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A descriptive review on the real-world impact of moderna, inc. COVID-19 vaccines

EXPERT REVIEW OF VACCINES 2024年第1期23卷 914-943页

作者： Bausch-Jurken, Mary Dawson, Rachel S. Ceddia, Francesca Urdaneta, Veronica Marks, Morgan A. Doi, Yohei Moderna Inc Med Affairs Sci Commun Cambridge MA USA Moderna Inc Clin Safety & Risk Management Binney St Cambridge MA 02142 USA Fujita Hlth Univ Sch Med Dept Microbiol Toyoake Japan Fujita Hlth Univ Sch Med Dept Infect Dis Toyoake Japan Univ Pittsburgh Sch Med Div Infect Dis Pittsburgh PA USA

IntroductionSince the original COVID-19 vaccines were developed, abundant clinical trial and real-world evidence evaluating the efficacy, effectiveness, and safety of COVID-19 vaccines has been collected. Knowledge of the relative benefits and risks of COVID-19 vaccines is essential for building trust within target populations, ensuring they remain effectively and safely protected against an enduring infectious *** coveredThis descriptive review discusses the benefits and risks associated with marketed moderna, inc. mRNA-based COVID-19 vaccines, focusing on their real-world effectiveness and safety profiles in various age groups. Adverse events of interest and potential benefits of vaccination are reviewed, including reduced risk for severe COVID-19 and long-term health outcomes, reduced economic and societal costs, and reduced risk for SARS-CoV-2 *** opinionPost-marketing safety and real-world data for moderna, inc. COVID-19 mRNA vaccines strongly support a positive benefit - risk profile favoring vaccination across all age groups. Although COVID-19 is no longer considered a global health pandemic, health risks associated with SARS-CoV-2 infection remain high. Concerted efforts are required to engage communities and maintain protection through vaccination. Continued surveillance of emerging variants and monitoring of vaccine safety and effectiveness are crucial for ensuring sustained protection against SARS-CoV-2.

关键词： COVID-19 mRNA-1273 booster omicron SARS-CoV-2 vaccine variant of concern

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Comparison of RT-qPCR With Branched DNA to Quantify a Lipid Nanoparticle-Encapsulated mRNA Therapeutic in Serum and Liver Tissue Samples From Nonclinical PK Studies

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AAPS JOURNAL 2025年第1期27卷 1-10页

作者： Ortiz, Jessica Brunner, Laura Ci, Lei Baek, Rena Jani, Darshana Marshall, Jean-Claude Pennucci, Jason Moderna Inc Cambridge MA 02142 USA

While the branched DNA (bDNA) assay is an established bioanalytical method for measurement of lipid nanoparticle (LNP)-encapsulated messenger RNA (mRNA) pharmacokinetic parameters, reverse transcription-quantitative polymerase chain reaction (RT-qPCR) has been considered as an alternative platform. RT-qPCR and bDNA platforms were compared for sensitivity, specificity, correlation, and overall assay performance using serum and tissue samples from 2 nonclinical mouse studies of a therapeutic mRNA candidate, LNP-PAH-mRNA, which encodes for human phenylalanine hydroxylase enzyme. Pharmacokinetic parameter noncompartmental analysis was completed using Phoenix WinNonlin. The assays were compared using simple linear regression and Bland-Altman analyses. Sensitivity ranged from 0.05 to 6.40 ng/mL for the bDNA assays, from 0.00000761 to 7.61 ng/mL in serum, and from 0.000179 to 179 ng/g in tissue for the RT-qPCR assay. Inter-assay accuracy was within +/- 10%, inter-assay precision was <= 10%, and the total error for both assays was <= 20%. RT-qPCR serum mRNA concentrations were 2- to fourfold lower compared with the bDNA assay, whereas tissue samples were comparable between assays. A linear relationship with - 0.37 to - 0.02 systematic bias demonstrated acceptable concordance. Bland-Altman plots demonstrated close equivalence, with a negative bias of < 0.5, and >= 95% of the data points were within the 95% limits of agreement. The comparison of the RT-qPCR with bDNA assay platforms for quantification of pharmacokinetic properties of an mRNA-LNP therapeutic has demonstrated acceptable concordance. This comparison reinforces the use of the RT-qPCR, a widely accessible strategy, as an alternative platform for the quantification of subsequent mRNA-LNP therapeutics.

