Drugs / mRNA-1273.222
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Spikevax bivalent Original/Omicron BA.4-5 | COVID-19 | 2022-09-28 | “EMA has accepted a variation for the evaluation of a 50 µg booster dose of the Omicron-containing bivalent COVID booster candidate, mRNA-1273.222” q4web.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04889209 | May 2021 → Jun 2023 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/33 trials · 2 met primary | ||||||
| Phase 2/3 | NCT05168813 | Dec 2021 → Apr 2024 | COVID-19, HIV infectious disease | COVID-19 Prevention Network | Completed | No outcome recorded |
| Phase 2/3 | NCT04927065 | May 2021 → Nov 2023 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 2/3 | NCT04649151 | Dec 2020 → Jun 2024 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05815498 | Mar 2023 → Apr 2025 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT05383560 Comparator | Sep 2022 → Jan 2024 | COVID-19 | Sheba Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2022-12-08 | ModernaTX, Inc. | Regulatory Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children 6 Months Through 5 Years of Age q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, in children 6 months through 5 years of age. |
| 2022-11-14 | ModernaTX, Inc. | Results Moderna's BA.4/BA.5 Targeting Bivalent Booster, mRNA-1273.222, Meets Primary Endpoint of Superiority Against Omicron Variants Compared to Booster Dose of mRNA-1273 in Phase 2/3 Clinical Trial q4web.com ↗
In a Phase 2/3 trial in over 500 adults, mRNA-1273.222, induced significantly higher neutralizing antibody titers against BA.4/BA.5 compared to a booster dose of mRNA-1273 |
| 2022-11-04 | ModernaTX, Inc. | Regulatory Moderna Receives Health Canada Authorization for Second Omicron-Targeting Bivalent Booster q4web.com ↗
today announced Health Canada has authorized the use of its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, as a booster dose for active immunization against COVID-19 caused by the SARS-CoV-2 virus in individuals 18 years of age and older. |
| 2022-11-01 | ModernaTX, Inc. | Regulatory 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 ↗
Moderna, Inc . (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.222 (Spikevax Bivalent Original/Omicron BA.4-5) in adults 18 years and older. |
| 2022-10-19 | ModernaTX, Inc. | Regulatory EMA Committee For Medicinal Products For Human Use Adopts Positive Opinion Recommending Authorization Of Moderna's Omicron BA.4-BA.5 Targeting Bivalent Covid-19 Vaccine In The European Union q4web.com ↗
Following the CHMP's positive opinion, the European Commission will make an authorization decision on the use of Spikevax bivalent Original/Omicron BA.4-5. |
| 2022-10-12 | ModernaTX, Inc. | Regulatory Moderna Receives FDA Authorization for Emergency Use of Omicron-Targeting Bivalent COVID-19 Booster Vaccine for Children and Adolescents 6 to 17 Years of Age q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, in children and adolescents 6 to 17 years of age. |
| 2022-09-28 | ModernaTX, Inc. | Regulatory European Medicines Agency Accepts Moderna's Conditional Marketing Authorization Filing for its Omicron BA.4/BA.5 Targeting Bivalent COVID-19 Vaccine q4web.com ↗ |
| 2022-08-31 | ModernaTX, Inc. | Regulatory Moderna Receives FDA Authorization for Emergency Use of Omicron-Targeting Bivalent COVID-19 Booster Vaccine for Adults 18 Years and Older q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its BA.4/.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222. |
| 2022-08-23 | ModernaTX, Inc. | Regulatory 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 ↗
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has completed its submission to the U.S. Food and Drug Administration (FDA) for emergency use authorization for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mRNA-1273.222 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05168813 ↗ |
| Modality | Vaccine | “A second booster (fourth dose) will be administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at a 4-12 month interval N=250” NCT04889209 ↗ |
| Route | Intramuscular | “2 IM injections of mRNA-1273.222 (50 ug each), 6 months apart” NCT04649151 ↗ |