Drugs / Influenza vaccine
Influenza vaccine
also known as
IIV3 · Flulaval · FluVac · influvac · MF59-adjuvanted vaccine · QIV · Sequiris Fluad Quad · SIIV · +4 more
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | mFLUSIVA | influenza | 2026-08-05 | “mRNA-1010 has been accepted for regulatory review in the European Union, Canada and Australia.” q4web.com ↗ |
| Filed | EU (EMA) | mFLUSIVA | influenza | 2026-08-05 | “mRNA-1010 has been accepted for regulatory review in the European Union, Canada and Australia.” q4web.com ↗ |
| Filed | US (FDA) | mFLUSIVA | influenza | 2026-01-05 | “The FDA will consider the recommendations of VRBPAC as part of its ongoing review of Moderna's Biologics License Application (BLA) for mRNA-1010.” q4web.com ↗ “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 ↗ |
| 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 | Other | — | influenza | 2026-01-05 | “Moderna has filed for marketing authorization in the U.S., EU, Canada and Australia for mRNA-1010” q4web.com ↗ “The Company's mRNA-1010 regulatory filings are under review in Europe, Canada and Australia” q4web.com ↗ |
| Filed | US (FDA) | — | influenza | 2025-01-13 | “The Company has filed with the FDA for regulatory approval of mRNA-1083.” q4web.com ↗ |
| Clinical hold | US (FDA) | — | influenza | 2024-10-16 | “has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates.” novavax.com ↗ “clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates” novavax.com ↗ “U.S. FDA removes clinical hold on Investigational New Drug application for COVID-19-Influenza Combination and stand-alone influenza vaccine candidates” novavax.com ↗ “FDA removes clinical hold on Investigational New Drug application for COVID-19-Influenza Combination and stand-alone influenza vaccine candidates” novavax.com ↗ |
| Filed | Other | — | influenza | 2023-11-07 | “Clover Completes BLA Submission for Seasonal Influenza Vaccine in Brazil” cloverbiopharma.com ↗ |
| Filed | US (FDA) | FluMist Quadrivalent | influenza | 2023-10-24 | “FluMist Quadrivalent, a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA).” astrazeneca.com ↗ |
| Filed | US (FDA) | FLULAVAL® QUADRIVALENT | influenza | 2016-02-02 | “GSK today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for FLULAVAL® QUADRIVALENT” gsk.com ↗ |
| Filed | EU (EMA) | — | influenza | 2012-03-05 | “Seasonal flu + COVID vaccine: The Company's mRNA-1083 filing is under review with the European Medicines Agency (EMA).” q4web.com ↗ “GSK has submitted US and EU regulatory applications seeking approval of a quadrivalent influenza vaccine” gsk.com ↗ |
| Filed | US (FDA) | — | influenza | 2012-03-05 | “A regulatory application has also been submitted to the U.S. FDA seeking approval for an H5N1 influenza vaccine.” gsk.com ↗ “GSK has submitted US and EU regulatory applications seeking approval of a quadrivalent influenza vaccine” gsk.com ↗ |
Trials 49
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03449459 | Dec 2018 → Dec 2020 | chronic obstructive pulmonary disease | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| Phase 0 | NCT03748524 | Oct 2018 → Sep 2021 | — | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT06355232 | May 2024 → Dec 2025 overdue | COVID-19, influenza | Vaxine Pty Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT02998736 | Nov 2017 → Sep 2022 | digestive system cancer | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT02665871 | Mar → Jun 2016 | influenza | Beijing Chaoyang District Centre for Disease Control and Prevention | Unknown | No outcome recorded |
| Phase 215 trials | ||||||
| Phase 2 | NCT07842367 | Sep 2026 → Oct 2027 expected | — | University of Arkansas, Fayetteville | Recruiting | No outcome recorded |
| Phase 2 | NCT05909423 | Sep 2023 → Sep 2025 overdue | colorectal cancer | Zealand University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05519839 | Dec 2022 → Jul 2023 | COVID-19, influenza | Novavax | Completed | No outcome recorded |
| Phase 2 | NCT05294588 | Apr 2022 → Feb 2026 | gonorrhea | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT05116917 | Nov 2021 → Oct 2023 | malignant pancreatic neoplasm | Herlev Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT03658629 | Sep 2018 → Apr 2019 | influenza | Novavax | Terminated | No outcome recorded |
| Phase 2 | NCT03277703 | Nov 2017 → Jan 2020 | inflammatory bowel disease, rheumatic disorder, type III hypersensitivity disease | Stony Brook University | Completed | No outcome recorded |
