NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--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 JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.

纽约和美因茨，德国--（商业新闻短讯）--辉瑞公司（纽约证券交易所：PFE，“辉瑞”）和BioNTech SE（纳斯达克：BNTX，“BioNTech”）今天宣布，欧洲药品管理局（EMA）的人类使用药品委员会（CHMP）已建议该公司的Omicron JN.1适应单价COVID-19疫苗（COMIRNATY®JN.1）进行主动免疫接种，以预防6个月及以上个体由SARS-CoV-2引起的COVID-19。

The adaptation is based on the recommendation from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency's Emergency Task Force (ETF) to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign.

这项调整是基于世界卫生组织（WHO）新型冠状病毒疫苗组成技术咨询小组和欧洲药品管理局紧急工作组（ETF）的建议，以更新新型冠状病毒疫苗，以针对2024-2025年疫苗接种运动的SARS-CoV-2变异JN.1。

ETF stated that “evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”1,2.

ETF表示，“有证据表明，随着SARS-CoV-2的不断发展，靶向JN.1将有助于维持疫苗的有效性。”1,2。

The European Commission (EC) will review the CHMP’s recommendation and is expected to make a final decision soon. Following the EC decision, the updated vaccine will be available to ship to applicable EU member states immediately. Pfizer and BioNTech have been manufacturing the Omicron JN.1-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for COVID-19 vaccination is expected to increase.2.

欧盟委员会（EC）将审查CHMP的建议，并有望很快做出最终决定。根据欧盟委员会的决定，更新后的疫苗将立即提供给适用的欧盟成员国。辉瑞和BioNTech一直在生产Omicron JN.1适应的单价COVID-19疫苗，以确保在即将到来的秋冬季节之前做好供应准备，届时COVID-19疫苗的需求预计会增加。

The CHMP’s recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines by Pfizer and BioNTech. The application also included manufacturing and pre-clinical data showing that the JN.1-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages, compared with the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.3.

CHMP的建议是基于之前的临床，非临床和现实世界的全部证据，这些证据支持辉瑞和BioNTech生产的新型冠状病毒疫苗的安全性和有效性。该应用还包括生产和临床前数据显示，与该公司的Omicron XBB.1.5适应的单价COVID-19疫苗相比，适应JN.1的单价COVID-19疫苗对多种Omicron JN.1亚系（包括KP.2，KP.3和其他目前流行的亚系）产生了显着改善的反应。

Pfizer and BioNTech are starting rolling applications with the U.S. Food and Drug Administration (FDA), per recent FDA recommendation, requesting approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals 6 months of age and older. The companies will continue to monitor the evolving epidemiology of COVID-19 and make appropriate preparations to meet global public health needs..

辉瑞（Pfizer）和BioNTech（BioNTech）根据美国食品和药物管理局（FDA）最近的建议，开始向美国食品和药物管理局（FDA）滚动申请，要求批准其适用于6个月及以上个体的Omicron KP.2单价COVID-19疫苗。这些公司将继续监测新型冠状病毒肺炎的流行病学演变，并为满足全球公共卫生需求做好适当准备。。

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 (COMIRNATY® Original/Omicron BA.4/5; COMIRNATY® Omicron XBB.1.5) 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..

辉瑞和BioNTech生产的新型冠状病毒肺炎疫苗（COMIRNATY®）基于BioNTech专有的mRNA技术，由两家公司开发。BioNTech是美国、欧盟、英国和其他国家COMIRNATY®及其改良疫苗（COMIRNATY®Original/Omicron BA.4/5；COMIRNATY®Omicron XBB.1.5）的上市许可持有人，也是美国（与辉瑞联合）和其他国家紧急使用授权或同等授权的持有人。。

INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION

指示、授权使用和重要安全信息

INDICATION

指示

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine for use in people 12 years of age and older to protect against coronavirus disease 2019 (COVID-19).

