Spikevax (elasomeran) / Moderna, Takeda - LARVOL DELTA

Evaluating COVID-19 vaccine effectiveness across epidemiologic designs: test-negative case-control versus retrospective cohort analyses in a nationwide study. (PubMed, Int J Epidemiol) - "Both designs yielded consistent effectiveness estimates across vaccines and clinically relevant outcomes, with only modest differences related to handling of health-seeking behavior. These findings demonstrate that, when rigorously implemented using quality data and harmonized analytic strategies, both designs produce comparable effectiveness estimates."

Clinical • Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Management of Refractory Gingival Bleeding During Periodontal Therapy in Vaccine-Associated Immune Thrombocytopenia: A Case Report. (PubMed, Spec Care Dentist) - "This case highlights the importance of recognizing vaccine-associated SITP in dentistry and demonstrates fibrin glue as an effective adjunctive hemostatic measure when conventional approaches are insufficient."

Journal • Hematological Disorders • Immune Thrombocytopenic Purpura • Infectious Disease • Novel Coronavirus Disease • Thrombocytopenia • Thrombocytopenic Purpura

Long-COVID syndrome and vaccination protection – a prospective study analysis (ERS 2026) - "Most of the individuals received two doses (58.5%), predominantly Comirnaty® (Pfizer), followed by Vaxzevria® (AstraZeneca)...No significant differences were observed with fatigue, however, lower scores were seen with with Janssen® alone (mean 9.0) and Janssen® plus Spikevax® (Moderna) (mean 9.5), whereas Pfizer regimens showed higher scores (mean 22). Our study supports the effectiveness of the vaccine protecting against acute infection severity, but it also shows a tendency in reducing respiratory symptom burden in Long-COVID, reinforcing its protective role beyond the acute phase."

Clinical • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Post-Marketing Safety of an 2024-2025 mRNA-1273 COVID vaccine (mRNA-1273.712): A U.S. Claims-Based Active Surveillance Study (Optum's de-identified Clinformatics® Data Mart Database and Humana Medicare Advantage Database) (IDWeek 2026) - No abstract available

Clinical • Medicare • P4 data • Reimbursement • US reimbursement • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

mFLUSIVA - an mRNA-based influenza vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Short-term mycophenolic acid withdrawal is associated with temporal changes in immune cell composition in mRNA-1273-vaccinated kidney transplant recipients: insights from high-dimensional immune profiling. (PubMed, Front Immunol) - "Effects varied by time since transplantation and age, reflecting heterogeneous immune reconstitution. High-dimensional profiling enabled detailed analysis of major and rare immune populations, highlighting its value in mechanistic transplantation studies."

Journal • Infectious Disease • Novel Coronavirus Disease • Transplantation • CD38 • CD4 • CD8

Long-term adverse effects following COVID-19 vaccination: A comparative analysis of Oxford AstraZeneca, Pfizer-BioNTech, and Moderna vaccines. (PubMed, Medicine (Baltimore)) - "This study aimed to investigate long-term adverse clinical symptoms following COVID-19 vaccination with the Oxford AstraZeneca (ChAdOx1 nCoV-19, Oxford), Pfizer-BioNTech (BNT162b2), and Moderna (mRNA-1273) vaccines. In conclusion, the most commonly reported long-term adverse effects after COVID-19 vaccination were chronic fatigue, cognitive impairment, and menstrual irregularity. Further large-scale studies are required to provide more conclusive evidence."

Clinical • Journal • Alzheimer's Disease • Cognitive Disorders • Fatigue • Infectious Disease • Novel Coronavirus Disease • Women's Health

Sisonke Boost: Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study. (clinicaltrials.gov) - P3 | N=500000 | Completed | Sponsor: Wits Health Consortium (Pty) Ltd | Recruiting ➔ Completed | Phase classification: P3b ➔ P3

Phase classification • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

GI Reactogenicity Signals Following mRNA COVID-19 Vaccination in Celiac Disease and Gluten-Related Disorders: A Multi-Year VAERS Disproportionality Analysis (ACG 2026) - " Retrospective disproportionality analysis of VAERS public use data (2020â2025), restricted to mRNA vaccines (BNT162b2, mRNA-1273). Among 1,245,612 VAERS reports, 9,373 met CD/GRD cohort criteria. CD/GRD patients showed significantly elevated RORs for all target GI symptoms versus non-CD/GRD reporters. Strongest signals: abdominal distension (ROR 3.66; 95% CI 2.47â5.42), dyspepsia (ROR 2.87; 95% CI 1.86â4.44), and abdominal pain (ROR 2.82; 95% CI 2.26â3.52)."

Celiac Disease • Dyspepsia • Immunology • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Comparator-Dependent Safety Signals for Incident Systemic Autoimmune Rheumatic Diseases After mRNA COVID-19 Vaccination: A Systematic Review. (PubMed, Vaccines (Basel)) - "The available evidence does not indicate a consistent increase in incident systemic AIRDs after mRNA COVID-19 vaccination. Although pharmacovigilance studies identified comparator-dependent signals for selected diseases, particularly polymyalgia rheumatica and giant cell arteritis, these findings were generally not confirmed in comparative population-based studies and should be considered hypothesis-generating. Delayed-onset disease remains poorly characterised, and studies with at least one year of follow-up are needed."

