Covovax (NVX-CoV2373) / Novavax, Takeda, Serum Institute of India - LARVOL DELTA

A randomised trial to evaluate the immune response of COVID-19 vaccines in adults and adolescents (ANZCTR) - P4 | N=1325 | Recruiting | Sponsor: The Kids Research Institute Australia | N=1000 ➔ 1325

Enrollment change • Infectious Disease • Novel Coronavirus Disease

REAL-WORLD EFFECTIVENESS OF NVX-COV2373 VERSUS BNT162B2 IN PREVENTING SARS-COV-2 INFECTION IN SOUTH KOREAN ADOLESCENTS (ESPID 2025) - "Background Adolescents typically experience mild COVID-19 symptoms but remain at risk for severe outcomes such as MIS-C (Multisystem Inflammatory Syndrome in Children) and long COVID, which may impact their health, education, and social development. The 180-day aHR (95% CI) for NVX-CoV2373 compared to BNT162b2 for any SARS-CoV-2 infection was 0.57 (0.33 - 1.01) post primary series and 0.68 (0.54 - 0.804) post 1 st booster. Conclusions/Learning Points Our findings suggest that across primary series and first booster vaccination in the adolescent population, NVX-CoV2373 trends to show more robust protection against SARS-CoV-2 infection compared to BNT162b2."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine (clinicaltrials.gov) - P3 | N=9320 | Active, not recruiting | Sponsor: Novavax | Not yet recruiting ➔ Active, not recruiting

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

Old hematopoietic stem cells retain competence to reconstitute a youthful B cell system that is highly responsive to protein-based vaccination. (PubMed, Immun Ageing) - "Both DO-HSCs and DY-HSCs established in the young recipient BM to a similar extend, suggesting that the concomitant reduction in the de novo reconstitution of CD19+ B cells in DO-HSC vs. DY-HSC transplanted animals is specifically related to old HSCs. DO-HSCs and DY-HSCs reconstitute very similar unchallenged B cell systems that efficiently elicit antigen-specific IgG antibodies by protein-based vaccination. Old HSCs thus retain competence to reconstitute a youthful and functional B cell system, at least in the young environment of transplanted RAG1-/- mice. This suggests that it is primarily age-related factors, and not HSCs per se, that influence the composition and functionality of the old B cell system."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Transplantation • PTPRC • RAG1

Immunogenicity and safety of a monovalent Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine in previously unvaccinated, SARS-CoV-2 seropositive participants: Primary day-28 analysis of a phase 2/3 open-label study. (PubMed, Vaccine) - P2/3 | "A single dose of NVX-CoV2601 in vaccine-naive participants with a history of SARS-CoV-2 infection elicited a robust neutralizing antibody response that was noninferior to that observed in vaccinated participants. The vaccine was well-tolerated. These data support the use of NVX-CoV2601 as a single dose, regardless of prior vaccination history."

Journal • P2/3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity of Adjuvanted Recombinant SARS-CoV-2 Spike Protein Vaccine after Earlier mRNA Vaccine Doses. (PubMed, J Allergy Clin Immunol) - P3 | "A heterologous regimen of two adjuvanted, recombinant spike protein vaccine doses following multiple mRNA vaccine doses produced robust immune responses, exhibiting cross-reactivity to some newer variants."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A small-molecule SARS-CoV-2 inhibitor targeting the membrane protein. (PubMed, Nature) - "In a post-exposure hamster model, JNJ-9676 was efficacious at 75 mg per kg twice per day even when added at 48 h after infection, when peak viral loads were observed. The M protein is an attractive antiviral target to block coronavirus replication, and JNJ-9676 represents an interesting chemical series towards identifying clinical candidates addressing the current and future coronavirus pandemics."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

US drug regulator delays Novavax Covid vaccine approval (24 News HD) - "The US drug regulator has missed a deadline for granting full approval to Novavax's Covid-19 vaccine...In a document sent to the financial markets regulator and seen by AFP, US drugmaker Novavax said it was still awaiting a response from the Food and Drug Administration (FDA), which had been promised to make a decision by April 1...The company is seeking full approval of its Covid-19 vaccine, which is already authorized in the United States through an emergency use procedure for people aged 12 and over."