| Phase 2 | NCT01924169 | Nov 2014 → Feb 2017 | hematologic disorder | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01403376 | Sep 2011 → Jan 2012 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT01072734 | Sep 2009 → Jan 2010 | systemic lupus erythematosus | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT00918268 | Jun → Jul 2009 | influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase 2 | NCT00596336 | Oct 2007 → Dec 2011 | chronic lymphocytic leukemia/small lymphocytic lymphoma | The Royal Bournemouth Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00408395 | Nov 2006 → Aug 2007 | influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase 2 | NCT00316628 | Jun 2005 → ? | influenza | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00316615 | Jun 2005 → ? | influenza | Novartis | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT03666806 | Aug 2018 → Sep 2019 | sickle cell disease | Makerere University | Unknown | No outcome recorded |
| Phase 2/3 | NCT00607178 | Jan → Sep 2008 | coronary artery disorder, myocardial infarction | Shahid Beheshti University of Medical Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT00607217 | Jan → Sep 2008 | intermediate coronary syndrome, myocardial infarction | Shahid Beheshti University of Medical Sciences | Completed | No outcome recorded |
| Phase 38 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT06279871 | Mar → Oct 2024 | COVID-19 | Arcturus Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT05091307 | Nov 2021 → Jun 2022 | — | Janssen Vaccines & Prevention B.V. | Completed | Mixed |
| Phase 3 | NCT03572491 | Sep 2017 → May 2018 | influenza | Research Institute for Biological Safety Problems | Completed | No outcome recorded |
| Phase 3 | NCT02545868 | Oct 2015 → Feb 2017 | relapsing-remitting multiple sclerosis | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT02519855 | Sep 2015 → Jan 2016 | herpes zoster | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01761435 | Oct 2012 → Jan 2014 | disease related to solid organ transplantation | Fundación Pública Andaluza Progreso y Salud | Completed | No outcome recorded |
| Phase 3 | NCT01034254 | Nov 2010 → May 2014 | influenza | Children's Hospital Medical Center, Cincinnati | Completed | Met primary |
| Phase 3 | NCT00999206 | Jan → Aug 2010 | influenza | Abbott Biologicals | Completed | No outcome recorded |
| Phase 413 trials · 1 met primary | ||||||
| Phase 4 | NCT05616546 | Oct 2023 → Dec 2029 expected | influenza | Emory University | Recruiting | No outcome recorded |
| Phase 4 | NCT06091410 | Sep 2023 → Feb 2025 | COVID-19, influenza | Catholic Kwandong University | Unknown | No outcome recorded |
| Phase 4 | NCT05654441 | Oct 2022 → Dec 2023 | — | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT04091880 | Sep 2019 → Jan 2020 | enterovirus infectious disease, influenza | China National Biotec Group Company Limited | Completed | No outcome recorded |
| Phase 4 | NCT03756246 | Jun 2019 → May 2020 | depressive disorder | University of Texas at Austin | Unknown | No outcome recorded |
| Phase 4 | NCT02947217 | Jan 2017 → Dec 2023 | infertility disorder | Center for Human Reproduction | Unknown | No outcome recorded |
| Phase 4 | NCT02946177 | Jan 2017 → Dec 2020 | habitual spontaneous abortion, infertility disorder | Center for Human Reproduction | Unknown | No outcome recorded |
| Phase 4 | NCT02831608 | Oct 2016 → Apr 2021 | heart failure, influenza, myocardial infarction, stroke disorder | Ole Frobert, MD, PhD | Completed | Met primary |
| Phase 4 | NCT02655874 | May 2016 → Jun 2017 | influenza | Tan Tock Seng Hospital | Completed | Mixed |
| Phase 4 | NCT02290691 | Nov 2014 → Jan 2015 | influenza | PharmaJet, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02311855 | Aug 2014 → Dec 2015 | rheumatoid arthritis | Bassett Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT01002508 | Nov 2009 → Mar 2010 | scleroderma | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01693380 | May → Jun 2009 | influenza | Butantan Institute | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07259252 | Dec 2025 → Mar 2029 expected | acute coronary syndrome | Tongji Hospital | Recruiting | No outcome recorded |
| — | NCT02653495 | Jan 2016 → Mar 2017 | immunodeficiency disease, metabolic syndrome X | Rockefeller University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02415166 | Jul 2015 → Mar 2016 | major depressive disorder | Laureate Institute for Brain Research, Inc. | Terminated | No outcome recorded |
