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

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

Safety of Matrix-M-adjuvanted COVID-19, seasonal influenza, combination influenza-COVID-19, and malaria vaccines: a review of the evidence. (PubMed, Expert Rev Vaccines) - "Two authorized Matrix-M - adjuvanted vaccines, NUVAXOVID (COVID-19) and R21/Matrix-M (Plasmodium falciparum malaria), have been administered to >10 million people worldwide. Active-comparator clinical trials and post-marketing studies demonstrate favorable reactogenicity profiles of Matrix-M - adjuvanted vaccines compared with licensed vaccines for the same diseases, particularly, lower reactogenicity rates post - NUVAXOVID versus mRNA COVID-19 vaccination. Research is ongoing to better characterize Matrix-M immune-stimulating mechanisms, continue technology improvements, and identify new applications to enhance vaccines and therapeutics."

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

COVID-19 Reactogenicity (clinicaltrials.gov) - P4 | N=1000 | Active, not recruiting | Sponsor: Marcel Curlin | Trial completion date: Jun 2028 ➔ Jun 2026 | Trial primary completion date: Apr 2027 ➔ Jun 2026 | Not yet recruiting ➔ Active, not recruiting

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

Impact of prior SARS-CoV-2 acquisition on binding and neutralizing antibody responses following COVID-19 vaccination: A cross-protocol analysis of individual-level data from six phase 3 clinical trials. (PubMed, Vaccine) - "In SARS-CoV-2-naïve individuals, a two-dose vaccine regimen is needed to provide antibody levels correlated with protection against disease caused by the cognate virus strain. In contrast, in individuals with prior SARS-CoV-2 acquisition, a single dose of any of the tested vaccines/platforms (mRNA/protein/vector) provides comparably high antibody levels."

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

Evaluating Safety and Immune Response of Janssen, Moderna, Pfizer/BNT, and Novavax COVID-19 Vaccines for Same and Mixed Boosters in Adolescents and Adults Aged 12-64 With and Without HIV in Kenya, DRC, and Rwanda (clinicaltrials.gov) - P2 | N=1919 | Completed | Sponsor: Victoria Biomedical Research Institute

New P2 trial • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Real-world impact of NVX-CoV2373 COVID-19 vaccine in immunocompromised individuals in South Korea. (PubMed, BMC Public Health) - "A similar risk of medically attended SARS-CoV-2 infection between IIC and non-IC was observed with both a homologous primary series and homologous or heterologous third and fourth doses of NVX-CoV2373, as well as across a variety of immunocompromising conditions."

Journal • Real-world evidence • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Real-World Effectiveness and Noninferiority Evaluation and Comparison of Messenger RNA-Based and Protein-Based COVID-19 Vaccines: Protocol for the BEEHIVE Randomized Study With a Hybrid Effectiveness Design. (PubMed, JMIR Res Protoc) - P4 | "Data from this study will provide valuable real-world VE data for a dose of the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine after an mRNA-based COVID-19 primary series."

Head-to-Head • Journal • Real-world evidence • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of a recombinant spike protein COVID vaccine in patients with inflammatory bowel disease and transplant recipient. (PubMed, Vaccine) - "NVX-CoV2601 was safe and immunogenic with similar humoral responses compared to healthy controls, making it a viable alternative for immunosuppressed patients."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Safety and immunogenicity of a single dose of a JN.1 variant COVID-19 vaccine in previously vaccinated adults: Primary analysis report of a phase 3 open-label trial. (PubMed, Vaccine) - P3 | "A single dose of NVX-CoV2705 induced a rapid and robust anti-SARS-CoV-2 immune response against the Omicron JN.1 and other circulating variants and had an acceptable safety profile. https://clinicaltrials.gov/study/NCT06409663."

