- Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and older
- Data demonstrate that the Omicron KP.2-adapted COVID-19 vaccine generates a substantially improved response against multiple circulating Omicron JN.1 sublineages as did the Omicron JN.1-adapted COVID-19 vaccine authorized by the European Commission in July 2024
- Doses will be ready to ship to applicable European Union member states as soon as possible upon European Commission authorization
NEW YORK and MAINZ, GERMANY, SEPTEMBER 20, 2024 — Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has recommended marketing authorization for the companies' Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY KP.2) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The European Commission ("EC") will review the CHMP's recommendation and is expected to make a final decision soon. Following the EC decision, Pfizer and BioNTech's Omicron KP.2-adapted COVID-19 vaccine will ship to European Union ("EU") member states that have specifically ordered this formulation.
The CHMP recommendation dated September 19, 2024, is based on the non-clinical and manufacturing data of the Omicron KP.2-adapted vaccine and the clinical and real-world evidence supporting the safety and efficacy of prior formulas of the COVID-19 vaccines by Pfizer and BioNTech. The non-clinical data showed that the KP.2-adapted vaccine generates a substantially improved response against multiple currently circulating Omicron JN.1 sublineages, including KP.2, LB.1, KP.3, and KP.3.1.1, compared with the companies' Omicron XBB.1.5-adapted COVID-19 vaccine.1
In July 2024, the EC granted marketing authorization for Pfizer and BioNTech's Omicron JN.1-adapted COVID-19 vaccine. This authorization was based on evidence showing that the JN.1-adapted COVID-19 vaccine generates a substantially improved response against multiple Omicron JN.1 sublineages, including KP.2, LB.1, KP.3, and KP.3.1.1, as compared with the companies' Omicron XBB. 1.5-adapted COVID-19 vaccine.
Pending authorization of the Omicron KP.2-adapted vaccine by the EC, both the Omicron KP.2-adapted vaccine and the Omicron JN.1-adapted vaccine will be available across the EU, though availability will vary based on individual country government requests and national recommendations.
In the United States, the U.S. Food and Drug Administration approved the companies' Omicron KP.2-adapted COVID-19 vaccine for individuals 12 years of age and older and granted emergency use authorization for individuals 6 months through 11 years of age on August 22, 2024. Pfizer and BioNTech will continue to monitor the evolving epidemiology of COVID-19 and remain prepared to develop modified vaccine formulas as the data support and as regulatory agencies recommend.
The COVID-19 vaccines (COMIRNATY) by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
AUTHORIZED USE IN THE EU:
COMIRNATY ▼ has been granted standard marketing authorization (MA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in individuals from the age of 6 months. The vaccine is administered as a single dose in people 5 years of age and older, and as a three-dose series, in infants and children from 6 months to 4 years who have not had COVID-19 with the first two doses are given three weeks apart, followed by a third dose given at least 8 weeks after the second dose. Adults and adolescents from the age of 12 are given 30 micrograms per dose; children aged 5 to 11 years are given 10 micrograms per dose; infants and children aged 6 months to 4 years are given 3 micrograms per dose. Additional doses may be administered to individuals aged 5 years and older who are severely immunocompromised in accordance with national recommendations. The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are available.
COMIRNATYJN.1 contains mRNA encoding for the spike protein of the JN.1 subvariant of SARS-CoV-2.
COMIRNATY JN.1may be administered as a single dose regardless of prior vaccination status in people aged 5 years and older. Children from 6 months to 4 years of age may have one or three doses depending on whether they have completed a primary vaccination course or have had COVID-19. There should be an interval of at least 3 months between administration of COMIRNATY JN.1 and the last prior dose of a COVID-19 vaccine.
IMPORTANT SAFETY INFORMATION
- Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
- There is an increased, but very rare risk (<1/10,000 cases) of myocarditis and pericarditis following vaccination with COMIRNATY. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males. Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed.
- From post-marketing experience very rare adverse reactions of myocarditis and pericarditis, uncommon incidence of dizziness; common incidence of vomiting, very common diarrhoea and unknown incidence (cannot be estimated from available data) of, paraesthesia, hypoaesthesia and erythema multiforme, extensive swelling of vaccinated limb, facial swelling (in vaccine recipients with a history of injection of dermatological fillers) have been identified.
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, paresthesia, hypoesthesia and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting.
- Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
- As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
- The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY JN.1may be lower in immunosuppressed individuals.
- As with any vaccine, vaccination with COMIRNATY JN.1 may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their vaccination.
- Adverse reactions observed during clinical studies and identified after post authorization experience are listed below according to the following frequency categories: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000).
- Very common side effects: injection site pain, injection site swelling, fever, chills, fatigue, headache, muscle pain, joint pain, diarrhea.
- Common side effects: injection site redness, nausea, vomiting, enlarged lymph nodes (more frequently observed after a booster dose).
- Uncommon side effects: feeling unwell, arm pain, insomnia, dizziness, injection site itching, allergic reactions such as rash, itching, feeling weak or lack of energy/sleepy, decreased appetite, excessive sweating, night sweats.
- Rare side effects: temporary one-sided facial drooping, allergic reactions such as hives or swelling of the face.
- Very rare side effects: inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis), which can result in breathlessness, palpitations or chest pain.
- Not known incidence (cannot be estimated from the available data): anaphylaxis, extensive swelling of vaccinated limbs; facial swelling, pins and needles/tingling, reduced sense of touch or sensation, a skin reaction that causes red spots or patches on the skin, heavy menstrual bleeding.
- Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received 58 micrograms of COMIRNATY. The vaccine recipients did not report an increase in reactogenicity or adverse reactions. In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
- A large amount of observational data from pregnant women vaccinated with the initially approved COMIRNATY vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. No data are available yet regarding the use of COMIRNATY JN.1during pregnancy. Based on data available with other vaccine variants, COMIRNATY JN.1can be used during pregnancy.
- No data are available yet regarding the use of COMIRNATY JN.1during breast-feeding. Observational data from women who were breast-feeding after vaccination with the initially approved COMIRNATY vaccine have not shown a risk for adverse effects in breast-fed newborns/infants. COMIRNATY JN.1can be used during breast-feeding.
- Interactions with other medicinal products or concomitant administration of COMIRNATY JN.1with other vaccines has not been studied in 3 mcg and 10 mcg dose. For 30 mcg dose, COMIRNATY JN.1may be administered concomitantly with seasonal influenza vaccine. Different injectable vaccines should be given at different injection sites.
- Animal studies with COMIRNATY Original do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
- The most frequent adverse reactions in infants 6 to 23 months of age that received any primary course dose included irritability (> 60%), drowsiness (> 40%), decreased appetite (> 30%), tenderness at the injection site (> 20%), injection site redness and fever (> 10%).
- The most frequent adverse reactions in children 2 to 4 years of age that received any primary course dose included pain at injection site and fatigue (> 40%), injection site redness and fever (> 10%).
- The overall safety profile of COMIRNATY in participants 5 to 11 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in children 5 to 11 years of age that received 2 doses were injection site pain (> 80%), fatigue (> 50%), headache (> 30%), injection site redness and swelling (≥ 20%), myalgia, chills, and diarrhoea (> 10%).
- The overall safety profile for the booster dose was similar to that seen after the primary course. The most frequent adverse reactions in children 5 to 11 years of age were injection site pain (> 60%), fatigue (> 30%), headache (> 20%), myalgia, chills, injection site redness and swelling (> 10%)
- The overall safety profile of COMIRNATY in adolescents 12 to 15 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in adolescents 12 to 15 years of age that received 2 doses were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).
- The most frequent adverse reactions in participants 16 years of age and older that received 2 doses were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 40%), chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
- The safety profile for the booster dose (third dose) was similar to that seen after 2 doses. The most frequent adverse reactions in participants 18 to 55 years of age were injection site pain (> 80%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills and arthralgia (> 20%).
- The safety profile for the COMIRNATY Original/Omicron BA.4-5 booster (fourth dose) was similar to that seen after 3 doses. The most frequent adverse reaction in participants 6 to 23 months of age was irritability (> 20%), decreased appetite (> 10%), and drowsiness (> 10%). The most frequent adverse reactions in participants 2 to 4 years of age were injection site pain (> 30%) and fatigue (> 20%). The most frequent adverse reactions in participants 5 to 11 years of age were injection site pain (> 60%), fatigue (> 40%), headache (> 20%), and muscle pain (> 10%). The most frequent adverse reactions in participants 12 years of age and older were injection site pain (> 60%), fatigue (> 50%), headache (> 40%), muscle pain (> 20%), chills (> 10%), and joint pain (> 10%).
- The safety of COMIRNATY JN.1 is inferred from safety data of the prior COMIRNATY vaccines.
- The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. As with any vaccine, vaccination with COMIRNATY JN.1may not protect all vaccine recipients.
- For complete information on the safety of COMIRNATY JN.1, always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website.
The black equilateral triangle ▼ denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance or directly to BioNTech using email medinfo@biontech.de, telephone +49 6131 9084 0, or via the website
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 175 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 . In addition, to learn more, please visit us on and follow us on X 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 September 20, 2024. 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 BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) including an Omicron-adapted monovalent COVID-19 vaccine candidate, based on the KP.2 strain of the JN.1 lineage, including a positive Committee for Medicinal Products for Human Use (CHMP) opinion for an Omicron KP.2-adapted COVID-19 vaccine in the European Union, expectations regarding the demand for COVID-19 vaccines, planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated availability, 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 Phase 1/2/3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, 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, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine 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 additional populations, for a potential booster dose for BNT162b2, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), 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, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent or bivalent vaccine candidates (including any submissions to regulatory authorities for the COVID-19 vaccine tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage), 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 or not meet expectations which may lead to reduced revenues or excess inventory on-hand and/or in the channel which, for our COVID-19 vaccine, resulted in significant inventory write-offs in 2023 and could continue to result in inventory write-offs, or other unanticipated charges; challenges related to the transition to the commercial market for our COVID-19 vaccine; uncertainties related to the public's adherence to vaccines, boosters, treatments or combinations; risks related to our ability to accurately predict or achieve our revenue forecasts for our COVID-19 vaccine or any potential future COVID-19 vaccines; potential third-party royalties or other claims related to our COVID-19 vaccine; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test a vaccine; challenges related to our vaccine's formulation, dosing 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 potential future annual boosters or re-vaccinations or new variant-based vaccines or combination vaccines; the risk that we may not be able to maintain 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, 2023 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 .
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech 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 (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as 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 and specialized pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.
