Drugs / mRNA-1273
mRNA-1273
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Spikevax | COVID-19 | 2025-05-23 | “today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula” q4web.com ↗ “it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula” q4web.com ↗ |
| Filed | US (FDA) | Spikevax | COVID-19 | 2024-06-07 | “today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2024-2025 formula” q4web.com ↗ “submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2024-2025 formula” q4web.com ↗ |
| 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 ↗ |
| Filed | Other | SPIKEVAX | COVID-19 | 2021-11-17 | “it has submitted for authorization with Health Canada for the evaluation of a 50 µg two-dose series of SPIKEVAX™” q4web.com ↗ |
| Filed | EU (EMA) | — | COVID-19 | 2021-11-09 | “Moderna Files to Expand the Conditional Marketing Authorization for its COVID-19 Vaccine in the European Union to Include Children Ages 6-11 Years” q4web.com ↗ |
| Filed | US (FDA) | — | COVID-19 | 2021-08-25 | “Moderna completed the rolling submission process for a Biologics License Application (BLA) for its COVID-19 vaccine (mRNA-1273) in the U.S.” q4web.com ↗ “Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine” q4web.com ↗ |
| Filed | EU (EMA) | COVID-19 vaccine | COVID-19 | 2021-06-07 | “today announced that it has submitted for a conditional marketing approval (CMA) for its COVID-19 vaccine in adolescents with the European Medicines Agency (EMA).” q4web.com ↗ “Today, Moderna also announced that it has submitted for conditional marketing approval for use of the vaccine by adolescents with the European Medicines Agency.” q4web.com ↗ “We have already filed for authorization with the U.S. FDA, Health Canada and the European Medicines Agency” q4web.com ↗ “We have already filed for authorization with Health Canada and the European Medicines Agency” q4web.com ↗ |
| Filed | Other | COVID-19 vaccine | COVID-19 | 2021-06-07 | “today announced that it has submitted for authorization of its COVID-19 vaccine in adolescents with Health Canada.” q4web.com ↗ “We have already filed for authorization with the U.S. FDA, Health Canada and the European Medicines Agency” q4web.com ↗ “has submitted an authorization application to Swissmedic for use of its COVID-19 vaccine in adolescents.” q4web.com ↗ “We have already filed for authorization with Health Canada and the European Medicines Agency” q4web.com ↗ “We have filed for authorization with Health Canada” q4web.com ↗ |
| Filed | US (FDA) | — | COVID-19 | 2021-06-01 | “has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration (FDA).” q4web.com ↗ “On June 1, 2021, the Company initiated the rolling submission process for a Biologics License Application (BLA) for the vaccine in the U.S.” q4web.com ↗ “We have already filed for authorization with the U.S. FDA, Health Canada and the European Medicines Agency” q4web.com ↗ |
| Filed | Japan (PMDA) | — | COVID-19 | 2021-03-05 | “New Drug Application Submitted to Import and Distribute Moderna’s COVID-19 Vaccine Candidate in Japan” q4web.com ↗ |
| Filed | EU (EMA) | COVID-19 Vaccine Moderna | COVID-19 | 2020-11-30 | “submitted a request for an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency” q4web.com ↗ “it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency.” q4web.com ↗ “filed for Emergency Use Authorization with the U.S.FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency.” q4web.com ↗ “filed for Emergency Use Authorization with the U.S.FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency.” q4web.com ↗ “filed for Emergency Use Authorization with the U.S.FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency.” q4web.com ↗ “filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) with the European Medicines Agency.” q4web.com ↗ |
| Filed | Other | — | COVID-19 | 2020-10-13 | “today announced the initiation of a rolling submission to Health Canada for mRNA-1273, the Company’s vaccine candidate against COVID-19.” q4web.com ↗ |
Trials 42
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05397223 | May 2022 → Feb 2026 | COVID-19, cytomegalovirus infection, influenza, respiratory syncytial virus infectious disease | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04785144 | Mar 2021 → Jul 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT04813796 | Mar 2021 → Jul 2023 | COVID-19 | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04283461 | Mar 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT05375838 | May → Dec 2022 | COVID-19, influenza | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT05280158 | Mar 2022 → Feb 2023 | Orthocoronavirinae infectious disease | University of California, Los Angeles | Terminated | No outcome recorded |
| Phase 1/2 | NCT05132855 | Nov 2021 → Apr 2023 | COVID-19 | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT04889209 | May 2021 → Jun 2023 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT04677660 | Jan 2021 → Feb 2022 | COVID-19 | Takeda | Completed | No outcome recorded |
| Phase 29 trials · 1 missed | ||||||
| Phase 2 | NCT05315362 | May → Sep 2022 | COVID-19 | Leiden University Medical Center | Unknown | Missed primary |
| Phase 2 | NCT05289037 | Mar 2022 → Nov 2023 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT04930770 | Sep → Dec 2021 | COVID-19 | Maria Joyera Rodríguez | Withdrawn | No outcome recorded |
| Phase 2 | NCT04969263 | Aug 2021 → Nov 2022 | disease related to solid organ transplantation | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT05027672 | Jul → Aug 2021 | — | Ministerio de Salud de Ciudad Autónoma de Buenos Aires | Unknown | No outcome recorded |
| Phase 2 | NCT04852978 | Apr 2021 → Nov 2022 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04847050 | Apr 2021 → May 2023 | leukemia, plasma cell myeloma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT04748471 | Feb → Jul 2021 | — | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 2 | NCT04405076 | May 2020 → Oct 2021 | Orthocoronavirinae infectious disease | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 2/35 trials · 4 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 | NCT05022329 | Sep 2021 → May 2022 | COVID-19, chronic kidney disease | Sunnybrook Health Sciences Centre | Terminated | 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 2/3 | NCT04649151 | Dec 2020 → Jun 2024 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 37 trials · 2 met primary | ||||||