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

Vaccine Platform-Dependent Differential Impact on Microbiome Diversity: Potential Advantages of Protein Subunit Vaccines. (PubMed, Vaccines (Basel)) - "Background: The COVID-19 pandemic accelerated the development of diverse vaccine platforms, including mRNA, adenoviral vector, and protein subunit vaccines. In comparison, repeated ChAdOx1 doses resulted in a sustained reduction in alpha diversity, whereas BNT162b2 showed a transient post-booster rise followed by a long-term decline in species richness. In the booster setting, the protein subunit vaccine NVX-CoV2373 exerted a distinct and favorable effect on gut microbiome diversity, increasing alpha diversity in contrast to the patterns observed with mRNA and adenoviral vector booster vaccines."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Reactogenicity and Immunogenicity following Heterologous and Homologous Third Dose COVID-19 vaccination in UK Adolescents (Com-COV3): A Randomised Controlled Non-Inferiority Trial. (PubMed, J Infect) - "All booster regimens evaluated elicited a robust immune response. 10μg fractional adult BNT162b2 vaccine demonstrated similar immunogenicity compared with 30μg BNT162b2 and superior immunogenicity compared with 10μg paediatric BNT162b2 vaccine. Fractional doses of the adult BNT162b2 vaccine are an alternative to the paediatric formulation for booster campaigns in adolescents."

Head-to-Head • Journal • Infectious Disease • Meningococcal Infections • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases

Safety and immunogenicity of a SARS-CoV-2 spike, subunit vaccine stabilised in the prefusion conformation by second generation Molecular Clamp evaluated in adults aged 18-55 years: a randomised, double-blind, active comparator, Phase I trial. (PubMed, J Infect Dis) - P1 | "Cases of confirmed COVID-19 infection during the study were also examined...UQSC2 was equally well tolerated to the authorised comparator vaccine and produced an equally robust boost in neutralising immune response. These findings support the effectiveness of the MC2 platform in producing vaccines against newly emerging variants of SARS-CoV-2, and other respiratory viruses, as well as the platform's potential use in emergency response to novel viruses."

Journal • P1 data • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Parental Vaccine Hesitancy in Children With Comorbidities: A Comparative Analysis (ISPOR-EU 2025) - "Given the heightened vulnerability for severe outcomes in CCIC to vaccine-preventable diseases, understanding and addressing PVH in this population is critical. A targeted search of PubMed and EMBASE up to 16 May 2025 identified studies that assessed PVH for general childhood and pediatric COVID-19 vaccines... There is an observed higher prevalence of parental vaccine hesitancy among parents of CCIC compared to parents of healthy children, with variations observed across different health conditions. Targeted interventions emphasizing enhanced healthcare provider communication and condition-specific, evidence-based information are essential to address parental concerns and improve vaccine uptake in these vulnerable pediatric populations."

Clinical • Autism Spectrum Disorder • Bone Marrow Transplantation • Diabetes • Genetic Disorders • Hematological Malignancies • Hepatology • Hypertension • Infectious Disease • Metabolic Disorders • Nephrology • Ophthalmology • Pediatrics • Renal Disease • Type 1 Diabetes Mellitus

Supporting equitable booster strategies: one-year real-world immunogenicity data in people with HIV (PWH) receiving different variant-adapted COVID-19 vaccines. (PubMed, Int J Infect Dis) - "Overall, mRNA boosters provided a stronger early humoral response, while Nuvaxovid may promote more sustained T-cell immunity. Both maintained robust responses over 12 months, supporting their use in PWH. Given its thermostability and accessibility, Nuvaxovid is a practical alternative when mRNA vaccines are unavailable or contraindicated."

Journal • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Precautionary Health Behaviours as Potential Confounders in COVID-19 Vaccine Effectiveness Studies. (PubMed, Vaccines (Basel)) - " PHBs should be considered a possible confounder of COVID-19 VE studies. Further research is needed to define when PHBs should be integrated into VE models, as the level of confounding may differ according to the study population and the epidemiological context."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Analysis of antibody markers as immune correlates of risk of severe COVID-19 in the PREVENT-19 efficacy trial of the NVX-CoV2373 recombinant protein vaccine. (PubMed, Clin Infect Dis) - "Post-vaccination NVX-CoV2373 antibody levels are stronger predictors of severe COVID-19 than any-severity Delta COVID-19. Low antibody responses indicate vulnerability to severe COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • KEAP1