FDA event • Novel Coronavirus Disease

Antibody persistence against omicron subvariants induced by monovalent mRNA, bivalent mRNA or nuvaxovid vaccines: final results from Phase D of the PRIBIVAC study, a randomised clinical trial (ESCMID Global 2025) - No abstract available

Clinical • Infectious Disease • Novel Coronavirus Disease

Lot Consistency Study of COVID-19 and Influenza Combination Vaccine (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: Novavax | N=1925 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

SHIELD: Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders in the United States (clinicaltrials.gov) - P4 | N=660 | Active, not recruiting | Sponsor: Novavax | Trial primary completion date: Dec 2024 ➔ Jun 2025

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

Artificial intelligence models predicting abnormal uterine bleeding after COVID-19 vaccination. (PubMed, Sci Rep) - "The analysis revealed three primary predictive features: COVID-19 vaccination frequency, NVX-CoV2373 (Novavax) COVID-19 vaccination count, and hemoglobin levels. These findings provide valuable insights into predicting the risk AUB following COVID-19 vaccination, potentially enhancing post-vaccination monitoring strategies."

Journal • Infectious Disease • Novel Coronavirus Disease • Women's Health

Novavax Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights (PRNewswire) - "Transitioned lead commercial responsibility of Nuvaxovid COVID-19 vaccine beginning with the 2025-2026 vaccination season for the U.S. and other select major markets...Prescription Drug User Fee Act target action date of April 2025 for Novavax's COVID-19 vaccine Biologics License Application (BLA)...Marketing authorization transfers to Sanofi for U.S. and European Union (EU) markets are expected in late 2025."

Commercial • Launch • PDUFA • Novel Coronavirus Disease

BEEHIVE: The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection (clinicaltrials.gov) - P4 | N=1188 | Completed | Sponsor: Sarang K. Yoon, DO, MOH | Recruiting ➔ Completed

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

Cost-Effectiveness of Introducing Nuvaxovid to COVID-19 Vaccination in the United Kingdom: A Dynamic Transmission Model. (PubMed, Vaccines (Basel)) - "Probabilistic sensitivity analysis indicated an approximately 70% probability of cost-effectiveness with Nuvaxovid-only versus mRNA-only vaccination across most cost-effectiveness thresholds (up to GBP 300,000/QALY gained). Nuvaxovid remained dominant over mRNA vaccines in scenario analyses assessing vaccine efficacy waning, Nuvaxovid market shares, and the vaccinated population."

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

The immunogenicity, reactogenicity, and safety of a bivalent mRNA or protein COVID-19 vaccine given as a fourth dose. (PubMed, J Infect) - P3 | "At day 28 post-vaccination, higher immunogenicity was observed following Moderna vaccination compared to Novavax vaccination when given as a fourth dose in healthy adults for Ancestral and Omicron subvariants, including JN.1. However, local and systemic reactogenicity was higher in the Moderna vaccine group compared with the Novavax vaccine group. These results may have important implications for ongoing booster strategies."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity, safety, and reactogenicity of concomitant administration of the novavax vaccine against Omicron XBB.1.5 (NVX-CoV2601) and a 20-valent pneumococcal conjugate vaccine in adults aged ≥60 years: A randomised, double-blind, placebo-controlled, non-inferiority trial. (PubMed, J Infect) - P4 | "Immunogenicity following co-administration of NVX-CoV2601 with PCV20 was non-inferior to administration of NVX-CoV2601 alone. Given the similar safety and reactogenicity profile, our findings may help to overcome concerns about concomitant vaccination and pave the way for combination vaccines."

Clinical • Head-to-Head • Journal • Infectious Disease • Novel Coronavirus Disease • Pneumococcal Infections • Respiratory Diseases

Safety of Covid-19 Boosters in People with Systemic Autoimmune Rheumatic Diseases on Rituximab (Covbird Study). (CRA-AHPA 2025) - "Participants chose to receive either a fourth dose of mRNA Spikevax® or NuvaxovidTM, a protein subunit vaccine (PSV)...Mean (SD) age was 57.3 (15.3); 73% were female; 91% White; 23% were on prednisone, 21% on antimalarials, and 42% on other immunosuppressors... Three of 86 patients experienced a disease flare and nine others required hospitalization, most for COVID-19/other infections. A fourth or fifth booster dose of either an mRNA or a PSV vaccine were not clearly associated with unexpected vaccine reactions in rituximab-treated SARD patients. Revaccination of patients on rituximab with either mRNA or PSV vaccines appears safe."

