The FDA’s decision is based on the positive results from the Phase 2 Phase 3 trials, including a romized, active-controlled observer-blinded Phase 3 trial assessing the safety, tolerability, immunogenicity of the pentavalent vaccine cidate compared to currently U.S. licensed meningococcal vaccines, with the goal of determining immunologic noninferiity. The Phase 3 trial (NCT04440163) uated me than 2,400 patients from the U.S. Europe.

The CDC Advisy Committee on Immunization Practices (ACIP) will meet on October 25, 2023, to discuss recommendations f the appropriate use of PENBRAYA in adolescents young adults.

About PENBRAYA Regulaty Review

In September 2022, Pfizer announced positive results from a romized, active-controlled observer-blinded Phase 3 trial assessing the safety, tolerability, immunogenicity of the PENBRAYA compared to currently licensed meningococcal vaccines, with the goal of determining immunologic noninferiity. The Phase 3 trial (NCT04440163) uated me than 2,400 patients from the U.S. Europe. This trial was followed by the FDA’s acceptance of PENBRAYA’s Biologics License Application (BLA) in December 2022.

Indication f PENBRAYA

PENBRAYA is indicated f active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, Y. PENBRAYA is approved f use in individuals 10 through 25 years of age.

PENBRAYA is administered as a two-dose series given six months apart.

Imptant Safety Infmation f PENBRAYA

• PENBRAYA should not be given to anyone with a histy of a severe allergic reaction to any component of PENBRAYA

• Fainting may happen after getting injectable vaccines, including PENBRAYA. Precautions should be taken to avoid falling injury due to fainting

• Some individuals with weakened immune system may have reduced immune responses to PENBRAYA

• Individuals with certain complement deficiencies individuals receiving treatment that inhibits terminal complement activation are at increased risk f invasive disease caused by N. meningitidis groups A, B, C, W, Y, even if they develop antibodies following vaccination with PENBRAYA

• Vaccination with PENBRAYA may not protect all who receive the vaccine against N. meningitidis group A, B, C, W, Y infections

• Vaccination with PENBRAYA does not substitute f vaccination with a tetanus toxoid–containing vaccine to prevent tetanus

• Guillain-Barré syndrome (GBS) has been repted following administration of other meningococcal vaccines. Ask your healthcare provider about the risks benefits of PENBRAYA if you have a histy of GBS

• The most common adverse reactions were pain at the injection site, fatigue, headache, injection site redness, muscle pain, injection site swelling, joint pain, chills.

• Tell your healthcare provider if you are pregnant plan to become pregnant

• Ask your healthcare provider about the risks benefits of PENBRAYA. Only a healthcare provider can decide if PENBRAYA is right f you your child

View the full Prescribing Infmation. There may be a delay as the document is d with the latest infmation. It will be available as soon as possible. Please check back f the d full infmation shtly.

U.S. Indication f TRUMENBA® (meningococcal group B vaccine)

TRUMENBA® (meningococcal group B vaccine) is indicated f active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age. Approval of TRUMENBA® is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prent strains in the United States. The effectiveness of TRUMENBA® against diverse serogroup B strains has not been confirmed.

Imptant Safety Infmation

• TRUMENBA® should not be given to anyone with a histy of a severe allergic reaction after a previous dose of TRUMENBA®.

• Individuals with weakened immune systems may have a reduced immune response.

• The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, chills.

• Data are not available on the safety effectiveness of using TRUMENBA®  other meningococcal group B vaccines interchangeably to complete the vaccination series.

• Tell your healthcare provider if you are pregnant, plan to become pregnant.

• Ask your healthcare provider about the risks benefits of TRUMENBA®. Only a healthcare provider can decide if TRUMENBA® is right f you your child.

Indication f Nimenrix® in the European Union

Nimenrix® is indicated f active immunization of individuals from the age of six weeks above against invasive meningococcal disease caused by Neisseria meningitidis group A, C, W-135, Y. Nimenrix® is not licensed in the U.S.