Journal • Review • Giant Cell Arteritis • Immunology • Infectious Disease • Inflammatory Arthritis • Influenza • Lupus • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Pfizer Versus Moderna COVID-19 Vaccine Effectiveness Against Mortality: Evidence from Linked Mortality and Vaccination Records in Indiana. (PubMed, Vaccines (Basel)) - "This difference was not known in real-time due to the failure of the available studies to address healthy-vaccinee bias. Controlling for such bias is vital when making vaccination policy."

Journal • Infectious Disease • Novel Coronavirus Disease

Bioactive lipid-derived nanoparticles for RNA delivery. (PubMed, Mater Today (Kidlington)) - "Lipid nanoparticles (LNPs) have emerged as the most widely used and clinically validated platform for delivering RNAs, including small interfering RNA (siRNA) and messenger RNA (mRNA), as exemplified by the FDA approvals of Onpattro, Comirnaty, Spikevax, and mRESVIA. We also discuss the structure-activity relationship of these bioactive lipids and overview their corresponding LNPs for specific biomedical applications. We further provide perspectives on the challenges and opportunities in translating bioactive lipid-derived LNPs into next-generation RNA nanomedicines."

Journal • Immunology

Patent lexicography: Cautionary tale of "Branched Alkyl" ≠ "Branched Alkyl" (ACS-Fall 2026) - "The court held Alnylam to its patent definition of "Branched Alkyl" to mean an "alkyl in which one carbon atom in the group (1) is bound to at least three other carbon atoms, and (2) is not a ring atom of a cyclic group," instead of Alnylam's later suggested ordinary meaning of "a saturated hydrocarbon moiety that is not a straight chain." The patent definition limited Alnylam's claims to covering only lipids that comprised tertiary or quaternary carbons. Therefore, Alnylam's claims could not cover Moderna's cationic lipid SM-102, which only comprised primary or secondary carbons, as used in its COVID-19 vaccine SPIKEVAX®."

Infectious Disease • Novel Coronavirus Disease

Implications for future pandemics from a living systematic review and critical evaluation of observational studies of the effectiveness of COVID-19 vaccination against the Omicron variant. (PubMed, Vaccine) - "Reliable evidence on COVID-19 vaccine effectiveness during the period of Omicron variant predominance was essential to inform global vaccination strategies...Weekly searches covering seven databases up to 31 December 2022 sought evidence for WHO-approved vaccine platforms, including mRNA vaccines (BNT162b2, mRNA-1273), adenoviral vector vaccines (ChAdOx1-S, SII-ChAdOx1 nCoV-19, Ad26.COV2·S, Gam-COVID-Vac) and inactivated virus vaccines (CoronaVac, BBV-152)...Most results were judged to be at moderate risk of bias (361, 18%) or at serious risk of bias (1591, 78%) with the principal concern being confounding. We discuss implications for future pandemic preparedness, including the importance of standardized study protocols; robust data linkage between vaccination, testing and outcomes; and validated risk-of-bias frameworks for diverse observational designs."

Journal • Observational data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A double-amine ionizable lipid library enables highly efficient mRNA delivery to T cells at reduced lipid mass. (PubMed, Biomater Sci) - "mRNA-based nucleic acid therapeutics have gained significant attention and undergone extensive clinical investigation since the FDA's approval of Spikevax and Comirnaty for the treatment of SARS-CoV-2. Upon analyzing the endocytic and intracellular pathways of the lead LNPs, we found that multiple pathways were involved in delivering the payload to the cell. This set of novel lipids holds great promise for mRNA delivery and warrants further investigation."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Extreme PTH-Independent Hypercalcemia Mediated by a Rare Non-Osteoclastic Osteolysis Mechanism in Newly Diagnosed High-Risk Biclonal IgA Multiple Myeloma: Temporal Association with the Second Dose of Moderna mRNA-1273 COVID-19 Vaccine. (PubMed, Int J Mol Sci) - "The biclonal gammopathy, Clone-1 (normal karyotype, CD33+, OCT-2+, MYC-, CD19+, PAX5-) and Clone-2 (complex high-risk karyotype, OCT-2-, MYC+low, CD19-), suggests epigenetic rather than genomic drivers in the predominant clone. This case proposes a novel mechanistic hypothesis for vaccine-associated hypercalcemia and generates testable questions that warrant prospective investigation."

Journal • Endocrine Disorders • Hematological Malignancies • Infectious Disease • Metabolic Disorders • Multiple Myeloma • Nephrology • Novel Coronavirus Disease • Oncology • Renal Disease • CD33 • PAX5

Immunogenicity of an additional COVID-19 mRNA vaccine dose in immunosuppressed children with two doses of primary immunization. (PubMed, Pediatr Neonatol) - "Although an additional mRNA-1273 dose was associated with increased humoral and cellular immune responses in children with hematological cancers and enhanced humoral responses in immunosuppressed children, the overall magnitude of response was limited. Immunogenicity following the additional dose was modest, and the clinical benefit of an additional dose in children with NS, IBD, or hematological cancers remains uncertain."

