Pfizer to Showcase Scientific Advancements in Respiratory and Other Infectious Diseases at IDWeek 2024
Pfizer Inc. (NYSE: PFE) will present 49 abstracts from company- and collaborator-led studies at IDWeek 2024 in Los Angeles from October 16-19, 2024. The presentations will showcase advancements in Pfizer's infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, and serious bacterial and fungal infections.
Key highlights include:
- Pharmacokinetics and safety of nirmatrelvir/ritonavir in pediatric COVID-19 patients
- Real-world effectiveness of Abrysvo vaccine against RSV-related hospitalizations
- Safety and immunogenicity of coadministered COVID-19 and RSV vaccines
- Effectiveness of COVID-19 vaccination against long COVID in older adults
- Updates on Lyme disease vaccine candidate VLA15
- Epidemiology of invasive meningococcal disease in the US
- Impact of pneumococcal conjugate vaccines on vaccine serotypes
Pfizer Inc. (NYSE: PFE) presenterà 49 abstract da studi condotti dall'azienda e dai suoi collaboratori all'IDWeek 2024 a Los Angeles dal 16 al 19 ottobre 2024. Le presentazioni metteranno in evidenza i progressi nel portafoglio di malattie infettive di Pfizer, coprendo RSV, COVID-19, malattia pneumococcica, malattia di Lyme, malattia meningococcica e gravi infezioni batteriche e fungine.
Tra i punti salienti ci sono:
- Farmacocinetica e sicurezza di nirmatrelvir/ritonavir in pazienti pediatrici con COVID-19
- Effettiva del vaccino Abrysvo contro le ospedalizzazioni correlate a RSV
- Sicurezza e immunogenicità dei vaccini COVID-19 e RSV somministrati insieme
- Efficacia della vaccinazione contro il COVID-19 per prevenire il long COVID negli adulti più anziani
- Aggiornamenti sul candidato vaccino contro la malattia di Lyme VLA15
- Epidemiologia della malattia meningococcica invasiva negli Stati Uniti
- Impatto dei vaccini coniugati pneumococcici sui sierotipi vaccinali
Pfizer Inc. (NYSE: PFE) presentará 49 resúmenes de estudios liderados por la compañía y colaboradores en IDWeek 2024 en Los Ángeles del 16 al 19 de octubre de 2024. Las presentaciones mostrarán los avances en el portafolio de enfermedades infecciosas de Pfizer, cubriendo RSV, COVID-19, enfermedad neumocócica, enfermedad de Lyme, enfermedad meningocócica e infecciones bacterianas y fúngicas graves.
Los puntos destacados incluyen:
- Farmacocinética y seguridad de nirmatrelvir/ritonavir en pacientes pediátricos con COVID-19
- Efectividad del vaccino Abrysvo contra hospitalizaciones relacionadas con RSV
- Seguridad e inmunogenicidad de las vacunas COVID-19 y RSV administradas conjuntamente
- Efectividad de la vacunación contra COVID-19 para prevenir el long COVID en adultos mayores
- Actualizaciones sobre el candidato vacunal para la enfermedad de Lyme VLA15
- Epidemiología de la enfermedad meningocócica invasiva en EE.UU.
- Impacto de las vacunas conjugadas neumocócicas en los serotipos vacunales
화이자 주식회사(Pfizer Inc.)(NYSE: PFE)는 2024년 10월 16일부터 19일 사이에 로스앤젤레스에서 열리는 IDWeek 2024에서 회사와 협력자들이 수행한 연구에서 49개의 초록을 발표할 예정입니다. 발표는 화이자의 감염병 포트폴리오에서의 발전을 보여줄 것이며, RSV, COVID-19, 폐렴구균 질환, 라임병, 수막구균 질환 및 심각한 세균 및 곰팡이 감염을 다룰 것입니다.
주요 하이라이트는 다음과 같습니다:
- 소아 COVID-19 환자에서 nirmatrelvir/ritonavir의 약동학 및 안전성
- RSV 관련 입원에 대한 Abrysvo 백신의 실제 효과
- 동시에 투여된 COVID-19 및 RSV 백신의 안전성 및 면역원성
- 노인에서 장기 COVID를 예방하기 위한 COVID-19 백신 접종의 효과
- 라임병 백신 후보 VLA15에 대한 업데이트
- 미국 내 침습성 수막구균 질환의 역학
- 폐렴구균 결합 백신이 백신 혈청형에 미치는 영향
Pfizer Inc. (NYSE: PFE) présentera 49 résumés d'études menées par l'entreprise et ses collaborateurs lors de IDWeek 2024 à Los Angeles du 16 au 19 octobre 2024. Les présentations mettront en avant les avancées dans le portefeuille de maladies infectieuses de Pfizer, couvrant RSV, COVID-19, maladie pneumococcique, maladie de Lyme, maladie méningococcique et infections bactériennes et fongiques graves.
