A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE (VLA15) IN HEALTHY CHILDREN 5 THROUGH 17 YEARS OF AGE

This study is to understand if the study vaccine (called VLA15) is safe in healthy children.
We are looking for children who:
* are healthy
* are age 5 through 17
* have not been diagnosed with any form of Lyme disease in the past
* have not received any vaccines for Lyme disease in the past
Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group.
Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo.
Everyone participating in this study will:
* get the shots in a clinic or in a hospital office
* receive a total of 4 shots
* receive the first 3 shots within 6 months
* receive the last shot about 1 year afterwards
* need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.

Start Date12 Dec 2022

Sponsor / Collaborator

Pfizer Inc.

NCT05477524 / Active, not recruitingPhase 3

A Phase 3, Multicenter, Placebo-Controlled, Randomized, Observer-Blinded Trial to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, and Lot Consistency of a 6-Valent OspA-Based Lyme Disease Vaccine in Healthy Participants ≥5 Years of Age

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence.
Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months after end of primary vaccination series. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. A subset of participants will be followed for a third Lyme disease season.
Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective.
If enrolled, participants will need to visit the research site at least 7 times during the study, and for a subset of participants up to 9 times. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years. The subset of participants followed for a third Lyme disease season will take part in this study for up to about to 3 and a half years.

Start Date04 Aug 2022

Sponsor / Collaborator

Pfizer Inc.

[+1]

EUCTR2018-003379-37-AT / Not yet recruitingPhase 2

IMMUNOGENICITY AND SAFETY STUDY OF VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS, IN HEALTHY ADULTS AGED 18 TO 65 YEARS - A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY.

Start Date20 Aug 2019

Sponsor / Collaborator

Valneva Austria GmbH

100 Clinical Results associated with Lyme disease vaccine(GlaxoSmithKline Plc)

100 Translational Medicine associated with Lyme disease vaccine(GlaxoSmithKline Plc)

100 Patents (Medical) associated with Lyme disease vaccine(GlaxoSmithKline Plc)

Literatures (Medical) associated with Lyme disease vaccine(GlaxoSmithKline Plc)

01 Nov 2024·The Lancet Infectious Diseases

Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in healthy adults in the USA: results of the booster phase of a randomised, controlled, phase 2 trial

Article

Author: Bender, Wolfgang ; Dubischar, Katrin ; Eder-Lingelbach, Susanne ; Hochreiter, Romana ; Derhaschnig, Ulla ; Larcher-Senn, Julian ; Obersriebnig, Michaela ; Wagner, Laura ; Ghadge, Santhosh Kumar ; Bézay, Nicole ; Klingler, Anton ; Schneider, Martina ; Kadlecek, Vera

BACKGROUNDIncidence rates of Lyme borreliosis, a tickborne disease attributed to infection by Borrelia species, are increasing, and limitations to existing treatments potentiate the possibility of severe outcomes. Nevertheless, there are no licensed vaccines for Lyme borreliosis prevention in humans. This study investigated the immunogenicity and safety of a booster dose of VLA15, an investigational outer surface protein A (OspA)-based Lyme borreliosis vaccine that has previously shown safety and immunogenicity when administered as a primary vaccination series, following a primary VLA15 vaccination series.METHODSWe report the results of the booster phase of a randomised, observer-blinded, placebo-controlled, multicentre, phase 2 study that enrolled healthy adults aged 18-65 years from five US clinical study centres to receive 135 μg or 180 μg VLA15 or placebo at months 0, 2, and 6 in the main study phase. Participants who received 180 μg VLA15 in the main study phase and did not have relevant protocol deviations were eligible for the booster phase (months 18-30). Participants were randomly reassigned (2:1) to receive an intramuscular injection of a VLA15 booster or placebo 1 year after the completion of primary vaccination (month 18) via a randomisation list generated by an unmasked statistician with a block size of six. Individuals involved in data safety monitoring, rerandomisation, vaccine handling, and vaccine accountability were unmasked; the study sponsor and statisticians were only unmasked after analysis of data up to 1 month after booster administration. All other individuals remained masked throughout the booster phase. The outcomes for the booster phase were the immunogenicity (evaluated in the booster per-protocol population) and safety (evaluated for all participants who received the booster) of the booster dose up to month 30. The study is registered at ClinicalTrials.gov (NCT03970733) and is completed.FINDINGSBetween Feb 4 and March 23, 2021, 58 participants (28 men and 30 women) were screened, randomly assigned, and received VLA15 (n=39) or placebo (n=19). One participant in the placebo group was lost to follow-up. The IgG geometric mean titres for each OspA serotype (serotypes 1-6) in the VLA15 group peaked at 1 month after the booster dose (1277·0 U/mL [95% CI 861·8-1892·3] to 2194·5 U/mL [1566·8-3073·7] vs 23·6 U/mL [18·1-30·8] to 36·8 U/mL [26·4-51·3] in the placebo group [p<0·0001 for all serotypes]), remained elevated at month 24 (137·4 U/mL [95·8-196·9] to 265·8 U/mL [202·9-348·2] vs 22·3 U/mL [17·7-28·0] to 29·1 U/mL [20·8-40·6] in the placebo group; p<0·0001 for all serotypes), and declined by month 30 (54·1 U/mL [38·6-75·7] to 101·6 U/mL [77·6-133·1] vs 21·9 U/mL [18·0-26·6] to 24·9 U/mL [19·0-32·6] in the placebo group; p<0·0001 for all serotypes except serotype 1 [p=0·0006]). Solicited local adverse events were reported more frequently in the VLA15 group (35 [92%, 95% CI 79-97] of 38 participants) than the placebo group (six [32%, 15-54] of 19 participants; p<0·0001) after booster vaccination. There was no significant difference in the frequency of solicited systemic adverse events between groups (20 [59%, 42-74] of 34 participants in the VLA15 group vs six [38%, 18-61] of 16 participants in the placebo group). Related unsolicited adverse events (none severe) were reported by two (5%, 1-17) of 39 participants in the VLA15 group and none (0%, 0-17) of 19 participants in the placebo group. There were no severe solicited local or systemic adverse events or deaths during the study.INTERPRETATIONA booster dose of VLA15 is safe and induces substantial anamnestic immune responses against all six OspA serotypes. As with previously investigated OspA-based Lyme borreliosis vaccines, waning immune responses were observed with VLA15, and annual boosters might therefore be required.FUNDINGValneva.

01 Sep 2024·The Lancet Infectious Diseases

Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies

Article

Author: Kadlecek, Vera ; Larcher-Senn, Julian ; Wressnigg, Nina ; Eder-Lingelbach, Susanne ; Obersriebnig, Michaela ; Bender, Wolfgang ; Wagner, Laura ; Bézay, Nicole ; Klingler, Anton ; Hochreiter, Romana ; Derhaschnig, Ulla ; Dubischar, Katrin ; Schneider, Martina