Imptant Safety Infmation

Nimenrix® (meningococcal group A, C, W-135, Y conjugate vaccine) should not be given to anyone with a histy of a severe allergic reaction after a previous dose of Nimenrix®.

Individuals with weakened immune systems may have a reduced immune response. The most common adverse reactions were loss of appetite, irritability, drowsiness, pain at the injection site, fatigue, redness at the injection site, swelling at injection site.

Tell your healthcare provider if you are pregnant, plan to become pregnant.

Ask your healthcare provider about the risks benefits of Nimenrix®. Only a healthcare provider can decide if Nimenrix® is right f you your child.

The marketing authization f LITFULO is valid in all 27 EU member states, in Icel, Liechtenstein, Nway. This authization follows the recommendation f approval by the European Medicines Agency’s (EMA) Committee f Medicinal Products f Human Use (CHMP) in July 2023. It also follows approvals by the U.S. Food Drug Administration (FDA) the Japanese Ministry of Health, Labour Welfare (MHLW) in June 2023.

The approval was based on the ALLEGRO clinical trial program, which included the ALLEGRO Phase 2b/3 study (NCT03732807) that investigated LITFULO in patients 12 years of age older with alopecia areata with 50% me scalp hair loss, including patients with alopecia totalis (total scalp hair loss) alopecia universalis (total body hair loss). Results from this pivotal study showed that 13.4% of adults adolescents saw 90% me scalp hair coverage (SALT ≤10) after 24 weeks of treatment with LITFULO 50 mg compared to 1.5% with placebo. Patient Global Impression of Change (PGI-C) response was also measured was a key secondary outcome suppting the approval. At week 24, 49.2% of participants repted a response of “moderate” to “great” improvement in their alopecia areata compared to 9.2% with placebo.

ALLEGRO-LT (NCT04006457) is an ongoing Phase 3, open-label, long-term study, with safety efficacy data being collected f adults with alopecia areata with 25% greater scalp hair loss adolescents from 12 years of age with alopecia areata with 50% greater scalp hair loss. Long-term efficacy safety data from this study were included in the submission to suppt the approval.

The most common adverse reactions repted with LITFULO included diarrhea (9.2%), acne (6.2%), upper respiraty tract infections (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), dizziness (2.3%).

About Alopecia Areata

Alopecia areata is an autoimmune disease characterized by patchy complete hair loss on the scalp, face, body.1,2 The disease has an underlying immuno-inflammaty pathogenesis develops when the immune system attacks the body’s hair follicles, causing hair to fall out.1,2,3 Impacting approximately 2% of the population at some point during their lifetime, alopecia areata can affect people of any age, gender, race, ethnicity can cause considerable burden beyond hair loss.1,2,3,4

About LITFULO™ (Ritlecitinib)

LITFULO is a first-of-its-kind treatment which irreversibly ively inhibits JAK3 the TEC family of kinases by blocking γ-common cytokine signaling reducing cytolytic activity of NK CD8+ cells. This decreases the activity of parts of the immune system that are involved in the inflammation of hair follicles that causes hair loss in people with alopecia areata.

Ritlecitinib is also being uated f potential additional indications. The Tranquillo Phase 3 study (NCT05583526) is investigating the efficacy, safety, tolerability of ritlecitinib in adults adolescents with non-segmental vitiligo.

US INDICATION

LITFULO is a kinase inhibit indicated f the treatment of severe alopecia areata in adults adolescents 12 years older.

Limitations of Use: Not recommended f use in combination with other JAK inhibits, biologic immunomodulats, cyclospine other potent immunosuppressants.

US IMPTANT SAFETY INFMATION

LITFULO may cause serious side effects, including:

Serious infections. LITFULO can lower the ability of your immune system to fight infections. Do not start LITFULO if you have any kind of infection unless your healthcare provider tells you it is okay. Some people have had serious infections while taking LITFULO other similar medicines, including tuberculosis (TB), infections caused by bacteria, fungi, viruses that can spread throughout the body, have been hospitalized. Some people taking similar medicines to LITFULO have died from these infections. You may be at a higher risk of developing shingles (herpes zoster).

