Comirnaty (tozinameran) / Pfizer, Fosun Pharma, BioNTech - LARVOL DELTA

A transferable SARS-CoV-2 IRES module enables dual translation initiation for enhanced antigen expression in COVID-19 mRNA vaccines. (PubMed, Mol Ther Nucleic Acids) - "Notably, unmodified Omicron BA.5 and XBB.1.5 mRNA vaccines containing this element elicited potent humoral and cellular immune responses at sub-microgram doses, comparable to those induced by the approved N1-methylpseudouridine-incorporated mRNA vaccine, raxtozinameran. These findings identify SL4.5-5 as a modular IRES element that enables dual translation initiation, promoting efficient protein synthesis under cap-dependent translation-restrictive conditions and expanding the functional landscape of mRNA vaccines and therapeutics beyond cap-dependent limitations."

Journal • Infectious Disease • Novel Coronavirus 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

Dermatomyositis with Anti-MDA5 Autoantibodies After SARS-CoV-2 mRNA Vaccination Treated with Tofacitinib: Integrating Literature Evidence and a Novel Observation. (PubMed, Antibodies (Basel)) - "The review was enriched by the inclusion of a new case: a 60-year-old woman who developed anti-MDA5-positive dermatomyositis two weeks after receiving her fourth dose of the BNT162b2 (Pfizer/BioNTech) vaccine. Treatment with oral prednisone, intravenous alprostadil, and the Janus kinase inhibitor tofacitinib resulted in marked clinical improvement. This case, together with the literature review, illustrates both typical and atypical presentations of vaccine-associated anti-MDA5 DM, highlights diagnostic challenges without lung involvement, and suggests JAK inhibition as a potential therapeutic option, contributing to a more comprehensive understanding of post-vaccination dermatomyositis."

Journal • Review • Dermatomyositis • Immunology • Infectious Disease • Interstitial Lung Disease • Melanoma • Myositis • Novel Coronavirus Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • IFIH1

Impaired booster-induced SARS-CoV-2 antibody responses in rituximab-treated B-cell lymphoma patients despite peripheral B-Cell Recovery. (PubMed, Radiol Oncol) - "Rituximab is associated with impaired vaccine-induced antibody responses. Despite recovery of peripheral B-cell counts, patients with B-cell lymphoma show reduced humoral responses compared with healthy individuals following booster COVID-19 vaccination."

Journal • Observational data • B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Respiratory Diseases • IFNG

Plus_Booster: Effectiveness, Immunogenicity and Safety of the Second Booster Dose of the Vaccine Against COVID-19 in the Elderly (clinicaltrials.gov) - P=N/A | N=260 | Completed | Sponsor: Federal University of Espirito Santo | Not yet recruiting ➔ Completed | N=490000 ➔ 260

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease

Risk of New-Onset Myasthenia Gravis Following COVID-19 Infection and Vaccination: A Population-Based Case-Control Study. (PubMed, Eur J Neurol) - "This study suggests no significant increased risk of new-onset MG following COVID-19 infection, but the Pfizer-BioNTech vaccine appears to be associated with a higher risk of developing MG, particularly within 180 days of vaccination."

Journal • CNS Disorders • Infectious Disease • Myasthenia Gravis • Novel Coronavirus Disease

IVY1: Safety and efficacy of intradermal mRNA SARS-CoV-2 vaccination in patients with Fibrodysplasia Ossificans Progressiva (IVY trial) (clinicaltrialsregister.eu) - P4 | N=10 | Recruiting | Sponsor: Amsterdam UMC Stichting | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • ACVR1

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

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

C4591059: Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data (clinicaltrials.gov) - P=N/A | N=1 | Active, not recruiting | Sponsor: Pfizer | Completed ➔ Active, not recruiting | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ May 2026

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

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

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

Immune Response to COVID-19 Vaccines: Updates in a Fast-Moving Scenario. (PubMed, Vaccines (Basel)) - "Far from being complete and exhaustive, this Special Issue provides the reader with fresh insights into several critical questions raised by or connected to the advent of COVID-19 vaccines. This introductory article provides an overview of their contribution, while offering a quick glance at the current state of the art."

Journal • Cardiovascular • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Rheumatology • Transplantation

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

IMPACT OF KP.2 BNT162B2 COVID-19 VACCINE ON ACUTE SYMPTOMS AMONG U.S. ADULTS DURING THE 2024-2025 RESPIRATORY SEASON (ISPOR 2026) - P | "BNT162b2 KP.2 vaccine was associated with lower COVID-19 symptom burden during the first week of infection compared to no receipt of KP.2 vaccine. These findings support staying up-to-date with recommended COVID-19 vaccination."

Clinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

IMPACT OF KP.2 BNT162B2 COVID-19 VACCINE ON HEALTH-RELATED QUALITY OF LIFE AMONG SYMPTOMATIC U.S. ADULTS WITH SARS-COV-2 DURING THE 2024-2025 RESPIRATORY SEASON (ISPOR 2026) - P | "BNT162b2 KP.2 vaccine was associated with improved HRQoL in the first week of COVID-19 infection during the 2024-2025 respiratory season. These results reinforce the benefits of COVID-19 vaccination and underscore the importance of remaining up to date with vaccine recommendations."

