In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives

在一项3期试验中，辉瑞和BioNTech针对流感和新型冠状病毒的联合候选疫苗达到了其两个主要免疫原性目标之一

The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines

尽管获得了更高的甲型流感反应和与对照疫苗相当的新型冠状病毒19反应，但该试验并未达到其针对乙型流感病毒株的非劣效性的主要免疫原性目标之一

The companies are evaluating adjustments to the candidate and will discuss next steps with health authorities

这些公司正在评估对候选人的调整，并将与卫生部门讨论下一步措施

Pfizer also provides update on its separate Phase 2 second-generation trivalent influenza mRNA vaccine trial which showed encouraging data demonstrating robust immunogenicity against all strains compared to a standard of care influenza vaccine

辉瑞公司还提供了其单独的第二阶段第二代三价流感mRNA疫苗试验的最新信息，该试验显示，与标准护理流感疫苗相比，令人鼓舞的数据显示出对所有菌株的强大免疫原性

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--

纽约和美因茨，德国--（商业新闻）--

Pfizer Inc.

辉瑞公司。

(NYSE: PFE, “Pfizer”) and

（纽约证券交易所代码：PFE，“辉瑞”）和

BioNTech SE

BioNTech SE

(Nasdaq: BNTX, “BioNTech”) today announced top-line results from their Phase 3 clinical trial to evaluate the companies’ combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age. The combination candidate consists of Pfizer’s mRNA-based influenza vaccine candidate with the companies’ licensed COVID-19 vaccine.

（纳斯达克：BNTX，“BioNTech”）今天宣布了他们的第三阶段临床试验的主要结果，以评估该公司针对18-64岁健康个体的流感和新型冠状病毒19的联合mRNA疫苗候选物。该组合候选物由辉瑞公司的基于mRNA的流感疫苗候选物和公司许可的新型冠状病毒肺炎疫苗组成。

The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against SARS-CoV-2 as well as immunogenicity against influenza A and B), of which one was met. In a separate Phase 2 trial, Pfizer evaluated trivalent (“tIRV”) influenza mRNA standalone vaccine candidates which demonstrated robust immunogenicity in individuals 18-64 years of age.

第三阶段试验测量了两个主要的免疫原性目标（针对SARS-CoV-2的免疫原性以及针对甲型和乙型流感的免疫原性），其中一个目标得到了满足。在另一项2期临床试验中，辉瑞公司评估了三价（“tIRV”）流感mRNA独立疫苗候选物，该候选物在18-64岁的个体中表现出强大的免疫原性。

The companies are evaluating adjustments to the combination vaccine candidate aimed at improving immune responses against influenza B and will discuss next steps with health authorities..

这些公司正在评估对候选组合疫苗的调整，旨在改善针对B型流感的免疫反应，并将与卫生部门讨论下一步措施。。

Update on Phase 3 Pfizer and BioNTech Combination Vaccine Trial

辉瑞和BioNTech三期联合疫苗试验的最新进展

The Phase 3 randomized, observer-blinded study (

第三阶段随机，观察者盲法研究(

NCT06178991

邮编06178991

) enrolled more than 8,000 adults 18 through 64 years of age to evaluate the safety, tolerability, and immunogenicity of a single dose combination vaccine candidate against influenza and COVID-19. In this clinical trial, the vaccine candidate was compared to a licensed influenza vaccine and the companies’ licensed COVID-19 vaccine given at the same visit.

)招募了8000多名18至64岁的成年人，以评估针对流感和COVID-19的单剂量联合候选疫苗的安全性，耐受性和免疫原性。在这项临床试验中，将候选疫苗与同一次就诊时获得许可的流感疫苗和公司获得许可的新型冠状病毒肺炎疫苗进行了比较。

The primary immunogenicity objectives were to demonstrate that the antibody responses to influenza (hemagglutination inhibition, “HAI”) and to SARS-CoV-2 (neutralizing titer, “NT”) elicited by the combination vaccine candidate were non-inferior (“NI”) to standard of care (“SOC”). Compared to a licensed influenza vaccine, the tIRV formulation was noteworthy for eliciting robust influenza A responses, including a continued trend of higher influenza A responses versus a licensed influenza vaccine, while it showed lower geometric mean titers (“GMT”) and seroconversion against the influenza B strain.