Your healthcare provider should test you f TB befe starting treatment with LITFULO should watch you closely f signs symptoms of TB during treatment with LITFULO.

Befe after starting LITFULO, tell your doct right away if you have an infection, are being treated f one, have symptoms of an infection, including:

• fever, sweating, chills

• muscle aches

• cough shtness of breath

• blood in your phlegm

• weight loss

• warm, red, painful skin ses on your body

• diarrhea stomach pain

• burning when you urinate urinating me often than usual

• feeling very tired

LITFULO can make you me likely to get infections wsen infections you have. If you get a serious infection, your healthcare provider may stop treatment with LITFULO until your infection is controlled.

There is an increased risk of death in people 50 years older who have at least one heart disease (cardiovascular) risk fact are taking a Janus kinase (JAK) inhibit. LITFULO is a kinase inhibit.

Cancer immune system problems. LITFULO may increase your risk of certain cancers by changing the way your immune system wks. Lymphoma other cancers, including skin cancers, can happen. People, especially current past smokers, have a higher risk of certain cancers, including lymphoma lung cancers, while taking a JAK inhibit. Follow your healthcare provider’s advice about having your skin checked f skin cancer during treatment. Tell your healthcare provider if you have ever had any type of cancer.

There is an increased risk of maj cardiovascular events such as heart attack, stroke, death in people 50 years older who have at least one heart disease (cardiovascular) risk fact are taking a JAK inhibit, especially f current past smokers.

Get emergency help right away if you have any symptoms of a heart attack stroke while taking LITFULO, including:

• discomft in the center of your chest that lasts f me than a few minutes, that goes away comes back

• severe tightness, pain, pressure, heaviness in your chest, throat, neck, jaw

• pain discomft in your arms, back, neck, jaw, stomach

• shtness of breath with without chest discomft

• breaking out in a cold sweat

• nausea vomiting

• feeling lightheaded

• weakness in one part on one side of your body

• slurred speech

Blood clots. Blood clots in the veins of your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), eyes can happen in some people taking LITFULO. This may be life-threatening. Blood clots in the veins of the legs lungs have happened me often in people 50 years older, with at least one heart disease (cardiovascular) risk fact, taking a JAK inhibit. Tell your healthcare provider if you have had blood clots in the past.

Stop taking LITFULO get medical help right away if you have any signs symptoms of blood clots, including swelling, pain, tenderness in one both legs; sudden, unexplained chest upper back pain; shtness of breath difficulty breathing; changes in vision, especially in one eye only.

Allergic reactions. Symptoms that may mean you are having an allergic reaction have been seen during treatment with LITFULO. Some of these reactions were serious. Stop taking LITFULO get emergency medical help right away if you have symptoms of allergic reaction, including hives; rash; trouble breathing; feeling faint dizzy; swelling of your lips, tongue, throat.

Changes in certain labaty test results. Your healthcare provider should do blood tests befe you start taking LITFULO during treatment to check your lymphocyte, platelet counts, liver enzyme, creatine phosphokinase (CPK) levels. You should not take LITFULO if your lymphocyte counts platelet counts are too low your liver tests are too high. Increased CPK levels in the blood are common with LITFULO can also be severe. Your healthcare provider may stop treatment f a period of time if there are changes in these blood test results.

Do not take LITFULO if you are allergic to ritlecitinib any of the ingredients in LITFULO. See the Medication Guide f a complete list of ingredients.

