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

T-cell responses induced by SARS-CoV-2 index-virus nanoparticle protein vaccine to the ancestral and omicron variants 6 months following primary vaccination. (PubMed, Commun Med (Lond)) - "NVX-CoV2373-induced T-cell responses to ancestral SARS-CoV-2 are comparable following vaccination with a single dose compared with a third dose administered 6 months after the second dose. Our findings suggest that an NVX-CoV2373 booster dose does not enhance T-cell immunity. Furthermore, NVX-CoV2373 vaccination induces greater T-cell response magnitudes to ancestral SARS-CoV-2, from which the vaccine is derived, compared with the Omicron variant."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • IFNG • TNFA

Safety and immunogenicity of four sequential doses of NVX-CoV2373 in adults and adolescents: A phase 3, randomized, placebo-controlled trial (PREVENT-19). (PubMed, Vaccine) - P3 | "NVX-CoV2373 elicited robust and durable humoral immune responses to ancestral SARS-CoV-2 as a 3rd and 4th dose after the primary series in adults and adolescents. Cross-reactivity to relevant variants provides insight into potential protection against antigenically related, but shifted, viral strains. Additional doses of NVX-CoV2373 were well tolerated with no new safety signals. These results support the utility of this vaccine platform and continued updates, based on currently circulating strains, to help effectively combat SARS-CoV-2 infection."

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

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children (clinicaltrials.gov) - P3 | N=1050 | Completed | Sponsor: PT Bio Farma | Recruiting ➔ Completed

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

Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data: A Secondary Cross-Protocol Analysis of 5 Randomized Clinical Trials. (PubMed, JAMA Netw Open) - "This secondary cross-protocol analysis constructed TND study datasets from study sites in 16 countries across 5 continents using the blinded phase cohorts of 5 harmonized phase 3 COVID-19 Prevention Network RCTs: COVE (Coronavirus Vaccine Efficacy and Safety), AZD1222, ENSEMBLE, PREVENT-19 (Prefusion Protein Subunit Vaccine Efficacy Novavax Trial COVID-19), and VAT00008...Participants received vaccines consisting of messenger RNA-1273 (COVE; 2 doses 28 days apart), ChAdOx1 nCoV-19 (AZD1222; 2 doses 28 days apart), Ad26.COV2.S (ENSEMBLE; 1 dose), NVX-CoV2373 (PREVENT-19; 2 doses 21 days apart), CoV2 preS dTM-AS03 (VAT00008; D614) (2 doses 21 days apart), or CoV2 preS dTM-AS03 (D614 plus B.1.351) (VAT00008; 2 doses 21 days apart) or placebo...In this cross-protocol analysis, the TND provided reliable inferences on COVID-19 vaccine effectiveness in health care-seeking populations for multiple vaccines and symptom definitions when confounding and selection bias were absent...."

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

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

Establishment of a novel adjuvant screening system for the development of intranasal vaccine adjuvants. (PubMed, Vaccine) - "Notable examples, such as the herpes zoster glycoprotein E subunit vaccine and the Novavax COVID-19 (NVX-CoV2373) vaccine, underscore the importance of adjuvants in vaccination...Using this screening system, we have to date identified some pharmaceutical additives, which induced a robust antigen-specific IgA antibody response following a single intranasal administration, without significant leukopenic toxicity or type I interferon inducibility. In this review, we discuss the development of our novel adjuvant evaluation system and its potential to enhance the efficacy of mucosal vaccines."

Journal • Herpes Zoster • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Varicella Zoster

FDA approves Novavax COVID-19 shot but with unusual restrictions (The Courier) - "The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions...the FDA granted the company full approval for its vaccine for use only in adults 65 and older – or those 12 to 64 who have at least one health problem that puts them at increased risk from COVID-19."

FDA approval • Novel Coronavirus Disease

Risk of new-onset seizures following immunization against COVID-19: a self-controlled case-series study. (PubMed, Epidemiol Health) - "We identified adults (≥18 years) who received COVID-19 vaccination (BNT162b2, ChAdOx1 nCoV-19, mRNA-1273, NVX-CoV2373, or Ad26.COV2.S) and had a diagnosis of NOS accompanied by prescriptions of anti-seizure drugs. There was no evidence of an increased risk of NOS following COVID-19 vaccination. These findings can be used as safety evidence in clinical decision-making and to bolster public confidence in COVID-19 vaccines. ."

Journal • CNS Disorders • Epilepsy • Infectious Disease • Novel Coronavirus Disease

Immune Response Against Recent Omicron Sub-Lineages in Persons with HIV Receiving a Protein-Based or mRNA XBB.1.5 SARS-CoV-2 Booster Vaccine. (PubMed, Int J Mol Sci) - "After controlling for confounders, there was no evidence for a difference in the T0-T1 change in nAbs titers against XBB.1.16 and JN.1 by the type of vaccine, while Nuvaxovid determined a smaller increase in D614G nAbs (p = 0.008). The XBB.1.5 protein-based vaccine's immunogenicity as a fifth or later booster was comparable to the Pfizer-BioNTech mRNA vaccine, particularly against recent Omicron variants."

Journal • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • IFNG

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

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