Drugs / mRNA-1273.214
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | COVID-19 | 2022-07-11 | “Moderna has completed regulatory submissions for mRNA-1273.214 in Australia, Canada, and the EU” q4web.com ↗ “Moderna has completed regulatory submissions for mRNA-1273.214 in EU, UK, and Australia” q4web.com ↗ |
| Filed | Other | — | COVID-19 | 2022-07-11 | “Moderna has completed regulatory submissions for mRNA-1273.214 in Australia, Canada, and the EU” q4web.com ↗ “Moderna has completed regulatory submissions for mRNA-1273.214 in EU, UK, and Australia” q4web.com ↗ |
| Filed | UK (MHRA) | — | COVID-19 | 2022-07-11 | “Moderna has completed regulatory submissions for mRNA-1273.214 in EU, UK, and Australia” q4web.com ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05585632 | Oct 2022 → Feb 2024 | Orthocoronavirinae infectious disease, influenza, respiratory syncytial virus infectious disease | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05584202 | Sep 2022 → Nov 2024 | COVID-19 | ModernaTX, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT05383560 | Sep 2022 → Jan 2024 | COVID-19 | Sheba Medical Center | Completed | No outcome recorded |
| Phase 2/33 trials · 3 met primary | ||||||
| Phase 2/3 | NCT05249829 | Feb 2022 → Jun 2023 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 2/3 | NCT04927065 | May 2021 → Nov 2023 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 2/3 | NCT04796896 | Mar 2021 → Mar 2024 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05436834 | Jun 2022 → Oct 2025 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 3 | NCT05330975 | Apr 2022 → Nov 2024 | respiratory syncytial virus infectious disease | ModernaTX, Inc. | Completed | Mixed |
| Comparator or background therapy1 trial | ||||||
| — | NCT05471440 Comparator | Aug → Sep 2022 | — | Erasmus Medical Center | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-02-17 | ModernaTX, Inc. | Regulatory Health Canada Authorizes Moderna's Omicron-Targeting Bivalent COVID-19 Vaccine in Children & Adolescents (6-17 Years) q4web.com ↗
This decision highlights the effectiveness and safety of our vaccine in this important age group. |
| 2022-12-16 | ModernaTX, Inc. | Regulatory EMA Committee for Medicinal Products for Human Use (CHMP) Recommends the Use of Moderna’s BA.1 Targeting Bivalent COVID-19 Booster in Children (6-11 Years) In the European Union q4web.com ↗ |
| 2022-10-19 | ModernaTX, Inc. | Results 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 ↗
Superior performance against Omicron BA.1 was also durable, with higher antibody titers sustained through three months. |
| 2022-09-12 | 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-1273.214 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-1273.214 (Spikevax Bivalent Original/Omicron BA.1). |
| 2022-09-01 | ModernaTX, Inc. | Regulatory Health Canada Authorizes Moderna's Omicron-Targeting Bivalent COVID-19 Booster Vaccine q4web.com ↗
mRNA-1273.214 is the first Omicron-targeting bivalent COVID-19 booster vaccine approved in Canada |
| 2022-09-01 | ModernaTX, Inc. | Regulatory EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of Moderna's Omicron-Targeting Bivalent Booster in the European Union q4web.com ↗ |
| 2022-08-30 | ModernaTX, Inc. | Regulatory Therapeutic Goods Administration Provisionally Approves Moderna’s Omicron-Containing Bivalent Booster Candidate, MRNA-1273.214, For Australia q4web.com ↗
We are delighted to receive provisional approval from the TGA for our next-generation bivalent vaccine, mRNA-1273.214. |
| 2022-08-29 | ModernaTX, Inc. | Regulatory Swissmedic Authorizes Moderna’s Omicron-Targeting Bivalent Booster Candidate, MRNA-1273.214 q4web.com ↗
We are delighted to receive authorization from Swissmedic for our next-generation bivalent vaccine, mRNA-1273.214. |
| 2022-08-15 | ModernaTX, Inc. | Regulatory Medicines and Healthcare Products Regulatory Agency (MHRA) Authorizes Moderna's Omicron-Containing Bivalent Booster in the UK q4web.com ↗
We are delighted with the MHRA's authorization of Spikevax Bivalent Original/Omicron, our next-generation COVID-19 vaccine. |
| 2022-07-11 | ModernaTX, Inc. | Results 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 ↗
Among participants without prior infection, bivalent mRNA-1273.214 resulted in significantly higher neutralizing titers against BA.4/5 compared to the currently authorized booster, with a geometric mean ratio of 1.69 (95% CI: 1.51-1.90)1. |
| 2022-06-22 | ModernaTX, Inc. | Results Moderna Announces Bivalent Booster mRNA-1273.214 Demonstrates Potent Neutralizing Antibody Response Against Omicron Subvariants BA.4 And BA.5 q4web.com ↗
In today's data, mRNA-1273.214 boosted neutralizing titers against BA.4/BA.5 by 5.4-fold (95% CI: 5.0, 5.9) above baseline in all participants regardless of prior infection, and by 6.3-fold (95% CI: 5.7, 6.9) in the subset of seronegative participants. |
| 2022-06-08 | ModernaTX, Inc. | Results Moderna Announces Omicron-Containing Bivalent Booster Candidate mRNA-1273.214 Demonstrates Superior Antibody Response Against Omicron q4web.com ↗
A 50 µg booster dose of mRNA-1273.214 met all pre-specified endpoints including superior neutralizing antibody response (geometric mean ratio) against the Omicron variant one month after administration when compared to the original mRNA-1273 vaccine. |
All press releases naming this drug 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mRNA-1273.214 | “The BNT162b2 OMI BA.1 boost was given to participants younger than 45 years, and the mRNA-1273.214 boost was given to participants 45 years or older, as per Dutch guidelines.” PMID 37088096 ↗ Apr 2023 |
| Modality | Messenger RNA (mRNA) | “mRNA-1273.214 (25 μg; omicron BA.1 and ancestral Wuhan-Hu-1 mRNA) primary series” PMID 38518789 ↗ Mar 2024 |
| Route | Intramuscular | “1 IM injection as Dose 3” NCT04796896 ↗ |