| — | NCT00466037 | Sep 2005 → Feb 2006 | rheumatoid arthritis | Tel-Aviv Sourasky Medical Center | Terminated | No outcome recorded |
| — | NCT00214071 | Oct 2004 → Jun 2006 | obstructive sleep apnea syndrome | University of Wisconsin, Madison | Completed | No outcome recorded |
| Comparator or background therapy26 trials | ||||||
| Phase 1 | NCT03996538 Background | Jun 2019 → Feb 2020 | immunodeficiency disease | UConn Health | Completed | No outcome recorded |
| Phase 1 | NCT03028116 Comparator | May → Jun 2016 | influenza | Research Institute for Biological Safety Problems | Completed | No outcome recorded |
| Phase 1 | NCT01488188 Comparator | Dec 2011 → May 2013 | — | International Vaccine Institute | Completed | No outcome recorded |
| Phase 1 | NCT00868218 Comparator | Mar 2009 → Jul 2010 | influenza | Rebecca Cox | Completed | No outcome recorded |
| Phase 1 | NCT00735020 Comparator | Jun → Aug 2008 | influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase 2 | NCT07587801 Background | May → Jul 2026 overdue | — | Central Adelaide Local Health Network Incorporated | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05074303 Background | Jul 2022 → Mar 2024 | — | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT01013675 Comparator | Nov 2009 → Apr 2011 | — | Abbott Biologicals | Completed | No outcome recorded |
| Phase 2 | NCT00915187 Comparator | Oct → Dec 2009 | influenza | NasVax Ltd | Completed | No outcome recorded |
| Phase 2 | NCT00880893 Comparator | Apr 2009 → Oct 2014 | Dengue hemorrhagic fever | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 2/3 | NCT01273974 Comparator | Oct → Nov 2009 | — | Shiraz University of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT06097273 Comparator | Oct 2023 → May 2024 | Orthocoronavirinae infectious disease, influenza | ModernaTX, Inc. | Completed | Met primary |
| Phase 3 | NCT05705440 Background | Feb 2023 → Jan 2025 | respiratory syncytial virus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04526574 Comparator | Sep 2020 → Jun 2021 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00231816 Background | Sep 2005 → Mar 2006 | herpes zoster | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT06336317 Comparator | Apr 2024 → Dec 2027 expected | acute myocardial infarction, inflammatory disease | Region Örebro County | Recruiting | No outcome recorded |
| Phase 4 | NCT03955991 Background | Jul 2016 → Jun 2024 | — | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT02565277 Comparator | Sep 2015 → Dec 2018 | autoinflammatory syndrome | Health Sciences North Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02268500 Comparator | Sep 2014 → Jan 2016 | heart failure | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 4 | NCT01698177 Comparator | Oct 2011 → Jun 2013 | influenza | Stony Brook University | Unknown | No outcome recorded |
| — | NCT06041867 Background | Sep → Dec 2023 | — | Maastricht University Medical Center | Completed | No outcome recorded |
| — | NCT05706350 Background | Oct → Dec 2022 | — | Maastricht University Medical Center | Completed | No outcome recorded |
| — | NCT02262091 Background | Aug → Dec 2014 | — | Nestlé | Completed | No outcome recorded |
| — | NCT01707628 Comparator | Oct 2012 → Jun 2013 | non-Hodgkin lymphoma | St. Antonius Hospital | Completed | No outcome recorded |
| — | NCT01508884 Comparator | Jan → Dec 2012 | — | The University of Hong Kong | Completed | No outcome recorded |
| — | NCT01215981 Comparator | Sep 2010 → Jun 2011 | disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm | Masonic Cancer Center, University of Minnesota | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 103
| Date | Issuer | Release |
|---|---|---|
| 2026-09-10 | CSL Behring | Results Lancet Publication Marks Important Advance in Influenza Prevention for Older Adults csl.com ↗
The peer-reviewed publication reports findings from a large-scale study of the first influenza vaccine to combine three proven approaches to enhancing protection in older adults: MF59 ® adjuvant, cell-based manufacturing, and a higher dose formulation compared to standard influenza vaccines. |
| 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. |
| 2026-05-13 | 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. |
| 2026-02-18 | 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 |
| 2025-10-21 | CSL Behring | Results Enhanced Influenza Vaccines Provide Essential Protection for Older Adults: CSL Seqirus Presents New Evidence Supporting Broader Adoption Across Europe csl.com ↗