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BioNTech Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer; the rate and degree of market acceptance of BioNTech's COVID-19 vaccine, including the Omicron KP.2-adapted monovalent COVID-19 vaccine; qualitative assessments of available data and expectations of potential benefits, including the adapted vaccine's response against multiple currently circulating Omicron JN.1 sublineages, including KP.2, LB.1, KP.3, and KP.3.1.1; regulatory submissions and regulatory approvals or authorizations and expectations regarding manufacturing, distribution and supply; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment; and expected regulatory recommendations to adapt vaccines to address new variants or sublineages. 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These risks and uncertainties include, but are not limited to: 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 data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech's pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after BioNTech's initial sales to national governments; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; the availability of raw materials to manufacture a vaccine; our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; competition from other COVID-19 vaccines or related to BioNTech's other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; 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; the timing of and BioNTech's ability to obtain and maintain regulatory approval for BioNTech's product candidates; the ability of BioNTech's COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's and its counterparties' ability to manage and source necessary energy resources; BioNTech's ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech's third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of the COVID-19 pandemic on BioNTech's development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of BioNTech's COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech; BioNTech's and its collaborators' ability to commercialize and market BioNTech's COVID-19 vaccine and, if approved, its product candidates; BioNTech's ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech's ability to effectively scale BioNTech's production capabilities and manufacture BioNTech's products, including BioNTech's target COVID-19 vaccine production levels, and BioNTech's product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.