主要免疫原性目标是证明由组合疫苗候选物引发的对流感（血凝抑制，“HAI”）和SARS-CoV-2（中和滴度，“NT”）的抗体反应不劣于（“NI”）护理标准（“SOC”）。与许可的流感疫苗相比，tIRV制剂在引发强烈的甲型流感反应方面值得注意，包括与许可的流感疫苗相比，甲型流感反应持续上升的趋势，同时它显示出较低的几何平均滴度（“GMT”）和针对B型流感病毒株的血清转化率。

In addition, the formulation demonstrated comparable responses against SARS-CoV-2 versus the companies’ licensed COVID-19 vaccine. No safety signals with the combination vaccine have been identified in an ongoing safety data review. Participants who received a licensed influenza and COVID-19 vaccine with co-administration continued to elicit robust immune responses against both influenza and COVID-19 with no safety signals identified to date..

此外，该制剂对SARS-CoV-2的反应与公司许可的COVID-19疫苗相当。在正在进行的安全数据审查中，尚未发现联合疫苗的安全信号。接受许可的流感和新型冠状病毒疫苗联合给药的参与者继续引发针对流感和新型冠状病毒的强烈免疫反应，迄今为止尚未发现安全信号。。

“We are encouraged by the robust immunogenicity we saw with our combination vaccine against influenza A, which was similar to what we had seen for our initial quadrivalent influenza vaccine where we saw superior relative vaccine efficacy against a comparator flu vaccine,” said Annaliesa Anderson, PhD, Senior Vice President and Head, Vaccine Research and Development at Pfizer.

辉瑞公司高级副总裁兼疫苗研发负责人Annaliesa Anderson博士说：“我们对甲型流感联合疫苗的强大免疫原性感到鼓舞，这与我们最初的四价流感疫苗的免疫原性相似，在四价流感疫苗中，我们看到了针对对照流感疫苗的优越相对疫苗效力。”。

“We are committed to developing vaccines that will reduce the burden of respiratory diseases and believe that combination vaccines are the most efficient way to do this. Today’s results provide insight and direction towards achieving this goal, and we remain optimistic about our combination COVID-19 and influenza program, for which we are evaluating the next steps.”.

“我们致力于开发能够减轻呼吸道疾病负担的疫苗，并相信联合疫苗是实现这一目标的最有效方法。今天的结果为实现这一目标提供了见识和方向，我们对我们的新型冠状病毒肺炎和流感联合疫苗计划仍持乐观态度，我们正在评估下一步。”。

“We are dedicated to developing combination vaccines which provide broader protection against multiple respiratory diseases,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “The insights gained from this combination vaccine trial are highly valuable and will play a crucial role in guiding the further development of Pfizer’s and our combination vaccine program against influenza and COVID-19.

。“从这项联合疫苗试验中获得的见解非常有价值，将在指导辉瑞和我们针对流感和新型冠状病毒的联合疫苗计划的进一步发展中发挥关键作用。

We are committed to drawing on our experience in developing mRNA-based vaccine candidates against multiple antigens and believe we can successfully accomplish this task in collaboration with our partner Pfizer.”.

我们致力于利用我们在开发针对多种抗原的基于mRNA的候选疫苗方面的经验，并相信我们可以与我们的合作伙伴辉瑞公司合作成功完成这项任务。”。

Update on Pfizer's Phase 2 Second Generation Influenza Vaccine Trial

辉瑞公司第二代流感疫苗第二阶段试验的最新进展

Pfizer’s Phase 2 trial (

辉瑞公司的第二阶段试验(

NCT06436703

时间06436703

) to evaluate second-generation candidates against influenza was initiated earlier this year and enrolled 450 participants 18-64 years of age, who were randomized to receive investigational mRNA-based influenza vaccines or influenza vaccines approved by the U.S.

)今年早些时候开始评估第二代抗流感候选人，招募了450名18-64岁的参与者，他们被随机分配接受研究性基于mRNA的流感疫苗或美国批准的流感疫苗。

Food and Drug Administration (“FDA”). As previously stated, Pfizer .

食品和药物管理局（“FDA”）。如前所述，辉瑞。

announced

已宣布

positive top-line Phase 3 results from its first-generation quadrivalent (“qIRV”) vaccine candidate which achieved the first and only demonstration of efficacy for an mRNA vaccine in a group of study participants 18-64 years of age. The primary endpoints for this qIRV first-generation candidate were not met in adults aged 65 and older, as statistical non-inferior relative vaccine efficacy (“rVE”) compared to a licensed influenza vaccine was not met based on the number of cases accrued.