Befe taking LITFULO, tell your healthcare provider if you:

• have an infection, are being treated f one, have one that won’t go away keeps returning

• have diabetes, chronic lung disease, HIV, a weak immune system

• have TB have been in close contact with someone with TB

• have had shingles (herpes zoster)

• have had hepatitis B hepatitis C

• live, have lived, traveled to certain areas (such as Ohio & Mississippi River Valleys the Southwest) where there is an increased chance f getting certain kinds of fungal infections. These infections may happen wsen when taking LITFULO. Ask your healthcare provider if you’re unsure if you have lived in an area where these infections are common

• have had any type of cancer

• have had blood clots

• are a current past smoker

• have had a heart attack, other heart problems, stroke

• have liver problems

• have abnmal blood tests (low platelet count white blood cell count)

• have recently received are scheduled to receive any vaccinations. People who take LITFULO should not receive live vaccines right befe during treatment

• are plan to become pregnant. It is not known if LITFULO will harm your unbn baby. Tell your healthcare provider if you are pregnant plan to become pregnant during treatment with LITFULO. There is a pregnancy registry f people who take LITFULO during pregnancy. Rept pregnancies to Pfizer, Inc. at 1-877-390-2940

• are breastfeeding plan to breastfeed. It is not known if LITFULO passes into your breast milk. Do not breastfeed during treatment with LITFULO f 14 hours after your last dose of LITFULO. Talk to your healthcare provider about the best way to feed your baby during treatment with LITFULO

Tell your healthcare provider about all the medicines you take, including preion over-the-counter medicines, vitamins, herbal supplements. LITFULO other medicines may affect each other causing side effects.

The most common side effects of LITFULO include headache; diarrhea; acne; rash; hives; inflamed hair pes (folliculitis); fever; eczema; dizziness; shingles; decreased red blood cell counts; mouth ses, redness swelling of the lining of your mouth. These are not all of the possible side effects of LITFULO.

NEW YK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE)  BioNTech SE (Nasdaq: BNTX) today announced that the Committee f Medicinal Products f Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authization f the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) administered as a single dose f individuals 5 years of age  older, regardless of pri COVID-19 vaccination histy. The Committee has also recommended the d vaccine f children 6 months through 4 years of age as part  all of the primary three-dose vaccination series, depending on how many pri doses they received,  as single dose f those with a histy of completion of a COVID-19 primary vaccination course  pri SARS-CoV-2 infection.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230829323192/en/

The European Commission (EC) will review the CHMP’s recommendation  is expected to make a final decision soon. Following a decision from the EC, the d vaccine will be ready to ship to applicable EU member states immediately. Pfizer  BioNTech have been manufacturing the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall  winter season when the dem f COVID-19 vaccination is expected to increase.2

“This season’s vaccine is ready to ship as soon as the final regulaty decision is made, so that people across Europe can better help protect themselves against COVID-19 illness as the risk rises,” said Albert Bourla, Chairman  Chief utive Officer at Pfizer. “It's been nearly a year since many citizens in the European Union were vaccinated against COVID-19  the d fmulation provides the opptunity f them to receive a vaccine me closely matched to current sublineages."

“As COVID-19 is expected to adopt a seasonal pattern, similar to other respiraty viruses, we remain committed to providing COVID-19 vaccines that are better matched to relevant circulating variants  sublineages to people wldwide, to suppt vaccinations in the upcoming fall  winter season,” said Prof. Ugur Sahin, M.D., CEO  Co-founder of BioNTech. “Omicron XBB-related sublineages are antigenically distant from pri Omicron strains  continue to account f the vast majity of COVID-19 cases globally. The d COVID-19 vaccine aims to further improve protection against severe illness  hospitalization.”

The CHMP’s recommendation is based on the full body of previous clinical, non-clinical,  real-wld evidence suppting the safety  efficacy of the COVID-19 vaccines by Pfizer  BioNTech. Further, the application included pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple XBB sublineages, including XBB.1.5, XBB.1.16,  XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Additional pre-clinical data demonstrate that serum antibodies induced by the d COVID-19 vaccine, when compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, also effectively neutralize the globally dominant  recently WHO-designated variant of interest EG.5.1 (Eris).3

Pfizer  BioNTech have also filed an application with the U.S. Food  Drug Administration (FDA) requesting approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine f individuals 6 months of age  older. A decision is expected in the coming days. The companies have submitted data f the d COVID-19 vaccine to other regulaty authities around the wld.