You should review the risks and uncertainties described under the heading "Risk Factors" in BioNTech's Report on Form 6-K for the period ended June 30, 2024, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC's website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
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1 Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Presentation- Pfizer/BioNTech Clinical and Preclinical Supportive Data 2024-2025 COVID19 Vaccine Formula. . Accessed 23 August 2024.
- 在歐洲委員會的授權下,Omicron KP.2改良的COVID-19疫苗將適用於6個月及以上的個體。
- 數據表明,Omicron KP.2改良的COVID-19疫苗對多個流行的Omicron JN.1亞線型產生了大幅改良的反應,就像歐洲委員會於2024年7月授權的Omicron JN.1改良的COVID-19疫苗一樣。
- 一旦歐洲委員會授權,劑量將準備好運送到適用的歐盟成員國。
紐約和德國邁因茨,2024年9月20日 — 輝瑞製藥公司(紐約證券交易所:輝瑞(Pfizer),NASDAQ:biontech(biontech))今天宣佈,歐洲藥品管理局(EMA)的人用藥品委員會(CHMP)推薦市場授權公司的歐米康 JN.1 -改編的單價COVID-19疫苗(COMIRNATY)用於6個月及以上的人進行積極免疫,以預防由SARS-CoV-2引起的COVID-19。 該適應基於世界衛生組織(WHO) COVID-19疫苗組成技術諮詢組的建議和歐洲藥品管理局緊急任務部隊(ETF)推薦更新COVID-19疫苗以針對2024-2025年的SARS-CoV-2 JN.1變體。ETF表示,「證據表明,瞄準JN.1將有助於保持疫苗的有效性,因爲SARS-CoV-2繼續進化。」BioNTech SE (納斯達克:BNTX,"biontech")今天宣佈,歐洲藥品監督管理局("EMA")的人用藥評估委員會("CHMP")已推薦對該公司的Omicron KP.2改良單價COVID-19疫苗(COMIRNATY KP.2)進行市場授權用於6個月及以上年齡段的個體中活躍的免疫以預防由SARS-CoV-2引起的COVID-19。歐洲委員會("EC")將審查CHMP的建議,並有望很快做出最終決定。在EC的決定之後,輝瑞和biontech的Omicron KP.2改良COVID-19疫苗將運送到已特別訂購此配方的歐盟成員國。
2024年9月19日CHMP的推薦基於Omicron KP.2適應性疫苗的非臨床和製造數據,以及支持輝瑞和biontech先前COVID-19疫苗配方的臨床和現實世界證據。非臨床數據顯示,KP.2適應性疫苗對多個當前流行的Omicron JN.1亞型,包括KP.2、Lb.1、KP.3和KP.3.1.1,的反應比公司的Omicron XBb.1.5適應性COVID-19疫苗有顯着改善。
2024年7月,EC批准了輝瑞和biontech的Omicron JN.1適應性COVID-19疫苗的營銷授權。這一授權基於證據,顯示JN.1適應性COVID-19疫苗對多個Omicron JN.1亞型,包括KP.2、Lb.1、KP.3和KP.3.1.1,的反應明顯改善,與公司的Omicron XBb.1.5適應性COVID-19疫苗相比。
在Omicron KP.2適應性疫苗獲得EC授權之前,歐盟將提供Omicron KP.2適應性疫苗和Omicron JN.1適應性疫苗,儘管供應將根據個別國家政府的要求和國家建議而有所不同。
在美國,美國食品和藥物管理局於2024年8月22日批准了公司的Omicron KP.2改良COVID-19疫苗,適用於12歲及以上的個人,並授予了6個月至11歲個體的緊急使用授權。輝瑞和biontech將繼續監測COVID-19的流行病學發展,並準備根據數據支持和監管機構的建議開發修改後的疫苗配方。
輝瑞和biontech的COVID-19疫苗(COMIRNATY)基於biontech的專有mRNA技術,並由兩家公司共同開發。biontech是COMIRNATY和其適應的疫苗在美國、歐盟、英國和其他國家的上市授權持有人,並在美國(與輝瑞聯合)和其他國家持有緊急使用授權或相當資格的持有人。
在歐盟的授權使用:
歐洲委員會已授予COMIRNATY標準的預防2019冠狀病毒病(COVID-19)的市場授權(MA),適用於6個月及以上的個人。該疫苗在5歲及以上人群中單劑使用,在6個月至4歲未感染COVID-19的嬰幼兒和兒童中,按三劑方案接種,兩劑間隔三週,隨後至少8周後再接種第三劑。12歲及以上的成年人和青少年每劑給予30微克;5至11歲的兒童每劑給予10微克;6個月至4歲的嬰幼兒和兒童每劑給予3微克。根據國家建議,可能需要向5歲及以上嚴重免疫功能受損的個人接種額外劑次。歐洲藥品管理局(EMA)的人用藥品委員會(CHMP)已完成了對COMIRNATY的嚴格評估,並一致認爲疫苗的質量、安全性和有效性具有充分有力的數據。
COMIRNATY JN.1 包含對 SARS-CoV-2 JN.1 亞變體刺突蛋白編碼的 mRNA。
COMIRNATY JN.1可以在5歲及以上人群中單劑使用,不論之前是否接種過疫苗。6個月至4歲兒童根據是否完成初次接種課程或已患COVID-19可能需要接種一劑或三劑。 COMIRNATY JN.1接種和最後一劑COVID-19疫苗之間應間隔至少3個月。
重要安全信息
- 已報告過敏反應事件。在注射疫苗後,應始終隨時做好適當的醫療治療和監督,以防止過敏反應。