| Phase 3 | NCT05119855 | Mar 2022 → Dec 2023 | COVID-19, human papilloma virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT05158140 | Jan 2022 → Feb 2023 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT05230953 | Jan 2022 → Jul 2024 | COVID-19 | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT05148845 | Nov 2021 → Jan 2022 | COVID-19 | Wits Health Consortium (Pty) Ltd | Completed | No outcome recorded |
| Phase 3 | NCT05047770 | Oct 2021 → Aug 2022 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT04860297 | Apr 2021 → May 2023 | COVID-19 | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04470427 | Jul 2020 → Dec 2022 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 49 trials · 1 missed | ||||||
| Phase 4 | NCT07863635 | Oct 2026 → Jan 2027 expected | Orthocoronavirinae infectious disease | ModernaTX, Inc. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07279766 | Dec 2025 → Aug 2026 | COVID-19 | Tor Biering-Sørensen | Completed | No outcome recorded |
| Phase 4 | NCT07266558 | Nov 2025 → Jun 2027 expected | COVID-19 | ModernaTX, Inc. | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05079633 | Sep → Oct 2021 | — | National Taiwan University Hospital | Completed | Missed primary |
| Phase 4 | NCT04969250 | Aug 2021 → Dec 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT04952402 | Jul 2021 → Feb 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT06189040 | May → Nov 2021 | COVID-19 | University of Antwerp | Completed | No outcome recorded |
| Phase 4 | NCT04792567 | Apr → Sep 2021 | secondary progressive multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT04818736 | Apr → Sep 2021 | — | McMaster University | Withdrawn | No outcome recorded |
| Phase not applicable3 trials · 2 met primary | ||||||
| — | NCT04927936 | Jun 2021 → Sep 2022 | COVID-19 | Erasmus Medical Center | Unknown | Met primary |
| — | NCT04900467 | May → Jul 2021 | — | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| — | NCT04715438 | Jan → Jun 2021 | cancer | University Medical Center Groningen | Unknown | Met primary |
| Comparator or background therapy17 trials | ||||||
| Phase 0 | NCT05081271 Comparator | Oct 2021 → May 2022 | multiple sclerosis | Griffin Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT07808697 Comparator | Sep 2026 → Aug 2029 expected | Orthocoronavirinae infectious disease | ModernaTX, Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05383560 Comparator | Sep 2022 → Jan 2024 | COVID-19 | Sheba Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT05345873 Comparator | Jul → Oct 2022 | COVID-19 | Sinocelltech Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05197153 Comparator | Jan → Jun 2022 | — | Medigen Vaccine Biologics Corp. | Completed | No outcome recorded |
| Phase 2 | NCT05137236 Comparator | Dec 2021 → Mar 2023 | Orthocoronavirinae infectious disease | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04988048 Comparator | Aug → Sep 2021 | COVID-19 | Ministry of Public Health, Argentina | Unknown | No outcome recorded |
| Phase 2 | NCT05324319 Comparator | Jun 2021 → Jul 2022 | COVID-19 | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 2 | NCT04894435 Comparator | May 2021 → Nov 2024 overdue | COVID-19 | Canadian Immunization Research Network | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05249829 Comparator | Feb 2022 → Jun 2023 | COVID-19 | ModernaTX, Inc. | Completed | Met primary |
| Phase 3 | NCT06097273 Comparator | Oct 2023 → May 2024 | Orthocoronavirinae infectious disease, influenza | ModernaTX, Inc. | Completed | Met primary |
| Phase 3 | NCT05228730 Comparator | May → Jul 2022 | COVID-19 | Murdoch Childrens Research Institute | Terminated | No outcome recorded |
| Phase 3 | NCT05543356 Comparator | May → Jul 2022 | COVID-19 | Murdoch Childrens Research Institute | Withdrawn | No outcome recorded |
| Phase 3 | NCT04805125 Comparator | Apr 2021 → Sep 2023 | immunodeficiency disease | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 4 | NCT05030974 Comparator | Oct 2021 → Mar 2022 | COVID-19, kidney disorder | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 4 | NCT04885907 Comparator | May → Jul 2021 | COVID-19, immunodeficiency disease | University Health Network, Toronto | Completed | No outcome recorded |
| — | NCT05074368 Comparator | Jul 2021 → Apr 2022 | — | National Taiwan University Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 115
| Date | Issuer | Release |
|---|---|---|
| 2026-08-27 | ModernaTX, Inc. | Regulatory Moderna Receives U.S. FDA Approval for Updated 2026-2027 COVID-19 Vaccines q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2026-2027 formulas for Spikevax® (COVID-19 Vaccine, mRNA) and mNEXSPIKE® (COVID-19 Vaccine, mRNA), containing the JN.1-lineage XFG subvariant of SARS-CoV-2 to help prevent COVID-19. |
| 2025-09-16 | ModernaTX, Inc. | Results Moderna Announces Updated COVID-19 Vaccine Against LP.8.1 Variant Generates Strong Immune Response in Humans q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced positive preliminary immunogenicity data for the 2025-2026 formula of Spikevax®, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. |
| 2025-08-27 | ModernaTX, Inc. | Regulatory Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2 q4web.com ↗
With the U.S. FDA's decision, Moderna's updated vaccines are expected to be available in the coming days. |
| 2025-08-22 | ModernaTX, Inc. | Regulatory Moderna Receives Health Canada Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1 q4web.com ↗
Moderna announced today that Health Canada has authorized its updated COVID-19 mRNA vaccine, Spikevax®, targeting the SARS-CoV-2 LP.8.1 variant, for individuals aged six months and older. |
| 2025-07-30 | ModernaTX, Inc. | Regulatory Moderna Receives European Commission Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1 q4web.com ↗ |
| 2025-07-25 | ModernaTX, Inc. | Regulatory EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna's COVID-19 mRNA Vaccine Targeting the SARS-CoV-2 Variant LP.8.1 q4web.com ↗
Following the CHMP's positive opinion, the European Commission will make a marketing authorization decision on Moderna's updated COVID-19 vaccine for the 2025-2026 season. |
| 2025-07-10 | ModernaTX, Inc. | Regulatory 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 ↗
We appreciate the FDA's diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease. |
| 2025-05-23 | ModernaTX, Inc. | Regulatory Moderna Files FDA Application for the LP.8.1 Targeting COVID-19 Vaccine q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 variant LP.8.1. |
| 2024-09-17 | ModernaTX, Inc. | Regulatory Moderna Receives Health Canada Approval For Updated COVID-19 Vaccine Targeting KP.2 Variant Of SARS-COV-2 For Ages Six Months And Older q4web.com ↗
Moderna Inc (Nasdaq:MRNA) today announced that Health Canada has authorized its updated COVID-19 vaccine, SPIKEVAX® KP.2 variant, to help prevent COVID-19 in individuals six months of age and older. |
| 2024-09-05 | ModernaTX, Inc. | Regulatory EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna's COVID-19 mRNA Vaccine Targeting the SARS-COV-2 Variant JN.1 q4web.com ↗
"The CHMP's positive recommendation for our updated COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1 is a key milestone, demonstrating our commitment to protecting citizens across the European Union," said Stéphane Bancel, Chief Executive Officer of Moderna. |
| 2024-09-03 | ModernaTX, Inc. | Regulatory Moderna Receives Medicines And Healthcare Products Regulatory Agency (MHRA) Authorization For Updated COVID-19 Vaccine Targeting SARS-COV-2 Variant JN.1 q4web.com ↗
Moderna, Inc. (Nasdaq:MRNA) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorized its updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2. |
| 2024-09-02 | ModernaTX, Inc. | Regulatory Taiwan Food & Drug Administration Approves Moderna’s COVID-19 mRNA Vaccine Targeting the SARS-COV-2 Variant JN.1 q4web.com ↗
the Taiwan Food & Drug Administration (FDA) has approved an updated formulation of the COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1. |
| 2024-08-23 | ModernaTX, Inc. | Regulatory Ministry of Health, Labour and Welfare in Japan Approves Partial Change Application for Moderna's COVID-19 mRNA Vaccine Targeting SARS-COV-2 Variant JN.1 q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change application for an updated formulation of its COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1. |
| 2024-08-22 | ModernaTX, Inc. | Regulatory Celebrating U.S. FDA Approval of Our Updated COVID-19 Vaccine modernatx.com ↗
Today, the U.S. Food and Drug Administration (FDA) approved Moderna’s updated COVID-19 vaccine for this fall for individuals 12 years of age and older. |
| 2024-08-22 | ModernaTX, Inc. | Regulatory Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2 q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax® (2024-2025 formula) for individuals 12 years and above. |
| 2024-06-07 | ModernaTX, Inc. | Regulatory Moderna Files FDA Application for the JN.1 Targeting COVID-19 Vaccine q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1. |
| 2023-09-14 | ModernaTX, Inc. | Regulatory EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna’s Updated Covid-19 Vaccine in The European Union q4web.com ↗
The CHMP's positive recommendation for our updated COVID-19 vaccine is a key milestone given we see increasing transmission of SARS-CoV-2 across Europe. |
| 2023-09-13 | ModernaTX, Inc. | Results Moderna Expands the Field of mRNA Medicine with Positive Clinical Results Across Cancer, Rare Disease, and Infectious Disease q4web.com ↗
Clinical trial data confirm mRNA-1273.815 showed a strong immune response in humans against BA.2.86, EG.5 and FL.1.5.1 variants. |
| 2023-09-11 | ModernaTX, Inc. | Regulatory Our Continued Innovation at Work: Celebrating U.S. FDA Approval of Our Updated COVID-19 Vaccine modernatx.com ↗
the U.S. Food and Drug Administration (FDA) has approved our supplemental Biologics License Application (sBLA) for Spikevax® (COVID-19 Vaccine, mRNA) for individuals 12 years of age and older |
| 2023-09-11 | ModernaTX, Inc. | Regulatory Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application(sBLA) for Spikevax® for ages 12 years and above. |
| 2022-10-19 | ModernaTX, Inc. | Regulatory 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 ↗
Following the CHMP's positive opinion, the European Commission will make an authorization decision on the use of Spikevax in children ages 6 months to 5 years. |
| 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. |
| 2022-07-22 | ModernaTX, Inc. | Regulatory EMA Committee for Medicinal Products for Human Use (CHMP) Recommends Use of the Moderna COVID-19 Booster in Adolescents (12-17 Years) in the European Union q4web.com ↗
The CHMP based this positive opinion on scientific evidence shared by the company, including comprehensive safety data. |
| 2022-07-18 | ModernaTX, Inc. | Regulatory Therapeutic Goods Administration Grants Provisional Approval for Moderna’s COVID-19 Vaccine in Children Aged Six Months to Five Years q4web.com ↗
Therapeutic Goods Administration has provisionally approved the use of Moderna's mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. |
| 2022-07-14 | ModernaTX, Inc. | Regulatory Health Canada Authorizes Moderna's COVID-19 Vaccine in Young Children (6 Months-5 Years) q4web.com ↗
Health Canada has approved the use of Moderna's mRNA COVID-19 vaccine, SPIKEVAX (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. |
| 2022-06-17 | ModernaTX, Inc. | Regulatory Moderna Receives FDA Authorization for Emergency Use of Its COVID-19 Vaccine for Children 6 Months of Age and Older q4web.com ↗
The company has also received emergency use authorization for a 50 μg two-dose regimen of mRNA-1273 for children ages 6 through 11 years old and a 100 μg two-dose regimen for adolescents aged 12 through 17 years old. |