COMIRNATY®（COVID-19疫苗，mRNA）是一种用于12岁及以上人群的疫苗，用于预防2019年冠状病毒病（COVID-19）。

IMPORTANT SAFETY INFORMATION

重要安全信息

You should NOT receive COMIRNATY® (COVID-19 Vaccine, mRNA) if you had a severe allergic reaction to a previous dose of COMIRNATY or any Pfizer-BioNTech COVID-19 vaccine* or to any ingredient in these vaccines.

如果您对先前剂量的COMIRNATY或任何辉瑞生物技术公司的COVID-19疫苗*或这些疫苗中的任何成分有严重的过敏反应，则不应接受COMIRNATY®（COVID-19疫苗，mRNA）。

*COMIRNATY (2023-2024 Formula) is made the same way as Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, but it encodes the spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).

*。

There is a remote chance that COMIRNATY could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination.

COMIRNATY引起严重过敏反应的可能性很小。服用后几分钟至1小时内通常会发生严重的过敏反应。因此，您的疫苗接种提供者可能会要求您留在接种疫苗的地方，以便在接种疫苗后进行监测。

Signs of a severe allergic reaction can include:.

严重过敏反应的迹象可能包括：。

Difficulty breathing

Swelling of your face and throat

脸和喉咙肿胀

A fast heartbeat

心跳加快

A bad rash all over the body

全身严重的皮疹

Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and pericarditis following COMIRNATY have occurred most commonly in adolescent males 12 through 17 years of age.

一些接受过mRNA COVID-19疫苗（包括COMIRNATY和Pfizer BioNTech COVID-19疫苗）的人发生了心肌炎（心肌炎症）和心包炎（心脏外衬里炎症）。社交后的心肌炎和心包炎最常见于12至17岁的青少年男性。

In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:.

在大多数这些人中，症状在接种疫苗后几天内开始。发生这种情况的可能性很低。如果您或您的孩子在接种疫苗后出现以下任何症状，尤其是在接种疫苗后的两周内，您应立即就医：。

Chest pain

胸痛

Shortness of breath

呼吸急促

Feelings of having a fast-beating, fluttering, or pounding heart

心跳加速、心跳加速或心跳加速的感觉

Fainting can happen after getting injectable vaccines including COMIRNATY. Your vaccination provider may ask you to sit or lie down for 15 minutes after receiving the vaccine

在接种包括COMIRNATY在内的注射疫苗后，可能会晕倒。接种疫苗后，您的疫苗接种者可能会要求您坐下或躺下15分钟

People with weakened immune systems may have a reduced immune response to COMIRNATY

免疫系统减弱的人对社交的免疫反应可能会降低

COMIRNATY may not protect all vaccine recipients

COMIRNATY可能无法保护所有疫苗接种者

Before getting COMIRNATY, tell your vaccination provider about all of your medical conditions, including if you:

在获得礼让之前，告诉你的疫苗接种提供者你的所有医疗状况，包括如果你：

have any allergies

有过敏症吗

had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine

在接种过任何一剂新型冠状病毒肺炎疫苗后出现严重的过敏反应

have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)

患有心肌炎（心肌炎症）或心包炎（心脏外衬里炎症）

have a fever

have a bleeding disorder or are on a blood thinner

患有出血性疾病或服用血液稀释剂

are immunocompromised or are on a medicine that affects the immune system

免疫功能低下或服用影响免疫系统的药物

are pregnant, plan to become pregnant, or are breastfeeding

怀孕、计划怀孕或正在母乳喂养

have received another COVID-19 vaccine

已经接种了另一种新型冠状病毒疫苗

have ever fainted in association with an injection

曾因注射而晕倒

Additional side effects that have been reported with COMIRNATY or Pfizer-BioNTech COVID-19 vaccines include:

COMIRNATY或Pfizer BioNTech COVID-19疫苗报告的其他副作用包括：

Non-severe allergic reactions such as rash, itching, hives, or swelling of the face

非严重过敏反应，如皮疹、瘙痒、荨麻疹或面部肿胀

Injection site reactions: pain, swelling, redness, arm pain

注射部位反应：疼痛、肿胀、发红、手臂疼痛

General side effects: tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, dizziness.