- 接種COMIRNATY後會出現心肌炎和心包炎的風險增加,但非常罕見(<1/10,000),這些症狀可能在接種後的幾天內發展,並主要發生在14天內。他們在第二次接種後更常見,在年輕男性中更常見。可用數據表明,大多數病例都恢復了。有些病例需要重症監護支持,並觀察到有致命病例。
- 根據市場後經驗,已經發現了非常罕見的心肌炎和心包炎不良反應,少見的頭暈發生率;嘔吐的發生率普遍,腹瀉非常普遍,未知的感覺異常發生率(無法從現有數據中估計),還有感覺異常、皮膚紅斑、疫苗接種部位腫脹、面部腫脹(曾注射皮膚填充劑的疫苗接種者)等。
- 接種疫苗過程中可能會發生與憂鬱症相關的反應,包括迷走神經反應(暈厥)、過度通氣或與壓力有關的反應(例如頭暈、心悸、心率增快、血壓變化、手腳麻木、感覺遲鈍和出汗)。與壓力相關的反應是臨時的,自行消退。應建議個人向接種醫生報告症狀以進行評估。應採取預防措施以避免因暈厥而造成的傷害。
- 接種COVID-19疫苗應推遲接種急性重症發熱疾病或急性感染的個體。雖然存在輕微感染和/或低熱病的人,但不應延遲接種。
- 與其他肌內注射一樣,應在接受抗凝治療或具有血小板減少或任何凝血障礙(如血友病)的個體中謹慎使用該疫苗,因爲這些個體在肌肉注射後可能出現出血或淤青。
- 該疫苗的療效、安全性和免疫原性尚未在免疫功能受損的個體中進行評估,包括正在接受免疫抑制治療的人群。在免疫抑制的個體中,COMIRNATY JN.1的療效可能較低。
- 與任何疫苗一樣,使用COMIRNATY JN.1接種可能不能保護所有接種者。個體接種後可能需要7天才能完全受到保護。
- 在臨床研究期間和授權後的實施經驗中觀察到的不良反應根據以下頻率類別列出:非常常見(≥ 1/10),常見(≥ 1/100到< 1/10),不常見(≥ 1/1,000到< 1/100),罕見(≥ 1/10,000到< 1/1,000),非常罕見(< 1/10,000)。
- 常見副作用:注射部位疼痛、注射部位腫脹、發熱、寒戰、疲勞、頭痛、肌肉疼痛、關節疼痛、腹瀉。
- 普通副作用:注射部位紅腫、噁心、嘔吐、淋巴結腫大(接種加強劑後觀察到更頻繁)。
- 不常見的副作用:不適感、胳膊疼痛、失眠、頭暈、注射部位瘙癢、過敏反應如皮疹、瘙癢、感到虛弱或缺乏精力/睏倦、食慾減退、過度出汗、盜汗。
- 罕見的副作用:暫時性單側面部下垂,過敏反應,例如蕁麻疹或面部腫脹。
- 極少見的副作用:心肌炎(心臟肌肉炎)或心臟外層膜炎(心包炎)的炎症,可能導致呼吸急促、心悸或胸痛。
- 無已知發生率(無法根據現有數據估計):過敏性反應(即嚴重過敏反應)、接種肢體腫脹、面部腫脹、針刺/刺痛、觸覺降低或感覺異常、導致皮膚上出現紅點或斑塊的皮膚反應、月經過多出血。
- 在臨床試驗中,由於稀釋錯誤,52名參與者接種了58微克的輝瑞疫苗。疫苗接種者沒有報告接種反應或不良反應的增加。在劑量過量的情況下,建議監測生命體徵並進行可能的症狀性治療。
- 來自接種最初批准的輝瑞疫苗的孕婦的大量觀察數據顯示,孕婦在第二和第三孕期接種疫苗並沒有增加不良妊娠結局的風險。雖然目前對第一孕期接種疫苗的妊娠結局數據有限,但沒有觀察到流產風險的增加。目前尚無關於在孕期使用輝瑞疫苗JN.1的數據。基於對其他疫苗變種的可用數據,輝瑞疫苗JN.1可以在孕期使用。
- 關於在哺乳期使用輝瑞疫苗JN.1的數據尚不可用。來自接種最初批准的輝瑞疫苗後哺乳的婦女的觀察數據顯示,母乳餵養的新生兒/嬰兒沒有出現不良反應的風險。輝瑞疫苗JN.1在哺乳期可以使用。
- 尚未研究COMIRNATY JN.1與其他藥物的相互作用或與其他疫苗同時接種的情況。對於30微克劑量,COMIRNATY JN.1可以與季節性流感疫苗同時接種。不同的可注射疫苗應在不同的注射部位給予。
- 接種原始COMIRNATY疫苗的動物研究表明,不存在任何關於生殖毒性方面的直接或間接有害影響。
- 6至23個月齡接受任何初級課程劑量的嬰兒中最常見的不良反應包括刺激性(>60%)、嗜睡(>40%)、食慾減退(>30%)、注射部位觸痛(>20%)、注射部位紅腫和發熱(>10%)。
- 2至4歲接受任何初級課程劑量的兒童中最常見的不良反應包括注射部位疼痛和疲勞(> 40%)、注射部位紅腫和發熱(> 10%)。
- 5至11歲孩子接種2劑疫苗後,總體安全性與16歲及以上的參與者相似。5至11歲兒童中接種2劑次的最常見不良反應是注射部位疼痛(> 80%)、疲勞(> 50%)、頭痛(> 30%)、注射部位紅腫和水腫(> 20%),肌肉痛、發冷和腹瀉(> 10%)。
- 第三劑次(增強劑)後的總體安全性與主要課程後相似。5至11歲兒童中最常見的不良反應是注射部位疼痛(> 60%)、疲勞(> 30%)、頭痛(> 20%)、肌肉痛、發冷、注射部位紅腫和腫脹(> 10%)。
- 12至15歲青少年的總體安全性與16歲及以上的參與者相似。12至15歲青少年中接種2劑疫苗後,最常見的不良反應是注射部位疼痛(> 90%)、疲勞和頭痛(> 70%)、肌肉痛和發冷(> 40%)、關節痛和發熱(> 20%)。
- 16歲及以上參與者接種2劑次的最頻繁不良反應是注射部位疼痛(> 80%)、疲勞(> 60%)、頭痛(> 50%)、肌肉痛(> 40%)、發冷(> 30%)、關節痛(> 20%)、發熱和注射部位腫脹(> 10%),通常是輕度或中度的,幾天後症狀就會消失。較大年齡段與副反應事件發生的幾率略有降低。
- 第三劑(加強劑)的安全性與兩劑後的情況類似。18到55歲參與者最常見的不良反應是注射部位疼痛(>80%)、疲勞(>60%)、頭痛(>40%)、肌肉痛(>30%)、畏寒和關節痛(>20%)。
- 接種COMIRNATY Original/Omicron BA.4-5增強劑(第四劑次)後的安全性與接種3劑後相似。6至23個月齡參與者中最常見的不良反應是刺激性(> 20%)、食慾減退(> 10%)和嗜睡(> 10%)。2至4歲參與者中最常見的不良反應是注射部位疼痛(> 30%)和疲勞(> 20%)。5至11歲參與者中最常見的不良反應是注射部位疼痛(> 60%)、疲勞(> 40%)、頭痛(> 20%)和肌肉疼痛(> 10%)。12歲及以上參與者中最常見的不良反應是注射部位疼痛(> 60%)、疲勞(> 50%)、頭痛(> 40%)、肌肉疼痛(> 20%)、發冷(> 10%)和關節痛(> 10%)。