| 2022-04-29 | ModernaTX, Inc. | Regulatory Moderna Files to Expand Conditional Marketing Authorization for Its COVID-19 Vaccine to Include Children Six Months to Under Six Years in The European Union q4web.com ↗
We are proud to announce this filing for the use of our COVID-19 vaccine in children six months to under six years of age in the European Union, said Stéphane Bancel, Chief Executive Officer of Moderna. |
| 2022-04-28 | ModernaTX, Inc. | Regulatory Moderna Files for Authorization of Its COVID-19 Vaccine in Young Children Six Months to Under Six Years of Age q4web.com ↗
We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children, |
| 2022-04-19 | ModernaTX, Inc. | Results Moderna Announces Clinical Update on Bivalent COVID-19 Booster Platform q4web.com ↗
Moderna's first bivalent booster vaccine candidate, mRNA-1273.211, demonstrated superior neutralizing titers compared to mRNA-1273 against all variants of concern, including Omicron; superiority was maintained for six months after booster for the Beta and Omicron variants |
| 2022-03-29 | ModernaTX, Inc. | Regulatory Moderna Receives FDA Approval for Emergency Use Authorization of 2nd Booster Dose of Its COVID-19 Vaccine, mRNA-1273 q4web.com ↗ |
| 2022-03-24 | ModernaTX, Inc. | Results Moderna Announces Clinical and Program Updates at 3rd Annual Vaccines Day q4web.com ↗
COVID-19 vaccine Phase 2/3 study in children 6 months to under 6 years has successfully met its primary endpoint with robust neutralizing antibody titers similar to adults. |
| 2022-03-23 | ModernaTX, Inc. | Results Moderna Announces its COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to Under 6 Years Has Successfully Met Its Primary Endpoint q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age. |
| 2022-03-17 | ModernaTX, Inc. | Regulatory Moderna Submits Amendment to the Emergency Use Authorization for an Additional Booster Dose of its COVID-19 Vaccine in the U.S. q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a request to the U.S. Food and Drug Administration (FDA) for an amendment to the emergency use authorization (EUA) to allow for a fourth dose of its COVID-19 vaccine (mRNA-1273) in adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. |
| 2022-03-17 | ModernaTX, Inc. | Regulatory Health Canada Authorizes Moderna's COVID-19 Vaccine in Children (6-11 Years) q4web.com ↗
Health Canada has approved the use of Moderna's mRNA COVID-19 vaccine, SPIKEVAX (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older. |
| 2022-03-11 | Joincare Pharmaceutical Group Industry Co., Ltd | Results 最新研究：第三针丽珠二价苗对Omicron中和水平具显著优势 joincare.com ↗
研究人员预计在接种完Moderna和辉瑞第二针14~30天后，对预防Delta感染的有效率分别为63%和78%，而在6~8个月后下降至36.0%和38%，而在接种第三针30天后，有效率均恢复至97%。 |
| 2022-02-24 | ModernaTX, Inc. | Regulatory EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for The Use of The Moderna Covid-19 Vaccine in Children (6-11 Years) In the European Union q4web.com ↗
The CHMP recommendation to authorize the use of our COVID-19 vaccine in children ages 6-11 years in Europe is an important milestone. |
| 2022-02-16 | ModernaTX, Inc. | Regulatory Therapeutic Goods Administration of Australia Authorizes Moderna's Covid-19 Vaccine in Children (6-11 Years) q4web.com ↗
The TGA authorization for the use of our COVID-19 vaccine in children 6-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorization for the use of our vaccine in this age group. |
| 2022-01-31 | ModernaTX, Inc. | Regulatory Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine Spikevax q4web.com ↗
Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older. |
| 2022-01-26 | ModernaTX, Inc. | Results Moderna Announces First Participant Dosed in Phase 2 Study of Omicron-Specific Booster Candidate and Publication of Data on Booster Durability Against Omicron Variant q4web.com ↗
While Omicron neutralization had declined 6.3-fold from peak titers at day 29 post-boost, levels remained detectable in all participants. |
| 2022-01-10 | ModernaTX, Inc. | Results Moderna Announces Advances Across Its Industry-Leading mRNA Pipeline and Provides Business Update q4web.com ↗
Currently authorized 50 µg booster of mRNA-1273 increased neutralizing antibody levels against Omicron approximately 37-fold compared to pre-boost levels and a 100 µg dose of mRNA-1273 increased neutralizing antibody levelsapproximately 83-fold compared to pre-boost levels |
| 2022-01-06 | Janssen Research & Development, LLC | Results Real World Evidence Shows Johnson & Johnson COVID-19 Vaccine Demonstrates Durable Protection Against Breakthrough Infection, Hospitalization, and Intensive Care Unit Admission in the United States jnj.com ↗
mRNA-1273 demonstrated a profile that showed an increase in hospitalizations in month 3 and breakthrough infections in month 2, with no waning of effectiveness for ICU admissions over the study period. |
| 2021-12-20 | ModernaTX, Inc. | Results Moderna Announces Preliminary Booster Data and Updates Strategy to Address Omicron Variant q4web.com ↗
The currently authorized 50 µg booster of mRNA-1273 increased neutralizing antibody levelsagainst Omicron approximately 37-fold compared to pre-boost levels and a 100 µg dose of mRNA-1273 increased neutralizing antibody levelsapproximately 83-fold compared to pre-boost levels. |
| 2021-11-19 | ModernaTX, Inc. | Regulatory U.S. CDC Advisory Committee on Immunization Practices Recommends Booster Vaccination with Moderna’s COVID-19 Vaccine q4web.com ↗
Today’s ACIP recommendation follows the FDA’s emergency use authorization of a booster dose. |
| 2021-11-19 | ModernaTX, Inc. | Regulatory Moderna Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older q4web.com ↗
This booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine. |
| 2021-11-17 | ModernaTX, Inc. | Regulatory Moderna Files for Authorization of its COVID-19 Vaccine with Health Canada to Include Children Ages 6-11 Years q4web.com ↗ |
| 2021-11-15 | ModernaTX, Inc. | Regulatory Health Canada Authorizes Booster Dose of Moderna’s COVID-19 Vaccine in Individuals 18 Years of Age and Older q4web.com ↗
Health Canada Authorizes Booster Dose of Moderna’s COVID-19 Vaccine in Individuals 18 Years of Age and Older |
| 2021-11-09 | ModernaTX, Inc. | Regulatory Moderna Files to Expand the Conditional Marketing Authorization for its COVID-19 Vaccine in the European Union to Include Children Ages 6-11 Years q4web.com ↗
Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted for a variation to the conditional marketing authorization (CMA) with the European Medicines Agency (EMA) for the evaluation of a 50 µg two-dose series of mRNA-12731 in children ages 6-11 years. |
| 2021-11-04 | ModernaTX, Inc. | Regulatory Moderna Reports Third Quarter Fiscal Year 2021 Financial Results and Provides Business Updates q4web.com ↗
U.S. FDA granted Priority Review to the Biologics License Application for Moderna’s COVID-19 vaccine |
| 2021-10-31 | ModernaTX, Inc. | Regulatory Moderna Provides Update on Timing of U.S. Emergency Use Authorization of its COVID-19 Vaccine for Adolescents q4web.com ↗
The FDA notified Moderna that this review may not be completed before January 2022. |
| 2021-10-26 | ModernaTX, Inc. | Regulatory Moderna Announces Swissmedic Authorizes Booster Dose of Moderna’s COVID-19 Vaccine q4web.com ↗
Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced Swissmedic has authorized a booster dose of Spikevax, the Company’s vaccine against COVID-19, at the 50 µg dose level in particularly vulnerable individuals 12 years of age and older, at least six months after completion of the primary series. |
| 2021-10-25 | ModernaTX, Inc. | Results Moderna Announces Positive Top Line Data from Phase 2/3 Study of COVID-19 Vaccine in Children 6 to 11 Years of Age q4web.com ↗
This interim analysis showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favorable safety profile. |
| 2021-10-25 | ModernaTX, Inc. | Regulatory Moderna Announces European Medicines Agency’s Committee for Medicinal Products for Human Use Recommends Booster Dose of Moderna’s COVID-19 Vaccine in the European Union q4web.com ↗
Moderna Announces European Medicines Agency’s Committee for Medicinal Products for Human Use Recommends Booster Dose of Moderna’s COVID-19 Vaccine in the European Union |
| 2021-10-20 | ModernaTX, Inc. | Regulatory Moderna Announces FDA Authorization of a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S. q4web.com ↗
The FDA also authorized a single booster dose of the Moderna COVID-19 Vaccine for individuals who have completed a primary vaccination with other authorized or approved COVID-19 vaccines. |
| 2021-10-14 | ModernaTX, Inc. | Regulatory Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S. q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 whose exposure to COVID-19 puts them at risk for COVID-19 complications or severe illness. |
| 2021-10-07 | Sanofi | Results Sanofi: Positive results from the first study of high-dose influenza vaccine with a COVID-19 mRNA booster support co-administration recommendations sanofi.com ↗
This is the first study to provide supportive evidence for vaccinating against influenza at the same time as a COVID-19 mRNA booster in seniors. |
| 2021-10-05 | ModernaTX, Inc. | Regulatory Moderna Announces European Medicines Agency Authorizes Third Dose of COVID-19 Vaccine for Immunocompromised Individuals Aged 12 Years and Older q4web.com ↗
Moderna Announces European Medicines Agency Authorizes Third Dose of COVID-19 Vaccine for Immunocompromised Individuals Aged 12 Years and Older |
| 2021-09-16 | ModernaTX, Inc. | Regulatory Moderna Announces Health Canada Approves its COVID-19 Vaccine q4web.com ↗
today announced Health Canada has approved the New Drug Submission (NDS-CV) for SPIKEVAX™ (elasomeran mRNA vaccine), which has been known as COVID-19 Vaccine Moderna, for active immunization to prevent COVID-19 in individuals 12 years of age and older. |
| 2021-09-15 | ModernaTX, Inc. | Results Moderna Highlights New Clinical Data on its COVID-19 Vaccine q4web.com ↗
New analysis of open-label portion of Phase 3 COVE study shows lower risk of breakthrough infection in participants vaccinated more recently (median 8 months after first dose) than participants vaccinated last year (median 13 months after first dose) |
| 2021-09-03 | ModernaTX, Inc. | Regulatory Moderna Announces Submission of Data to European Medicines Agency for its COVID-19 Vaccine Booster q4web.com ↗
today announced it has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. |
| 2021-09-01 | ModernaTX, Inc. | Regulatory Moderna Announces Submission of Initial Data to U.S. FDA for Its COVID-19 Vaccine Booster q4web.com ↗
Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has initiated its submission to the U.S. Food and Drug Administration (FDA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. |
| 2021-08-25 | ModernaTX, Inc. | Regulatory Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine q4web.com ↗
Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine |
| 2021-08-13 | ModernaTX, Inc. | Regulatory Moderna Announces FDA Authorization of Third Dose of COVID-19 Vaccine for Immunocompromised Individuals q4web.com ↗
Moderna Announces FDA Authorization of Third Dose of COVID-19 Vaccine for Immunocompromised Individuals |
| 2021-08-12 | ModernaTX, Inc. | Results Moderna Announces New Study Showing Its COVID-19 Vaccine Maintains Antibodies Against Variants of Concern and Interest to 6 Months q4web.com ↗
According to the paper, the majority of individuals vaccinated with the Moderna COVID-19 vaccine maintained both binding and functional antibodies against SARS-CoV-2 variants for six months after the second dose. |
| 2021-08-09 | ModernaTX, Inc. | Regulatory Australian Therapeutic Goods Administration Grants Provisional Registration for Moderna’s COVID-19 Vaccine q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) has granted provisional registration to the COVID-19 Vaccine Moderna in Australia for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. |
| 2021-07-23 | ModernaTX, Inc. | Regulatory EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of the Moderna COVID-19 Vaccine in Adolescents (12-17 Years of Age) in the European Union q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older. |
| 2021-06-29 | ModernaTX, Inc. | Results Moderna Provides a Clinical Update on the Neutralizing Activity of its COVID-19 Vaccine on Emerging Variants Including the Delta Variant First Identified in India q4web.com ↗
Consistent with previous results, a 7.3 or 8.4-fold reduction in neutralizing titers was observed with the additional versions of the Beta variant relative to the ancestral strain. |
| 2021-06-29 | ModernaTX, Inc. | Regulatory Moderna Announces Emergency Use Authorization for its COVID-19 Vaccine Granted by Government of India q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the government of India has issued a registration certificate and a permission to import the COVID-19 Vaccine Moderna for restricted use in an emergency situation. |
| 2021-06-14 | ModernaTX, Inc. | Regulatory Moderna Submits Authorization Application for its COVID-19 Vaccine in Adolescents in Switzerland q4web.com ↗
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted an authorization application to Swissmedic for use of its COVID-19 vaccine in adolescents. |
| 2021-06-10 | ModernaTX, Inc. | Regulatory Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States q4web.com ↗
today announced that it has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration (FDA). |
| 2021-06-07 | ModernaTX, Inc. | Regulatory Moderna Files for Conditional Marketing Approval for its COVID-19 Vaccine in Adolescents in the European Union q4web.com ↗
“We are pleased to announce that we have submitted for conditional marketing approval of our COVID-19 vaccine with the European Medicines Agency for use in adolescents in the European Union,” said Stéphane Bancel, Chief Executive Officer of Moderna. |
| 2021-06-07 | ModernaTX, Inc. | Regulatory Moderna Files for Authorization with Health Canada for its COVID-19 Vaccine in Adolescents q4web.com ↗
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted for authorization of its COVID-19 vaccine in adolescents with Health Canada. |
| 2021-06-01 | ModernaTX, Inc. | Regulatory Moderna Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for the Moderna COVID-19 Vaccine q4web.com ↗
We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine, |
| 2021-05-25 | ModernaTX, Inc. | Results Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June q4web.com ↗
In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition. |
| 2021-05-21 | Takeda | Regulatory Takeda Announces Approval of Moderna’s COVID-19 Vaccine in Japan takeda.com ↗ |
| 2021-05-21 | ModernaTX, Inc. | Regulatory Ministry of Food and Drug Safety of South Korea (MFDS) Authorizes Moderna’s COVID-19 Vaccine q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Ministry of Food and Drug Safety of South Korea (MFDS) has approved the Company’s application for Conditional Marketing Authorization for its mRNA vaccine against COVID-19. |
| 2021-05-21 | ModernaTX, Inc. | Regulatory Japan’s Ministry of Health, Labour and Welfare (MHLW) Approves Moderna’s COVID-19 Vaccine q4web.com ↗
Japan’s Ministry of Health, Labour and Welfare (MHLW) Approves Moderna’s COVID-19 Vaccine |
| 2021-05-06 | ModernaTX, Inc. | Results Moderna Reports First Quarter Fiscal Year 2021 Financial Results and Provides Business Updates q4web.com ↗
Initial analysis of the Phase 2/3 TeenCOVE study of mRNA-1273 showed vaccine efficacy against COVID-19 of 96%; mRNA-1273 was generally well tolerated with no serious safety concerns identified to date |
| 2021-05-06 | ModernaTX, Inc. | Results Moderna Announces New Supply Agreement with Switzerland for 7 Million Booster Vaccine Doses in 2022 and Option for Additional 7 Million Doses q4web.com ↗
Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally comparable to those observed after the second dose of mRNA-1273 in the previously reported Phase 2 and Phase 3 studies. |
| 2021-05-05 | ModernaTX, Inc. | Results Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern q4web.com ↗
A booster dose of mRNA-1273.351, the Company’s strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273. |
| 2021-04-30 | ModernaTX, Inc. | Regulatory Moderna Announces Emergency Use Listing Granted by the World Health Organization for its COVID-19 Vaccine q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. |
| 2021-04-13 | ModernaTX, Inc. | Results Statement on CVST or Thrombotic Events modernatx.com ↗
A comprehensive assessment of the totality of the available safety data for mRNA-1273 after over 64.5 million doses administered globally does not suggest an association with cerebral venous sinus thrombosis (CVST) or thrombotic events. |
| 2021-04-13 | ModernaTX, Inc. | Results Moderna Provides Clinical and Supply Updates on COVID-19 Vaccine Program Ahead of 2nd Annual Vaccines Day q4web.com ↗
Updated cases show continued strong efficacy, including greater than 90% against cases of COVID-19 and greater than 95% against severe cases of COVID-19, with approximately 6 months median follow-up post dose 2 |
| 2021-04-07 | ModernaTX, Inc. | Results Moderna Highlights Publication of Antibody Persistence Data of its COVID-19 Vaccine out to 6 Months in the New England Journal of Medicine q4web.com ↗
As detected by three distinct serologic assays, antibodies elicited by the Moderna COVID-19 vaccine persisted through 6 months after the second dose. |
| 2021-04-01 | ModernaTX, Inc. | Regulatory Moderna Provides Storage Update & Announces the U.S. FDA Authorizes Up To 15-Doses Per Vial of its COVID-19 Vaccine q4web.com ↗
The FDA also authorized inclusion of a new vial presentation with a maximum of 15 doses of its COVID-19 vaccine. |
| 2021-03-05 | ModernaTX, Inc. | Regulatory Moderna Announces New Drug Application Submitted to Import and Distribute Moderna’s COVID-19 Vaccine Candidate in Japan q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Takeda Pharmaceutical Co., Ltd (NYSE: TAK) submitted a New Drug Application to the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to import and distribute Moderna’s vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan. |