一般副作用：疲倦、头痛、肌肉疼痛、发冷、关节疼痛、发烧、恶心、感觉不适、淋巴结（淋巴结肿大）、食欲下降、腹泻、呕吐、头晕。

These may not be all the possible side effects of COMIRNATY. Ask your healthcare provider about any side effects that concern you.

这些可能不是礼让的所有可能的副作用。询问您的医疗保健提供者有关您的任何副作用。

You may report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov/reportevent.html. In addition, you can report side effects to Pfizer Inc. at 1-800-438-1985 or www.pfizersafetyreporting.com

您可以向FDA/CDC疫苗不良事件报告系统（VAERS）报告副作用。VAERS的免费电话是1-800-822-7967或在线报告至www.VAERS.hhs.gov/reportevent.html。此外，您可以通过1-800-438-1985或www.pfizersafetyreporting.com向辉瑞公司报告副作用

Please click here for full Prescribing Information and Patient Information for COMIRNATY

请点击此处获取完整的处方信息和患者信息

AUTHORIZED USE

授权使用

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)* is FDA authorized under Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months through 11 years of age.

辉瑞生物技术公司COVID-19疫苗（2023-2024配方）*是FDA根据紧急使用授权（EUA）授权的，用于预防6个月至11岁个体中由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的2019年冠状病毒病（COVID-19）。

*Hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine

*以下简称辉瑞生物技术新型冠状病毒肺炎疫苗

EMERGENCY USE AUTHORIZATION

紧急使用授权

Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months through 11 years of age. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner..

辉瑞生物技术公司的新型冠状病毒肺炎疫苗尚未获得美国食品和药物管理局的批准或许可，但已被美国食品和药物管理局授权紧急使用，根据欧盟预防冠状病毒病2019（新型冠状病毒肺炎），用于6个月至11岁的个体。本产品的紧急使用仅在声明存在证明根据FD＆C法案第564（b）（1）节授权紧急使用医疗产品的情况的持续时间内获得授权，除非声明被终止或授权被提前撤销。。

IMPORTANT SAFETY INFORMATION

重要安全信息

A person should NOT get Pfizer-BioNTech COVID-19 Vaccine if they had a severe allergic reaction after a previous dose of any Pfizer-BioNTech COVID-19 vaccine or to any ingredients in these vaccines

如果一个人在服用任何一剂辉瑞生物技术新型冠状病毒疫苗或这些疫苗中的任何成分后出现严重的过敏反应，则不应接种辉瑞生物技术新型冠状病毒疫苗

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, the vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination.

疫苗引起严重过敏反应的可能性很小。接种疫苗后几分钟至一小时内通常会发生严重的过敏反应。因此，疫苗接种提供者可能会要求您留在接种疫苗的地方，以便在接种疫苗后进行监测。

If your child experiences a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Signs of a severe allergic reaction can include:.

如果您的孩子出现严重的过敏反应，请致电9-1-1，或前往最近的医院。严重过敏反应的迹象可能包括：。

difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, or dizziness and weakness

呼吸困难，面部和喉咙肿胀，心跳加快，全身出现严重皮疹，或头晕和虚弱

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following Pfizer-BioNTech COVID-19 vaccines have occurred most commonly in adolescent males 12 through 17 years of age.

一些接受过mRNA COVID-19疫苗的人发生了心肌炎（心肌炎症）和心包炎（心脏外衬里炎症）。辉瑞生物技术公司新型冠状病毒肺炎疫苗接种后的心肌炎和心包炎最常见于12至17岁的青少年男性。

In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. Seek medical attention right away if your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:.