Les points saillants comprennent :
- Pharmacocinétique et sécurité de nirmatrelvir/ritonavir chez les patients pédiatriques atteints de COVID-19
- Efficacité du vaccin Abrysvo contre les hospitalisations liées au RSV
- Sécurité et immunogénicité des vaccins COVID-19 et RSV administrés ensemble
- Efficacité de la vaccination contre le COVID-19 pour prévenir le long COVID chez les personnes âgées
- Mises à jour sur le candidat-vaccin VLA15 contre la maladie de Lyme
- Épidémiologie de la maladie méningococcique invasive aux États-Unis
- Impact des vaccins conjugués pneumococciques sur les sérotypes vaccinaux
Die Pfizer Inc. (NYSE: PFE) wird auf der IDWeek 2024 in Los Angeles vom 16. bis 19. Oktober 2024 49 Abstracts aus von der Firma und ihren Partnern durchgeführten Studien präsentieren. Die Präsentationen werden Fortschritte im Portfolio der Infektionskrankheiten von Pfizer zeigen, die RSV, COVID-19, pneumokokkale Erkrankungen, Lyme-Borreliose, meningokokkale Erkrankungen und schwere bakterielle sowie pilzliche Infektionen umfassen.
Wichtige Höhepunkte sind:
- Pharmakokinetik und Sicherheit von nirmatrelvir/ritonavir bei pädiatrischen COVID-19-Patienten
- Effektivität des Abrysvo-Impfstoffs gegen RSV-bedingte Krankenhausaufenthalte
- Sicherheit und Immunogenität von gleichzeitig verabreichten COVID-19- und RSV-Impfstoffen
- Wirksamkeit der COVID-19-Impfung gegen Long COVID bei älteren Erwachsenen
- Updates zum Impfstoffkandidaten VLA15 gegen Lyme-Borreliose
- Epidemiologie invasiver meningokokker Infektionen in den USA
- Einfluss pneumokokkaler Konjugatimpfstoffe auf Impfstoff-Serotypen
- Pfizer will present data from 49 abstracts at IDWeek 2024, demonstrating progress in multiple infectious disease areas
- Presentations cover advancements in RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, and serious bacterial and fungal infections
- Real-world effectiveness data for Abrysvo vaccine against RSV-related hospitalizations will be presented
- Study results on coadministration of COVID-19 and RSV vaccines will be shared
- Updates on Lyme disease vaccine candidate VLA15 will be presented
- None.
Insights
This announcement from Pfizer highlights their significant presence at IDWeek 2024, showcasing 49 abstracts across various infectious disease areas. While not directly impactful to immediate financial performance, it demonstrates Pfizer's continued investment and progress in key therapeutic areas like RSV, COVID-19, pneumococcal disease and Lyme disease.
The presentations cover a wide range of topics, including:
- Vaccine effectiveness studies for RSV and COVID-19 vaccines
- Real-world data on nirmatrelvir/ritonavir (Paxlovid) use
- Economic burden analyses for diseases like Lyme and RSV
- Updates on pipeline candidates like the Lyme disease vaccine
This robust scientific presence reinforces Pfizer's position as a leader in infectious diseases, which could translate to future product launches and revenue streams. However, investors should note that many of these studies are early-stage or observational and may not lead to immediate commercial impact.
The focus on RSV is particularly noteworthy, with multiple presentations on Abrysvo, Pfizer's recently approved RSV vaccine. Strong real-world data could drive adoption and sales growth for this new product.
While this news doesn't provide immediate financial implications, it offers insights into Pfizer's R&D focus and potential future revenue drivers. The company's strong presence at IDWeek 2024 with 49 abstracts demonstrates continued investment in infectious diseases, a key therapeutic area.
Investors should pay attention to the following points:
- Emphasis on RSV: Multiple presentations on Abrysvo, Pfizer's new RSV vaccine, suggest the company is positioning this as a significant growth driver.
- COVID-19 updates: Ongoing studies on vaccine effectiveness and Paxlovid use indicate Pfizer's commitment to maintaining its leadership in COVID-19 therapeutics.
- Pipeline progress: Data on the Lyme disease vaccine candidate and other early-stage programs provide visibility into potential future products.
While not immediately impactful to the
Investors should monitor how these scientific advancements translate into commercial success, particularly for newer products like Abrysvo and pipeline candidates in the coming years.