| 2021-02-11 | ModernaTX, Inc. | Regulatory Qatar Ministry of Public Health Issues Emergency Use Authorization for COVID-19 Vaccine Moderna q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Qatar Ministry of Public Health has issued an emergency use authorization for COVID-19 Vaccine Moderna. |
| 2021-02-03 | ModernaTX, Inc. | Regulatory Singapore Health Sciences Authority (HSA) Approves Interim Authorization of COVID-19 Vaccine Moderna For Use q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Singapore Health Sciences Authority (HSA) has approved the interim authorization of its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under the Pandemic Special Access Route (PSAR). |
| 2021-01-25 | ModernaTX, Inc. | Results Moderna COVID-19 Vaccine Retains Neutralizing Activity Against Emerging Variants First Identified in the U.K. and the Republic of South Africa q4web.com ↗
Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced results from in vitro neutralization studies of sera from individuals vaccinated with Moderna COVID-19 Vaccine showing activity against emerging strains of SARS-CoV-2. |
| 2021-01-20 | ModernaTX, Inc. | Regulatory Statement on California Department of Public Health (CDPH) Report modernatx.com ↗
Providers that paused vaccine administration from Moderna Lot 41L20A can immediately resume. |
| 2021-01-12 | ModernaTX, Inc. | Regulatory Swissmedic Authorizes COVID-19 Vaccine Moderna for Use in Switzerland q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. |
| 2021-01-08 | ModernaTX, Inc. | Regulatory United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under Regulation 174. |
| 2021-01-06 | ModernaTX, Inc. | Regulatory European Commission Authorizes COVID-19 Vaccine Moderna in Europe q4web.com ↗
European Commission Authorizes COVID-19 Vaccine Moderna in Europe |
| 2021-01-04 | ModernaTX, Inc. | Regulatory Israeli Ministry of Health Authorizes COVID-19 Vaccine Moderna for Use in Israel q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel. |
| 2020-12-31 | ModernaTX, Inc. | Results Moderna Announces Publication of Results from the Pivotal Phase 3 Trial of the Moderna COVID-19 Vaccine in The New England Journal of Medicine q4web.com ↗ |
| 2020-12-23 | ModernaTX, Inc. | Results Statement on Variants of the SARS-CoV-2 Virus modernatx.com ↗
Based on the data to date, Moderna expects that the vaccine-induced immunity from the Moderna COVID-19 Vaccine would be protective against the variants of the SARS-CoV-2 virus recently described in the UK. |
| 2020-12-23 | ModernaTX, Inc. | Regulatory Health Canada Authorizes Moderna COVID-19 Vaccine in Canada q4web.com ↗
The authorization comes under Health Canada's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and is based on a rolling review of data that was announced on October 12, 2020. |
| 2020-12-19 | ModernaTX, Inc. | Regulatory U.S. CDC Advisory Committee on Immunization Practices Recommends Vaccination with Moderna’s COVID-19 Vaccine for Persons 18 Years and Older q4web.com ↗
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted today to recommend the use of the Moderna COVID-19 vaccine in people 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). |
| 2020-12-18 | ModernaTX, Inc. | Regulatory Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S. q4web.com ↗
The Moderna COVID-19 Vaccine is now authorized for distribution and use under an Emergency Use Authorization (EUA). |
| 2020-12-17 | ModernaTX, Inc. | Regulatory Moderna Receives FDA Advisory Committee Vote Supporting Emergency Use for Moderna’s Vaccine Against COVID-19 in the United States q4web.com ↗
20 VRBPAC members recommended for EUA, 0 members voted against, and 1 abstained. |
| 2020-12-03 | ModernaTX, Inc. | Results Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate q4web.com ↗
at day 119, 3 months post-second 100 μg dose, binding and neutralizing antibody titers remain high in all participants |
| 2020-11-30 | ModernaTX, Inc. | Results Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization q4web.com ↗
The data analysis indicates a vaccine efficacy of 94.1%. |
| 2020-11-17 | ModernaTX, Inc. | Regulatory European Medicines Agency Begins Rolling Review of Moderna’s mRNA Vaccine Candidate Against COVID-19 (mRNA-1273) q4web.com ↗
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the European Medicines Agency (EMA) human medicines committee (CHMP) has started a rolling review of mRNA-1273, the Company’s vaccine candidate against COVID-19, following the confirmation of eligibility of mRNA-1273 for submission on October 14, 2020. |
| 2020-11-16 | ModernaTX, Inc. | Results Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study q4web.com ↗
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. |
| 2020-11-16 | ModernaTX, Inc. | Regulatory Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures q4web.com ↗
We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. |
| 2020-11-13 | ModernaTX, Inc. | Regulatory Swissmedic Begins Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 (mRNA-1273) q4web.com ↗
Moderna has initiated the rolling submission of mRNA-1273 data in consideration of a potential authorization for use of the vaccine candidate in Switzerland by Swissmedic, provided it meets Swissmedic’s rigorous standards of safety, effectiveness, and quality standards. |
| 2020-10-27 | ModernaTX, Inc. | Regulatory UK Medicines and Healthcare products Regulatory Agency Begins Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 (mRNA-1273) q4web.com ↗
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has started the rolling review process of mRNA-1273, the Company’s vaccine candidate against COVID-19. |
| 2020-10-14 | ModernaTX, Inc. | Regulatory Moderna Receives Confirmation of Eligibility for Submission of Marketing Authorization Application to the European Medicines Agency for mRNA Vaccine Against COVID-19 (mRNA-1273) q4web.com ↗
Confirmation of eligibility was given in response to the submission of a letter of intent enabling Moderna to evaluate the opportunity for submitting a Marketing Authorization Application (MAA) for mRNA-1273 with the EMA. |
| 2020-10-13 | ModernaTX, Inc. | Regulatory Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273) q4web.com ↗