在大多数这些人中，症状在接种疫苗后几天内开始。发生这种情况的可能性很低。如果您的孩子在接种疫苗后出现以下任何症状，尤其是在接种疫苗后的两周内，请立即就医：。

Chest pain

胸痛

Shortness of breath or difficulty breathing

呼吸急促或呼吸困难

Feelings of having a fast-beating, fluttering, or pounding heart

心跳加速、心跳加速或心跳加速的感觉

Additional symptoms, particularly in children, may include:

Fainting

昏厥

Unusual and persistent irritability

异常和持续的烦躁不安

Unusual and persistent poor feeding

异常和持续的不良喂养

Unusual and persistent fatigue or lack of energy

异常且持续的疲劳或缺乏活力

Persistent vomiting

持续呕吐

Persistent pain in the abdomen

腹部持续疼痛

Unusual and persistent cool, pale skin

异常持久的清凉苍白皮肤

Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination

在接种包括辉瑞生物技术新冠肺炎疫苗在内的可注射疫苗后，可能会发生晕厥。因此，您的疫苗接种提供者可能会要求您留在接种疫苗的地方，以便在接种疫苗后进行监测

People with weakened immune systems may have a reduced immune response to Pfizer-BioNTech COVID-19 Vaccine

免疫系统减弱的人对辉瑞生物技术公司新型冠状病毒肺炎疫苗的免疫反应可能会降低

Pfizer-BioNTech COVID-19 Vaccine may not protect everyone

辉瑞生物技术新冠肺炎疫苗可能无法保护所有人

Tell your vaccination provider about all of your child’s medical conditions, including if your child:

告诉您的疫苗接种提供者您孩子的所有医疗状况，包括您的孩子是否：

has any allergies

有任何过敏症

has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)

患有心肌炎（心肌炎症）或心包炎（心脏外衬里炎症）

has a fever

发烧了

has a bleeding disorder or is on a blood thinner

患有出血性疾病或服用血液稀释剂

is immunocompromised or is on a medicine that affects the immune system

免疫功能低下或服用影响免疫系统的药物

is pregnant or is breastfeeding

has received another COVID-19 vaccine

已经接种了另一种新型冠状病毒疫苗

has ever fainted in association with an injection

曾因注射而晕倒

Side effects that have been reported with Pfizer-BioNTech COVID-19 vaccines include:

辉瑞生物技术公司新型冠状病毒肺炎疫苗的副作用包括：

Severe allergic reactions

严重过敏反应

Non-severe allergic reactions such as rash, itching, hives, or swelling of the face

非严重过敏反应，如皮疹、瘙痒、荨麻疹或面部肿胀

Myocarditis (inflammation of the heart muscle)

心肌炎（心肌炎症）

Pericarditis (inflammation of the lining outside the heart)

心包炎（心外膜发炎）

Injection site pain/tenderness

Tiredness

Headache

头痛

Muscle pain

肌肉疼痛

Arm pain

手臂疼痛

Fainting in association with injection of the vaccine

与注射疫苗有关的晕厥

Chills

寒战

Joint pain

关节疼痛

Fever

发烧

Injection site swelling

注射部位肿胀

Injection site redness

注射部位发红

Nausea

恶心

Feeling unwell

感觉不舒服

Swollen lymph nodes (lymphadenopathy)

淋巴结肿大（淋巴结病）

Decreased appetite

食欲下降

Diarrhea

腹泻

Vomiting

呕吐

Dizziness

头晕

Irritability

易怒

These may not be all the possible side effects. Serious and unexpected side effects may occur. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

这些可能不是所有可能的副作用。可能会出现严重和意外的副作用。致电疫苗接种提供者或医疗保健提供者，了解令人烦恼的副作用或不会消失的副作用。

Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov/reportevent.html. Please include “Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA” in the first line of box #18 of the report form..

向美国食品和药物管理局（FDA）和疾病控制和预防中心（CDC）疫苗不良事件报告系统（VAERS）报告疫苗副作用。VAERS的免费电话是1-800-822-7967或在线报告至www.VAERS.hhs.gov/reportevent.html。请将“辉瑞生物技术新型冠状病毒肺炎疫苗（2023-2024配方）EUA”列入报告表第18框的第一行。。

In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.

