Drugs / Quadrivalent influenza vaccine

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Rejected (CRL) US (FDA) — influenza 2026-02-10

“for its investigational influenza vaccine, mRNA-1010, and has issued a Refusal-to-File (RTF) letter” q4web.com ↗

Filed EU (EMA) — influenza 2026-01-05

“Moderna has filed for marketing authorization in the U.S., EU, Canada and Australia for mRNA-1010” q4web.com ↗

Filed US (FDA) — influenza 2026-01-05

“Moderna has filed for marketing authorization in the U.S., EU, Canada and Australia for mRNA-1010” q4web.com ↗

“mRNA-1010 has now been accepted for review in the United States” q4web.com ↗

Trials 24

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT04363359 Jan 2020 → Sep 2021 influenza Shanghai Institute Of Biological Products Completed No outcome recorded
Phase 2 NCT03336593 Nov 2017 → Mar 2018 — PT Bio Farma Completed No outcome recorded
Phase 314 trials · 3 met primary · 1 missed
Phase 3 NCT06049927 Sep 2023 → May 2024 influenza Sinovac Biotech Co., Ltd Completed Met primary
Phase 3 NCT05245552 Aug 2022 → Aug 2023 influenza Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 3 NCT04848467 Oct → Nov 2021 COVID-19 Bayer Withdrawn No outcome recorded
Phase 3 NCT04544267 Sep 2020 → Jun 2021 influenza Sanofi Pasteur, a Sanofi Company Terminated No outcome recorded
Phase 3 NCT04210349 Jan → Dec 2020 influenza Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 3 NCT04001504 Jul 2019 → Aug 2022 acute coronary syndrome Hospital Israelita Albert Einstein Completed Missed primary
Phase 3 NCT03765437 Jan → Mar 2019 influenza Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 3 NCT03744104 Oct 2018 → Oct 2019 influenza Shanghai Institute Of Biological Products Completed No outcome recorded
Phase 3 NCT03859141 Feb → Apr 2018 influenza Sinovac Biotech Co., Ltd Completed Mixed
Phase 3 NCT03853993 Jan → Aug 2018 influenza Sinovac Biotech Co., Ltd Completed Met primary
Phase 48 trials · 1 met primary
Phase 4 NCT05970887 Oct → Dec 2022 — Catholic Kwandong University Completed No outcome recorded
Phase 4 NCT05996549 Sep 2022 → Jul 2024 — International Centre for Diarrhoeal Disease Research, Bangladesh Unknown No outcome recorded
Phase 4 NCT05471531 Nov 2021 → Mar 2022 — Sinovac Biotech Co., Ltd Completed Met primary
Phase 4 NCT05499351 Oct → Dec 2021 COVID-19 Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT04997239 Oct 2021 influenza Sinovac Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT05313893 Sep → Dec 2021 influenza Jiangsu Province Centers for Disease Control and Prevention Completed No outcome recorded
Phase 4 NCT04801888 Mar → May 2021 COVID-19, influenza Sinovac Research and Development Co., Ltd. Completed No outcome recorded
Phase 4 NCT04667117 Jan 2021 → Jul 2023 multiple sclerosis Novartis Pharmaceuticals Completed No outcome recorded
Comparator or background therapy5 trials
Phase 1 NCT05227001 Comparator Apr 2022 → Aug 2023 influenza Pfizer Completed No outcome recorded
Phase 2 NCT02860039 Comparator Sep 2016 → Dec 2021 cancer, disease related to hematopoietic stem cell transplant, influenza Vanderbilt-Ingram Cancer Center Completed Met primary
Phase 3 NCT05513391 Comparator Nov 2022 → Oct 2023 — Sanofi Pasteur, a Sanofi Company Terminated No outcome recorded Stop: Business
Phase 3 NCT05540522 Comparator Sep 2022 → Mar 2024 influenza Pfizer Completed No outcome recorded
Phase 3 NCT01964989 Comparator Nov 2013 → Oct 2015 influenza Seqirus Completed Missed primary