BACKGROUNDRising Lyme borreliosis incidence rates, potential for severe outcomes, and limitations in accurate and timely diagnosis for treatment initiation suggest the need for a preventive vaccine; however, no vaccine is currently available for human use. We performed two studies in adults to optimise the dose level and vaccination schedule for VLA15, an investigational Lyme borreliosis vaccine targeting outer surface protein A (OspA) serotypes 1-6, which are associated with the most common pathogenic Borrelia species in Europe and North America.METHODSBoth randomised, observer-blind, placebo-controlled, multicentre phase 2 studies included participants aged 18-65 years without recent history of Lyme borreliosis or tick bites. Study one was conducted at nine clinical research and study centre sites in the USA (n=6), Germany (n=2), and Belgium (n=1); study two was conducted at five of the study one US sites. Based on a randomisation list created by an unmasked statistician for each study, participants were randomly assigned via an electronic case report form randomisation module to receive 90 μg (study one only), 135 μg, or 180 μg VLA15 or placebo by intramuscular injection at months 0, 1, and 2 (study one) or 0, 2, and 6 (study two). Study one began with a run-in phase to confirm safety, after which the Data Safety Monitoring Board recommended the removal of the 90 μg group and continuation of the study. In the study one run-in phase, randomisation was stratified by study site, whereas in the study one main phase and in study two, randomisation was stratified by study site, age group, and baseline B burgdorferi (sensu lato) serostatus. All individuals were masked, other than staff involved in randomisation, vaccine preparation or administration, or safety data monitoring. The primary endpoint for both studies was OspA-specific IgG geometric mean titres (GMTs) at 1 month after the third vaccination and was evaluated in the per-protocol population. Safety endpoints were evaluated in the safety population: all participants who received at least one vaccination. Both studies are registered at ClinicalTrials.gov (study one NCT03769194 and study two NCT03970733) and are completed.FINDINGSFor study one, 573 participants were screened and randomly assigned to treatment groups between Dec 21, 2018, and Sept, 26, 2019. For study two, 248 participants were screened and randomly assigned between June 26 and Sept 3, 2019. In study one, 29 participants were assigned to receive 90 μg VLA15, 215 to 135 μg, 205 to 180 μg, and 124 to placebo. In study two, 97 participants were assigned to receive 135 μg VLA15, 100 to 180 μg, and 51 to placebo. At 1 month after the third vaccination (ie, month 3), OspA-specific IgG GMTs in study one ranged from 74·3 (serotype 1; 95% CI 46·4-119·0) to 267·4 units per mL (serotype 3; 194·8-367·1) for 90 μg VLA15, 101·9 (serotype 1; 87·1-119·4) to 283·2 units per mL (serotype 3; 248·2-323·1) for 135 μg, and 115·8 (serotype 1; 98·8-135·7) to 308·6 units per mL (serotype 3; 266·8-356·8) for 180 μg. In study two, ranges at 1 month after the third vaccination (ie, month 7) were 278·5 (serotype 1; 214·9-361·0) to 545·2 units per mL (serotype 2; 431·8-688·4) for 135 μg VLA15 and 274·7 (serotype 1; 209·4-360·4) to 596·8 units per mL (serotype 3; 471·9-754·8) for 180 μg. Relative to placebo, the VLA15 groups had more frequent reports of solicited local adverse events (study one: 94%, 95% CI 91-96 vs 26%, 19-34; study two: 96%, 93-98 vs 35%, 24-49 after any vaccination) and solicited systemic adverse events (study one: 69%, 65-73 vs 43%, 34-52; study two: 74%, 67-80 vs 51%, 38-64); most were mild or moderate. In study one, unsolicited adverse events were reported by 52% (48-57) of participants in the VLA15 groups and 52% (43-60) of those in the placebo groups; for study two these were 65% (58-71) and 69% (55-80), respectively. Percentages of participants reporting serious unsolicited adverse events (study one: 2%, 1-4; study two: 4%, 2-7) and adverse events of special interest (study one: 1%, 0-2; study two: 1%, 0-3) were low across all groups. A single severe, possibly related unsolicited adverse event was reported (worsening of pre-existing ventricular extrasystoles, which resolved after change of relevant concomitant medication); no related serious adverse events or deaths were reported.INTERPRETATIONVLA15 was safe, well tolerated, and elicited robust antibody responses to all six OspA serotypes. These findings support further clinical development of VLA15 using the 180 μg dose and 0-2-6-month schedule, which was associated with the greatest immune responses.FUNDINGValneva.