Relative vaccine effectiveness (rVE) between aQIV and HD-QIV was comparable: -0.9% (95% CI: -9.9, 7.3) across all settings and 0.5% (95% CI: -12.1, 11.6) in emergency or inpatient settings. |
| 2025-07-24 | Novavax | Results Novavax's H5N1 Vaccine Candidate Demonstrates Immunogenicity in Preclinical Study novavax.com ↗
Results showed that a single dose administered by either IN or IM routes induced neutralizing antibody responses (IN: 1:54; IM: 1:1,160), at or above the 1:40 titer generally considered to be a protective antibody response. |
| 2025-07-17 | SK Bioscience Co., Ltd. | Regulatory SK bioscience Submits IND for Phase 1/2 Clinical Trial of Adjuvanted Influenza Vaccine Candidate skbioscience.com ↗ |
| 2025-07-10 | Osivax | Results Osivax Publishes Phase 2a Results Supporting Co-Administration of OVX836 with Seasonal Flu Vaccine in Vaccines Journal osivax.com ↗
Co-administration of OVX836 with seasonal inactivated influenza vaccine (Fluarix® Tetra) was well-tolerated and demonstrated a favorable safety profile |
| 2025-06-11 | Novavax | Results Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Vaccine Candidates Showed Robust Immune Responses and Were Well Tolerated in Initial Cohort of a Phase 3 Trial novavax.com ↗
Both stand-alone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline). |
| 2025-05-28 | ModernaTX, Inc. | Results Moderna Announces Update on Investigational Pandemic Influenza Program q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced positive interim data from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older. |
| 2025-04-10 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Receives U.S. FDA Fast Track Designation for the STARR® mRNA Vaccine Candidate ARCT-2304 for Pandemic Influenza A Virus H5N1 arcturusrx.com ↗
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicine company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, designed for active immunization to protect against disease caused by influenza A H5N1 subtype contained in the vaccine. |
| 2025-04-08 | AstraZeneca | Results AstraZeneca showcases innovation in infectious disease protection at ESCMID Global 2025 astrazeneca.com ↗
Data include 20 years of real-world effectiveness for Fluenz/FluMist |
| 2024-11-12 | Novavax | Regulatory Novavax Reports Third Quarter 2024 Financial Results and Operational Highlights novavax.com ↗
In November 2024 , the U.S. Food and Drug Administration (FDA) removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. |
| 2024-11-11 | Novavax | Regulatory U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial novavax.com ↗
The FDA has cleared the Company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues. |
| 2024-11-11 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial arcturusrx.com ↗
the U.S. Food and Drug Administration (FDA) has issued a “Study Can Proceed” notification |
| 2024-10-23 | SK Bioscience Co., Ltd. | Regulatory SK bioscience Receives Approval of Quadrivalent Influenza Vaccine in Indonesia skbioscience.com ↗
This marks the first time a domestically developed influenza vaccine has been licensed in Indonesia. |
| 2024-10-16 | Novavax | Regulatory Update on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. |
| 2024-09-12 | GlaxoSmithKline | Results GSK announces positive headline data from phase II seasonal influenza mRNA vaccine programme gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive headline results of a phase II trial (NCT06431607) for its mRNA seasonal influenza vaccine programme. |
| 2024-09-12 | ModernaTX, Inc. | Results Moderna R&D Day Highlights Progress and Strategic Priorities q4web.com ↗
In an older adult extension study of P303, mRNA-1010 met all primary immunogenicity endpoints-including superiority for all strains-compared to a licensed enhanced flu vaccine (Fluzone HD®) and showed an acceptable reactogenicity profile. |
| 2024-08-16 | BioNTech SE | Results Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age biontech.com ↗
The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines |
| 2024-06-25 | Merck Sharp & Dohme LLC | Regulatory USDA Approves Merck Animal Health’s NOBIVAC® NXT Canine Flu H3N2 – The First and Only RNA-Particle Technology Vaccine for Canine Influenza merck.com ↗ |
| 2024-04-25 | NPO Petrovax | Results Immunization week: experts discuss past and future of modern vaccines at a conference in Kazakhstan petrovax.com ↗
For instance, between 2022 and 2023 in England, the vaccination led to a 28% reduction in hospitalizations among the elderly and by 35% in the USA over the same period in the same age group [ 5 ] . |