Matrix-M adjuvant - A key adjuvant in global vaccine development (ASTMH 2025) - "Early distribution to draining lymph nodes produces long-lasting memory B-cells and broad-based T-cell immunity.1 Matrix-M-containing vaccines are immunogenic and safe in both pediatric [e.g., malaria (R21/MM)2 and COVID-193] and adult populations [e.g., malaria (R21/MM),4,5 COVID-19, influenza,6 and Ebola7]...Additional experiments are underway to better understand the mechanisms of action and utility of Matrix-M in conjunction with various vaccine platforms and across different formulations. (Note: references available upon request)"

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

Detection of Anti-SARS-CoV-2 Mucosal Immunoglobulin A in Clinical Saliva Samples After a Dose of Novavax COVID-19 Vaccine. (PubMed, J Med Virol) - P3 | "These participants had previously received ≥ 2 mRNA-based COVID-19 vaccinations prior to enrollment and received a single intramuscular study dose of NVX-CoV2601 (XBB.1.5) or bivalent vaccine (NVX-CoV2601 + NVX-CoV2373 [Wuhan]). Furthermore, cross-reactivity by identification of anti-JN.1 and anti-Wuhan IgA was also observed. The detection of IgA in clinical mucosal samples using this assay will be a valuable tool in supporting vaccine development."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 update: 2025-2026 vaccine formulations and recommendations. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease

Difference in reactogenicity events between mRNA and Protein-subunit Vaccines: Results from the Booster Epidemiological Evaluation of Health, Illness, and Vaccine Efficacy (BEEHIVE) Study, a U.S. randomized trial of 2023-2024 COVID-19 vaccines (XBB.1.5) (IDWeek 2025) - No abstract available

Clinical • Infectious Disease • Novel Coronavirus Disease

Effectiveness of NVX-CoV2373 and BNT162b2 COVID-19 Vaccination in South Korean Adolescents. (PubMed, Pediatr Infect Dis J) - "These results suggest that NVX-CoV2373 may provide more robust protection against medically attended COVID-19 as a third dose, compared with BNT162b2. While the aHR for the primary series also indicated lower risk with NVX-CoV2373, this difference was not statistically significant."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19: Efficacy and Safety of NVX-CoV2705 (clinicaltrials.gov) - P4 | N=6500 | Not yet recruiting | Sponsor: Novavax

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

Structural serology of polyclonal antibody responses to mRNA-1273 and NVX-CoV2373 COVID-19 vaccines. (PubMed, Cell Rep) - P1, P1/2 | "High-resolution cryo-EMPEM studies reveal extensive pAb responses to and around the supersite, with unique angles of approach and engagement. NTD supersite pAbs are also the most susceptible to variant mutations compared to other specificities, indicating that ongoing Spike ectodomain-based vaccine design strategies should consider immuno-masking this site to prevent induction of these strain-specific responses."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

One-year follow-up of the immunogenicity and safety of a first and second booster dose of the NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults who had previously received a primary series of COVID-19 mRNA vaccine: Final report of a phase 3 open-label trial. (PubMed, Vaccine) - P3 | "The two NVX-CoV2373 boosters induced durable anti-SARS-CoV-2 immune responses up to 1 year after each dose and are therefore expected to persistently protect against SARS-CoV-2 infections and severe disease outcomes in Japanese adults. No new safety concerns were identified, demonstrating the expected acceptable safety profile in healthy Japanese participants."

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

Heterologous COVID-19 vaccine schedule with protein-based prime (NVX-CoV2373) and mRNA boost (BNT162b2) induces strong humoral responses: results from COV-BOOST trial. (PubMed, J Infect) - P3 | "A BNT162b2 third dose booster dose in individuals primed with two doses of NVX-COV2373 is safe and induces strong and durable immunogenic responses, higher than seen in other comparable studies. These findings support the use and investigation of heterologous booster strategies and early investigation of heterologous vaccine technology schedules should be a priority in the development of vaccines against new pathogens."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases