Spikevax (elasomeran) / Moderna, Takeda - LARVOL DELTA

TAILORED MRNA-1273 BOOSTER STRATEGIES IMPROVE VACCINE RESPONSE IN ESKD FOLLOWING CHADOX1 NCOV-19 (ISN-WCN 2026) - "Significant interaction effects between pre-vaccination antibody levels and booster response were observed in both continuous (β = 869.40; p = 0.0004) and categorical (β = 697.74; p = 0.0002) models.Conclusion A full-dose mRNA-1273 booster significantly enhances humoral immunity in ESKD patients primed with ChAdOx1 nCoV-19, yielding higher post-booster titers than half-dose strategies in non-dialysis individuals. These findings support the need for tailored booster regimens in vulnerable populations."

Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

COMPARATIVE EFFECTIVENESS OF MRNA-1273 AND BNT162B2 BOOSTER VACCINATION IN HEMODIALYSIS PATIENTS DURING THE OMICRON ERA (ISN-WCN 2026) - "Patients vaccinated with mRNA-1273 showed significantly lower risks of infection (aHR 0.84; 95% CI 0.80–0.88) and hospitalization (aHR 0.80; 95% CI 0.72–0.88) compared to those vaccinated with BNT162b2.Conclusion A third mRNA COVID-19 vaccine dose substantially enhanced protection against SARS-CoV-2 infection and severe outcomes in HD patients during the Omicron period, with the mRNA-1273 vaccine demonstrating superior effectiveness compared to BNT162b2. Booster vaccination strategies are essential to reduce severe COVID-19 outcomes in this high-risk population."

Clinical • HEOR • Infectious Disease • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

Liver-Detargeted Aromatic Bioreducible mRNA Lipid Nanoparticles Confer Lymph Node Tropism and Robust Antigen-Specific Immunity. (PubMed, J Am Chem Soc) - "These vehicles are particularly advantageous for vaccination due to their ease of production, highly tunable composition, and ability to induce robust immune responses without an adjuvant, as exemplified most recently by the clinical success of the Pfizer/BioNTech and Moderna COVID-19 vaccines...Additionally, aroLNPs are strongly retained in the injection site and induce low levels of systemic inflammatory cytokines. Together, these results establish aroLNPs as a promising platform for vaccine delivery and potentially other immune-focused therapeutic applications."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Risk factors of myocarditis and pericarditis following mRNA-1273 vaccination: a population-based case-cohort study in five VAC4EU European databases (ESCMID Global 2026) - No abstract available

Clinical • Cardiovascular • Inflammation

Hematologic adverse events following COVID-19 vaccination and revaccination in persons aged 12 and above: A Canadian Immunization Research Network study. (PubMed, Hum Vaccin Immunother) - "The vaccines associated with hematologic AEFIs were BNT162b2 (17, 44.7%), ChAdOx1 (11, 28.9%), and mRNA-1273 (10, 26.3%). Twenty-seven (71.1%) participants were revaccinated; 14 (51.9%) received the same vaccine product as their initial vaccine while 13 (48.1%) received a different product. There were no recurrences of the same AEFI reported after revaccination with an mRNA vaccine, including the two patients with TTS, suggesting that hematologic AEFI recurrences following COVID-19 vaccines are likely uncommon."

Adverse events • Journal • Cardiovascular • Hematological Disorders • Immune Thrombocytopenic Purpura • Infectious Disease • Novel Coronavirus Disease • Pulmonary Embolism • Respiratory Diseases • Thrombocytopenia • Thrombocytopenic Purpura

DAN-COVID: Effectiveness of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19 (clinicaltrials.gov) - P4 | N=285000 | Active, not recruiting | Sponsor: Tor Biering-Sørensen | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Low risk of severe COVID-19 in vaccinated people with multiple sclerosis: a nationwide Norwegian study. (PubMed, BMJ Neurol Open) - "NevroVAX is a Norwegian multicentre cohort study including 3559 pwMS and 449 healthy controls (HCs) who received at least one dose of BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna) or ChAdOx1 (AstraZeneca/Oxford) between January 2021 and December 2022. Humoral vaccine responses were impaired in pwMS receiving anti-CD20 or S1PR therapies, but severe COVID-19 was rare. These findings support continued vaccination programmes and tailored protective measures for immunomodulated populations."

Journal • CNS Disorders • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and efficacy over 12 months following a fourth dose of a bivalent mRNA or protein-based COVID-19 vaccine: A randomised controlled trial in Australia. (PubMed, J Infect) - "While the bivalent Moderna vaccine induced higher immune responses than the Ancestral Novavax vaccine as a fourth dose, both vaccines appeared to provide comparable protection against SARS-CoV-2 Omicron variants over 12-months."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

A modified self-controlled case series on mortality risk following primary series doses of COVID-19 vaccines in U.S. Medicare beneficiaries aged 65 years and older. (PubMed, Vaccine) - "We did not observe an increased risk of mortality in U.S. older adults 4 weeks following a primary series dose of a COVID-19 vaccine."