| 2023-11-07 | Clover Biopharmaceuticals AUS Pty | Regulatory Clover Completes BLA Submission for Seasonal Influenza Vaccine in Brazil cloverbiopharma.com ↗
Clover Completes BLA Submission for Seasonal Influenza Vaccine in Brazil |
| 2023-10-26 | Pfizer | Results Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19 pfizer.com ↗
The data from the trial showed that the companies' lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains. |
| 2023-10-05 | Pfizer | Results Pfizer Presents New Data at IDWeek 2023 Highlighting Advances in Prevention and Treatment of Certain Respiratory Illnesses and Other Infectious Diseases pfizer.com ↗
Eight abstracts have been selected for oral presentation, including data on the successful coadministration of ABRYSVO with an influenza vaccine in older adults and results from the Phase 3 REVISIT study of Pfizer’s investigational antibiotic combination aztreonam-avibactam (ATM-AVI) candidate. |
| 2023-09-18 | CSL Behring | Results CSL Seqirus Shares Data Demonstrating the Potential for Influenza Vaccination to Reduce the Burden on Healthcare Resources csl.com ↗
The French data highlights how vaccines may reduce the strain on hospital beds by 10-15%. |
| 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 ↗
Company's flu vaccine, mRNA-1010, met its primary endpoint in Phase 3 trial; separate Phase 1/2 data demonstrated higher HAI titers than Fluzone HD |
| 2023-06-29 | Sanofi | Results Press Release: Vaccines R&D pipeline raises the bar in RSV, influenza, meningitis, and pneumococcal disease sanofi.com ↗
promising results of the next-gen eration n euraminidase - encoding mRNA F lu vaccine, supporting further development of this novel program. |
| 2023-05-09 | Novavax | Results Positive Phase 2 Topline Results Show Novavax's COVID-Influenza Combination, Stand-alone Influenza and High-dose COVID Vaccine Candidates Demonstrate Robust Immune Responses novavax.com ↗
The stand-alone influenza vaccine candidate achieved statistically significant hemagglutination inhibition (HAI) antibody responses 31 to 56% higher for all four strains compared to Fluad. |
| 2023-05-09 | Novavax | Results Novavax Reports First Quarter 2023 Financial Results and Operational Highlights novavax.com ↗
Announced positive Phase 2 COVID-Influenza Combination (CIC) vaccine, standalone influenza, and high-dose COVID vaccine data, which evaluated safety and immunogenicity of different formulations |
| 2023-04-11 | ModernaTX, Inc. | Results Moderna Announces Clinical and Program Updates at 4th Vaccines Day q4web.com ↗
Company's first influenza candidate, mRNA-1010, did not accrue sufficient cases at the interim efficacy analysis to declare early success in the Phase 3 Northern Hemisphere efficacy trial and the independent DSMB recommended continuation of efficacy follow-up |
| 2023-02-02 | SK Bioscience Co., Ltd. | Regulatory SK bioscience’s World-First Cell Culture-Based Quadrivalent Influenza Vaccine Is Approved in Chile skbioscience.com ↗
The world first cell culture-based influenza vaccine, ‘SKYCellflu®’ is approved for the first time in South America |
| 2022-10-05 | CSL Behring | Results CSL Announces Positive Preclinical Data for Self-Amplifying Messenger RNA (sa-mRNA) Influenza Vaccine Candidates csl.com ↗
CSL (ASX:CSL) today announced results from the preclinical studies of the company's self-amplifying messenger RNA (sa-mRNA) influenza vaccine candidates, the next generation of mRNA vaccines. |
| 2022-09-26 | CSL Behring | Results New Real-World Data Presented at OPTIONS XI Show Cell-Based and MF59®-Adjuvanted Influenza Vaccines Can Reduce the Burden of Seasonal Influenza on Hospitals and Health Systems csl.com ↗
CSL Seqirus, a business of CSL Limited (ASX:CSL), today announced new data from four real-world studies showing the impact that cell-based and adjuvanted influenza vaccines can have in reducing the burden of seasonal influenza on hospitals and health systems. |
| 2022-05-09 | Novavax | Results Novavax Reports First Quarter 2022 Financial Results and Operational Highlights novavax.com ↗
Immune response confirmed in stand-alone influenza vaccine candidate and CIC vaccine candidate with potential path forward for both |
| 2022-04-21 | Osivax | Results Osivax Announces Publication of Phase 2a Trial Results for Influenza Vaccine Candidate OVX836 in Frontiers in Immunology osivax.com ↗
The study demonstrated that OVX836 induced a significant increase of NP-specific cellular immune responses, including CD4+ and CD8+ T cells, and initial efficacy signals while being safe and well-tolerated in 300 adult subjects. |