第一代四价（“qIRV”）候选疫苗产生了阳性的第三阶段结果，该候选疫苗在一组18-64岁的研究参与者中首次也是唯一一次证明了mRNA疫苗的功效。65岁及以上的成年人未达到该qIRV第一代候选者的主要终点，因为根据累积病例数，与许可的流感疫苗相比，统计学上的非劣效相对疫苗效力（“rVE”）未得到满足。

Pfizer developed second-generation candidates with the goal of improving immunogenicity and potentially breadth of protection, including new tIRV formulations that matched updated recommendations by the World Health Organization (“WHO”) and the FDA’s Vaccines and Related Biological Products Advisory Committee (“VRBPAC”).

辉瑞公司开发了第二代候选药物，旨在提高免疫原性和潜在的保护范围，包括符合世界卫生组织（“WHO”）和FDA疫苗和相关生物产品咨询委员会（“VRBPAC”）最新建议的新tIRV制剂。

The tIRV formulations elicited robust influenza A responses and B responses, including continued trend of higher influenza A responses versus a licensed influenza vaccine. There were no safety signals reported. Data from this Phase 2 trial for adults 65 years of age and older will become available at a later date..

tIRV制剂引起强烈的甲型流感反应和乙型流感反应，包括与许可的流感疫苗相比，甲型流感反应持续增加的趋势。没有安全信号报告。这项针对65岁及以上成年人的第二阶段试验的数据将在晚些时候提供。。

Pfizer will also continue to evaluate its influenza vaccine program and discuss next steps with health authorities.

辉瑞还将继续评估其流感疫苗计划，并与卫生部门讨论下一步行动。

About Influenza

关于流感

Influenza causes an estimated 140,000 to 710,000 hospitalizations, 12,000 to 52,000 deaths

据估计，流感导致140000至710000人住院，12000至52000人死亡

1

1

and about $25 billion in economic loss

大约250亿美元的经济损失

2

2

in the U.S. each year. People 65 and older are at increased risk of serious complications from influenza, including hospitalization and death.

每年在美国。65岁及以上的人患流感严重并发症的风险增加，包括住院和死亡。

3

3

Even when a vaccine matches circulating strains well, current influenza vaccines typically confer 40% to 60% protection each year, with even lower protection in years with poor matching of strains.

即使疫苗与流行毒株匹配良好，目前的流感疫苗通常每年提供40%至60%的保护，在毒株匹配不佳的年份，保护率甚至更低。

4

4

The impact of influenza on racial and ethnic minority groups in the U.S. is even larger. Black Americans are nearly two times more likely than their white counterparts to be hospitalized for influenza while Latino and Indigenous Americans are 1.2 and 1.3 times more likely, respectively.

流感对美国种族和少数民族群体的影响更大。美国黑人因流感住院的可能性是白人的近两倍，而拉丁裔和土著美国人分别是白人的1.2倍和1.3倍。

.5

.5

With circulating influenza strains continually changing, predicting the best match for the next season’s vaccine is difficult for global health experts as those strains are chosen more than six months before the start of the flu season that they target. The flexibility of mRNA technology and its rapid manufacturing could potentially allow better strain matches in future years, and in a pandemic influenza situation, mRNA technology could enable rapid, large-scale manufacturing of vaccines..

随着流行的流感毒株不断变化，全球卫生专家很难预测下一季疫苗的最佳匹配，因为这些毒株是在他们针对的流感季节开始前六个多月选择的。mRNA技术的灵活性及其快速制造可能会在未来几年产生更好的菌株匹配，并且在大流行性流感的情况下，mRNA技术可以实现疫苗的快速大规模制造。。

INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION

指示、授权使用和重要安全信息

INDICATION

指示

COMIRNATY

委员会

®

®

(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).

（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

你应该

NOT

不是

receive COMIRNATY

接收礼让

®

®

(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.

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

*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).

*COMIRNATY（2023-2024配方）与辉瑞生物技术公司的COVID-19疫苗（原始单价）和辉瑞生物技术公司的COVID-19疫苗（二价）相同，但它编码SARS-CoV-2 Omicron变异谱系XBB.1.5（Omicron XBB.1.5）的穗蛋白。

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

呼吸困难

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

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, 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.

