Drugs / Spikevax
last change Jul 2025 re-read 3 minutes ago

Spikevax

Vaccine

Developed for
COVID-19 · Orthocoronavirinae infectious disease
Investigated by
Jules Bordet Institute · Roche Pharma AG

Trials 1

20222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 41 trial
Phase 4 NCT05075538 Dec 2021 → Jan 2024 cancer Jules Bordet Institute Terminated No outcome recorded Stop: Enrollment
Comparator or background therapy4 trials
Phase 2 NCT05160766 Comparator Nov 2021 → Oct 2022 — Oliver Cornely, MD Completed No outcome recorded
Phase 2/3 NCT05236491 Comparator Mar 2022 → Jun 2023 overlapping connective tissue disease, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis +2 Paul R Fortin Unknown No outcome recorded
Phase 3 NCT06354998 Comparator Apr → May 2024 Orthocoronavirinae infectious disease ModernaTX, Inc. Completed No outcome recorded
Phase 3 NCT05048940 Comparator Sep 2021 COVID-19 Marqués de Valdecilla Research Institute (IDIVAL) Withdrawn No outcome recorded

Press releases naming this drug 14 releases

DateIssuerRelease
2025-07-10 ModernaTX, Inc. Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease q4web.com ↗
2022-11-01 ModernaTX, Inc. Ministry of Health, Labour and Welfare in Japan Approves Partial Change to a New Drug Authorization for Moderna's Omicron-Targeting Bivalent Booster COVID-19 Vaccine, mRNA-1273.222 q4web.com ↗
2022-10-19 ModernaTX, Inc. EMA Committee for Medicinal Products for Human Use Issues Positive Opinion Recommending Authorization for the Use of Spikevax (mRNA-1273) in Children 6 Months - 5 Years in the European Union q4web.com ↗
2022-10-19 ModernaTX, Inc. 90-Day Analysis Shows Moderna’s Omicron BA.1-Targeting Bivalent Vaccine, mRNA-1273.214, Demonstrates Superior Antibody Response as Fourth Booster Compared to Spikevax Prototype Booster q4web.com ↗
2022-09-12 ModernaTX, Inc. Ministry Of Health, Labour and Welfare in Japan Approves Partial Change to a New Drug Authorization for Moderna's Omicron-Targeting Bivalent Booster COVID-19 Vaccine, mRNA-1273.214 q4web.com ↗
2022-08-30 ModernaTX, Inc. Therapeutic Goods Administration Provisionally Approves Moderna’s Omicron-Containing Bivalent Booster Candidate, MRNA-1273.214, For Australia q4web.com ↗
2022-08-29 ModernaTX, Inc. Swissmedic Authorizes Moderna’s Omicron-Targeting Bivalent Booster Candidate, MRNA-1273.214 q4web.com ↗
2022-08-23 ModernaTX, Inc. Moderna Completes Application To U.S. Food And Drug Administration For Emergency Use Authorization Of Omicron-Targeting Bivalent Covid-19 Booster Vaccine, mRNA-1273.222 q4web.com ↗
2022-07-11 ModernaTX, Inc. Moderna's Omicron-Containing Bivalent Booster Candidate, mRNA-1273.214, Demonstrates Significantly Higher Neutralizing Antibody Response Against Omicron Subvariants BA.4/5 Compared To Currently Authorized Booster q4web.com ↗
2022-06-08 ModernaTX, Inc. Moderna Announces Omicron-Containing Bivalent Booster Candidate mRNA-1273.214 Demonstrates Superior Antibody Response Against Omicron q4web.com ↗
2022-05-31 Takeda Takeda and Moderna Announce Plans to Transfer Marketing Authorization for Spikevax TM COVID-19 Vaccine in Japan to Moderna takeda.com ↗
2022-05-31 ModernaTX, Inc. Moderna and Takeda Announce Plans to Transfer Marketing Authorization for Spikevax(TM) COVID-19 Vaccine in Japan to Moderna q4web.com ↗

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as Spikevax “For the Moderna SPIKEVAX Bivalent Original/Omicron BA.4/5: participants will receive one (1) intramuscular injection of 0.5 mL (50 mcg).” NCT05236491 ↗
4

NCT05075538 ↗

NCT05048940 ↗

NCT06354998 ↗

NCT05160766 ↗

Known as mRNA-1273 “Spikevax (mRNA-1273)” NCT05160766 ↗
Known as SPIKEVAX Bivalent Original/Omicron BA.4/5 “For the Moderna SPIKEVAX Bivalent Original/Omicron BA.4/5: participants will receive one (1) intramuscular injection of 0.5 mL (50 mcg).” NCT05236491 ↗
Known as Spikevax Moderna vaccine “Spikevax (Moderna) vaccine” NCT05048940 ↗
Modality Vaccine “vaccination with mRNA-1273 as 3rd vaccination” NCT05160766 ↗
Route Intramuscular “0.5 ml millilitre(s) Intramuscular use” NCT05048940 ↗