30 Aug 2024·Open Forum Infectious Diseases

Preclinical Evidence for the Protective Capacity of Antibodies Induced by Lyme Vaccine Candidate VLA15 in People

Article

Author: Meinke, Andreas ; Anderson, Annaliesa S ; Timofoyeva, Yekaterina ; Simon, Raphael ; Lundberg, Urban ; Kanevsky, Isis ; Hochreiter, Romana

AbstractBackgroundVaccine candidate VLA15 is designed to protect against the dominant Borrelia genospecies-causing Lyme disease in North America and Europe. Active immunization with VLA15 has protected in the mouse model of tick challenge. VLA15 is currently under evaluation in clinical studies for the prevention of Lyme borreliosis.MethodsMice were passively administered sera from clinical trial participants vaccinated with VLA15, or normal human serum from unvaccinated individuals as control. Posttransfer serum anti-outer surface protein A (OspA) immunoglobulin G titers were assessed by enzyme-linked immunosorbent assay. Following passive transfer, mice were challenged with Ixodes ticks colonized with Borrelia burgdorferi (OspA serotype 1) or Borrelia afzelii (OspA serotype 2) and infection was determined by serology for VlsE C6 or by polymerase chain reaction and culture to assess the presence of Borrelia bacteria.ResultsPassive transfer of immune sera prevented transmission of Borrelia from the tick vector and protected mice against challenge. Posttransfer protective threshold immunoglobulin G antibody titers were observed in this animal model of 131 U/mL for B burgdorferi (OspA serotype 1) and 352 U/mL for B afzelii (serotype 2).ConclusionsPassive transfer of sera from trial participants immunized with VLA15 protected mice from borreliosis in a tick challenge model. This indicates that VLA15 induces functional immune responses in people that can be linked to efficacy in a stringent preclinical model.

News (Medical) associated with Lyme disease vaccine(GlaxoSmithKline Plc)

11 Oct 2024

·endpts.com

Valneva and Pfizer eye 2027 launch for partnered Lyme disease vaccine

Valneva is eyeing a 2027 launch for its Pfizer-partnered Lyme disease vaccine, CEO Thomas Lingelbach said Thursday during the company’s investor day. Pfizer has sole commercial responsibility for the candidate, VLA15, which is currently in Phase 3. Pending those results, Lingelbach said a 2026 regulatory filing may be in reach, meaning vaccines could roll out as early as the fall of 2027. The CEO said the annual peak sales estimate is “certainly north of” $1 billion. “We can start vaccinating people in the autumn of 2027 for the tick season 2028,” Lingelbach said. Tick season typically occurs between April and October in the Northern Hemisphere. Lyme disease is on the rise in the US and Europe . The CDC estimates there are about 476,000 cases in the US each year. Pfizer put down $130 million upfront in 2020 to partner with Valneva on VLA15, which targets a surface protein on the bacteria that cause Lyme disease. The goal is to prevent the bacteria from leaving ticks and infecting humans. Last month, the partners announced new Phase 2 results showing “strong immune responses” in patients who received a second booster dose of the vaccine, supporting the potential case for annual dosing. Pfizer confirmed on Friday that recruitment in its Phase 3 VALOR trial is complete, and participants will be monitored until the end of Lyme season in 2025. That timeline is consistent with a delay Pfizer and Valneva announced in 2023 following quality standard issues at a contractor running some clinical sites. Pfizer declined to comment on those issues on Friday. Valneva did not respond to a request for comment. When an analyst asked how VLA15’s potential market size compares to GSK’s Lymerix, which was discontinued in 2002 over insufficient demand, Lingelbach responded that “you cannot compare” the two markets. “The number of confirmed Lyme cases was in a different ballpark,” he said, adding that the market opportunity will also depend on ACIP’s recommendations for use.

Phase 2VaccinePhase 3Clinical Result

08 Oct 2024

·www.biospace.com

Pfizer to Showcase Scientific Advancements in Respiratory and Other Infectious Diseases at IDWeek 2024

Presentations highlight momentum of Pfizer’s portfolio of infectious disease prevention and treatment options NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will present data across its infectious disease portfolio at the upcoming IDWeek 2024 congress, held in Los Angeles from October 16-19, 2024. Data in 49 abstracts from company- and collaborator-led studies, will highlight the advances Pfizer is making in helping prevent and treat infectious diseases. “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 Name/Type Date/Time (PDT) 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 2:45 – 2:57 PM US PT 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. McLaughlin, PhD Oct 17 10:42 – 10:54 AM US PT 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 Southern California (KPSC), November 2023-April 2024 Sara Tartof, PhD, MPH, (KPSC)* Oct 17 1:45 – 3:00 PM US PT 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 1:45 – 2:03 PM US PT 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 12:15 – 1:30 PM US PT Hall J & K P - 1906 - Early COVID-19 and Severity of Subsequent Omicron Infection in Ontario, Canada Caroline Kassee, MPH (Sinai Health)* Oct 19 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 the United States Alon Yehoshua, PharmD, MS Oct 19 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT Hall J & K P - 1287 - Incidence of Symptomatic Lyme Borreliosis in Nine European Countries, 2018−2022 Frederick Angulo, DVM PhD Oct 18 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT Hall J & K P - 1293 - Healthcare Costs Associated with Lyme Disease in a U.S. Insured Population Holly Yu, MSPH Oct 18 12:15 – 1:30 PM US PT Hall J & K Meningococcal Disease P - 1299 - Epidemiology of Invasive Meningococcal Disease in the United States: Review of Recent Data and Identified Risk Factors Jessica Presa, MD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1304 - Public Health Impact of changes to Meningococcal vaccination platform in the United States Katharina Schley, Dr. rer pol. Oct 18 12:15 – 1:30 PM US PT Hall J & K Pneumococcal disease P - 8 - Assessment of 13-valent pneumococcal conjugate vaccine effectiveness among people living with HIV in the United States Amanda C. Miles, MPH Oct 17 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT Hall J & K P - 674 - The Economic Burden of Infant RSV Among US Caregivers Amy W. Law, PharmD Oct 17 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT Hall J & K P - 1204 - Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in Ontario, Canada Sazini Nzula, PhD Oct 18 12:15 – 1:30 PM US PT 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 Ontario, Canada Sazini Nzula, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 677 - Estimation of Respiratory Syncytial Virus-Attributable Hospitalizations Among Older Adults in Japan between 2015 and 2018: An Administrative Health Claims Database Analysis Asuka Yoshida, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 680 - Estimated Respiratory Syncytial Virus (RSV)-Related Hospitalizations and Deaths Among Adults in Norway between 2010–2019 Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT Hall J & K P – 683 – Estimation of RSV-Attributable Cardiovascular and Respiratory Hospitalizations in Adults in Germany, Between 2015-2019 Caroline Beese Oct 17 12:15 – 1:30 PM US PT 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 Southern California (KPSC) November 2023-April 2024 Negar Aliabadi, MD, MS Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 53 - Trends in Co-administration of Adult Vaccinations in the US Retail Pharmacy Setting Reiko Sato, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 603 - Potential Public Health Impact of Respiratory Syncytial Virus (RSV) Vaccines for Prevention of RSV Among Older Adults in the United States Reiko Sato, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 600 - Efficacy Of a Bivalent RSVpreF Vaccine in Older Adults Across a Second RSV Season John Woodside, PhD Oct 17 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 Germany Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT Hall J & K P - 595 - Public Health Impact of RSVpreF Vaccination on Older Adult Disease Outcomes Daniel Eiras, MD, MPH Oct 17 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15-1:30 PM US PT Hall J & K P - 1080 Aztreonam-Avibactam Activity Against Gram-negative Bacteria Isolated From Patients with Pneumonia from Europe, Asia, and Latin America (2021–2023) Helio S. Sader, MD, PhD, FIDSA Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1256 - Pharmacokinetic/Pharmacodynamic (PK/PD) Target Attainment Analyses for Aztreonam-Avibactam Dosing Regimens Susan Raber*, PharmD, MPH Oct 17 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 12:15 – 1:30 PM US PT 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 and . Please see full Prescribing Information for COMIRNATY ® (COVID-19 Vaccine, mRNA) or visit . Please see full Prescribing Information for CRESEMBA ® (Isavuconazonium Sulfate) or visit Please see full Prescribing Information for PAXLOVID TM (Nirmatrelvir and Ritonavir) or visit . Please see full Prescribing Information for PREVNAR 20 TM (Pneumococcal 20-valent Conjugate Vaccine) or visit . 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 . In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer . 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 U.S. Securities and Exchange Commission and available at and . Contacts Media Contact: PfizerMediaRelations@Pfizer.com +1 (212) 733-1226 Investor Contact: IR@Pfizer.com +1 (212) 733-4848

