Spikevax (elasomeran) / Moderna, Takeda - LARVOL DELTA

Association between sars-cov-2 infection, COVID-19 vaccines and immune thrombocytopenia in adults. a nationwide population-based study in France. (ASH 2025) - P=N/A | "Although such cases were expected to be sporadic, the possibility of an increased risk at thepopulation level remained uncertain to date.Therefore, we aimed to measure the association between COVID-19 vaccines overall and by type (mRNAvaccines: Comirnaty Pfizer - BNT162b2; Spikevax Moderna - mRNA-12773; and adenovirus-basedvaccines: Vaxzevria AstraZeneca -ChadOx-1-S, and JCovden Janssen AD26COV-2.S) and the occurrence ofITP at the nationwide scale in France. This nationwide population-based study using three different designs showed an associationbetween SARS-CoV-2 infection and ChadOx1-S vaccine with ITP occurrence, while no association wasfound for mRNA vaccines."

Clinical • Hematological Disorders • Immune Thrombocytopenic Purpura • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Thrombocytopenia • Thrombocytopenic Purpura

P108 Association between COVID-19 vaccines and bullous pemphigoid: a UK population-based study. (PubMed, Br J Dermatol) - "aORs were estimated for the general association between COVID-19 vaccines and BP; for products: the AstraZeneca, Pfizer and Spikevax vaccines; and for vaccine types: mRNA or vector...In conclusion, we did not find evidence of COVID-19 vaccines leading to an onset of BP. Our finding of a potential protective effect with three or more doses may reassure clinicians and people currently eligible to consider COVID-19 vaccination, and in particular provide evidence to discuss risks and benefits with vaccine-hesitant patients at risk of BP when considering COVID-19 vaccination."

Journal • Alzheimer's Disease • Bullous Pemphigoid • Cardiovascular • CNS Disorders • Dementia • Dermatology • Dermatopathology • Immunology • Infectious Disease • Movement Disorders • Novel Coronavirus Disease • Parkinson's Disease

Pityriasis rubra pilaris triggered by vaccination. (PubMed, Ital J Dermatol Venerol) - "In conclusion, PRP post-vaccination is rare and likely underdiagnosed, but recognizing the association is important to evaluate any new exposures to the trigger. A thorough patient history, including recent vaccinations, is crucial."

Journal • Dermatology • Infectious Disease • Measles • Mumps • Novel Coronavirus Disease • Pediatrics • Pertussis • Respiratory Diseases • Rubella • Tetanus

Inhibition of CXCL10 and IFN-γ ameliorates myocarditis in preclinical models of SARS-CoV-2 mRNA vaccination. (PubMed, Sci Transl Med) - "Through analysis of human plasma data and in vitro experiments with human macrophages and T cells, we identified increased C-X-C motif chemokine ligand 10 (CXCL10) and interferon-γ (IFN-γ) after exposure to BNT162b2 (Pfizer) or mRNA-1273 (Moderna). In mice exposed to these cytokines or receiving BNT162b2 vaccination, genistein treatment reduced cardiac injury markers and attenuated infiltration of neutrophils and macrophages into the heart. These findings implicate CXCL10-IFN-γ signaling as a contributor to myocardial injury in experimental models of mRNA vaccination and indicate that pharmacologic modulation, such as with genistein, may mitigate cytokine-driven injury."

Journal • Preclinical • Cardiovascular • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • CXCL10 • IFNG

Inference on Controlled Effects for Assessing Immune Correlates of Protection Based on a Cox Model. (PubMed, Stat Med) - P3 | "In this article, we analytically derive the asymptotic variance of this estimator, providing an analytic approach for constructing both pointwise and uniform confidence bands. We evaluate the finite sample performance of these methods in a simulation study and illustrate their use on data from the Coronavirus Efficacy (COVE) placebo-controlled phase 3 trial (NCT04470427) of the mRNA-1273 COVID-19 vaccine."

Biomarker • Journal • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P4 | N=30000 | Not yet recruiting | Sponsor: ModernaTX, Inc.