Clinical • ANCA Vasculitis • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Myositis • Novel Coronavirus Disease • Pain • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Comparing Immunogenicity with Protein Subunit and mRNA COVID-19 Vaccines in Patients with Rheumatic Diseases on Rituximab (COVBIRD Study) (CRA-AHPA 2025) - "Participants chose to receive either a fourth dose of mRNA (Spikevax®) or PSV (NuvaxovidTM) vaccines...Mean (SD) age was 57.3 (15.3); 73% were female; 91% White; 23% were on prednisone, 21% on antimalarials, and 42% on other immunosuppressors... In SARDs patients on rituximab, both fourth and fifth dose PSV vaccine recipients had decreased anti-RBD titers at 6 months, while post fourth dose mRNA recipients increased their anti-RBD up to 6 months post-vaccination. Overall, humoral response in mRNA vaccine recipients seemed superior to those receiving PSV. This emphasizes the importance of thorough evaluation of new COVID-19 vaccines in the immunocompromised."

Clinical • ANCA Vasculitis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Myositis • Novel Coronavirus Disease • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Efficacy, immunogenicity, and safety of the Novavax COVID-19 vaccine in immunocompromised patients: A targeted literature review. (PubMed, Vaccine) - "Limited efficacy data indicates that the Novavax COVID-19 vaccine may help protect IIC against symptomatic/severe COVID-19; however, additional studies with larger sample sizes are needed. Future research should include disease-specific populations to assess how individual characteristics (e.g., disease state, concomitant medications, prior COVID-19 vaccination) impact vaccine response."

Journal • Review • CNS Disorders • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Rheumatology • Transplantation

Vaccine efficacy of NVX-CoV2373 against SARS-CoV-2 infection in adolescents in the USA: an ancillary study to a phase 3, observer-blinded, randomised, placebo-controlled trial. (PubMed, Lancet Microbe) - P3 | "Among adolescents participating in the PREVENT-19 trial during the delta (B.1.617.2) variant wave of the COVID-19 pandemic, the NVX-CoV2373 vaccine was highly efficacious against SARS-CoV-2 infection regardless of symptoms, indicating its potential to reduce the reservoir of infections that contribute to community transmission."

Journal • P3 data • Allergy • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of Omicron Protein Vaccines in mRNA-Vaccinated Adolescents: A Phase 3, Randomised Trial. (PubMed, J Infect) - "NVX-CoV2601 elicited more robust antibody responses to XBB.1.5 and ancestral virus, compared with a bivalent formulation. The safety profile within each group was consistent with NVX-CoV2373, which contains ancestral recombinant spike protein."

Journal • P3 data • Cardiovascular • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of a monovalent omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose in US adults: interim analysis of a single-arm phase 2/3 study. (PubMed, Lancet Infect Dis) - P2/3 | "The coprimary endpoints were met, and NVX-CoV2601 was well tolerated. These interim data support NVX-CoV2601 use per guidance for XBB.1.5-directed COVID-19 vaccines and demonstrate the adaptability of this vaccine platform for updated SARS-CoV-2 spike proteins."

Journal • P2/3 data • Asthma • Cardiovascular • Fatigue • Hypertension • Immunology • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Pulmonary Disease • Respiratory Diseases

Globally approved vaccines for COVID-19: a systematic review. (PubMed, Braz J Microbiol) - "The vaccines included in this study were: Cominarty, mRNA-1273 or Spikevax, Vaxzevria or AZD1222 or Covishield, CoronaVac or PicoVacc, and Ad26.COV2.S, SputnikV or Gam-Covid-Vac, Covaxin, NVX-CoV2373 or Covovax or Nuvaxovid, WIV04 and HB02, CoVLP or Covifenz and Convidecia or Ad5-nCoV...All vaccines evaluated have different compositions, dosages, populations, and study designs. All are effective in at least preventing symptomatic COVID-19, causing mild or moderate adverse effects when present."

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

Multi-Stakeholder Call to Action for the Future of Vaccine Post-Marketing Monitoring: Proceedings from the First Beyond COVID-19 Monitoring Excellence (BeCOME) Conference. (PubMed, Drug Saf) - No abstract available

Journal • P4 data • Infectious Disease • Novel Coronavirus Disease