关键词： bDNA bioanalytical mRNA therapeutics pharmacokinetics RT-qPCR

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mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial

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NATURE MEDICINE 2025年 1-10页

作者： Rudman Spergel, Amanda K. Ananworanich, Jintanat Guo, Ruiting Deng, Weiping Carmona, Lizbeth Schaefers, Kristin Paila, Yamuna D. Kandinov, Boris Eger, Charles H. Sinkiewicz, Melissa Shao, Sarah Henry, Carole Shaw, Christine A. Moderna Inc Cambridge MA 02142 USA Moderna Biopharm Canada Corp Toronto ON Canada Veloc Clin Res Inc Cincinnati OH USA

A multicomponent vaccine targeting several seasonal respiratory pathogens may provide simultaneous protection in a single-injection regimen. We present interim (28 days) findings from a phase 1/2 study of an mRNA-based multicomponent vaccine (mRNA-1083), encoding seasonal influenza and SARS-CoV-2 antigens. Adults (18-79 years) were randomly assigned to receive different compositions of mRNA-1083 at varying dose levels on day 1. The primary study objectives were reactogenicity through 7 days and safety through 28 days postvaccination, and the secondary study objective was immunogenicity against vaccine-matched influenza and SARS-CoV-2 strains at day 29 assessed by hemagglutination inhibition and pseudovirus neutralization assays, respectively. The multicomponent mRNA-1083 vaccine was generally well-tolerated, with most solicited adverse reactions being Grade 1 or 2 in severity. The incidence of unsolicited adverse events was similar across vaccine groups. mRNA-1083 induced immune responses against influenza and SARS-CoV-2 that were, in general, similar to or higher than those achieved with licensed quadrivalent influenza (standard or high dose) and SARS-CoV-2 (bivalent mRNA-1273) vaccines. These data support ongoing phase 3 evaluation of the mRNA-1083 vaccine. *** registration: NCT05827926.

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Leveraging Real-World Evidence to Define Severe RSV Lower Respiratory Tract Disease in Adults

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INFECTIOUS DISEASES AND THERAPY 2025年第1期14卷 275-281页

作者： Panozzo, Catherine A. Walsh, Edward E. Yang, Zhen Wilson, Eleanor Goswami, Jaya Stoszek, Sonia K. Loback, Adrianna Ng, Tony Francis, Beverly M. Simorellis, Alana K. Huang, Wenmei Li, Linwei Vislay-Wade, Rebecca Zheng, Zhe Anderson, Evan J. August, Allison Chen, Grace Falsey, Ann R. Moderna Inc Infect Dis Clin Dev 325 Binney St Cambridge MA 02142 USA Univ Rochester Dept Med Rochester NY USA Moderna Inc Data Sci & Artificial Intelligence Cambridge MA USA Moderna Inc Med Affairs Cambridge MA USA Moderna Inc Clin Dev Operat Cambridge MA USA

IntroductionAs no standard case definitions for respiratory syncytial virus-associated lower respiratory tract disease (RSV-LRTD) in adults are available, this study analyzed definitions for severe RSV-LRTD from previously published data in hospital and community cohorts of adults with RSV-associated *** frequency, sensitivity, and specificity of acute respiratory disease symptoms among hospitalized and community cohorts of adults with RSV were analyzed. RSV-LRTD signs/symptoms assessed included shortness of breath (dyspnea), cough and/or fever, wheezing/rales/rhonchi (abnormal lung sounds by auscultation), sputum production, tachypnea, hypoxemia, and pleuritic chest *** and tachypnea provided the best differentiation between hospitalized and community RSV-positive cases. The severe RSV-LRTD case definition yielding one of the highest and best-balanced sensitivity and specificity was dyspnea paired with either abnormal lung sounds by auscultation, hypoxemia, tachypnea, cough and/or fever, sputum, or chest *** alone, and in combination with certain other lower respiratory tract disease signs/symptoms, was a leading symptomatic indicator for severe RSV outcomes. These results contribute to the harmonization of case definitions for RSV disease.