| 2022-04-20 | Novavax | Results Initial Results from Novavax' COVID-19-Influenza Vaccine Trial are First to Show Feasibility of Combination Vaccine novavax.com ↗
The preliminary trial results found that various CIC vaccine formulations induced immune responses in participants comparable to reference stand-alone influenza and stand-alone COVID-19 vaccine formulations (for H1N1, H3N2, B-Victoria HA and SARS-CoV-2 rS antigens). |
| 2022-03-24 | ModernaTX, Inc. | Results Moderna Announces Clinical and Program Updates at 3rd Annual Vaccines Day q4web.com ↗
In an interim analysis of a Phase 2 study of influenza vaccine candidate mRNA-1010, no significant safety concerns were identified, and the immunogenicity data is consistent with a potential for superiority to standard dose vaccine for influenza A strains. |
| 2021-12-10 | ModernaTX, Inc. | Results Moderna Announces Positive Interim Phase 1 Data for mRNA Flu Vaccine and Provides Program Update q4web.com ↗
In the study, mRNA-1010 successfully boosted hemagglutination inhibition (HAI) assay geometric mean titers against all strains 29 days after vaccination at all doses tested in both younger and older adults. |
| 2021-12-07 | CSL Behring | Results New Data Supports the Effectiveness of Adjuvanted Seasonal Influenza Vaccine in Reducing Influenza-Related Hospitalizations and Healthcare Costs in Older Adults csl.com ↗
In this study, findings demonstrated that aTIV was associated with 12% lower risk of hospitalization and a 37% lower risk of respiratory-related hospitalizations compared with TIV and QIV. |
| 2021-12-02 | Novavax | Results Novavax Statement on Omicron Variant Response novavax.com ↗
Novavax’ Phase 3 trial of NanoFlu™, our quadrivalent nanoparticle vaccine candidate against seasonal influenza, demonstrated the strong role our proprietary Matrix-M™ adjuvant can play in addressing rapid viral genetic drift. |
| 2021-11-18 | Novavax | Results Novavax Statement on Publication of Positive Results from First Study of Co-administered COVID-19 and Influenza Vaccines novavax.com ↗
The previously announced results demonstrate that vaccine efficacy and safety appeared to be preserved in those receiving both NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate, and Seqirus’ adjuvanted, trivalent seasonal influenza vaccine (aTIV) or a cell-based, quadrivalent seasonal influenza vaccine (QIVc), compared to those vaccinated with NVX-CoV2373 alone. |
| 2021-10-14 | CSL Behring | Results The New England Journal of Medicine Publishes First-of-its-Kind Study on Cell-Based Quadrivalent Seasonal Influenza Vaccine (QIVc) Efficacy in Children and Adolescents ≥2 to < 18 Years of Age csl.com ↗
today announced that The New England Journal of Medicine has published absolute efficacy data on the company’s cell-based quadrivalent influenza vaccine (QIVc) from a randomized controlled trial (RCT) which met its primary endpoint. |
| 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 ↗
Positive results from the first study of high-dose influenza vaccine with a COVID-19 mRNA booster support co-administration recommendations |
| 2021-09-23 | Novavax | Results Results from Novavax NanoFlu Influenza Vaccine Phase 3 Clinical Trial Published in The Lancet Infectious Diseases novavax.com ↗
In the complete analysis, NanoFlu was well-tolerated and produced significantly enhanced humoral and cellular immune responses versus the comparator vaccine. |
| 2021-07-16 | Merck Sharp & Dohme LLC | Results Merck Announces U.S. FDA Approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes merck.com ↗
The non-inferiority criteria for the comparisons of GMTs were met for the 15 pneumococcal serotypes in VAXNEUVANCE and for the 4 influenza vaccine strains tested. |
| 2020-12-14 | CSL Behring | Results Seqirus Presents Real-World Data for Cell-Based Quadrivalent Seasonal Influenza Vaccine (QIVc) at ESWI 2020 csl.com ↗
A Late-breaking poster presentation demonstrating that QIVc prevented significantly more influenza-related medical encounters among individuals aged ≥4 years (n=2,113,216) with at least one health condition, compared to QIVe in the 2018/19 U.S. influenza season. |
| 2020-12-14 | CSL Behring | Results Seqirus Presents New Late-Breaking Data at ESWI 2020 Highlighting Value of MF59®-Adjuvanted Seasonal Influenza Vaccine csl.com ↗
Results indicate that relative vaccine effectiveness (rVE) favored aTIV over non-adjuvanted standard dose quadrivalent and trivalent influenza vaccines in averting influenza-related medical encounters.1 |