Presentations highlight momentum of Pfizer’s portfolio of infectious disease prevention and treatment options
“Pfizer is at the forefront of vaccine and therapeutic development in respiratory and infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “IDWeek 2024 provides a crucial platform to showcase our innovative advancements and engage with the scientific community, as we work to effectively tackle the ongoing challenge posed by infectious diseases.”
"As we approach another respiratory virus season, the importance of preventive vaccines and treatments to help keep us healthy is more apparent than ever,” said Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals, Pfizer. “We’re excited to present new, meaningful data that we hope will help further inform healthcare providers.”
Pfizer will present research from its robust infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, and serious bacterial and fungal infections. Details for Pfizer-sponsored, investigator-sponsored and collaborative research oral and poster presentations are below:
Title/Abstract Number |
Presenting
|
Date/Time
|
Location
|
ORAL & LATE-BREAKING PRESENTATIONS |
|||
580 - Pharmacokinetics (PK) and Safety of Nirmatrelvir/Ritonavir (NMV/r) in Non-Hospitalized Symptomatic Pediatric Patients Ages 6 Years and Older with COVID-19 Who Are at Increased Risk of Progression to Severe Disease (EPIC-Peds) |
Jacqueline Gerhart, PhD |
Oct 19
|
403 A |
88 - Efficacy of Nirmatrelvir/Ritonavir in High-Risk Trial Participants With Prior SARS-CoV-2 Infection or Vaccination: A Pooled Analysis |
John M. |
Oct 17
|
411 |
165 - Real-world Abrysvo vaccine effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related severe acute respiratory infection (ARI) hospitalizations and emergency department (ED) visits—Kaiser Permanente of |
Sara Tartof, PhD, MPH, (KPSC)* |
Oct 17
|
403A |
571 – Safety and Immunogenicity of Coadministered Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine With and Without Quadrivalent Influenza Vaccine in Adults ≥ 65 Years of Age |
Rahsan Erdem, MD
|
Oct 19
|
408 A |
POSTER PRESENTATIONS |
|||
COVID-19 |
|||
P - 1194 - Comparison of COVID-19 Inpatient Burden in Hospitalized Children Age < 5years, by SARS-CoV-2 Variant
|
Kathleen M. Andersen, PhD MSc |
Oct 18
|
Hall J & K |
P - 1906 - Early COVID-19 and Severity of Subsequent Omicron Infection in |
Caroline Kassee, MPH (Sinai Health)*
|
Oct 19
|
Hall J & K
|
P - 1977 - Six-Month Trajectory of Symptoms of COVID-19 Fatigue by Age and BNT162b2 COVID-19 Vaccination Status: A Prospective Study Among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy
|
Manuela Di Fusco, PhD |
Oct 19
|
Hall J & K |
P - 2047 - Public Health Impact and Economic Value of an Additional Dose of Pfizer-BioNTech XBB.1.5-adapted COVID-19 Vaccine for Older Adults in |
Alon Yehoshua, PharmD, MS |
Oct 19
|
Hall J & K |
P - 2048 - COVID-19 XBB.1.5 vaccine uptake based on state vaccine registries compared to national survey data |
Angela Cook, MS |
Oct 19
|
Hall J & K |
P - 2054 - Effectiveness of a Single COVID-19 mRNA Vaccine Dose in Individuals Previously Infected with SARS-CoV-2: A Systematic Review
|
Hannah R. Volkman, PhD, MPH
|
Oct 19
|
Hall J & K |
P - 2060 - Effectiveness of BNT162b2 COVID-19 Vaccination Against Long COVID Among Older Adults: A Nationwide Study |
Manuela Di Fusco, PhD
|
Oct 19
|
Hall J & K
|
P - 2062 - COVID-19 XBB.1.5-adapted vaccine uptake in immunocompromised individuals using tokenized state vaccine registries |
Matthew A. Brouillette, MPH |
Oct 19
|
Hall J & K |
P - 2017 - Patient Reported Outcomes of Nirmatrelvir/Ritonavir Treatment for High-risk, Nonhospitalized Adults with Symptomatic COVID-19 |
Ashley S. Cha-Silva, PharmD, MS |
Oct 19
|
Hall J & K |
Lyme Disease |
|||
P - 599 - 6-Valent, OspA-Based VLA15 Lyme Disease Vaccine Candidate Against Lyme Borreliosis in a Healthy Pediatric and Adult Study Population: A Phase 2 Study Update |
James H. Stark, PhD |
Oct 17
|
Hall J & K |
P - 1287 - Incidence of Symptomatic Lyme Borreliosis in Nine European Countries, 2018−2022 |
Frederick Angulo, DVM PhD |
Oct 18
|
Hall J & K |
P - 1291 - Racial disparities in Lyme disease among beneficiaries of US Medicaid and Medicare |
L. Hannah Gould, PhD, MS, MBA |
Oct 18
|
Hall J & K |
P - 1293 - Healthcare Costs Associated with Lyme Disease in a |
Holly Yu, MSPH |
Oct 18
|
Hall J & K |
Meningococcal Disease |
|||
P - 1299 - Epidemiology of Invasive Meningococcal Disease in |
Jessica Presa, MD |
Oct 18
|
Hall J & K |
P - 1304 - Public Health Impact of changes to Meningococcal vaccination platform in |
Katharina Schley, Dr. rer pol. |
Oct 18
|
Hall J & K |
Pneumococcal disease |
|||
P - 8 - Assessment of 13-valent pneumococcal conjugate vaccine effectiveness among people living with HIV in |
Amanda C. Miles, MPH |
Oct 17
|
Hall J & K |
P - 628 - Real-world impact of pneumococcal conjugate vaccines on vaccine serotypes and cross-reacting non-vaccine serotypes |
Kevin Apodaca, MPH |
Oct 17
|
Hall J & K |
P - 629 - The health and economic impact of the PCV15 and PCV20 priming series during the first year of life in the US |
Mark Rozenbaum, PhD, M.B.A |
Oct 17
|
Hall J & K |
Respiratory Syncytial Virus (RSV) |
|||
P - 673 - Respiratory Syncytial Virus (RSV) Hospitalizations During Off-Season Months Among Infants in US |
Amy W. Law, PharmD |
Oct 17
|
Hall J & K |
P - 674 - The Economic Burden of Infant RSV Among US Caregivers |
Amy W. Law, PharmD |
Oct 17
|
Hall J & K |
P - 40 - Impact of case and control selection on influenza vaccine effectiveness (VE) among adults aged 40 years and older hospitalized with acute respiratory illness (ARI) during 2022-2023 using a test negative design (TND): secondary analysis of the North America Multi-Specimen Study |
Negar Aliabadi, MD, MS |
Oct 17
|
Hall J & K |
P - 1204 - Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in |
Sazini Nzula, PhD |
Oct 18
|
Hall J & K |
P - 1205 - Impact of the COVID-19 Pandemic on Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in |
Sazini Nzula, PhD |
Oct 18
|
Hall J & K |
P - 677 - Estimation of Respiratory Syncytial Virus-Attributable Hospitalizations Among Older Adults in |
Asuka Yoshida, PhD |
Oct 17
|
Hall J & K |
P - 680 - Estimated Respiratory Syncytial Virus (RSV)-Related Hospitalizations and Deaths Among Adults in |
Caihua Liang, MD, PhD |
Oct 17
|
Hall J & K |
P - 682 - The Risk of Cardiorespiratory Events for Up to 180 days Following Respiratory Syncytial Virus (RSV) Infection Hospitalization: A Self-Controlled Case Series Analysis |
Caihua Liang, MD, PhD |
Oct 17
|
Hall J & K |
P – 683 – Estimation of RSV-Attributable Cardiovascular and Respiratory Hospitalizations in Adults in |
Caroline Beese |
Oct 17
|
Hall J & K |
P - 604 - Preliminary real-world Abrysvo vaccine effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related lower respiratory tract disease (LRTD) hospitalizations and emergency department (ED) visits—Kaiser Permanente of |
Negar Aliabadi, MD, MS |
Oct 17
|
Hall J & K |
P - 53 - Trends in Co-administration of Adult Vaccinations in the US Retail Pharmacy Setting |
Reiko Sato, PhD |
Oct 17
|
Hall J & K |
P - 603 - Potential Public Health Impact of Respiratory Syncytial Virus (RSV) Vaccines for Prevention of RSV Among Older Adults in |
Reiko Sato, PhD |
Oct 17
|
Hall J & K |
P - 600 - Efficacy Of a Bivalent RSVpreF Vaccine in Older Adults Across a Second RSV Season |
John Woodside, PhD |
Oct 17
|
Hall J & K |
P - 596 - Immunobridging Demonstrating Effectiveness of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Adults 18-59 Years of Age at High Risk of Severe RSV Disease in a Phase 3 Trial: The C3671023 MONeT Study Results |
Elliot N. DeHaan, MD |
Oct 17
|
Hall J & K |
P - 681 - Estimated Incidence of Respiratory Syncytial Virus (RSV)-Related Hospitalizations for Acute Respiratory Infections (ARIs), including Community Acquired Pneumonia (CAP), in Adults in |
Caihua Liang, MD, PhD |
Oct 17
|
Hall J & K |
P - 605 - Bivalent RSV Prefusion F-Based Subunit Vaccine Generates High and Durable Neutralizing Titers Across an Entire RSV Season Among Older Adults |
Tarek Mikati, MD, MPH |
Oct 17
|