关键词： Case definitions Lower respiratory tract disease Older adults Respiratory syncytial virus Severe respiratory syncytial virus

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Safety and Immunogenicity of SARS-CoV-2 Spike Receptor-Binding Domain and N-Terminal Domain mRNA Vaccine

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JOURNAL OF INFECTIOUS DISEASES 2025年第4期231卷 e754-e763页

作者： Chalkias, Spyros Pragalos, Antionette Akinsola, Adebayo Berman, Gary Ampajwala, Madhavi Meyer, Jay Schoch, Lorraine Zhou, Wen Paila, Yamuna D. Deng, Weiping Feng, Jing de Windt, Elizabeth Edwards, Darin Miller, Jacqueline Das, Rituparna Moderna Inc Infect Dis Dev 325 Binney St Cambridge MA 02142 USA CTI Clin Trial & Consulting Serv Covington KY USA Tekton Res Atlanta GA USA Clin Res Inst Inc Minneapolis MN USA Univ N Texas Plano TX USA Veloc Clin Res Lincoln NE USA Moderna Inc Clin Operat Infect Dis Cambridge MA USA Moderna Inc Biostat Cambridge MA USA Moderna Inc Clin Biomarkers Infect Dis Cambridge MA USA Moderna Inc Clin Safety Cambridge MA USA Moderna Inc Infect Dis Cambridge MA USA Moderna Inc Res & Dev Infect Dis 325 Binney St Cambridge MA 02142 USA

Background mRNA-1283 is an investigational coronavirus disease 2019 (COVID-19) mRNA vaccine encoding the receptor-binding and N-terminal domains of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in contrast to the original mRNA-1273 vaccine, which encodes the full-length spike *** A phase 2a, dose-ranging, observer-blind, randomized study conducted in adults (aged >= 18 years) previously vaccinated with mRNA-1273 evaluated the safety and immunogenicity of a single dose of mRNA-1283 (2.5, 5, and 10 mu g) and its bivalent formulation, mRNA-1283.211 (5 and 10 mu g;encoding original SARS-CoV-2 and Beta) against the comparator mRNA-1273 vaccine, 50 mu g (part A). A subsequent, open-label study (part B) evaluated the safety and immunogenicity of a monovalent Omicron BA.1 vaccine, mRNA-1283.529 (5 and 10 mu g).Results A total of 340 participants were randomized in part A, and 200 participants were enrolled in part B. All dose levels of mRNA-1283 vaccines were well tolerated and increased the neutralizing antibody (nAb) responses at day 29 compared to baseline against SARS-CoV-2 D614G and Beta. The nAb responses elicited by mRNA-1283 were higher than those elicited by mRNA-1273. mRNA-1283.529 (part B) increased nAb at day 29 against Omicron BA.1. Antibody responses remained detectable for a year *** mRNA-1283 was well tolerated and exhibited improved immunogenicity compared to *** Trials Registration NCT05137236. The mRNA-1283 vaccine encoding the RBD and NTD of the SARS-CoV-2 spike protein was well tolerated and had improved immunogenicity compared with mRNA-1273, regardless of the vaccine valency (monovalent, bivalent) or the variant sequence tested (SARS-CoV-2 D614G, Beta, Omicron BA.1).

关键词： COVID-19 SARS-CoV-2 mRNA vaccines mRNA-1283 mRNA-1273 booster vaccination clinical study

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Characterization of a novel conditional knockout mouse model to assess efficacy of mRNA therapy in the context of severe OTC deficiency

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MOLECULAR THERAPY 2025年第3期33卷 1197-1212页

作者： Zhou, Jenny Liang, Shi Yin, Ling Frassetto, Andrea Graham, Anne-Renee White, Rebecca Principe, Maria Severson, Madelyn Palmer, Tiffany Naidu, Shan Jacquinet, Eric Zimmer, Mike Finn, Patrick F. Martini, Paolo G. V. Moderna Inc 325 Binney St Cambridge MA 02142 USA

Ornithine transcarbamylase deficiency (OTCD) is the most common urea-cycle disorder, characterized by hyperammonemia and accompanied by a high unmet patient need. mRNA therapies have been shown to be efficacious in hypomorphic Sparse-fur abnormal skin and hair (Spf-ash) mice, a model of late-onset disease. However, studying the efficacy of ornithine transcarbamylase (OTC) mRNA therapy in traditional knockout mice, a model for severe early-onset OTCD, is hampered by the rapid lethality of the model and poor lipid nanoparticle (LNP) uptake into neonatal mouse liver. We developed a novel tamoxifen-inducible mouse to study the effect of mRNA therapy in the context of complete or near-complete OTC loss in adult animals. Characterization of the model showed that it is highly reproducible, 100% penetrant, and phenocopies hallmarks of human disease, with animals exhibiting decreased body weight, hyperammonemia, and brain edema. Delivery of OTC mRNA increased survival, maintained body weight, delayed the onset of hyperammonemia, and reduced brain edema. Therefore, this model provides a platform to study LNP-mediated mRNA therapies for the treatment of late-onset OTCD.