The rolling submission has been accepted under the Canadian Minister of Health's Interim Order, which permits companies to submit safety and efficacy data and information as they become available. |
| 2020-09-29 | ModernaTX, Inc. | Results Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Older Adult Age Cohorts in Phase 1 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273) q4web.com ↗
This analysis found that both the 25 µg and 100 µg dose levels were generally well-tolerated in both age cohorts. |
| 2020-07-28 | ModernaTX, Inc. | Results Moderna Announces Publication in The New England Journal of Medicine of Non-Human Primate Preclinical Viral Challenge Study of its mRNA Vaccine Against COVID-19 (mRNA-1273) q4web.com ↗
The study showed a two-dose vaccination schedule of mRNA-1273 led to a robust immune response and protection against SARS-CoV-2 infection in the upper and lower airways in non-human primates, without evidence of vaccine-associated enhanced respiratory disease (VAERD). |
| 2020-07-14 | ModernaTX, Inc. | Results Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273) q4web.com ↗
This interim analysis evaluated a two-dose vaccination schedule of mRNA-1273 given 28 days apart across three dose levels (25, 100, 250 µg) in 45 healthy adult participants ages 18-55 years, and reports results through Day 57. |
| 2020-05-18 | ModernaTX, Inc. | Results Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus q4web.com ↗
Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). |
| 2020-05-12 | ModernaTX, Inc. | Regulatory Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus q4web.com ↗
Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). |
| 2020-05-07 | ModernaTX, Inc. | Regulatory Moderna Reports First Quarter 2020 Financial Results and Provides Business Updates q4web.com ↗
Progress on novel coronavirus vaccine (mRNA-1273) includes FDA clearance to proceed with Phase 2 study |
| 2020-04-27 | ModernaTX, Inc. | Regulatory Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus q4web.com ↗
Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus |
All press releases naming this drug 758 releases
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Evidence & citations 14 cited values
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| Field | Value | Cited text |
|---|---|---|
| Known as | mRNA-1273 | “Participants ( n =273) with CKD not on dialysis or receiving dialysis were randomized 1:1 to third dose 30- µ g BNT162b2 (Pfizer-BioNTech) or 100- µ g mRNA-1273 (Moderna).” PMID 37847518 ↗ Oct 202358“We recruited adult volunteers for homologous or heterologous prime-boost vaccinations with adenoviral (ChAdOx1, AstraZeneca) and/or mRNA (mRNA-1273, Moderna) vaccines.” PMID 35305895 ↗ Mar 2022 “The mRNA vaccine, mRNA-1273/TAK-919, encodes the prefusion-stabilised spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).” PMID 35177302 ↗ Feb 2022 “mRNA-1273 or Spikevax Moderna Switzerland GmbH and the National Institute of Allergy and Infectious Diseases (NIAID) of the United States.” NCT04988048 ↗ “The participants were assigned to receive no booster, an Ad26.COV2.S booster, an mRNA-1273 booster, or a BNT162b2 booster.” PMID 35045226 ↗ Jan 2022 “mRNA-1273 Injection (Drug Product) is an lipid nanoparticles (LNPs) dispersion containing a single mRNA sequence” NCT04847050 ↗ “Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna)” NCT04930770 ↗ “This means Ad26.COV2.S if they originally received BNT162b2 or mRNA-1273 or vice versa” NCT05081271 ↗ “mRNA-1273, COVID-19 Vaccine Moderna, mARN vaccine, administrated by intramuscular” NCT04900467 ↗ “the vaccine produced by Moderna (mRNA-1273)” NCT05027672 ↗ “with mRNA-1273 (Moderna COVID-19) vaccine” NCT04818736 ↗ |
| Known as | COVID-19 Vaccine Moderna | “Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna)” NCT04930770 ↗1“mRNA-1273, COVID-19 Vaccine Moderna, mARN vaccine, administrated by intramuscular” NCT04900467 ↗ |
| Known as | Elasomeran | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05543356 ↗ |
| Known as | messenger RNA-1273 | “SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine” NCT05074368 ↗ |
| Known as | Moderna | “Participants ( n =273) with CKD not on dialysis or receiving dialysis were randomized 1:1 to third dose 30- µ g BNT162b2 (Pfizer-BioNTech) or 100- µ g mRNA-1273 (Moderna).” PMID 37847518 ↗ Oct 20231“SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine” NCT05074368 ↗ |
| Known as | Moderna (mRNA-1273 or Spikevax) | “Moderna (mRNA-1273 or Spikevax)” NCT04988048 ↗ |
| Known as | Moderna COVID-19 vaccine | “Moderna COVID-19 Vaccine, mRNA-1273 (100 μg)” NCT04805125 ↗3“mRNA-1273 (Moderna COVID-19 vaccine) 50 ug” NCT05280158 ↗ “mRNA-1273 (Moderna COVID-19 vaccine)” NCT07279766 ↗ “Moderna COVID-19 vaccine (mRNA 1273)” NCT05079633 ↗ |
| Known as | Moderna mRNA-1273 | “For dose 1 and 2, the currently available mRNA vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) are two dose vaccines which were studied in schedules of either 0 and...” NCT04894435 ↗ |
| Known as | Moderna mRNA-1273 COVID-19 vaccine | “Study-provided Moderna mRNA-1273 COVID-19 vaccine” NCT04952402 ↗ |
| Known as | mRNA-1273 SARS-CoV-2 Vaccine | “Participants will be blinded and receive two doses (0.20 mg/mL each) of mRNA-1273 SARS-CoV-2 vaccine via intramuscular injection in the deltoid muscle 28 days apart.” NCT04894435 ↗1“mRNA-1273 SARS-CoV-2 Vaccine” NCT05022329 ↗ |
| Known as | Spikevax | “single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer) vaccine and/or after having...” NCT05315362 ↗2“For this arm, the current variant formulation of Spikevax (mRNA-1273) vaccine will be used.” NCT07279766 ↗ “following mRNA-1273 (Spikevax™) vaccination” PMID 36376733 ↗ Nov 2022 |
| Known as | TAK-919 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04677660 ↗ |
| Modality | Messenger RNA (mRNA) | “The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine” PMID 33378609 ↗ Dec 2020 |
| Route | Intramuscular | “Subjects will receive an intramuscular (IM) injection (0.5 milliliters \[mL\]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle” NCT04283461 ↗ |