Hall J & K |
P - 595 - Public Health Impact of RSVpreF Vaccination on Older Adult Disease Outcomes |
Daniel Eiras, MD, MPH |
Oct 17
|
Hall J & K |
P - 21 - Comparison of Three RSV Vaccine Lower Respiratory Tract Disease Primary Endpoint Definitions for Adult Vaccine |
Sarah E. Williams, MD. MPH |
Oct 17
|
Hall J & K |
P - 2357 - Respiratory Syncytial Virus (RSV) Disease Burden Among Adults in Primary Care Settings in High-Income Countries: A Systematic Review and Modelling Study |
You Li; multiple Pfizer co-authors
|
Oct 19
|
Hall J & K |
Aztreonam-Avibactam |
|||
P - 105 - Aztreonam-Avibactam Compared with Adjunctive Colistin Combined with Meropenem for the Treatment of Serious Gram-Negative Bacterial Infections: Subgroup Analysis of the Phase 3 REVISIT Study |
Heidi Leister-Tebbe, BSN
|
Oct 17
|
Hall J & K |
P - 1080 Aztreonam-Avibactam Activity Against Gram-negative Bacteria Isolated From Patients with Pneumonia from |
Helio S. Sader, MD, PhD, FIDSA
|
Oct 18
|
Hall J & K |
P - 1256 - Pharmacokinetic/Pharmacodynamic (PK/PD) Target Attainment Analyses for Aztreonam-Avibactam Dosing Regimens |
Susan Raber*, PharmD, MPH
|
Oct 17
|
Hall J & K |
P - 1508 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolates Producing Multiple β-lactamases Collected Globally as a Part of the ATLAS Global Surveillance Program From 2018-2022
|
Mark Estabrook*, PhD
|
Oct 17
|
Hall J & K |
P - 1509 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolated From Pediatric and Adult Patients Collected During the ATLAS Global Surveillance Program, 2018-2022 |
Mark Estabrook*, PhD |
Oct 18
|
Hall J & K |
Isavuconazole |
|||
P - 1168 - Activity of Isavuconazole and Comparator Agents Against Pediatric Fungal Isolates Collected from 2017–2023 in a Global Surveillance Program |
Marisa Winkler, MD, PhD
|
Oct 17
|
Hall J & K |
Ceftazidime-Avibactam |
|||
P- 1506 - In Vitro Activity of Ceftazidime-Avibactam and Comparator Agents Against Pseudomonas aeruginosa Collected from Patients with Presumed Hospital- and Community-Acquired Respiratory Tract Infections as a Part of the ATLAS Global Surveillance Program 2018-2022 |
Mark Estabrook, PhD
|
Oct 17
|
Hall J & K |
P- 1507 - In Vitro Activity of Ceftazidime-Avibactam Against Enterobacterales Isolates Producing Multiple β-lactamases Collected Globally as a Part of the ATLAS Global Surveillance Program from 2018-2022 |
Mark Estabrook, PhD
|
Oct 17
|
Hall J & K |
* =multiple Pfizer co-authors
Prescribing Information for Pfizer Medicines
Please see full Prescribing Information for ABRYSVO® (Respiratory Syncytial Virus Vaccine) or visit https://abrysvoadult.pfizerpro.com/ and https://abrysvomaternal.pfizerpro.com/.
Please see full Prescribing Information for COMIRNATY® (COVID-19 Vaccine, mRNA) or visit https://comirnatyhcp.com.
Please see full Prescribing Information for CRESEMBA® (Isavuconazonium Sulfate) or visit www.cresemba.com.
Please see full Prescribing Information for PAXLOVIDTM (Nirmatrelvir and Ritonavir) or visit https://paxlovid.pfizerpro.com.
Please see full Prescribing Information for PREVNAR 20TM (Pneumococcal 20-valent Conjugate Vaccine) or visit https://prevnar20.pfizerpro.com/.
Please see full Prescribing Information for PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine).
Please see full Prescribing Information for ZAFICEFTA® (Ceftazidime-Avibactam).
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at 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.
DISCLOSURE NOTICE: The information contained in this release is as of October 8, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, 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. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease products and product candidates; 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; risks associated with interim and preliminary data; 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 any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the
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Source: Pfizer Inc.
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