- COMIRNATY JN.1 的安全性推斷於先前的 COMIRNATY 疫苗的安全數據。
- 疫苗提供的保護持續時間目前尚不清楚,因爲它仍在進行中的臨床試驗中確定。與任何疫苗一樣,接種 COMIRNATY JN.1 可能不能保護所有疫苗接種者。
- 有關 COMIRNATY JN.1 安全性的完整信息,請始終參考歐洲藥物管理局網站上提供的歐盟所有語言的批准產品特徵摘要和包裝說明書。
黑色三角形 ▼ 表示需要額外監測以獲取任何不良反應。這將有助於快速識別新的安全信息。個人可以通過向 EudraVigilance 或直接向 BioNTech 發送電子郵件 ,或通過電話 +49 6131 9084 0 ,或通過網站來報告任何可能發生的副作用。 medinfo@biontech.de,電話 +49 6131 9084 0 ,或通過網站
關於輝瑞:突破改變患者的生命
本發佈中所包含的信息截至2024年8月16日。輝瑞不承擔更新本發佈中的前瞻性聲明的義務,因爲會有新信息,事件或發展。 或了解更多信息,請訪問我們的網站,在X上關注我們@Pfizer和@Pfizer News,並在Facebook上點贊。本文中包含的信息截至2024年6月27日。輝瑞不承擔更新本公告中的前瞻性聲明的義務。(COVID-19疫苗,mRNA)(BNT162b2),包括一種Omicron適應性單價COVID-19疫苗候選者,基於JN.1譜系,包括向歐洲藥品管理局(EMA)提交一種基於JN.1譜系的Omicron適應性單價COVID-19疫苗,有關COVID-19疫苗的需求預期,計劃的監管提交,可用數據的定性評估,潛在的好處,臨床試驗的預期,潛在的監管提交,預期的數據讀數時間,監管提交,監管批准或授權以及預期的大規模製造、分銷和供應。這些都涉及到大量的風險和不確定性,可能導致實際結果與這些聲明所表達或暗示的結果有重大差異。風險和不確定性包括但不限於研究和開發的不確定性,包括滿足預期的臨床終點,開始和/或完成臨床試驗的日期,監管提交日期,監管批准日期和/或上市日期,以及有關兒童、青少年或成人的任何單價或雙價疫苗候選者或BNT162項目中的任何其他疫苗候選者的我們所有研究中的任何數據(包括1/2/3期或4期數據),包括本公告中爲BNT162b2、任何單價或雙價疫苗候選者或BNT162計劃中的任何其他疫苗候選者或任何實際證據的數據,包括可能的不利新的臨床前、臨床或安全數據和現有臨床前、臨床或安全數據的進一步分析;能否產生可比的臨床或其他結果,包括迄今爲止觀察到的疫苗有效性和安全性以及可耐受性;任何其他次生效應的觀察來分析臨床或其他數據;能否在更大、更多樣化的人群中進行實際數據研究分析或在發刊之前的進一步分析中產生可比的臨床或其他結果;BNT162b2、任何單價或雙價疫苗候選者或任何未來疫苗能否預防因新興病毒變種引起的COVID-19;使用疫苗更加廣泛會不會提供關於疫苗的新信息,包括效力、安全性或其他方面的信息,包括產生額外嚴重不良反應的風險;臨床前和臨床試驗數據的風險和不確定性,包括科學界的同行評審或出版過程期間的對數據進行的不同解釋和評估以及監管機構的評估;BNT162 mRNA疫苗程序的任何其他數據是否會在科學期刊中出版,如果出版,何時以及在進行何種修改和解釋;監管機構是否會對這些和任何未來臨床前和臨床研究的設計和結果感到滿意;以及提交請求爲BNT162b2在其他人群中請求緊急使用或有條件銷售授權、爲BNT162b2、任何單價或雙價疫苗候選者向特定司法轄區提交任何其他生物許可和/或緊急使用授權申請或修改任何該等申請的時機和是否提交,以及如果獲得,在何時將出現這樣的緊急使用授權或許可;提交請求BNT162b2(包括任何緊急使用或有條件銷售授權的請求的修正),任何單價或雙價疫苗候選者(包括基於JN.1譜系的Omicron適應性單價COVID-19疫苗的提交給EMA),或BNT162計劃可能會產生的其他疫苗的任何申請是否會得到特定監管機構的批准,這將取決於無數因素,包括是否作出決定認爲該疫苗的益處超過其已知的風險,以及該疫苗的功效,並且如果獲得批准,它是否會獲得商業上的成功;監管機構是否會有影響標籤或營銷、製造過程、安全和/或其他事項的決定,這些決定可能影響疫苗可用性或商業潛力,包括其他公司開發產品或療法;我們與合作伙伴、臨床試驗網站或第三方供應商的關係出現中斷的風險;任何產品的需求量可能會減少或不再存在或不能滿足預期,這可能導致營收減少或手頭和/或渠道管道中存在過量庫存,對於我們的COVID-19疫苗,2023年產生了顯着的庫存減值,可能繼續導致庫存減值或其他意外費用;關於我們的COVID-19疫苗向商業市場的轉型存在挑戰;與公衆接種疫苗、加強劑、治療方案或組合相關的挑戰;關於我們能否準確預測或實現我們對我們的COVID-19疫苗或任何潛在未來COVID-19疫苗的營收預測的不確定性;涉及我們的COVID-19疫苗產生第三方版稅或其他索賠的風險;其他公司可能會生產出更優秀或競爭性的產品的風險;涉及獲得原材料進行疫苗製造或測試的風險;與我們疫苗的配方、劑量時間表以及相應的存儲、分銷和管理要求相關的挑戰,包括涉及輝瑞交付後的存儲和處理的風險;我們可能無法成功開發其他疫苗配方、加強劑或潛在未來的年度加強劑或補種,或基於新變種的疫苗;我們可能無法按時保持或擴大製造能力,或按與全球對我們的疫苗的需求相符的時間表,保持物流或供應渠道的訪問,這將對我們在預期時間範圍內提供疫苗預估的劑量數產生負面影響,以前述所示;是否會達成額外供應協議存在不確定性;能否獲得來自疫苗諮詢或技術委員會以及其他公共衛生機構的建議存在不確定性,以及任何此類建議的商業影響的不確定性;與公衆對疫苗信心或認識有關的挑戰;關於COVID-19對輝瑞業務、運營和財務結果的影響的不確定性;以及競爭發展。@Pfizer和頁面。@Pfizer News, LinkedIn, YouTube,並在Facebook上點贊Facebook.com/Pfizer.