关键词： conditional knockout LNP-mediated delivery mouse model mRNA therapy ornithine transcarbamylase deficiency OTC OTCD

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Evaluating the Effectiveness of mRNA-1273.815 Against COVID-19 Hospitalization Among Adults Aged ≥ 18 Years in the United States

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INFECTIOUS DISEASES AND THERAPY 2025年第1期14卷 199-216页

作者： Wilson, Amanda Rahai, Neloufar Beck, Ekkehard Beebe, Elisha Conroy, Brian Esposito, Daina Govil, Priya Kopel, Hagit Lu, Tianyi Mansi, James Marks, Morgan A. Mues, Katherine E. Shah, Rohan Skornicki, Michelle Sun, Tianyu Toyip, Astra Yousefi, Mitra Martin, David Araujo, Andre B. Moderna Inc 325 Binney St Cambridge MA 02142 USA Aetion New York NY USA

IntroductionIn September 2023 the Food and Drug Administration (FDA) approved an updated mRNA COVID-19 vaccine targeting the XBB.1.5 sublineage. This study evaluates the effectiveness of mRNA-1273.815, a 2023-2024 Omicron XBB.1.5-containing mRNA COVID-19 vaccine in preventing COVID-19-related hospitalizations and medically attended COVID-19 in US adults aged >= 18 *** observational, matched cohort study used medical and pharmacy claims data from HealthVerity. Adults vaccinated with mRNA-1273.815 between September 12, 2023, and December 31, 2023, were followed through January 26, 2024. Vaccinated individuals were matched with individuals unvaccinated with any 2023-2024 COVID-19 vaccine on demographic and clinical characteristics. The primary and secondary outcomes were COVID-19 hospitalization and medically attended COVID-19, respectively. Inverse probability of treatment weighting and Cox proportional hazards regression were utilized to estimate vaccine effectiveness (VE).ResultsThe study included 1,272,161 vaccinated individuals matched 1:1 with unvaccinated individuals, with a maximum follow-up of 128 (median 84) days. The VE against COVID-19 hospitalization was 51% (95% confidence interval [CI]: 48-54%). Subgroup analyses showed a VE of 56% (95% CI 51-61%) among adults >= 65 years and 46% (95% CI 39-52%) in immunocompromised adults. For medically attended COVID-19, the VE was 25% (95% CI 24-27%). Time-varying analyses showed that while VE declined over time, VE remained *** the 2023-2024 respiratory season, the mRNA-1273.815 vaccine significantly protected against COVID-19-related hospitalizations and medically attended COVID-19 across diverse adult populations and demonstrated durability of the effect. These results support the continued use of updated COVID-19 vaccines to mitigate severe outcomes and maintain public health safety.

关键词： MRNA-1273.815 COVID-19 vaccine Hospitalization Medically attended COVID-19 Vaccine effectiveness

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A Narrative Review of Key Risk Factors for Severe Illness Following SARS-CoV-2, Influenza Virus, and Respiratory Syncytial Virus Infection

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INFECTIOUS DISEASES AND THERAPY 2025年第SUPPL1期14卷 39-61页

作者： Branche, Angela Ramesh, Mayur Francis, Beverly Univ Rochester Rochester NY 14627 USA Henry Ford Hosp Detroit MI USA Moderna Inc Cambridge MA USA

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza, and respiratory syncytial virus (RSV) are highly infectious respiratory viruses that affect people of all ages and are typically associated with mild symptoms and few complications in immunocompetent individuals. However, the risk of severe outcomes (e.g., hospitalization and death) following infection with these respiratory viruses is higher in certain populations, including older adults and individuals of certain race/ethnic and sociodemographic groups. Additionally, immunocompromising conditions and pre-existing comorbidities, including underlying cardiovascular (e.g., congestive heart failure) and respiratory diseases (e.g., chronic obstructive pulmonary disease), diabetes, chronic kidney disease, and obesity, are key factors that predispose individuals to SARS-CoV-2-, influenza-, and RSV-related severe outcomes. increased risk for severe outcomes associated with advancing age and comorbidities is compounded by residence in long-term care facilities due to the enhanced spread of respiratory infections in congregate living environments. In this narrative review, risk factors associated with severe outcomes following infection with SARS-CoV-2, influenza, and RSV in adult populations are explored. Additionally, distinct clinical outcomes based on underlying comorbidities following infection are discussed in the context of high-risk populations. Factors unique to each virus that underpin distinct risk profiles are described and suggest the potential for tailored surveillance and healthcare approaches to target and ultimately mitigate SARS-CoV-2-, influenza-, and RSV-associated disease burden in vulnerable populations. Mutual risk factors for severe outcomes are also highlighted;these similarities indicate that cohesive risk reduction strategies may also be feasible, particularly since vaccines are available for each of these respiratory viruses. Ultimately, a more thorough understanding of the