The COVID-19 vaccines (COMIRNATY®) by Pfizer  BioNTech are based on BioNTech’s proprietary mRNA technology  were developed by both companies. BioNTech is the Marketing Authization Holder f COMIRNATY  its adapted vaccines (COMIRNATY iginal/Omicron BA.1; COMIRNATY iginal/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada  other countries,  the holder of emergency use authizations  equivalents in the United States (jointly with Pfizer)  other countries.

INDICATION & AUTHIZED USE

AUTHIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (iginal  Omicron BA.4/BA.5) is FDA authized under Emergency Use Authization (EUA) f active immunization to prevent conavirus disease 2019 (COVID-19) caused by severe acute respiraty syndrome conavirus 2 (SARS-CoV-2) in individuals 6 months of age  older.

EMERGENCY USE AUTHIZATION

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

IMPTANT SAFETY INFMATION

Tell your vaccination provider about all of your medical conditions, including if you:

• have any allergies

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

• have a fever

• have a bleeding disder  are on a blood thinner

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

• are pregnant, plan to become pregnant,  are breastfeeding

• have received another COVID-19 vaccine

• have ever fainted in association with an injection

• The vaccine may not protect everyone

• A person should NOT get Pfizer-BioNTech COVID-19 Vaccine, Bivalent if they have had a severe allergic reaction after a previous dose of Pfizer-BioNTech COVID-19 Vaccine*, Pfizer-BioNTech COVID-19 Vaccine, Bivalent,  COMIRNATY® (COVID-19 Vaccine, mRNA)  to any ingredients in these vaccines.

• 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 1 hour after getting a dose of the vaccine. F this reason, your vaccination provider may ask you to stay at the place where you received the vaccine f moniting after vaccination. If you experience a severe allergic reaction, call 9-1-1  go to the nearest hospital

Seek medical attention right away if you have any of the following symptoms:

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

• Myocarditis (inflammation of the heart muscle)  pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Pfizer-BioNTech COVID-19 Vaccine,  COMIRNATY (COVID-19 Vaccine, mRNA). The observed risk is higher among adolescent males  adult males under 40 years of age than among females  older males,  the observed risk is highest in males 12 through 17 years of age. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low. Seek medical attention right away if the vaccine recipient has any of the following symptoms:

• Chest pain

• Shtness of breath  difficulty breathing

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

Additional symptoms, particularly in children, may include:

• Fainting

• Unusual  persistent irritability

• Unusual  persistent po feeding

• Unusual  persistent fatigue  lack of energy

• Persistent vomiting

• Persistent pain in the abdomen

• Unusual  persistent cool, pale skin

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

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

Side effects that have been repted with Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Pfizer-BioNTech COVID-19 Vaccine,  COMIRNATY (COVID-19 Vaccine, mRNA) include:

• Severe allergic reactions

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

• Myocarditis (inflammation of the heart muscle)

• Pericarditis (inflammation of the lining outside the heart)

• Injection site pain/tenderness

• Tiredness

• Headache

• Muscle pain

• Chills

• Joint pain

• Fever

• Injection site swelling

• Injection site redness

• Nausea

• Feeling unwell

• Swollen lymph nodes (lymphadenopathy)

• Decreased appetite

• Diarrhea

• Vomiting

• Arm pain

• Fainting in association with injection of the vaccine

• Dizziness

• Irritability

These may not be all the possible side effects of these vaccines. Call the vaccination provider  healthcare provider about bothersome side effects  side effects that do not go away.

• Individuals should always ask their healthcare providers f medical advice about adverse events. Rept vaccine side effects to the US Food  Drug Administration (FDA)  the Centers f Disease Control  Prevention (CDC) Vaccine Adverse Event Repting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967  rept online to www.vaers.hhs.gov/reptevent.html. In addition, individuals can rept side effects to Pfizer Inc. at www.pfizersafetyrepting.com  by calling 1-800-438-1985

Please click f Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vaccination Provider  Recipient  Caregiver EUA Fact Sheets