Journal • Medicare • Reimbursement • US reimbursement • Infectious Disease • Novel Coronavirus Disease

mRNA-CRID-001: A Study of Modified mRNA Vaccines in Healthy Adults (clinicaltrials.gov) - P1 | N=308 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cytomegalovirus Infection • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Combining Activation-Induced Markers With PD-L1 Selectively Enhances Detection of Antigen-Specific T Cells in Virus-Infected Individuals. (PubMed, J Immunol Res) - "A multiparameter flow cytometry panel, including six common activation markers: CD40L, CD137, CD69, OX40, CD25, and PD-L1, was used for detecting antigen-specific T cells following infection (SARS-CoV-2 and CMV) or vaccination (mRNA-1273 SARS-CoV-2)...The majority of antigen-specific CD8 T cells were captured by the dual combination of CD69 plus CD25. In conclusion, combining CD137, CD69, OX40, CD25, and PD-L1 in an AIM assay results in robust and optimal detection of both specific CD4 T helper subsets and CD8 T cells in different antigenic contexts."

IO biomarker • Journal • Cytomegalovirus Infection • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD40LG • CD69 • CD8 • IL2RA • ISG20 • PD-L1 • TNFRSF9

Dose-dependent IFN programs in myeloid cells after mRNA and adenovirus COVID-19 vaccination. (PubMed, JCI Insight) - "However, to date, no study has directly compared immune responses to all 3 FDA-approved COVID-19 vaccines at single-cell multiomic resolution.METHODSWe longitudinally profiled SARS-CoV-2-naive adults (n = 31) vaccinated with BNT162b2, mRNA-1273, or Ad26.COV2.S, integrating plasma cytokines, antibody titers, and single-cell multiomic data (DOGMA-Seq).RESULTSWe discovered a distinct, transient IFN program termed ISG-dim, which emerged specifically 1-2 days after the first mRNA dose in approximately 10% of myeloid cells. This state was characterized by ISGF3 complex activation and its target genes (e.g., MX1, MX2, DDX58), with transcriptional and epigenetic profiles distinct from the robust IFN program observed after mRNA boosting or a single Ad26.COV2.S dose (ISG-high). In vitro stimulation of human monocytes showed that IFN-α alone recapitulates ISG-dim, whereas both IFN-α and IFN-γ are required for ISG-high.CONCLUSIONThese findings define dose-dependent IFN programming..."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • DDX58 • IFNA1 • IFNG • MX1

A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations (clinicaltrials.gov) - P4 | N=1094 | Recruiting | Sponsor: ModernaTX, Inc. | N=764 ➔ 1094 | Trial completion date: May 2026 ➔ Dec 2026 | Trial primary completion date: May 2026 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Detection of spike protein in term placentas of COVID-19 vaccinated and/or SARS-CoV-2 infected women. (PubMed, PLoS One) - "The spike protein of SARS-CoV-2 has been be detected in placental Hofbauer and Trophoblast cells as well as villous endothelia after infection and vaccination indicating a possible transplacental transfer or uptake. These findings may suggest a potential for transplacental transfer or cellular uptake; however, the extent, mechanisms, and clinical significance of this phenomenon remain to be fully understood. Clinical trial registration: DRKS00022506."

Journal • Gynecology • Infectious Disease • Novel Coronavirus Disease • Obstetrics • Respiratory Diseases

mRNA-based SARS-CoV-2 vaccines: intracellular processing and aggregation of the encoded spike protein as a mechanistic contributor to cardiac cellular stress. (PubMed, Front Immunol) - "For this reason, the two mRNA-based corona vaccines Comirnaty (BNT162b2, Pfizer/BioNTech) and Spikevax (mRNA-1273, Moderna) first induce the production of a spike monomer in body cells. Only the secreted S1 subunit was detected as an immunogen in the supernatant of all three cell lines. Our findings may help to improve the safety and specificity of future mRNA platform technologies by emphasizing the importance of evaluating intracellular protein processing and the potential cellular effects of translated immunogens already during preclinical development."

Journal • Cardiovascular • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Class switching toward IgG4 six months after primary mRNA-based COVID-19 vaccination in kidney patients. (PubMed, PLoS One) - "Approximately half of KTRs lacked detectable S-binding B cells after two mRNA-1273 doses, despite antibody formation. Among responders, S-binding B cells persisted up to 6 months after vaccination with a relative shift toward IgG4, a pattern also observed in dialysis patients, CKD patients and controls. The clinical significance of this subclass skewing requires confirmation in larger cohorts with functional antibody readouts."

