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
Pfizer:
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PfizerMediaRelations@pfizer.com
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BioNTech:
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Media@biontech.de
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- 委員會審查的臨牀數據顯示,在5至5歲的兒童中,疫苗具有良好的安全性和90.7%的高效力
- 試驗中用於5至5歲兒童的10微克劑量水平
- 如果授予緊急使用授權,輝瑞-生物科技新冠肺炎疫苗將是美國批准用於治療的第一種新冠肺炎疫苗這個年齡段
2021年10月26日,德國紐約和美因茨 — 輝瑞。(紐約證券交易所股票代碼:PFE)和BioNTech SE(納斯達克股票代碼:BNTX)今天宣佈,美國食品和藥物管理局(FDA)疫苗及相關生物製品諮詢委員會以17票贊成、0票反對、1票棄權的投票結果,建議食品和藥物管理局授予這兩家公司新冠肺炎疫苗用於5至5歲兒童的緊急使用授權。
該委員會審查了這些公司共享的全部科學證據,包括2/3期隨機對照試驗的結果,該試驗包括約4500名5至5歲的兒童
我們非常感謝有機會展示我們的臨牀數據,證明我們的新冠肺炎疫苗在5至12歲以下兒童中的安全性和高效性。凱瑟琳·U·詹森(Kathrin U.Jansen)博士,輝瑞公司高級副總裁兼疫苗研發主管。“新冠肺炎對美國這個年齡段的2800多萬兒童來説是一個持續的威脅,因為他們仍然處於感染的風險中。美國每週大約10%的病例發生在5歲到12歲以下的兒童中,他們有潛在的併發症風險。此外,給兒童接種疫苗將有助於我們更接近羣體免疫力,有可能更快地遏制疫情。我們感謝食品和藥物管理局顧問委員會的審查和積極建議,他們支持緊急使用授權,以幫助保護這一年輕羣體。”
我們致力於通過擴大新冠肺炎保護者的人數來支持在世界各地減少感染和新冠肺炎病例的持續努力。özlem Türeci,醫學博士,BioNTech聯合創始人兼首席醫療官。審查的臨牀數據強調,當Delta是流行毒株時,我們的疫苗在兒童中誘導了強烈的免疫反應,因此可能有助於解決這一公共衞生危機。“
FDA預計將在未來幾天做出決定。如果獲得美國疾病控制和預防中心免疫實踐諮詢委員會的授權並隨後推薦,輝瑞-生物科技新冠肺炎疫苗將成為第一種可用於5歲至5歲兒童的新冠肺炎疫苗。
輝瑞公司和生物科技公司已經向包括歐洲藥品管理局在內的世界各地的其他監管機構提交了他們的新冠肺炎疫苗在這個年齡段的授權請求。來自正在進行的輝瑞-BioNTech兒童臨牀試驗的其他兩個年齡段隊列的初步數據-這兩個年齡段到
輝瑞-生物科技新冠肺炎疫苗是由生物科技和輝瑞共同開發的,它基於生物科技的專有基因技術。BioNTech是美國、歐盟、英國、加拿大的營銷授權持有者,也是美國(與輝瑞聯合)和其他國家的緊急使用授權或等價物的持有者。在最初獲得緊急使用授權或同等許可的國家尋求監管批准的申請正在計劃中或正在進行中。
美國的適應症和授權使用
疫苗是如何接種的?
疫苗將作為肌肉注射。
初級系列:疫苗以2劑系列接種,間隔3周。第三次接種可以在第二次接種後至少四周給那些被確定有某些免疫損害的個人。
助推器劑量:
- 單次加強劑量的疫苗可在初級系列結束後至少6個月接種給個人:
- 65歲及以上
- 18至64歲是嚴重新冠肺炎的高危人羣
- 18至64歲,經常接觸SARS-CoV-2機構或職業
- 可向使用不同授權新冠肺炎疫苗完成初級接種的某些個人接種單劑加強劑量的疫苗。個人應該諮詢他們的醫療保健提供者,瞭解是否有資格獲得加強劑量,以及時間安排。
適應症和授權用途是什麼?
FDA批准的COMIRNATY®新冠肺炎疫苗和美國食品及藥物管理局授權的輝瑞-生物技術新冠肺炎疫苗具有相同的配方,可互換用於提供新冠肺炎初級疫苗系列或加強劑量。
公益性®新冠肺炎疫苗是美國食品和藥物管理局批准的新冠肺炎疫苗,由輝瑞公司為生物技術公司生產。
- 它被批准為兩劑系列,用於16歲及以上的個人預防新冠肺炎。
- 根據歐盟協議,它還被授權提供:
-
- 在12至15歲的個體中進行的兩劑初級系列試驗
- 第三種初級系列劑量適用於12歲及以上已被確定為有某些免疫損害的個人
- 向以下已完成輝瑞-生物科技新冠肺炎疫苗或COMIRNATY®初級系列疫苗的個人提供單次加強劑:
- 65歲及以上
- 18至64歲是嚴重新冠肺炎的高危人羣
- 18至64歲,經常接觸SARS-CoV-2機構或職業
- 向使用不同授權新冠肺炎疫苗完成初級疫苗接種的合格個人提供單劑加強劑。加強劑資格和時間表基於用於初級系列的疫苗的標籤信息。
輝瑞-生物科技新冠肺炎疫苗已獲得美國食品和藥物管理局的歐盟批准,將提供:
- 一項針對12歲及以上人羣的雙劑初級系列研究
- 第三個初級系列劑量適用於12歲及12歲以上已被確定為有某些免疫損害的個人
- 向以下已完成輝瑞-生物科技新冠肺炎疫苗或COMIRNATY®初級系列疫苗的個人提供單次加強劑:
- 65歲及以上
- 18至64歲是嚴重新冠肺炎的高危人羣
- 18至64歲,經常接觸SARS-CoV-2機構或職業
- 向使用不同授權新冠肺炎疫苗完成初級疫苗接種的合格個人提供單劑加強劑。加強劑資格和時間表基於用於初級系列的疫苗的標籤信息。
EUA聲明
疫苗的緊急使用尚未獲得美國食品和藥物管理局的批准或許可,但已獲得美國食品和藥物管理局的授權,根據緊急使用授權,在12歲及以上的個人中預防2019年冠狀病毒病(新冠肺炎)。緊急使用僅在根據FD&C法案第564(B)(1)條存在有理由授權緊急使用醫療產品的情況的聲明期間獲得授權,除非聲明被終止或授權被更早撤銷。請訪問www.cvdaccumon-us.com查看EUA情況説明書。
重要安全信息
個人應該不如果他們:
- 在前一劑疫苗後出現嚴重過敏反應
- 對這種疫苗的任何成分都有嚴重的過敏反應
個人應告知疫苗接種提供者他們的所有健康狀況,包括他們是否:
- 有任何過敏症嗎?
- 有過心肌炎(心肌發炎)或心包炎(心外膜發炎)
- 發燒了
- 有出血性疾病或正在服用血液稀釋劑
- 免疫功能受損或正在服用影響免疫系統的藥物
- 懷孕、計劃懷孕或正在哺乳
- 已經接種了另一種新冠肺炎疫苗
- 曾因打針而暈倒過嗎?
疫苗可能不會保護所有人。
據報道,疫苗的副作用包括:
- 疫苗引起嚴重過敏反應的可能性很小。
- 嚴重的過敏反應通常會在接種疫苗後的幾分鐘到一小時內發生。因此,疫苗接種提供者可以要求個人在接種疫苗後留在接種疫苗的地方進行監測。
- 嚴重過敏反應的症狀包括呼吸困難、面部和喉嚨腫脹、心跳加快、全身出現嚴重皮疹、頭暈和虛弱。
- 如果一個人有嚴重的過敏反應,他們應該撥打9-1-1或去最近的醫院。
- 一些接種疫苗的人出現了心肌炎(心肌炎症)和心包炎(心臟外襯裏的炎症)。在這些人中,大多數人在接種第二劑疫苗後幾天內開始出現症狀。發生這種情況的可能性非常低。個別人士在接種疫苗後,如有下列任何病徵,應立即求醫:
- 胸痛
- 氣短
- 心跳加速、撲騰或跳動的感覺
- 據報道,該疫苗的副作用包括:
- 嚴重過敏反應;非嚴重過敏反應,如皮疹、瘙癢、麻疹或面部腫脹;心肌炎(心肌炎症);心包炎(心臟外襯裏炎症);注射部位疼痛;疲倦;頭痛;肌肉疼痛;寒戰;關節疼痛;發燒;注射部位腫脹;注射部位發紅;噁心;感覺不適;淋巴結腫大(淋巴結病變);食慾減退;腹瀉;嘔吐;手臂疼痛;注射相關暈厥
- 這些可能不是疫苗所有可能的副作用。可能會出現嚴重且意想不到的副作用。該疫苗可能的副作用仍在臨牀試驗中研究。打電話給疫苗接種提供者或醫療保健提供者,詢問令人煩惱的副作用或持續不去的副作用
有關與其他疫苗同時接種該疫苗的數據尚未提交給FDA。考慮與其他疫苗一起接種這種疫苗的個人,應該與他們的醫療保健提供者討論他們的選擇。
患者應該總是向他們的醫療保健提供者尋求關於不良事件的醫療建議。鼓勵個人向美國食品和藥物管理局(FDA)和疾病控制和預防中心(CDC)報告疫苗的負面副作用。請訪問http://www.vaers.hhs.gov或致電1-8008227967。此外,副作用可通過www.pfizerSafetyreporting.com或致電1-800-438-1985向輝瑞公司報告。
請點擊此處查看完整的預售信息(16歲以上)。請單擊此處查看疫苗接種提供者(12歲以上)的情況説明書。請單擊此處查看受助人和照顧者情況説明書(12歲以上)。
關於輝瑞公司:改變患者生活的突破
在輝瑞,我們應用科學和我們的全球資源為人們帶來延長和顯著改善他們生活的療法。我們致力於在發現、開發和製造保健產品(包括創新葯物和疫苗)方面設定質量、安全和價值的標準。每天,輝瑞的同事們在發達國家和新興市場工作,以促進健康、預防、治療和治療,挑戰我們這個時代最令人畏懼的疾病。我們秉承作為全球首屈一指的創新型生物製藥公司之一的責任,與醫療保健提供者、政府和當地社區合作,在世界各地支持和擴大獲得可靠、負擔得起的醫療保健的機會。170多年來,我們一直致力於為所有依賴我們的人帶來改變。我們經常在我們的網站www.pfizer.com上發佈對投資者可能重要的信息。此外,要了解更多信息,請訪問www.pfizer.com,在Twitter上關注我們@Pfizer,在@Pfizer News、LinkedIn、YouTube上關注我們,在Facebook上關注我們(Facebook.com/Pfizer)。
輝瑞披露公告
本新聞稿中包含的信息截至2021年10月26日。輝瑞公司不承擔因新信息或未來事件或發展而更新本新聞稿中包含的前瞻性陳述的義務。
本新聞稿包含有關輝瑞公司對抗新冠肺炎的努力、生物技術公司和輝瑞公司合作開發新冠肺炎疫苗、BNT162mRNA疫苗計劃和COMIRNATY(新冠肺炎疫苗)(BNT162b2)(包括在5至5歲兒童中的潛力)的前瞻性信息
有關風險和不確定性的進一步描述,請參閲輝瑞公司截至2020年12月31日的財年的Form 10-K年度報告和隨後的Form 10-Q報告,包括其中標題為“風險因素”和“前瞻性信息和可能影響未來業績的因素”的章節,以及其後續的Form 8-K報告。這些報告都已提交給美國證券交易委員會(SEC),可在www.sec.gov和www.pfizer.com上查閲。
關於BioNTech
生物製藥新技術公司是下一代免疫治療公司,致力於開創癌症和其他嚴重疾病的新療法。該公司利用廣泛的計算髮現和治療藥物平台來快速開發新型生物製藥。其廣泛的腫瘤學候選產品組合包括個性化和現成的基於mRNA的療法、創新的嵌合抗原受體T細胞、雙特異性檢查點免疫調節劑、靶向癌症抗體和小分子。基於其在mRNA疫苗開發和內部製造能力方面的深厚專業知識,BioNTech及其合作者在其多樣化的腫瘤學流水線的同時,正在為一系列傳染病開發多種候選mRNA疫苗。BioNTech已經與多家全球製藥合作伙伴建立了廣泛的關係,其中包括Genmab、賽諾菲、拜耳動物健康公司、羅氏集團成員基因泰克、Regeneron、Genevant、復星國際製藥公司和輝瑞公司。欲瞭解更多信息,請訪問www.BioNTech.de。
BioNTech前瞻性陳述
本新聞稿包含符合1995年“私人證券訴訟改革法”的生物技術公司的“前瞻性聲明”。這些前瞻性陳述可能包括但不限於以下陳述:生物技術公司對抗新冠肺炎的努力;生物技術公司和輝瑞公司之間的合作,包括開發新冠肺炎疫苗的計劃和COMIRNATY(新冠肺炎疫苗)(BNT162b2)(包括在5至5歲兒童中的潛力)。
有關這些和其他風險和不確定性的討論,請參閲BioNTech截至2020年12月31日的年度報告Form 20-F,該報告於2021年3月30日提交給證券交易委員會,可在證券交易委員會網站www.sec.gov上查閲。本新聞稿中的所有信息都是截至發佈之日的信息,除非法律要求,否則BioNTech不承擔更新這些信息的責任。
觸點
輝瑞:
媒體關係
+1 (212) 733-1226
郵箱:PfizerMediaRelations@pfizer.com
投資者關係
+1 (212) 733-4848
郵箱:ir@pfizer.com
BioNTech:
媒體關係
茉莉·阿拉托維奇(Jasmina Alatovic)
+49 (0)6131 9084 1513
郵箱:media@biontech.de
投資者關係
西爾克·馬斯(Sylke Maas),博士。
+49 (0)6131 9084 1074
郵箱:Investors@biontech.de
譯文內容由第三人軟體翻譯。
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