此外，个人可以通过www.pfizersafetyreporting.com或致电1-800-438-1985向辉瑞公司报告副作用。

Please click here for Pfizer-BioNTech COVID-19 Vaccine Healthcare Providers Fact Sheet and Vaccine Recipient and Caregiver EUA Fact Sheet.

请单击此处查看辉瑞生物技术公司新型冠状病毒肺炎疫苗医疗保健提供者情况说明书以及疫苗接受者和护理者EUA情况说明书。

About Pfizer: Breakthroughs That Change Patients’ Lives

关于辉瑞：改变患者生活的突破

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.

在辉瑞，我们运用科学和全球资源为人们带来治疗方法，延长并显着改善他们的生活。我们努力为包括创新药物和疫苗在内的保健产品的发现、开发和制造制定质量、安全和价值标准。

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.

辉瑞公司的同事们每天都在发达市场和新兴市场开展工作，促进健康、预防、治疗和治愈，挑战我们这个时代最可怕的疾病。作为世界首屈一指的创新生物制药公司之一，我们与医疗保健提供者、政府和当地社区合作，支持和扩大全球可靠、负担得起的医疗保健服务。

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 www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer..

175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很重要的信息。此外，要了解更多信息，请访问我们的网站www.Pfizer.com，并在X上关注我们@Pfizer和@Pfizer News，LinkedIn，YouTube，以及在Facebook上关注我们。。

Pfizer Disclosure Notice

辉瑞披露通知

The information contained in this release is as of June 27, 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.

本版本中包含的信息截至2024年6月27日。辉瑞没有义务因新信息或未来事件或发展而更新本版本中包含的前瞻性声明。

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 JN.1 lineage, including a submission to the European Medicines Agency (EMA) for an Omicron-adapted monovalent COVID-19 vaccine, based on the JN.1 lineage, 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 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.

本版本包含有关辉瑞公司抗击COVID-19的努力，BioNTech与辉瑞公司合作开发COVID-19疫苗，BNT162b2 mRNA疫苗计划以及辉瑞公司BioNTech COVID-19疫苗（也称为COMIRNATY®（COVID-19疫苗，mRNA）（BNT162b2））的前瞻性信息，包括基于JN.1谱系的Omicron适应的单价COVID-19候选疫苗，包括向欧洲药品管理局（EMA）提交的基于JN.1谱系的Omicron适应的单价COVID-19疫苗，对需求的期望新型冠状病毒肺炎疫苗、计划的监管提交、可用数据的定性评估、潜在益处、临床试验的预期、潜在的监管提交、数据读取的预期时间、监管提交、监管批准或授权以及预期的制造，涉及重大风险和不确定性的分销和供应，可能导致实际结果与此类声明明示或暗示的结果存在重大差异。

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 safet.

除其他外，风险和不确定性包括研究和开发固有的不确定性，包括满足预期临床终点的能力，临床试验的开始和/或完成日期，监管提交日期，监管批准日期和/或推出日期，以及与临床前和临床数据（包括1/2/3期或4期数据）相关的风险，包括本版本中讨论的BNT162b2，任何单价或二价疫苗候选物或BNT162计划中任何其他候选疫苗在我们的任何儿科，青少年或成人研究中或现实世界的证据，包括不利的新临床前，临床或安全的可能性。

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.

关于风险和不确定性的进一步描述，可以在辉瑞公司截至2023年12月31日的10-K财年年度报告和随后的10-Q表格报告中找到，包括标题为“风险因素”和“前瞻性信息和可能影响未来结果的因素”的部分，以及随后的8-K表格报告中找到，所有这些报告都提交给美国。

Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com..

证券交易委员会，网址为www.sec.gov和www.pfizer.com。。

About BioNTech

关于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.

生物制药新技术（BioNTech）是一家全球下一代免疫治疗公司，开创了癌症和其他严重疾病的新疗法。BioNTech利用各种计算发现和治疗药物平台快速开发新型生物制药。

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.