輝瑞披露聲明
此發佈內容截至2024年9月20日。輝瑞不承擔更新此發佈中前瞻性聲明的義務,因爲新信息、未來事件或發展結果。
本發佈包含有關輝瑞努力抗擊COVID-19、輝瑞與biontech合作開發COVID-19疫苗、BNT162b2 mRNA疫苗計劃以及輝瑞-biontech COVID-19疫苗(也稱爲COMIRNATY)的前瞻性信息(COVID-19疫苗,mRNA)(BNT162b2),包括一種針對Omicron適應的單價COVID-19疫苗候選疫苗,基於JN.1譜系的KP.2株,包括歐盟對Omicron KP.2適應的COVID-19疫苗的積極藥品人類應用委員會(CHMP)意見,有關COVID-19疫苗需求的預期,計劃的監管提交,對可用數據的定性評估,潛在好處,臨床試驗的預期,潛在監管提交,數據披露的預期時間,監管提交,監管批准或授權和預期供應,製造,分發和涉及實質性風險的供應,這些風險和不確定性可能導致實際結果與此類聲明所表達的結果大不相同。風險和不確定性包括但不限於研究和開發固有的不確定性,包括是否能夠實現預期的臨床終點、臨床試驗的開始和/或完成日期,監管提交日期,監管批准日期和/或上市日期,以及與臨床前和臨床數據(包括BNT162b2的本發佈中討論的數據、任何BNT162項目的單價或雙價疫苗候選疫苗或任何其他疫苗候選疫苗,在我們在兒童、青少年或成年人的任何研究中的臨床1/2/3期或4期數據)相關的風險,以及實際世界證據,包括不利新的臨床前、臨床或安全數據及進一步分析現有臨床前、臨床或安全數據的可能性;是否會產生相當的臨床或其他結果,包括截至目前觀察到的疫苗有效性和安全性以及耐受性特徵,額外分析第3期試驗和額外研究,實際世界數據研究或在商業化後在更大、更多樣化的人群中的更大研究中;BNT162b2能否、任何單價或雙價疫苗候選疫苗能否或任何未來疫苗能否預防因新興病毒變種引起的COVID-19的風險;疫苗更廣泛使用將導致新的有效性、安全性或其他發展信息,包括更多不良反應的風險,其中一些可能是嚴重的;臨床前和臨床試驗數據可能存在不同的解釋和評估風險,包括在同行評審/出版過程中、科學界普遍以及監管機構的解釋;BNT162 mRNA疫苗計劃的其他數據是否會在科學期刊發表,並且如果會的話,何時以及具備什麼修改和解釋;監管機構是否對這些研究和任何未來的臨床前和臨床研究的設計和結果感到滿意;是否以及何時針對BNT162b2在其他人群中、針對BNT162b2潛在增強劑量的提出的應急使用或有條件的上市授權,在任何潛在未來疫苗(包括潛在未來年度增強劑量或重新接種)的投遞人群,以及/或其他生物製品許可證和/或急救應用程序或者這些應用程序或者這些應用程序的改動可能在特定管轄區域,以及如果獲得批准,則這些緊急使用授權或許可證將在何時到期或終止;任何可能待定或就BNT162b2(包括任何對緊急使用或有條件的營銷授權的請求的修改)、任何單價或雙瓣候選疫苗(包括針對戴米瑞猩猩Omikron JN.1譜系的SARS-CoV-2 Omicron KP.2 株疫苗在BNT162項目中的任何提交)或可能來自BNT162項目的其他疫苗(包括潛在的基於變種、劑量更高或雙瓣疫苗)的任何申請可能會在特定監管機構獲得批准,這將取決於很多因素,包括判斷疫苗的益處是否超過其已知的風險及疫苗的效力的決定,如果獲批准,是否會在商業上成功;監管機構的決定影響標籤或營銷、製造過程、安全性和/或其他可能影響疫苗可用性或商業潛力產品開發或治療;在我們與合作伙伴、臨床試驗地點或第三方供應商關聯關係中出現的中斷;任何產品的需求可能會減少或不再存在或達不到預期,這可能導致收入減少或商業商店中和/或管道中的庫存過剩,對我們的COVID-19疫苗來說,在2023年已導致重大庫存沖銷,可能會繼續導致庫存沖銷或其他未預期費用產生的風險;與我們的COVID-19疫苗轉向商業市場相關的挑戰;與公衆對疫苗、增強劑、治療或組合的遵從相關的不確定性;與我們能否準確預測或實現我們的COVID-19疫苗或任何未來潛在COVID-19疫苗的莊嚴預測的風險;與我們的COVID-19疫苗相關的第三方版稅或其他索賠的風險;其他公司可能生產出更好或更有競爭性的產品的風險;與生產或測試疫苗的原材料供應的風險相關;與我們疫苗的製劑、劑量計劃以及隨後的存儲、分銷和管理要求有關的挑戰,包括交付後的存儲和處理風險,可能會導致更多臨床查詢或其他結果,包括迄今爲止觀察到的疫苗有效性和安全性比率以及在第3期試驗和額外研究的額外分析中、在實際世界數據研究中或在更大、更多元化的人口中,是否產生相似的臨床或其他結果,包括比率的實際世界數據研究或在更大、更多元化的人口中,是否執行了迄今爲止的疫苗有效性和安全性比率的差異評估。
有關風險和不確定性的進一步說明,請參見輝瑞在截至2023年12月31日的財年內提交給美國證券交易委員會的10-K表格的《風險因素》和《前瞻性信息和可能影響未來業績的因素》和其隨後提交的10-Q表格的其他部分,以及在其隨後提交的8-K表格中,所有這些表格均可以提交給美國證券交易委員會並且可以在其中找到。www.sec.gov和頁面。.
生物製藥新技術是一家開創癌症和其他嚴重疾病新療法的下一代免疫治療公司。該公司利用廣泛的計算發現和治療藥物平台,快速開發新型生物製藥。其廣泛的腫瘤學產品候選品組合包括個性化和即用型基於 mRNA 的療法、創新的嵌合抗原受體 T 細胞、雙特異性免疫檢查點調節劑、有針對性的癌症抗體和小分子化合物。基於其在 mRNA 疫苗開發和內部
BioNTech(生物-疫苗技術公司)是一家全球的下一代免疫治療公司,開創了治療癌症和其他重大疾病的新療法。BioNTech利用廣泛的計算機發現和治療藥物平台,快速開發新型生物製藥。其廣泛的腫瘤學產品候選包括個性化和非個性化的mRNA基療法、創新的嵌合抗原受體(CAR)T細胞、幾種蛋白質爲基礎的治療藥物,包括雙特異性免疫檢查點調節劑、靶向癌症抗體和抗體-藥物結合物(ADC)治療藥物以及小分子化合物。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及其合作伙伴正在開發多種mRNA疫苗候選者,用於預防一系列傳染性疾病,以及其多樣化的腫瘤學產品線。BioNTech已與多個全球和專業藥品合作伙伴建立了廣泛的關係,包括Biotheus, DualityBio, Fosun Pharma, 嶺南控股, Pfizer,CureVac, Regeneron和Sanofi等。
有關更多信息,請訪問 .