| 2020-11-18 | Sanofi | Regulatory European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older sanofi.com ↗
The European Commission has granted a marketing authorization for Supemtek ® , a quadrivalent (four-strain) recombinant influenza vaccine, for the prevention of influenza in adults aged 18 years and older. |
| 2020-09-22 | Sanofi | Regulatory CHMP recommends approval of Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Supemtek® (recombinant influenza vaccine) for active immunization for the prevention of influenza in adults. |
| 2020-01-22 | Vaxart | Results Results from Influenza Challenge Study Published in Lancet Infectious Diseases vaxart.com ↗
The study demonstrated a single dose with the Vaxart oral tablet H1 influenza vaccine was well tolerated and provided statistically significant protection against H1 influenza infection in the human challenge model. |
| 2020-01-02 | SK Bioscience Co., Ltd. | Regulatory SK bioscience Receives WHO PQ of Cell Culture-Based Quadrivalent Influenza Vaccine skbioscience.com ↗
SK bioscience announced on the 2nd that the company has obtained WHO PQ certification for their in-house cell culture-based influenza vaccine, ‘SKYCellflu® Quadrivalent´ only seven months after submitting it. |
| 2019-12-11 | CSL Behring | Regulatory Seqirus announces Health Canada approval of first cell-based seasonal influenza vaccine csl.com ↗
Seqirus, a global leader in influenza prevention, announced today that its cell-based quadrivalent influenza vaccine (QIVc) has received approval from Health Canada for use in people 9 years of age and older. |
| 2019-12-09 | CSL Behring | Results New Data Demonstrate that FLUAD® (Influenza Vaccine, Adjuvanted) Significantly Reduces Hospitalization Risk for Adults 65+ Living in U.S. Nursing Homes Compared to Standard Trivalent Influenza Vaccine csl.com ↗
Researchers reported that in their intent-to-treat analysis, residents offered FLUAD experienced 6 percent fewer hospitalizations from all causes compared with those who received a standard non-adjuvanted TIV (adjusted hazard ratio 0.94, 95% CI: 0.89, 0.99, p=0.02). |
| 2019-08-31 | CSL Behring | Results Seqirus Presents New Scientific Data Comparing Circulating Influenza B Viruses With Both Cell-Based and Egg-Based Influenza B Reference Viruses csl.com ↗
Seqirus, a global leader in influenza prevention, today presented new scientific data at the Options for the Control of Influenza (OPTIONS X) Conference in Singapore that demonstrated circulating influenza B/Victoria (B/Vic) viruses are a closer match to cell-based B/Vic vaccine viruses compared with egg-based B/Vic vaccine viruses. |
| 2019-08-30 | SK Bioscience Co., Ltd. | Regulatory SK bioscience Begins Shipment of Cell Culture-Based Influenza Vaccine skbioscience.com ↗
SK bioscience announced on the 30th that its influenza vaccine, ‘SKYCellflu®,´ received the government’s approval for shipment, which was the final step before sales to the market. |
| 2019-08-30 | CSL Behring | Results Seqirus Presents New Clinical Data that Reinforce the Ability of MF59® Adjuvanted Seasonal and Pandemic Influenza Vaccines to Increase Immune Response csl.com ↗
Seqirus, a global leader in influenza prevention, today presented data at the Options for the Control of Influenza (OPTIONS X) Conference in Singapore from clinical studies demonstrating the ability of a MF59® adjuvanted influenza vaccine to increase immune responses when used in both seasonal and pandemic influenza vaccines, across pediatric and adult populations. |
| 2019-08-28 | FluGen Inc | Results Single-replication BM2SR vaccine provides sterilizing immunity and cross-lineage influenza B virus protection in mice flugen.com ↗
BM2SR vaccine viruses provided apparent sterilizing immunity to mice against intra- and inter-lineage drifted B virus challenge. |
| 2019-05-10 | ModernaTX, Inc. | Results Moderna Announces Publication of Phase 1 Data for mRNA Vaccines Against Two Potential Pandemic Influenza Strains q4web.com ↗
Both studies met their primary safety and secondary immunogenicity endpoints, and there were no vaccine-related serious adverse events (AEs) reported. |
| 2019-04-12 | Vaxart | Results Vaxart to Present at the 29th European Congress of Clinical Microbiology & Infectious Diseases vaxart.com ↗
In contrast, 100% of the animals receiving the oral Vaxart vaccine survived. |
| 2019-04-11 | NPO Petrovax | Results In Europe, the results of the latest study on the adjuvant role as an influenza vaccine ingredient were presented petrovax.com ↗