其广泛的肿瘤学产品候选组合包括个体化和现成的基于mRNA的疗法，创新的嵌合抗原受体（CAR）T细胞，几种基于蛋白质的疗法，包括双特异性免疫检查点调节剂，靶向癌症抗体和抗体-药物缀合物（ADC）疗法，以及小分子。

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.

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及其合作者正在为多种传染病开发多种mRNA疫苗候选物，以及其多样化的肿瘤学管道。BioNTech与多个全球和专业的制药合作伙伴建立了广泛的关系，包括Biotheus，DualityBio，复星制药，Genentech，罗氏集团成员，Genevant，Genmab，MediLink，OncoC4，辉瑞和Regeneron。

For more information, please visit www.BioNTech.com..

有关更多信息，请访问www.BioNTech.com。。

BioNTech Forward-looking Statements

BioNTech前瞻性声明

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 JN.1-adapted monovalent COVID-19 vaccine; qualitative assessments of available data and expectations of potential benefits, including the adapted vaccine’s response against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages; 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.

本新闻稿包含1995年《私人证券诉讼改革法案》修订版所指的前瞻性声明，包括但不限于以下声明：BioNTech抗击新型冠状病毒的努力；BioNTech和辉瑞之间的合作；BioNTech的COVID-19疫苗（包括Omicron JN.1适应的单价COVID-19疫苗）的市场接受率和程度；定性评估现有数据和潜在益处的预期，包括适应疫苗对多个Omicron JN.1亚系的反应，包括KP.2，KP.3和其他目前流行的亚系；有关制造、分销和供应的监管提交和监管批准或授权和期望；对新型冠状病毒肺炎疫苗需求预期变化的预期，包括订购环境的变化；以及预期的监管建议，以适应疫苗以解决新的变异或亚系。

In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

在某些情况下，前瞻性陈述可以通过“意志”、“可能”、“应该”、“期望”、“打算”、“计划”、“目标”、“预期”、“相信”、“估计”、“预测”、“潜在”、“继续”或这些术语或其他类似术语的否定词来识别，尽管并非所有前瞻性陈述都包含这些词语。

The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements.

本新闻稿中的前瞻性声明既不是承诺也不是保证，您不应过度依赖这些前瞻性声明，因为它们涉及已知和未知的风险、不确定性和其他因素，其中许多因素超出了BioNTech的控制范围，可能导致实际结果与这些前瞻性声明所表达或暗示的结果存在重大差异。

These risks and uncertaint.

这些风险和不确定性。

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 March 31, 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..

除法律要求外，BioNTech不承担在新信息、未来发展或其他情况下更新或修改本新闻稿中包含的任何前瞻性声明的任何意图或责任。。

1 World Health Organization (WHO) Statement on the antigen composition of COVID-19 vaccines. 26April 2024. Available at: https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines#:~:text=In%20May%202023%2C%20the%20TAG,1.5%2C%20as%20the%20vaccine%20antigen (Accessed 26.06.2024)..

1世界卫生组织（WHO）关于新型冠状病毒疫苗抗原组成的声明。2024年4月26日。网址：https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines#:~：text=在%20May%202023%2C%20TAG中，1.5%2C%20as%20the%20vaccine%20antigen（2024年6月26日访问）。。

2 European Medicines Agency (EMA) ETF recommends updating COVID-19 vaccines to target new JN.1 variant. 30April 2024. Available at: https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant (Accessed 26.06.2024).

2欧洲药品管理局（EMA）ETF建议更新COVID-19疫苗以靶向新的JN.1变体。2024年4月30日。网址：https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant（2024年6月26日访问）。

3 Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Presentation- Pfizer/BioNTech Clinical and Preclinical Supportive Data 2024-2025 COVID19 Vaccine Formula. https://www.fda.gov/media/179144/download (Accessed 26.06.2024)

3疫苗和相关生物产品咨询委员会2024年6月5日会议介绍-辉瑞/BioNTech临床和临床前支持数据2024-2025 COVID19疫苗配方。https://www.fda.gov/media/179144/download（2024年6月26日访问）

Category: Vaccines

类别：疫苗