BioNTech前瞻性聲明。
本新聞稿包含根據1995年《私人證券訴訟法》的修正案解釋的前瞻性陳述,包括但不限於以下陳述:BioNTech努力抗擊 COVID-19;BioNTech與輝瑞之間的合作;BioNTech COVID-19 疫苗的市場接受程度和率,包括Omicron KP.2 適應性單價 COVID-19 疫苗;對可用數據的定性評估和預期效益,包括改良疫苗對當前多種流行的Omicron JN.1 亞基型包括 KP.2、Lb.1、KP.3 和 KP.3.1.1 的應對能力;監管提交及監管批准或授權以及製造、分銷和供應方面的預期;預期 COVID-19 疫苗需求變化,包括對訂購環境的變化;以及預期的調整疫苗以應對新變種或亞基型的監管建議。在某些情況下,前瞻性陳述可以通過諸如「將要」、「可能」、「應該」、「預計」、「打算」、「計劃」、「旨在」、「預計」、「相信」、「估計」、「預測」、「潛在」、「持續」或這些術語的否定形式或其他類似術語來識別,儘管並非所有前瞻性陳述都包含這些詞。本新聞稿中的前瞻性陳述既不是承諾也不是保證,您不應過度依賴這些前瞻性陳述,因爲它們涉及已知和未知的風險、不確定性和其他因素,其中許多因素超出了BioNTech的控制範圍,且可能導致實際結果與這些前瞻性陳述所表達或暗示的結果大爲不同。這些風險和不確定性包括但不限於:研究和發展的不確定性,包括是否能夠達到預期的臨床終點、臨床試驗開始和/或完成日期、監管提交日期、監管批准日期和/或上市日期,以及與臨床前和臨床數據相關的風險,包括本公告中討論的數據,包括不利的新臨床前、臨床或安全性數據以及進一步分析現有臨床前、臨床或安全性數據的可能性;臨床數據的性質,該性質正在進行持續的同行評審、監管審查和市場解讀;BioNTech在初步銷售給國家政府後與政府機關、私人健康保險公司和其他第三方支付方的定價和覆蓋範圍談判;COVID-19 疫苗初始或增強劑量的未來商業需求和醫療需求;生產疫苗的原材料的可用性;我們疫苗的配方、劑量方案及相關的儲存、分銷和管理要求的風險,包括交付後的儲存和處理風險;來自其他 COVID-19 疫苗的競爭或與BioNTech的其他產品候選相關的競爭,包括因療效、成本、儲存和分銷便利性、獲得批准使用的廣度、副作用概況和免疫反應持久性等因素,基於不同的作用機制和不同的製造和分銷限制;獲得來自疫苗諮詢委員會、技術委員會和其他公共衛生機構的推薦以及任何此類推薦的商業影響的不確定性;BioNTech獲得和保持其產品候選的監管批准的時間和能力;BioNTech COVID-19 疫苗防止由新變異病毒引起的 COVID-19 的能力;BioNTech及其交易對手管理和獲取所需能源資源的能力;BioNTech確定研究機會並發現和開發試驗性藥物的能力;BioNTech的第三方合作伙伴願意繼續與BioNTech的開發候選及試驗性藥物相關的研究和開發活動的能力和意願;COVID-19 疫情對BioNTech的開發計劃、供應鏈、合作伙伴和財務業績的影響;意外的安全問題和潛在的因使用BioNTech的 COVID-19 疫苗及BioNTech開發或製造的其他產品和產品候選引起的索賠而導致的索賠;BioNTech及其合作伙伴商業化和市場營銷BioNTech的COVID-19疫苗,以及如果獲批,其產品候選;BioNTech管理發展和擴張的能力;美國和其他國家的監管發展;BioNTech有效擴大BioNTech的生產能力、製造BioNTech的產品,包括BioNTech的目標COVID-19疫苗產量水平的能力以及BioNTech的產品候選;全球金融體系和市場的風險;以及BioNTech目前未知的其他因素。
您應該在BioNTech於2024年6月30日結束的報告6-k中的"風險因素"標題下審查所述的風險和不確定性,並在BioNTech隨後向SEC提交的文件中對此進行了說明,這些文件可在SEC的網站www.sec.gov上獲得。這些前瞻性陳述僅適用於本日的日期。除法律規定外,BioNTech不承擔更新或修訂本新聞稿中包含的任何前瞻性陳述的意圖或責任,以防發生新信息、未來發展或其他情況。
輝瑞:
媒體關係
+1 (212) 733-1226
PfizerMediaRelations@pfizer.com
投資者關係
+1 (212) 733-4848
IR@pfizer.com
BioNTech:
媒體關係
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
投資者關係
維多利亞梅斯納,醫學博士。
Investors@biontech.de
1 疫苗和相關生物製品諮詢委員會2024年6月5日會議報告-輝瑞/ biontech臨床和臨床前支持數據2024-2025年COVID19疫苗配方。 。 途徑 2024年8月23日。