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

Immunogenicity of JN.1- and KP.2-Encoding mRNA COVID-19 Vaccines Against JN.1 Subvariants in Adult Participants. (PubMed, Open Forum Infect Dis) - "In this ongoing, open-label, phase 3b/4 study, JN.1- and KP.2-encoding monovalent mRNA-1273 vaccines elicited robust neutralization of vaccine-matched variants (JN.1, KP.2) and cross-neutralized JN.1 subvariants circulating during the study (September 2024-November 2024; KP.3.1.1, XEC, LP.8.1) in vaccinated adults, showing reduced cross-neutralization against all subvariants tested. No safety concerns were identified."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Sustained superior humoral immune responses of mRNA vaccines compared to Sputnik V viral vector COVID-19 vaccines in naïve and convalescent populations. (PubMed, Vaccine) - "mRNA vaccination provides markedly superior and sustained antibody responses compared to adenoviral vector vaccine, which is particularly relevant for long-term protection strategies."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2457 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

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

Immuno-functionomics reveals geographical variation and a role for TLR8 in mRNA vaccine responses. (PubMed, iScience) - "In Europeans vaccinated with mRNA-1273, baseline IFNγ production by innate lymphocytes correlated with SARS-CoV-2 spike-specific immune responses. In vitro mRNA vaccine stimulation also induced IFNγ production, which was TLR8 dependent and reduced in rural Indonesians. This study highlights functional immune diversity and TLR8's potential role in mRNA vaccine responses."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • TLR8

Incidence of stroke following COVID-19 vaccination: a nationwide self‑controlled risk interval study in Qatar. (PubMed, Expert Rev Vaccines) - "IRRs for the 0-21-day window were 1.39 (95% CI: 1.08-1.80) for BNT162b2 and 1.15 (95% CI: 0.78-1.69) for mRNA-1273. By subtype, IRRs were 1.34 (95% CI: 1.07-1.68) for ischemic stroke, 1.11 (95% CI: 0.58-2.11) for hemorrhagic stroke, and 1.46 (95% CI: 0.38-5.56) for cerebral venous sinus thrombosis. A small, transient increase in stroke incidence was observed within 21 days of vaccination; however, such events remain exceedingly rare, with an estimated excess risk substantially lower than that typically associated with infection."

Journal • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Infectious Disease • Ischemic stroke • Novel Coronavirus Disease • Thrombosis

Observations of Wart Clearance Following COVID-19 Vaccination: Coincidence or Missed Immunologic Signals? (PubMed, Vaccines (Basel)) - "Clearance occurred within approximately 2-4 weeks following the second or third vaccine dose (either mRNA-based [BNT162b2, mRNA-1273] or adenoviral vector [ChAdOx1-S]) and was sustained for 2-8 months of follow-up with no recurrences reported. While causality cannot be determined, the convergence of reports across diverse patients, consistent timing of clearance, and plausible immunologic pathways suggest that COVID-19 vaccination may, in rare instances, trigger beneficial immune activation against HPV-infected keratinocytes. Recognition of such unexpected outcomes underscores the need for broader vaccine safety and efficacy surveillance that includes both adverse and beneficial immune effects."

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

Prospective SARS-CoV-2 additional vaccination in immunosuppressant-treated individuals with autoimmune diseases in a randomized controlled trial. (PubMed, JCI Insight) - P2 | "Additional COVID-19 vaccination is effective and safe in individuals with ADs treated with immunosuppressants, regardless of whether MMF/MPA or MTX is withheld."