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

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

Association between nucleic acid COVID-19 vaccines and acute myocardial infarction in adults: a systematic review. (PubMed, Front Cardiovasc Med) - "A Malaysian study (22.2 million) found no significant increase after BNT162b2 (dose 1 IRR: 0.97; dose 2 IRR: 1.08) or ChAdOx1 (dose 1 IRR: 1.02; dose 2 IRR: 1.58)...Case reports lack the methodological rigor to establish causality. The documented protective effects after booster doses and consistency across diverse populations demonstrate vaccine cardiovascular safety, supporting continued vaccination policies."

Journal • Review • Cardiovascular • Infectious Disease • Myocardial Infarction • Novel Coronavirus Disease • Respiratory Diseases

Possible role of pre-vaccination T-lymphocyte subpopulations in the antibody response to COVID-19 vaccines in children undergoing chemotherapy. (PubMed, Front Immunol) - "This study evaluated the humoral immune response after SARS-CoV-2 vaccination in children with cancer following two doses of the BNT162b2 mRNA vaccine...We have similar observations as previously reported with influenza vaccination, suggesting that CD3+CD56+ T cells may be involved in the immune response to SARS-CoV-2 vaccines. We highlight the connection between pre-vaccination CD4+ MAIT cell populations and the antibody response."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Oncology • Pediatrics • Respiratory Diseases • CD4 • CD8 • NCAM1

Robust effector memory features of human T-bethi B cells induced by repeated mRNA vaccination. (PubMed, iScience) - "Here, we identified a transcriptionally distinct cluster of T-bethi B cells, among SARS-CoV-2 RBD-specific B cells in PBMCs from healthy individuals vaccinated with the BNT162b2 SARS-CoV-2 mRNA vaccine...Notably, these T-bethi B cells were affinity-matured and exhibited rapid differentiation into antibody-secreting cells (ASCs) producing neutralizing antibodies comparable to classical memory B cells, underscoring their role in early recall responses. Taken together, these findings illuminate the potent effector memory roles of T-bethi B cells in adaptive immunity following vaccinations."

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

Effect of dynamics and timing of SARS-CoV-2 vaccination on immune response in people with multiple sclerosis during cladribine treatment. (PubMed, Clin Immunol) - "Herein, we evaluated humoral and T cell-mediated immune responses against BNT162b2 mRNA vaccine in pwMS treated with cladribine (n = 30), focusing on how the time interval between drug administration and vaccination affects the magnitude and dynamics of vaccine-induced immune response. Accordingly, vaccination after cladribine administration resulted in reduced antibody production but preserved T cell responses, whereas pwMS receiving vaccine before cladribine exhibited an effective humoral immunity but hampered SARS-CoV-2 Spike-specific T cell response. Our findings may inform the clinical decision-making process by providing evidence to support the identification of an appropriate time window for vaccination during cladribine treatment."

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

Modeling the potential public health and economic impact and cost-effectiveness of vaccination strategies using a COVID-19 vaccine in Costa Rica. (PubMed, Expert Rev Vaccines) - "Using a previously published, combined Markov-decision tree model adapted for Costa Rica, this study estimated the outcomes of different vaccination strategies with BNT162b2 COVID-19 mRNA vaccine, targeting various age and risk groups...Expanding vaccination to adults aged ≥60 years and high-risk individuals aged 18-59 years further increased benefits. Implementing an adapted COVID-19 vaccine strategy for high-risk and older adults in Costa Rica is expected to be cost-saving, with broader age group eligibility yielding even greater benefits."

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

Effectiveness of bivalent BA.1 mRNA booster vaccines during the autumn 2022 COVID-19 booster programme in adults aged 50+ in England: observational matched cohort study using OpenSAFELY. (PubMed, Vaccine) - "Rates of COVID-19-related hospitalisation and death were substantially lower after bivalent original/omicron BA.1 mRNA booster vaccine than in people who remained unboosted. Apparent protection against fracture suggests some unmeasured confounding. Outcomes appeared similar for the Moderna and Pfizer-BioNTech vaccines."

Journal • Infectious Disease • Musculoskeletal Diseases • Novel Coronavirus Disease • Orthopedics

Comparative analysis of clinically approved lipid nanoparticles for intranasal siRNA delivery against SARS-CoV-2. (PubMed, Drug Deliv Transl Res) - "We examined three clinically approved lipid nanoparticle (LNP) formulations that mimic the compositions of Alnylam's Onpattro (MC3), Moderna's Spikevax (SM-102), and Pfizer-BioNTech's Comirnaty (ALC-0315) RNA-based therapeutics, to identify the optimal formulation for antiviral siRNA therapeutic respiratory delivery and antiviral efficacy. Our study demonstrates that LNP-encapsulated and chemically modified siRNAs can provide an effective and mutation-resilient antiviral strategy. This study compares clinically relevant LNP formulations for siRNA delivery to the respiratory tract, demonstrating that MC3-based LNPs offer a promising platform for safe and effective RNA therapeutic delivery."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases