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VaccinesDrug intelligence

Spikevax

mRNA-1273

mRNA vaccine expressing the SARS-CoV-2 spike (S) antigen. Developed by Moderna. Clinical, regulatory, and source evidence are connected below.

Company
Moderna
Target / MOA
SARS-CoV-2 spike protein
Aliases
Spikevax · Moderna COVID Vaccine
Signals
21
Clinical trials
14
Approvals
0
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations

Phase 4 · NOT_YET_RECRUITING · ModernaTX, Inc.

clinical trialClinicalTrials.gov

Effectiveness of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19

Phase 4 · COMPLETED · Tor Biering-Sørensen

clinical trialClinicalTrials.gov

Effectiveness of An Influenza/COVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years

Phase 4 · NOT_YET_RECRUITING · Tor Biering-Sørensen

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Spikevax · BLA125752 · label version 11, effective Aug 17, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: • 65 years of age and older, or • 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

European Union (EMA)

Spikevax · EMEA/H/C/005791 · Authorised, authorised Jan 6, 2021 (Commission decision C(2021) 94) · EPAR

Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax bivalent Original/Omicron BA.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against COVID-19. The use of this vaccine should be in accordance with official recommendations. Spikevax bivalent Original/Omicron BA.4-5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax LP.8.1 is indicated for active immunisation to prevent COVID 19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax XFG is indicated for active immunisation to prevent COVID 19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

EMA's summary; the full indication is in the product information on the EPAR page.

Not covered here: mNexspike and mCombriax (Other Moderna vaccines, not Spikevax.)

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

BLA125752 · ModernaTX, Inc. · first licensed Jan 31, 2022

Drugs@FDA does not cover vaccines: the licence date is from FDA's Purple Book, and the linked FDA page lists each approval letter since.

European Union

  • Spikevax: Authorised since Jan 6, 2021

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

BLA125752 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

The list is FDA's for drugs (CDER); safety communications about vaccines come from FDA's CBER and are not covered here.

Clinical trials

Key active studies

A focused view of recently updated studies · 14 linked records.

Phase 4NOT YET RECRUITINGNCT07863635

A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations

ModernaTX, Inc. · Updated Oct 7, 2026

Phase 4COMPLETEDNCT07279766

Effectiveness of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19

Tor Biering-Sørensen · Updated Oct 6, 2026

Phase 4NOT YET RECRUITINGNCT07790523

Effectiveness of An Influenza/COVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years

Tor Biering-Sørensen · Updated Aug 27, 2026

N/AACTIVE NOT RECRUITINGNCT06333704

Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE

ModernaTX, Inc. · Updated Apr 16, 2026

N/ACOMPLETEDNCT06113692

A Study on the Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis After Moderna COVID-19 Vaccine

ModernaTX, Inc. · Updated Aug 1, 2025

N/AACTIVE NOT RECRUITINGNCT06189053

A Study to Assess Long-term Outcomes of Myocarditis Following Administration of COVID-19 mRNA Vaccine (SPIKEVAX)

ModernaTX, Inc. · Updated Aug 1, 2025

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 7, 202620EMA Human Medicinesofficial · Latest Oct 14, 20261
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.