Journal • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Rheumatology

A Test-Negative Design for Immune Correlates Approximates a Traditional Exposure Proximal Design but Requires Far Fewer Blood Samples. (PubMed, J Infect Dis) - "We compared traditional to test-negative immune correlates methods in the mRNA-1273 SARS-CoV-2 vaccine efficacy clinical trial...Analogous ratios for binding antibody assay were 0.69 (95% CI: 0.52, 0.94) and 0.78 (95% CI 0.50, 1.20. The results support use of the logistically simpler test-negative immune correlates design."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Population-based cohort study assessing the effectiveness of maternal BNT162b2/mRNA-1273 vaccination against infant coronavirus disease 2019 outcomes during Omicron predominance: The VENUS study. (PubMed, Hum Vaccin Immunother) - "VE of the second and third doses against infection was 1% (95% confidence interval [CI]:-87% to 47%) and 71% (95% CI:-7% to 92%), respectively. This study indicates that a third dose during pregnancy may be effective in protecting infants from COVID-19 infection during Omicron predominance, while a second dose limited effectiveness."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Long-term trends in reporting of cardiac adverse drug reactions to COVID-19 vaccines - an exploratory analysis of the EudraVigilance database. (PubMed, BMC Infect Dis) - "The frequency of reporting suspected SCADRs after COVID-19 vaccinations appears to change dynamically over time. Concerning the administration of vaccine doses, the reporting of potential post-vaccination ADRs seems to be more distributed in time. These observations suggest that post-approval long-term monitoring of suspected ADRs may be valuable for improving data capture and supporting vaccine safety assessment. This underlines the potential importance of comprehensive surveillance in the context of infectious diseases and vaccine development programs."

Adverse drug reaction • Journal • Cardiovascular • Hematological Disorders • Infectious Disease • Inflammation • Novel Coronavirus Disease • Thrombosis

Incidence and Management of COVID-19 Infections in Vaccinated Patients with CLL (ASH 2023) - P | "The incidence of COVID-19 was comparable amongst men and women in the initial cohort (4%, 2%) and booster cohort (25%, 24%) as well as those who received mRNA-1273 and BNT162b2 vaccines (2%, 4%) and (24%, 26%). There were no infections in the 6 pts who received Ad26.COV2.S in the initial cohort nor 4 in booster cohort. Infections by treatment in initial cohort: 1% of treatment-native, 4% BTKi, 7% CD20 mAb + venetoclax, 9% BTKi + venetoclax...All infections (8/8) occurred in the initial cohort prior to the receipt of tixagevimab/cilgavimab or in those who did not receive prophylaxis; 84% (27/32) in the booster cohort... There were 243 pts enrolled in the initial vaccine cohort from 03/21-09/21 and 129 in the booster cohort from 08/21-02/22; 73 pts from initial cohort enrolled into the booster cohort. Patient characteristics are in Table 1. Eight pts (3.3%) reported COVID-19 in the initial cohort within 1 year of receiving the initial vaccine or prior to receipt of a..."

Clinical • Chronic Lymphocytic Leukemia • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD20

Lipid Nanoparticle Library Towards Development of Next Generation Genomic Medicines (ASH 2023) - "Ionizable amino lipids are a major constituent of the lipid nanoparticles for delivering nucleic acid therapeutics (e. g. , DLin-MC3-DMA in ONPATTRO®, ALC-0315 in Comirnaty®, SM-102 in Spikevax®). Further, using ionizable lipids from the library, we have shown gene editing of various targets in rodents. We believe that these studies will pave the path to the advancement in nucleic acid based therapeutics and vaccines, or cell & gene therapy agents for early diagnosis and detection of cancer, and for targeted genomic medicines towards cancer treatment and diagnosis."

Lipid Nanoparticle • Gene Therapies

Impact of PEGylated COVID-19 vaccination on patient tolerability to pegunigalsidase alfa – a new PEGylated enzyme replacement therapy for Fabry disease (SSIEM 2023) - P3 | "Infusion-related reactions (IRRs) and anti-PEG antibodies were assessed from first infusion and post-vaccination (based on PEGLNP COVID-19 vaccine [tozinameran, Pfizer-BioNTech; mRNA-1273, Moderna] approval, patients treated with PA between Dec 1, 2020 to study end or data cutoff were analyzed). PEGLNP vaccines (eg, COVID-19 mRNA vaccines), do not appear to increase the risk of IRRs or anti-PEG antibodies in PA-treated patients. PA is a well-tolerated ERT for patients with FD."

