Also known as: Spikevax
mRNA-1273 is the Moderna COVID-19 mRNA vaccine marketed as Spikevax for prevention of COVID-19. It is used for active immunization against SARS-CoV-2 in age and risk-defined populations. The FDA first approved Spikevax on January 31, 2022.
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Moderna's mCOMBRIAX, the world's first combination Covid-19 and influenza vaccine, for individuals 50 years and older.
Moderna announced UK authorization for its updated Spikevax vaccine targeting the LP.8.1 variant and European Commission marketing authorization for mNEXSPIKE, its third vaccine approved in the EU.
Moderna partners with Recordati on propionic acidemia therapy for up to $160 million, while FDA Commissioner defends mRNA vaccine support following funding cuts and regulatory challenges.
BioNTech filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging that Moderna's next-generation COVID-19 vaccine mNEXSPIKE violates its mRNA vaccine design patent.
Moderna received European Commission marketing authorization for its COVID-19 vaccine mNEXSPIKE for individuals aged 12 and older. The FDA also reversed its decision and agreed to review the company's seasonal flu vaccine application.
Moderna faces a pivotal transition from pandemic-era revenues to a diversified mRNA portfolio, with recent regulatory setbacks offset by strong RSV vaccine performance and upcoming Phase 3 oncology readouts.
A phase 1 clinical trial demonstrates that mRNA-1283, a next-generation COVID-19 vaccine encoding receptor-binding and N-terminal domains of the spike protein, induces durable T cell immunity at a 10 µg dose comparable to the standard 100 µg mRNA-1273 vaccine.
The European Commission has granted marketing authorization for Moderna's mNEXSPIKE (mRNA-1283) COVID-19 vaccine for individuals aged 12 years and older across all 27 EU member states plus Iceland, Liechtenstein and Norway.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07266558 |
A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19) |
ACTIVE_NOT_RECRUITING | PHASE4 |
| NCT06113692 |
A Study on the Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis After Moderna COVID-19 Vaccine |
COMPLETED | |
| NCT05397223 |
A Study of Modified mRNA Vaccines in Healthy Adults |
COMPLETED | PHASE1 |
| NCT05375838 |
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old |
COMPLETED | PHASE1/PHASE2 |
| NCT05345873 |
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine as a Booster Dose in Population Aged 12-17 Years |
UNKNOWN | PHASE2 |
| NCT05324319 |
Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients |
UNKNOWN | PHASE2 |
| NCT05315362 |
Establishing Immunogenicity and Safety of Needle-free Intradermal Delivery of mRNA COVID-19 Vaccine |
UNKNOWN | PHASE2 |
| NCT05289037 |
COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) |
COMPLETED | PHASE2 |
| NCT05249829 |
A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19 |
COMPLETED | PHASE2/PHASE3 |
| NCT05158140 |
Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911) |
COMPLETED | PHASE3 |