关键词： Comorbidities COVID-19 Immunocompromised hosts Influenza Older adults Respiratory syncytial virus Risk factors SARS-CoV-2

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US consumer and healthcare professional preferences for combination COVID-19 and influenza vaccines

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JOURNAL OF MEDICAL ECONOMICS 2025年第1期28卷 279-290页

作者： Poulos, Christine Buck, Philip O. Ghaswalla, Parinaz Rudin, Deborah Kent, Cannon Mehta, Darshan RTI Hlth Solut 3040 East Cornwallis Rd Res Triangle Pk NC 27709 USA Moderna Inc Cambridge MA USA

AimsTo quantify preferences for an adult combination vaccine for influenza and COVID-19 (flu + COVID) compared with standalone influenza and COVID-19 *** and methodsThis survey study used a series of direct-elicitation questions to assess preferences for a single-shot combination flu + COVID, standalone influenza, and standalone COVID-19 vaccines among US consumers (N = 601) and healthcare professionals (HCPs) (N = 299). Response frequencies described the proportion of each sample that would prefer a flu + COVID vaccine to standalone influenza and COVID-19 vaccines. A multivariate logit regression model explored how certain characteristics influenced the odds of selecting the flu + COVID vaccine over a standalone influenza *** consumers (398/601;66.2%) and HCPs (250/298;83.9%) preferred a flu + COVID vaccine to a standalone influenza vaccine. When not forced to choose between flu + COVID and standalone influenza vaccines, most consumers again selected the flu + COVID vaccine (62.3%);14.7% would prefer separate standalone influenza and COVID-19 vaccines, 8.3% a standalone influenza vaccine only, 7.3% a COVID-19 vaccine only, and 7.4% neither vaccine. Consumers aged >= 50 years with a body mass index >= 40, those aged >= 65 years who previously received a COVID-19 vaccine, and those who had previously experienced severe impacts from influenza were more likely to choose a flu + COVID vaccine over a standalone influenza vaccine than were consumers without these characteristics. HCPs whose practice stocks high-dose influenza vaccines were more likely to choose the flu + COVID vaccine for patients aged >= 65 with no risk factors and patients aged 18-64 with >= 1 risk factor over the standalone influenza *** are subject to potential hypothetical, responder, selection, and information *** US consumers and HCPs would likely prefer a single-shot combination flu + COVID vaccine compared with standalone in

关键词： Combination vaccine COVID-19 healthcare professional influenza patient preferences United States I12 I18

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Immunostimulatory/Immunodynamic model of mRNA-1273 to guide pediatric vaccine dose selection

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CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY 2025年第1期14卷 42-51页

作者： Ivaturi, Vijay Attarwala, Husain Deng, Weiping Ding, Baoyu Schnyder Ghamloush, Sabine Girard, Bethany Iqbal, Javid Minnikanti, Saugandhika Zhou, Honghong Miller, Jacqueline Das, Rituparna Pumas AI Inc Dover DE USA Manipal Acad Higher Educ Ctr Pharmacometr MCOPS Manipal India Moderna Inc 325 Binney St Cambridge MA 02142 USA

COVID-19 vaccines, including mRNA-1273, have been rapidly developed and deployed. Establishing the optimal dose is crucial for developing a safe and effective vaccine. Modeling and simulation have the potential to play a key role in guiding the selection and development of the vaccine dose. In this context, we have developed an immunostimulatory/immunodynamic (IS/ID) model to quantitatively characterize the neutralizing antibody titers elicited by mRNA-1273 obtained from three clinical studies. The developed model was used to predict the optimal vaccine dose for future pediatric trials. A 25-mu g primary vaccine series was predicted to meet non-inferiority criteria in young children (aged 2-5 years) and infants (aged 6-23 months). The geometric mean titers and geometric mean ratios for this dose level predicted using the IS/ID model a priori matched those observed in the pediatric clinical study. These findings demonstrate that IS/ID models represent a novel approach to guide data-driven clinical dose selection of vaccines.

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