Clinical • Fabry Disease • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease

COVID-19 Vaccine-Induced Cardiac Inflammation: A Review of 103 Cases and Appraisal of VAERS Database (AHA 2025) - "The BNT162b2 (Pfizer) vaccine was associated with the highest number of cases (n=67), followed by mRNA1273 (Moderna, n=29), and Ad26.COV2.S (J&J, n=4). Clinical outcomes were favorable in 93.1% of cases, with symptom resolution and discharge. Five deaths were reported."

Clinical • Review • Cardiovascular • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of a SARS-CoV-2 N-terminal domain and receptor-binding domain monovalent XBB.1.5 vaccine in Japanese participants. (PubMed, Vaccine) - "mRNA-1283.815 elicited noninferior neutralizing antibody responses to mRNA-1273.815 against Omicron XBB.1.5 at Day 29, meeting the primary immunogenicity objective, with the GMR indicating higher responses of mRNA-1283.815 vs mRNA-1273.815 (GMR [95 % CI], 1.195 [1.028-1.389]). These results support the effectiveness of a monovalent formulation of mRNA-1283."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Acute Granulomatous Interstitial Nephritis Post-COVID-19 Vaccination (KIDNEY WEEK 2025) - "In this case, we have identifed a patient with acute granulomatous interstitial nephritis likely associated with Moderna Covid-19 vaccine...Differentials: sarcoidosis ( chest CT neg),TB, fungal infection (culture neg) , pauci-immune glomerulonephrritis and drug (finasteride) induced reaction was considered unlikely...He responded again to prednisone and was switched to and maintained on cellcept.Althought the course is somewhat atypical, association with Moderna vaccination is more likely than other causes...Diffuse acute granulomas intersitial nephritis H&E stain. 200x"

Alopecia • Dyslipidemia • Erectile Dysfunction • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Novel Coronavirus Disease • Renal Disease • Sarcoidosis

Projected Public Health Impact of Synchronized COVID-19 and Influenza Vaccination With a Combination Vaccine in US Older Adults (ISPOR-EU 2025) - "The base case reflected observed, asynchronous vaccine coverage rates (VCRs) and used CDC-derived influenza vaccine effectiveness (VE) and real-world VE data for the mRNA-1273 COVID-19 vaccine...Scenario 2: Scenario 1 plus improved VE reflecting next-generation COVID-19 vaccines (e.g., mRNA-1283)... A synchronized COVID-19 and influenza vaccination campaign could significantly reduce COVID-19 hospitalizations. Combination vaccines incorporating next generation vaccines may further amplify this benefit via improved efficacy and driving uptake."

Clinical • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 mRNA-1273 Vaccination in the UK: A Comparative Modeling Study of Alternative Eligibility Criteria (ISPOR-EU 2025) - "Despite uncertainties of the post-pandemic COVID-19 burden in the UK, vaccination of adults ≥ 65 years and high-risk individuals <65 results in significant reductions in severe COVID-19 outcomes including hospitalisation, critical care admission and deaths. Broader vaccination eligibility to include the full 65-74 age group aligns with the UK government's prevention-oriented health policy goals and contributes to healthcare system resilience."

Infectious Disease • Novel Coronavirus Disease

Health-Related Quality of Life Following Administration of Influenza and COVID-19 Combination Vaccine in Older Adults: Results From a Phase 3 Randomized Controlled Trial (ISPOR-EU 2025) - P3 | "This study evaluated short-term HRQoL changes within the first 7 days post-vaccination in older adults (≥65 years), including subgroups aged 65-74 and ≥75 years, in a Phase 3, randomized, observer-blind, active-controlled trial (NCT06097273). Participants (1:1 randomization) received either mRNA-1083 with placebo or co-administered Fluzone High-Dose Quadrivalent (HD-IIV4) and mRNA-1273 (Spikevax). mRNA-1083 was associated with a transient and minor decrements in participants' HRQoL, which were not meaningful. These findings are consistent with other currently licensed vaccines and support the tolerability of mRNA-1083 from a patient-reported outcomes perspective."

Clinical • HEOR • P3 data • Herpes Zoster • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Varicella Zoster