*The iginal Pfizer-BioNTech COVID-19 Vaccine is no longer authized f use in the United States.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science  our global resources to bring therapies to people that extend  significantly improve their lives. We strive to set the stard f quality, safety  value in the discovery, development  manufacture of health care products, including innovative medicines  vaccines. Every day, Pfizer colleagues wk across developed  emerging markets to advance wellness, prevention, treatments  cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the wld's premier innovative biopharmaceutical companies, we collabate with health care providers, governments  local communities to suppt  exp access to reliable, affdable health care around the wld. F me than 170 years, we have wked to make a difference f all who rely on us. We routinely post infmation that may be imptant to invests on our website at www.pfizer.com. In addition, to learn me, please visit us on  follow us on Twitter at X (twitter.com)  Pfizer Inc. (@pfizer_news) / X (twitter.com), Pfizer | LinkedIn, youtube.com/pfizer  like us on Facebook at Pfizer - Home | Facebook.

Pfizer Disclosure Notice

The infmation contained in this release is as of August 30, 2023. Pfizer assumes no obligation to  fward-looking statements contained in this release as the result of new infmation  future events  developments.

This release contains fward-looking infmation about Pfizer’s effts to combat COVID-19, the collabation between BioNTech  Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program,  Pfizer  –BioNTech's COVID-19 vaccines, defined collectively herein as COMIRNATY (including regulaty applications pending with the European Commission  the U.S. Food  Drug Administration (FDA) f an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, data submitted f an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine to other regulaty authities, qualitative assessments of available data, potential benefits, expectations regarding dem f COVID-19 vaccination, expectations f clinical trials, potential regulaty submissions, the anticipated timing of data readouts, regulaty submissions, regulaty approvals  authizations  anticipated manufacturing, distribution  supply) involving substantial risks  uncertainties that could cause actual results to differ materially from those expressed  implied by such statements. Risks  uncertainties include, among other things, the uncertainties inherent in research  development, including the ability to meet anticipated clinical endpoints, commencement / completion dates f clinical trials, regulaty submission dates, regulaty approval dates / launch dates, as well as risks associated with pre-clinical  clinical data (including Phase 1/2/3  Phase 4  pre-clinical data f COMIRNATY,  any vaccine cidate in the BNT162 program, including the data discussed in this release) in any of our studies in pediatrics, adolescents,  adults  real wld evidence, including the possibility of unfavable new pre-clinical, clinical  safety data  further analyses of existing pre-clinical, clinical  safety data  further infmation regarding the quality of pre-clinical, clinical  safety data, including the risk that additional data against newer Omicron sublineages could differ from previously repted data; the ability to produce comparable clinical  other results f COMIRNATY, any vaccine cidate  any other vaccines that may result from the BNT162 program  any other COVID-19 program, including the rate of vaccine effectiveness  safety  tolerability profile observed to date, in additional analyses of the Phase 3 trial  additional studies, in real wld data studies  in larger, me diverse populations following commercialization; the ability of COMIRNATY, any vaccine cidate  any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that use of the vaccine will lead to new infmation about efficacy, safety,  other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that pre-clinical  clinical trial data are subject to differing interpretations  assessments, including during the peer review/publication process, in the scientific community generally,  by regulaty authities; whether  when additional data from the BNT162 mRNA vaccine program  other COVID-19 programs will be published in scientific journal publications , if so, when  with what modifications  interpretations; whether regulaty authities will be satisfied with the design of  results from existing  future pre-clinical  clinical studies; whether  when submissions to request emergency use  conditional marketing authizations f COMIRNATY  any future vaccines in additional populations, f a potential booster dose f COMIRNATY, any vaccine cidate  any potential future vaccines (including potential future annual boosters  re-vaccinations), / other biologics license / emergency use authization applications  amendments to any such applications may be filed in particular jurisdictions f COMIRNATY, any vaccine cidates  any other potential vaccines that may arise from the BNT162 program,  if obtained, whether  when such emergency use authizations  licenses,  existing emergency use authizations, will expire  terminate; whether  when any applications that may be pending  filed f COMIRNATY (including any requested amendments to the emergency use  conditional marketing authizations  including the applications pending with the FDA  the European Commission f the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine), any vaccine cidates  other vaccines that may result from the BNT162 program  any other COVID-19 program may be approved by particular regulaty authities, which will depend on myriad facts, including making a determination as to whether the vaccine’s benefits outweigh its known risks  determination of the vaccine’s efficacy , if approved, whether it will be commercially successful; decisions by regulaty authities impacting labeling  marketing, manufacturing processes, safety / other matters that could affect the availability  commercial potential of a vaccine, including the authization  approval of products  therapies developed by other companies; disruptions in the relationships between us  our collabation partners, clinical trial sites  third-party suppliers, including our relationship with BioNTech; the risk that dem f any products may be reduced, no longer exist  not meet expectations, which may lead to excess inventy on-h / in the channel  reduced revenues; challenges related to  uncertainties regarding the timing of a transition to the commercial market f any of our products; uncertainties related to the public’s adherence to vaccines  boosters; risks related to our ability to achieve our revenue fecasts f COMIRNATY  any potential future COVID-19 vaccines; the risk that other companies may produce superi  competitive products; risks related to the availability of raw materials to manufacture  test a vaccine; challenges related to our vaccine’s fmulation, dosing schedule  attendant stage, distribution  administration requirements, including risks related to stage  hling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine fmulations, booster doses  potential future annual boosters  re-vaccinations  new variant-based  next generation vaccines  potential combination respiraty vaccines; the risk that we may not be able to maintain manufacturing capacity  access to logistics  supply channels commensurate with global dem f our vaccines, which would negatively impact our ability to supply our vaccines within the projected time periods; whether  when additional supply  purchase agreements will be reached  existing agreements will be completed  renegotiated; uncertainties regarding the ability to obtain recommendations from vaccine advisy  technical committees  other public health authities  uncertainties regarding the commercial impact of any such recommendations; pricing  access challenges; challenges related to public confidence in,  awareness of COMIRNATY; uncertainties around future changes to applicable healthcare policies  guidelines issued by the U.S. federal government in connection with the declared termination of the federal government’s COVID-19 public health emergency as of May 11, 2023; trade restrictions; potential third party royalties  other claims; the uncertainties inherent in business  financial planning, including, without limitation, risks related to Pfizer’s business  prospects, adverse developments in Pfizer’s markets,  adverse developments in the U.S.  global capital markets, credit markets, regulaty environment  economies generally; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations  financial results;  competitive developments.