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。你应该这样做。

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:

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，请立即就医：

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

在获得友谊之前，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

发烧

have a bleeding disorder or are on a blood thinner

患有出血性疾病或正在服用血液稀释剂

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

您可以向FDA/CDC疫苗不良事件报告系统（VAERS）报告副作用。VAERS免费电话是1-800-822-7967或在线报告

www.vaers.hhs.gov/reportevent.html

www.vaers.hhs.gov/reportevent.html

. In addition, you can report side effects to Pfizer Inc. at 1-800-438-1985 or

此外，您可以通过1-800-438-1985或

www.pfizersafetyreporting.com

www.pfizer safereporting.com

Please click here for full

请单击此处查看完整信息

Prescribing Information

处方信息

and

和

Patient Information

患者信息

for COMIRNATY

为了友谊

AUTHORIZED USE

授权使用

Pfizer-BioNTech COVID-19 Vaccine

辉瑞-BioNTech新冠肺炎疫苗

(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.

（2023-2024年配方）*是FDA根据紧急使用授权（EUA）授权在6个月至11岁的个体中预防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

一个人应该

NOT

不是

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

如果他们在服用任何一剂辉瑞生物技术新型冠状病毒肺炎疫苗或这些疫苗中的任何成分后出现严重的过敏反应，请接种辉瑞生物技术新型冠状病毒肺炎疫苗

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

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

. 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 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. .

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。

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

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:

其他症状，尤其是儿童，可能包括：

Fainting

昏厥

Unusual and persistent irritability

异常和持续的烦躁不安

Unusual and persistent poor feeding

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

:

:

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

怀孕或哺乳

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

注射部位疼痛/压痛

Tiredness

疲倦

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

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

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

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免费电话是1-800-822-7967或在线报告

www.vaers.hhs.gov/reportevent.html

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.

。请将“辉瑞生物技术新型冠状病毒肺炎疫苗（2023-2024配方）EUA”列在报告表格第18框的第一行。

In addition, individuals can report side effects to Pfizer Inc. at

此外，个人可以向辉瑞公司报告副作用

www.pfizersafetyreporting.com

www.pfizer safereporting.com

or by calling 1-800-438-1985.

或者拨打1-800-438-1985。

Please click here for

请单击此处

Pfizer-BioNTech COVID-19 Vaccine Healthcare Providers Fact Sheet

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简介

and

和

Vaccine Recipient and Caregiver EUA Fact Sheet

疫苗接种者和护理者EUA概况

.

.

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 .

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上发布对投资者可能很重要的信息。

www.Pfizer.com

www.Pfizer.com

and follow us on X at

并在X上跟踪我们

@Pfizer

@辉瑞公司

and

和

@Pfizer News

@辉瑞新闻

,

,

LinkedIn

LinkedIn

,

,

YouTube

YouTube

and like us on Facebook at

就像我们在脸书上

Facebook.com/Pfizer

Facebook.com/Pfizer

Pfizer Disclosure Notice

The information contained in this release is as of August 15, 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8月15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 investigational modified RNA (modRNA) influenza vaccine candidates, potential next-generation mRNA flu and combination vaccine formulations, Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, the flu and COVID/flu combination programs, Pfizer’s respiratory vaccines portfolio and mRNA technology, including their potential benefits, that involves 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的研究性修饰RNA（modRNA）流感疫苗候选物，潜在的下一代mRNA流感和组合疫苗制剂，辉瑞公司和BioNTech公司的基于mRNA的流感和COVID-19组合疫苗候选物，流感和COVID/流感组合计划，辉瑞公司的呼吸道疫苗组合和mRNA技术（包括其潜在益处）的前瞻性信息，这些信息涉及重大风险和不确定性，可能导致实际结果与此类声明所表达或暗示的结果产生重大差异。

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 our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data, including uncertainties regarding the outcome of the ongoing Phase 2 trial of Pfizer’s second-generation influenza vaccine candidates in adults 65 years of age and older; uncertainties regarding the future development of Pfizer’s mRNA influenza vaccine candidates, potential next-generation mRNA flu and combination vaccine formulations and Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, including whether or when any such candidates will advance to future studies or phases of development; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic .

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，我们临床试验的开始和/或完成日期，监管提交日期，监管批准日期和/或发布日期，以及不利的新临床数据和对现有临床数据的进一步分析的可能性，包括辉瑞公司第二代流感疫苗候选人在65岁及以上成年人中进行的第二阶段试验结果的不确定性；关于辉瑞mRNA流感疫苗候选物，潜在的下一代mRNA流感和组合疫苗制剂以及辉瑞和BioNTech基于mRNA的流感和新型冠状病毒19组合疫苗候选物的未来发展的不确定性，包括是否或何时任何此类候选物将进入未来的研究或发展阶段；临床试验数据受到监管机构不同解释和评估的风险；监管机构是否会对我们临床研究的设计和结果感到满意；是否以及何时生物。

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 .

证券交易委员会，网址为。

www.sec.gov

www.sec.gov

and

和

www.pfizer.com

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 .

有关更多信息，请访问。

www.BioNTech.com

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: the collaboration between BioNTech and Pfizer, including Pfizer’s investigational modified RNA (modRNA) influenza vaccine candidates, potential next-generation mRNA flu and combination vaccine formulations, and Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, and mRNA technology;; qualitative assessments of available data and expectations of potential benefits, ; regulatory submissions and regulatory approvals or authorizations and expectations regarding manufacturing, distribution and supply; expectations regarding anticipated changes in vaccine demand, including changes to the ordering environment; and expected regulatory recommendations to adapt vaccines to address new strains, 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和辉瑞之间的合作，包括辉瑞的研究性修饰RNA（modRNA）流感疫苗候选物，潜在的下一代mRNA流感和组合疫苗制剂，以及辉瑞和BioNTech的基于mRNA的流感和新型冠状病毒的组合疫苗候选物，以及mRNA技术；；对现有数据和潜在收益预期的定性评估；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；；以及预期的监管建议，以适应疫苗以应对新的菌株，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 uncertainties i.

这些风险和不确定性i。

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

您应该查看BioNTech在截至2024年6月30日的表格6-K中的报告以及BioNTech随后向SEC提交的文件中“风险因素”标题下描述的风险和不确定性，这些文件可在SEC的网站上找到

www.sec.gov

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..

这些前瞻性声明仅在本协议签署之日有效。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

1

Disease Burden of Flu. Centers for Disease Control & Prevention. Available at

流感的疾病负担。疾病控制与预防中心。可在

https://www.cdc.gov/flu/about/burden/index.html

https://www.cdc.gov/flu/about/burden/index.html

2

2

Putri et al, Vaccine. 2018 Jun 22;36(27):3960-3966. doi: 10.1016/j.vaccine.2018.05.057

Putri等人，疫苗。2018年6月22日；36（27）：3960-3966。doi:10.1016/j.vaccine.2018.05.057

3

3

Flu & People 65 Years and Older. Centers for Disease Control and Prevention. Available at:

流感&65岁及以上的人。疾病控制和预防中心。网址：

Flu & People 65 Years and Older | CDC

流感和65岁及以上人群| CDC

4

4

Vaccine Effectiveness: How Well do the Flu Vaccines Work? Centers for Disease Control & Prevention. Available at

疫苗有效性：流感疫苗的效果如何？疾病控制与预防中心。可在

https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm

https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm

.

.

5

5

Flu Disparities Among Racial and Ethnic Minority Groups CDC. Available at

种族和少数民族群体之间的流感差异CDC。可在

https://www.cdc.gov/flu/highrisk/disparities-racial-ethnic-minority-groups.html

https://www.cdc.gov/flu/highrisk/disparities-racial-ethnic-minority-groups.html

.

.

Pfizer:

辉瑞：

Media Relations

媒体关系

+1 (212) 733-1226

+1 (212) 733-1226

PfizerMediaRelations@pfizer.com

PfizerMediaRelations@pfizer.com

Investor Relations

投资者关系

+1 (212) 733-4848

+1 (212) 733-4848

IR@pfizer.com

IR@pfizer.com

BioNTech:

BioNTech：

Media Relations

媒体关系

Jasmina Alatovic

Jasmina Alatovic

+49 (0)6131 9084 1513

+49 (0)6131 9084 1513

Media@biontech.de

Media@biontech.de

Investor Relations

投资者关系

Victoria Meissner, M.D.

医学博士维多利亚·梅斯纳。

+1 617 528 8293

+1 617 528 8293

Investors@biontech.de

Investors@biontech.de

Source: Pfizer Inc.

资料来源：辉瑞公司。