击此处查看疫苗接种提供者(12岁以上)的情况说明书。请单击此处查看受助人和照顾者情况说明书(12岁以上)。
关于辉瑞公司:改变患者生活的突破
在辉瑞,我们应用科学和我们的全球资源为人们带来延长和显著改善他们生活的疗法。我们致力于在发现、开发和制造保健产品(包括创新药物和疫苗)方面设定质量、安全和价值的标准。每天,辉瑞的同事们在发达国家和新兴市场工作,以促进健康、预防、治疗和治疗,挑战我们这个时代最令人畏惧的疾病。我们秉承作为全球首屈一指的创新型生物制药公司之一的责任,与医疗保健提供者、政府和当地社区合作,在世界各地支持和扩大获得可靠、负担得起的医疗保健的机会。170多年来,我们一直致力于为所有依赖我们的人带来改变。我们经常在我们的网站www.pfizer.com上发布对投资者可能重要的信息。此外,要了解更多信息,请访问www.pfizer.com,在Twitter上关注我们@Pfizer,在@Pfizer News、LinkedIn、YouTube上关注我们,在Facebook上关注我们(Facebook.com/Pfizer)。
辉瑞披露公告
本新闻稿中包含的信息截至2021年10月26日。辉瑞公司不承担因新信息或未来事件或发展而更新本新闻稿中包含的前瞻性陈述的义务。
本新闻稿包含有关辉瑞公司对抗新冠肺炎的努力、生物技术公司和辉瑞公司合作开发新冠肺炎疫苗、BNT162mRNA疫苗计划和COMIRNATY(新冠肺炎疫苗)(BNT162b2)(包括在5至5岁儿童中的潜力)的前瞻性信息
有关风险和不确定性的进一步描述,请参阅辉瑞公司截至2020年12月31日的财年的Form 10-K年度报告和随后的Form 10-Q报告,包括其中标题为“风险因素”和“前瞻性信息和可能影响未来业绩的因素”的章节,以及其后续的Form 8-K报告。这些报告都已提交给美国证券交易委员会(SEC),可在www.sec.gov和www.pfizer.com上查阅。
关于BioNTech
生物制药新技术公司是下一代免疫治疗公司,致力于开创癌症和其他严重疾病的新疗法。该公司利用广泛的计算发现和治疗药物平台来快速开发新型生物制药。其广泛的肿瘤学候选产品组合包括个性化和现成的基于mRNA的疗法、创新的嵌合抗原受体T细胞、双特异性检查点免疫调节剂、靶向癌症抗体和小分子。基于其在mRNA疫苗开发和内部制造能力方面的深厚专业知识,BioNTech及其合作者在其多样化的肿瘤学流水线的同时,正在为一系列传染病开发多种候选mRNA疫苗。BioNTech已经与多家全球制药合作伙伴建立了广泛的关系,其中包括Genmab、赛诺菲、拜耳动物健康公司、罗氏集团成员基因泰克、Regeneron、Genevant、复星国际制药公司和辉瑞公司。欲了解更多信息,请访问www.BioNTech.de。
BioNTech前瞻性陈述
本新闻稿包含符合1995年“私人证券诉讼改革法”的生物技术公司的“前瞻性声明”。这些前瞻性陈述可能包括但不限于以下陈述:生物技术公司对抗新冠肺炎的努力;生物技术公司和辉瑞公司之间的合作,包括开发新冠肺炎疫苗的计划和COMIRNATY(新冠肺炎疫苗)(BNT162b2)(包括在5至5岁儿童中的潜力)。
有关这些和其他风险和不确定性的讨论,请参阅BioNTech截至2020年12月31日的年度报告Form 20-F,该报告于2021年3月30日提交给证券交易委员会,可在证券交易委员会网站www.sec.gov上查阅。本新闻稿中的所有信息都是截至发布之日的信息,除非法律要求,否则BioNTech不承担更新这些信息的责任。
触点
辉瑞:
媒体关系
+1 (212) 733-1226
邮箱:PfizerMediaRelations@pfizer.com
投资者关系
+1 (212) 733-4848
邮箱:ir@pfizer.com
BioNTech:
媒体关系
茉莉·阿拉托维奇(Jasmina Alatovic)
+49 (0)6131 9084 1513
邮箱:media@biontech.de
投资者关系
西尔克·马斯(Sylke Maas),博士。
+49 (0)6131 9084 1074
邮箱:Investors@biontech.de
译文内容由第三方软件翻译。
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