Journal • Chronic Kidney Disease • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • Transplantation

Contactin 1 Membranous Nephropathy after mRNA 1273 (NKF-SCM 2026) - "These antigen antibody complexes either deposited in the subepithelial space of this patient or formed in situ in the subepithelial space and led to 2.9 grams of proteinuria. As time distanced from the final provacatory vaccination, the proteinuria diminished—suggesting that the antigen antibody complexes cleared."

Complement-mediated Rare Disorders • Endocrine Disorders • Glomerulonephritis • Grave’s Disease • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Novel Coronavirus Disease • Renal Disease • Systemic Lupus Erythematosus • CNTN • CNTN1 • NECTIN1 • TTN

Modeling the cost-effectiveness of the next-generation COVID-19 mRNA-1283 vaccine in the United States. (PubMed, J Med Econ) - "mRNA-1283 was compared with no annual vaccination and originally licensed mRNA vaccines mRNA-1273 and BNT162b2. Based on rVE assumptions made, mRNA-1283 was estimated to dominate originally-licensed mRNA vaccines in this recommended population. mRNA-1283 may provide a valuable option to optimize US COVID-19 immunization programs and protect those most vulnerable."

HEOR • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Background incidence rates and observed-to-expected ratios of adverse events of special interest after covid-19 mRNA vaccination during pregnancy in France: a nationwide population-based study. (PubMed, Lancet Reg Health Eur) - "We calculated OE ratios for events after the homologous vaccination schemes during 2021-2023 with mRNA vaccines (BNT: BTN162b2 or MOD: mRNA-1273)...It contributes to the growing body of evidence regarding its safety. This study did not receive any specific grant."

Adverse events • Journal • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Novel Coronavirus Disease • Pulmonary Embolism • Respiratory Diseases

A Phase 4 Pragmatic, Randomized Trial to Evaluate the Effectiveness and Safety of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19 (DAN-COVID) (clinicaltrialsregister.eu) - P4 | N=275000 | Active, not recruiting | Sponsor: Gentofte Hospital, Moderna Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase 4 Pragmatic, Randomized Trial to Evaluate the Effectiveness and Safety of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19 (DAN-COVID) (clinicaltrialsregister.eu) - P4 | N=275000 | Recruiting | Sponsor: Gentofte Hospital, Moderna Inc.

New P4 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Unconventional Lysine-Type Lipid Assemblies Enable Efficient Antisense Oligonucleotide Delivery with Distinct Structural Features. (PubMed, Pharmaceutics) - "Among the tested LPX and LNP formulations, the K3C16 lipoplex demonstrated ASO delivery efficiency and immune responses comparable to the benchmark SpikeVax LNP formulation. Notably, Cryo-EM imaging revealed novel structures that have not been reported previously; the K3C14 lipoplex formed a rouleaux-like structure, whereas the K3C16 lipoplex exhibited a lipid nanosheet-like structure, distinct from the conventional LNP structure. These results highlight the potential of an unconventional type of lipid assembly for efficient ASO delivery."

Journal • CNS Disorders

Using Machine Learning to Identify Factors Affecting Antibody Production and Adverse Reactions After COVID-19 Vaccination. (PubMed, Vaccines (Basel)) - "The Spikevax vaccine induced adverse reaction symptoms with higher antibody production in cases of fever...Furthermore, characteristics of participants at risk for fever symptoms included longer telomere length, higher antibody production patterns, and higher CD4-positive T cell counts. Further investigation of these identified influencing factors is expected to clarify the rationale for new vaccine development and identify lifestyle and dietary habits that enhance vaccine efficacy."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Preventing COVID-19 in at-risk populations: moving towards next-generation mRNA-1283 COVID-19 vaccine to address current challenges. (PubMed, Expert Rev Vaccines) - "While the original mRNA COVID-19 vaccine, mRNA-1273, targets the full-length SARS-CoV-2 spike protein, mRNA-1283 is a novel next-generation mRNA COVID-19 vaccine that specifically targets immunodominant domains within the spike protein. Initial modeling studies indicate that mRNA-1283 could prevent more hospitalizations than current COVID-19 vaccines. Evidence to date suggests that the novel next-generation mRNA-1283 vaccine holds promise to advance progress in reducing the ongoing burden of COVID-19 across vulnerable populations."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Reanalysis of the FDA's Benefit-Risk Assessment of Moderna's mRNA-1273 COVID Vaccine Based on a Model Incorporating Benefits Derived from Prior COVID Infection. (PubMed, Vaccines (Basel)) - "The outcome of a vaccine benefit-risk assessment may be dramatically impacted by accounting for the benefits derived from prior infection by the vaccine-targeted disease. To increase public confidence in vaccines and thereby reduce vaccine hesitancy, public-health agencies should employ benefit-risk models capable of supporting stratification of vaccination recommendations not only based on age and sex but also on prior-infection and comorbidity status."

Benefit-risk assessment • Journal • Cardiovascular • Infectious Disease • Inflammation • Novel Coronavirus Disease