A further deion of risks  uncertainties can be found in Pfizer’s Annual Rept on Fm 10-K f the fiscal year ended December 31, 2022  in its subsequent repts on Fm 10-Q, including in the sections thereof captioned “Risk Facts”  “Fward-Looking Infmation  Facts That May Affect Future Results”, as well as in its subsequent repts on Fm 8-K, all of which are filed with the U.S. Securities  Exchange Commission  available at www.sec.gov  www.pfizer.com.

About BioNTech

Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies f cancer  other serious diseases. The Company exploits a wide array of computational discovery  therapeutic drug platfms f the rapid development of novel biopharmaceuticals. Its broad ptfolio of oncology product cidates includes individualized  off-the-shelf mRNA-based therapies, innovative chimeric antigen recept CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulats, targeted cancer antibodies  antibody-drug conjugate (ADC) therapies, as well as small molecules. Based on its deep expertise in mRNA vaccine development  in-house manufacturing capabilities, BioNTech  its collabats are developing multiple mRNA vaccine cidates f a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collabats, including DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron, Sanofi,  Pfizer.

F me infmation, please visit www.BioNTech.com.

BioNTech Fward-looking Statements

This press release contains fward-looking statements within the meaning of the Private Securities Litigation Refm Act of 1995, as amended, including, but not be limited to, statements concerning: BioNTech’s effts to combat COVID-19; the collabation between BioNTech  Pfizer; the rate  degree of market acceptance of BioNTech’s COVID-19 vaccine, including the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine; qualitative assessments of available data  expectations of potential benefits; regulaty submissions  regulaty approvals  authizations  expectations regarding manufacturing, distribution  supply; expectations regarding anticipated changes in COVID-19 vaccine dem, including changes to the dering environment;  expected regulaty recommendations to adapt vaccines to address new variants  sublineages. In some cases, fward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,”  the negative of these terms  other comparable terminology, although not all fward-looking statements contain these wds. The fward-looking statements in this press release are neither promises n guarantees,  you should not place undue reliance on these fward-looking statements because they involve known  unknown risks, uncertainties,  other facts, many of which are beyond BioNTech’s control  which could cause actual results to differ materially from those expressed  implied by these fward-looking statements. These risks  uncertainties include, but are not limited to: the uncertainties inherent in research  development, including the ability to meet anticipated clinical endpoints, commencement / completion dates f clinical trials, regulaty submission dates, regulaty approval dates / launch dates, as well as risks associated with preclinical  clinical data, including the data discussed in this release,  including the possibility of unfavable new preclinical, clinical  safety data  further analyses of existing preclinical, clinical  safety data; the nature of the clinical data, which is subject to ongoing peer review, regulaty review  market interpretation; BioNTech's pricing  coverage negotiations with governmental authities, private health insurers  other third-party pays after BioNTech's initial sales to national governments; the future commercial dem  medical need f initial  booster doses of a COVID-19 vaccine; the availability of raw materials to manufacture a vaccine; our vaccine’s fmulation, dosing schedule  attendant stage, distribution  administration requirements, including risks related to stage  hling after delivery; competition from other COVID-19 vaccines  related to BioNTech's other product cidates, including those with different mechanisms of action  different manufacturing  distribution constraints, on the basis of, among other things, efficacy, cost, convenience of stage  distribution, breadth of approved use, side-effect profile  durability of immune response; the ability to obtain recommendations from vaccine advisy  technical committees  other public health authities  uncertainties regarding the commercial impact of any such recommendations; the timing of  BioNTech's ability to obtain  maintain regulaty approval f BioNTech's product cidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's  its counterparties’ ability to manage  source necessary energy resources; BioNTech's ability to identify research opptunities  discover  develop investigational medicines; the ability  willingness of BioNTech's third-party collabats to continue research  development activities relating to BioNTech's development cidates  investigational medicines; the impact of the COVID-19 pemic on BioNTech's development programs, supply chain, collabats  financial perfmance; unfeseen safety issues  potential claims that are alleged to arise from the use of BioNTech's COVID-19 vaccine  other products  product cidates developed  manufactured by BioNTech; BioNTech's  its collabats’ ability to commercialize  market BioNTech's COVID-19 vaccine , if approved, its product cidates; BioNTech's ability to manage its development  expansion; regulaty developments in the United States  other countries; BioNTech's ability to effectively scale BioNTech's production capabilities  manufacture BioNTech's products, including BioNTech's target COVID-19 vaccine production levels,  BioNTech's product cidates; risks relating to the global financial system  markets;  other facts not known to BioNTech at this time.

You should review the risks  uncertainties described under the heading “Risk Facts” in BioNTech’s Rept on Fm 6-K f the period ended June 30, 2023  in subsequent filings made by BioNTech with the U.S. Securities  Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, BioNTech disclaims any intention  responsibility f updating  revising any fward-looking statements contained in this press release in the event of new infmation, future developments  otherwise. These fward-looking statements are based on BioNTech’s current expectations  speak only as of the date hereof.

1 Wld Health ganization. COVID-19 Weekly Epidemiological . Available at: https://www.who.int/emergencies/diseases/novel-conavirus-2019/situation-repts

2 Wiemken TL, Khan F, Nguyen JL, Jodar L, McLaughlin JM. Is COVID-19 seasonal? A time series modeling approach. medRxiv. 2022:2022.06.17.22276570.

3 Wld Health ganization. EG.5 Initial Risk uation. Available at: https://www.who.int/docs/default-source/conaviruse/09082023eg.5_ire_final.pdf?sfvrsn=2aa2daee_1

Categy: Vaccines