VaccinePhase 3Phase 2Clinical Result

06 Sep 2024

·pmlive.com

Pfizer/Valneva share promising results for Lyme disease vaccine candidate

Pfizer and Valneva have shared promising immune response and safety results from a mid-stage study of their Lyme disease vaccine candidate. The phase 2 VLA15-221 trial randomised healthy participants to receive VLA15 or placebo during a primary vaccination phase, followed by a first booster dose at month 18 and a second at month 30. There are currently no approved human vaccines for Lyme disease, a bacterial infection caught from the bite of an infected tick. It is considered the most common vector-borne illness in the Northern Hemisphere and, if left untreated, can cause serious complications affecting the skin, joints, heart and nervous system. New results from the study demonstrated a significant anamnestic antibody response across all six serotypes covered by the vaccine in paediatric, adolescent, adult and older adult participants, measured one month after administration of the second booster dose. The safety and tolerability profile of the second booster was comparable to that observed after the first booster, the companies said, noting that no safety concerns have been observed in any treatment or age group to date. Annaliesa Anderson, senior vice president and head vaccine research and development at Pfizer, said: “Personal preventive behaviours are currently the only recommended strategies to help protect yourself from Lyme disease. “This data from the VLA15-221 study is an important step towards a potential vaccine that could help prevent the disease and ease the burden of acute, severe and sometimes persistent consequences.” VLA15-221 is currently being evaluated in a phase 3 study of individuals aged five years and older in highly endemic regions in the US and Europe, and in another phase 3 trial that is aiming to provide further evidence on the safety profile of VLA15 in paediatric participants. Pfizer is aiming to submit regulatory applications for the vaccine to the US Food and Drug Administration and European Medicines Agency in 2026, subject to positive phase 3 data. Also commenting on the latest results for the candidate, Valneva’s chief medical officer, Juan Carlos Jaramillo, said: “As Lyme disease continues to spread, it represents a significant unmet medical need, affecting numerous individuals throughout the Northern Hemisphere. “Each new set of positive data brings us one step closer to potentially bringing this vaccine to both adults and children living in areas where Lyme disease is endemic.”

Clinical ResultVaccinePhase 3Phase 2

100 Deals associated with Lyme disease vaccine(GlaxoSmithKline Plc)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lyme Disease	Phase 3	US	Valneva Sweden AB	30 Jan 2022
Lyme Neuroborreliosis	Discovery	BE	Pfizer Inc.	31 Jan 2017
Lyme Neuroborreliosis	Discovery	US	Pfizer Inc.	31 Jan 2017
Lyme Neuroborreliosis	Discovery	US	Valneva Austria GmbH	31 Jan 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03970733 (CTgov)	Phase 2	Lyme Disease	246	VLA15 (VLA15 With Alum Lower Dose)	dhuwqmqkfa(sydpselsln) = tfciistyev eidhyiwngj (zpzqdtilup, hahpbpxwfy - pmmamqzsen) View more	-	08 Jul 2021
				VLA15 (VLA15 With Alum Higher Dose)	dhuwqmqkfa(sydpselsln) = gyznzfoljc eidhyiwngj (zpzqdtilup, jjfqbzpzlr - gqstqdiety) View more
NCT03769194 (CTgov)	Phase 2	Lyme Disease	572	VLA15 (VLA15 Low Dose)	cdldxkdglz(vwotnjkoxb) = peyrrtxrfe gwclwzutnj (okihksvcpe, wfdxbkblti - uwpxuyllze) View more	-	30 Jun 2021
				VLA15 (VLA15 Medium Dose)	cdldxkdglz(vwotnjkoxb) = mxresvxtdb gwclwzutnj (okihksvcpe, lylngjyfpc - cthvxqvvoo) View more

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