Journal • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Bowel Disease • Nephrology • Novel Coronavirus Disease • Oncology • Renal Disease

Moderna wins Korea approval for updated Covid-19 vaccine targeting latest variants (Korea Biomedical Review) - "Under Korea's National Immunization Program, high-risk groups—including adults aged 65 years and older, residents and inpatients of long-term care and other infection-vulnerable facilities, and immunocompromised individuals—will be eligible to receive the vaccine free of charge."

Korea approval • Novel Coronavirus Disease

Comparative immunogenicity of mRNA-1273 and BNT162b2 SARS-CoV-2 bivalent booster vaccines in US nursing home residents. (PubMed, Hum Vaccin Immunother) - "We conducted a longitudinal immunologic evaluation of U.S. NHRs who received either the mRNA-1273 or BNT162b2 bivalent vaccine. Both mRNA-1273 and BNT162b2 mRNA vaccines elicit similarly robust humoral immunity in NHRs, supporting their interchangeable use in booster strategies. Our findings underscore the importance of timely booster administration over exact product selection in protecting this high-risk, immunosenescent population."

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

Anti-SARS-CoV-2 receptor-binding domain IgG titers and associated factors after heterologous mRNA booster vaccination in individuals primed with the inactivated vaccine. (PubMed, Acta Trop) - "This cross-sectional study evaluated anti-SARS-CoV-2 receptor-binding domain (RBD) IgG titers and associated factors among adults who had completed a two-dose CoronaVac primary series and received a mRNA-based booster dose (BNT162b2 or mRNA-1273) 1-13 months before sampling, with no documented or self-reported history of COVID-19...Overweight participants had higher titers than those with normal body mass index in the combined analysis (adjusted GMR=1.73; 95%CI: 1.04-2.86). These findings suggest lower humoral immune responses with increasing time after heterologous mRNA booster vaccination in individuals primed with CoronaVac and may inform future booster strategies."

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

Immunogenicity, reactogenicity, and safety of an mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine, mRNA-1083, in adults aged ≥50 years in Japan. (PubMed, Vaccine) - P3 | "Participants aged ≥50 years were randomized (1:1) to receive mRNA-1083 + placebo or Japan-licensed influenza hemagglutinin (HA) vaccine + mRNA-1273. These findings support mRNA-1083 as a single-dose approach to seasonal vaccination against influenza and SARS-CoV-2 in adults ≥50 years. ClinicalTrials.govidentifier: NCT06694389 (https://clinicaltrials.gov/study/NCT06694389)."

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

Anti-PEG Antibodies From mRNA COVID-19 Vaccines Affect In Vitro Measurements of Pegylated Drug Levels. (PubMed, Clin Transl Sci) - "Elevated anti-PEG antibody titers with prolonged prevalence were detected in individuals who received the mRNA-1273 vaccine as compared to control samples...Serum from those who received the BNT162b2 or Ad26.COV2.S vaccines had anti-PEG antibody levels similar to control samples. Serum from individuals with elevated anti-PEG antibodies, regardless of study group, typically showed decreased detection of the pegylated drug, pegfilgrastim. This study demonstrates that anti-PEG antibodies have the potential to interfere with bioanalytical assays used for pharmacokinetic drug measurement during the development of pegylated pharmaceutical products, as well as during the establishment of comparability to pegylated reference products during development of biosimilar drug products."

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

Vaccine Efficacy Against Naturally Asymptomatic Infections: A Novel Estimand for Quantifying Vaccine Effects. (PubMed, Epidemiology) - "Finally, we apply these methods to a randomized trial of the coronavirus disease 2019 mRNA-1273 vaccine. In this trial, VENAI was higher than standard estimates of efficacy against asymptomatic infections and was similar in magnitude to efficacy against any infection. Reporting VENAI in vaccine trials in addition to other vaccine effects would improve interpretability and could broaden understanding of vaccine impact on transmission, providing insights into immunological mechanisms."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 mRNA Vaccination Reduces Guillain-Barré Syndrome Risk: Evidence from a Large Longitudinal Cohort Study. (PubMed, medRxiv) - "This protective association was observed only among recipients of mRNA vaccines (BNT162b2: IRR = 0.38, P 0.05). Additional factors associated with GBS risk included sex, vaccine dose, and pre-existing comorbidities such as stroke, neurological disorders, and autoimmune diseases. Overall, our N3C large-scale study provides evidence that COVID-19 mRNA vaccination reduces GBS risk, supporting the safety profile of mRNA vaccines and warranting further mechanistic investigation."

Journal • Cardiovascular • CNS Disorders • Immunology • Infectious Disease • Novel Coronavirus Disease