News releases announcing trial results or a regulatory action · 47

DateIssuerRelease
2026-09-01 GlaxoSmithKline Results GSK to advance mRNA seasonal flu vaccine candidate to phase III following positive phase II data gsk.com ↗
GSK’s vaccine candidate showed higher immune responses against all influenza strains tested compared to licensed standard dose and high dose inactivated flu vaccines in younger and older adults respectively, and was generally well tolerated.
2026-08-05 ModernaTX, Inc. Regulatory Moderna Receives U.S. FDA Approval for Influenza Vaccine mFLUSIVA q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA® (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older.
2026-06-18 ModernaTX, Inc. Regulatory Moderna Announces FDA Advisory Committee Votes Unanimously in Favor of the Benefit-Risk Profile of mRNA-1010, an Investigational Seasonal Influenza Vaccine q4web.com ↗
2026-05-13 CSL Behring Results Published Large U.S. Study Finds Comparable Effectiveness Between Adjuvanted and High-Dose Influenza Vaccines in Adults 65 Years and Older csl.com ↗
Adjuvanted and high-dose influenza vaccines did not differ in effectiveness against laboratory-confirmed influenza in any setting or influenza with emergency department visits or hospitalization.
2026-05-06 ModernaTX, Inc. Results Moderna Announces New England Journal of Medicine Publication of Pivotal Phase 3 Clinical Safety and Efficacy Data for Its Investigational Seasonal Influenza Vaccine, mRNA-1010 q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced a publication in the New England Journal of Medicine of the positive Phase 3 study results evaluating mRNA-1010, its vaccine candidate for seasonal influenza.
2026-04-06 ModernaTX, Inc. Results Moderna to Present Revaccination Data for Its Investigational Seasonal Influenza Vaccine and for mRESVIA at ESCMID 2026 q4web.com ↗
Additionally, there were no increases in solicited adverse reactions or new safety concerns observed with sequential mRNA-1010 vaccination.
2026-02-18 ModernaTX, Inc. Regulatory Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission q4web.com ↗
Following submission of the amended application, the FDA has accepted the biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026.
2026-02-13 ModernaTX, Inc. Regulatory Moderna Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Provides Business Updates q4web.com ↗
Announces influenza vaccine filing accepted for regulatory review in the EU, Canada and Australia; Company received Refusal-to-File letter from U.S. FDA and has requested Type A meeting to understand path forward
2026-02-10 ModernaTX, Inc. Regulatory Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010 q4web.com ↗
CBER's RTF letter, signed by Center Director Vinayak Prasad, MD, MPH, identified the choice of a licensed standard-dose seasonal influenza vaccine comparator as the sole reason for the refusal to initiate the review of Moderna's application.
2026-01-05 ModernaTX, Inc. Regulatory Moderna Announces Global Regulatory Submissions for Its Investigational Seasonal Influenza Vaccine q4web.com ↗
The Company has filed for marketing authorization with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and the Therapeutic Goods Administration (TGA) in Australia.
2025-10-19 ModernaTX, Inc. Results Moderna Highlights Seasonal Flu and H5 Pandemic Flu Candidates at IDWeek 2025 q4web.com ↗
rVE was 26.6% (95%CI: 16.7%, 35.4%) in the overall study population, meeting the prespecified superiority criteria.
2025-08-14 Sinovac Biotech Co., Ltd Results 《免疫学前沿》刊文:科兴四价流感疫苗与23价肺炎疫苗在老年慢病人群中同时接种具有良好的免疫原性和安全性 sinovac.com ↗

All press releases naming this drug 47 releases

DateIssuerRelease

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 33 sources stand behind the page.

FieldValueCited text
Known as Quadrivalent Influenza Vaccine “the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.” NCT05499351 ↗
28

NCT02860039 ↗

NCT05970887 ↗

NCT01240746 ↗

NCT05227001 ↗

NCT06049927 ↗

NCT05996549 ↗

NCT01964989 ↗

NCT05471531 ↗

NCT04210349 ↗

NCT04801888 ↗

Show 18 more sources

Known as IIV4 “Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection...” PMID 25843270 ↗ Apr 2015
3

“Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains (H1N1 and H3N2) and one strain from each B lineage (Victoria and Yamagata)” PMID 32732142 ↗ Jul 2020

“non-adjuvanted inactivated influenza vaccine (ie, trivalent inactivated influenza vaccine [IIV3] or quadrivalent inactivated influenza vaccine [IIV4])” PMID 29631857 ↗ Apr 2018

“Biological: Quadrivalent influenza vaccine (IIV4)” NCT05513391 ↗

Known as QIV “The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent...” NCT01481454 ↗
5

“Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)” NCT01964989 ↗

“new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season” NCT01967784 ↗

“flu vaccine called seasonal quadrivalent influenza vaccine (QIV)” NCT04848467 ↗

“licensed quadrivalent influenza vaccine (QIV)” NCT05540522 ↗

“Quadrivalent influenza vaccine (QIV)” NCT05227001 ↗

Known as QIV-HD “high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose quadrivalent influenza vaccine (QIV-SD)” NCT04544267 ↗
Known as QIV-SD “high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose quadrivalent influenza vaccine (QIV-SD)” NCT04544267 ↗
Known as SD-QIV “We demonstrated in a primary phase 2 randomized controlled trial that 2 post-HCT doses of high-dose trivalent influenza vaccine (HD-TIV) given 4 weeks apart were more...” PMID 39279435 ↗ Feb 2025
Known as standard-dose quadrivalent influenza vaccine “We demonstrated in a primary phase 2 randomized controlled trial that 2 post-HCT doses of high-dose trivalent influenza vaccine (HD-TIV) given 4 weeks apart were more...” PMID 39279435 ↗ Feb 2025
Modality Vaccine “Quadrivalent Influenza Vaccine, No Preservative” NCT01240746 ↗
Route Intramuscular “0.25 mL (6 to 35 months), or 0.5 mL(3 to \<9 years), Intramuscular” NCT01240746 ↗