Thus, Polyoxidonium as an adjuvant in influenza vaccines modulates immune responses and providing for vaccines’ efficacy and immunogenicity at low antigen doses. |
| 2019-01-14 | CSL Behring | Regulatory First cell-based quadrivalent influenza vaccine approved for use in Europe csl.com ↗
Seqirus, a global leader in influenza prevention, today announced that the European Commission has issued marketing approval for its new cell-based seasonal influenza vaccine, FLUCELVAX® TETRA▼ [influenza vaccine (surface antigen, inactivated, prepared in cell cultures)]. |
| 2018-12-05 | CSL Behring | Results Next Generation Cell-based Influenza Vaccine Shows Significantly Greater Effectiveness Compared to Standard Egg-based Options in the 2017-18 US Influenza Season csl.com ↗
The rVE estimated from the study’s primary analysis indicated that QIVc was more effective than standard egg-based QIVs in preventing ILI (rVE of 36.2%, 95% CI (26.1,44.9; P<0.001)). |
| 2018-11-16 | CSL Behring | Results Seqirus Releases Real-World Data Indicating Significantly Greater Effectiveness of Cell-Based Seasonal Influenza Vaccines Compared to Standard Influenza Vaccine Options csl.com ↗
Seqirus, a global leader in influenza prevention, today released a new real-world evidence analysis indicating that its cell-based quadrivalent influenza vaccine (QIVc) was 36.2 percent more effective than standard egg-based quadrivalent vaccine (QIVe) in preventing influenza-like illness (ILI) captured within primary care visits in people aged 4 years and above during the 2017/18 influenza season in the United States, a season characterized by egg-adapted changes. |
| 2018-10-04 | Vaxart | Results New Data from Phase 2 Flu Challenge Study Demonstrates Vaxart’s Oral H1 Flu Vaccine Generated Protective Mucosal Immunity vaxart.com ↗
Further analysis of the data also confirm that, while our vaccine also generated protective hemagglutinin inhibition (HAI) antibodies in serum like conventional injectable flu vaccines, it primarily protected through the mucosal mechanism, providing a robust 39% reduction in illness versus placebo overall. |
| 2018-09-04 | Altimmune, Inc. | Results Altimmune Announces Additional Positive Data from Its Phase 2a Study of NasoVAX Intranasal Influenza Vaccine altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced additional positive data from a Phase 2a study of its NasoVAX intranasal influenza vaccine candidate. |
| 2018-03-27 | Altimmune, Inc. | Results Altimmune Announces Positive Data From Its Phase 2a Study of NasoVAX Intranasal Influenza Vaccine and Provides an Update on Its Phase 1b Study of HepTcell Targeted Immunotherapy in Chronic Hepatitis B Infection altimmune.com ↗
Results from the Phase 2a study of NasoVAX™ intranasal flu vaccine in 60 healthy individuals showed 100% seroprotection in the mid- and high-dose groups. |
| 2018-03-06 | GlaxoSmithKline | Results New clinical data demonstrate high vaccine efficacy of Fluarix Tetra (Influenza Vaccine) in children 6-35 months of age gsk.com ↗
The study met its two primary endpoints, demonstrating 63.2% (97.5% CI: 51.8–72.3) vaccine efficacy against laboratory-confirmed moderate-to-severe influenza, and 49.8% (97.5% CI: 41.8–56.8) vaccine efficacy against influenza of any severity in children six to 35 months of age. |
| 2018-01-25 | FluGen Inc | Results Get ready, some medical experts are predicting the worst flu season in history flugen.com ↗
In Australia it has been effective in only 10 percent of cases, reports The New England Journal of Medicine . |
| 2018-01-22 | Inovio Pharmaceuticals | Results Inovio Pharmaceuticals' Published Universal Flu Vaccine Data Demonstrates Protective Responses Against All Major, Lethal H1N1 Influenza Viruses From the Last 100 Years in Animal Models inovio.com ↗
The flu vaccine also affords 100% protection against lethal challenge in the gold standard ferret model, demonstrating the functionality of such broad protective immune responses. |
| 2017-09-26 | ModernaTX, Inc. | Results Moderna Announces Publication in Molecular Therapy Characterizing Potent Immune Response Generated by Its mRNA Prophylactic Vaccines modernatx.com ↗
In the study, the H10N8 vaccine induced protective titers of HA antibody, as well as CD4+ T cell responses, after intramuscular or intradermal injection into non-human primates (NHPs). |
| 2017-09-14 | NPO Petrovax | Results Clinical trial results of first Russian quadrivalent influenza vaccine presented at the Sixth ESWI Influenza Conference petrovax.com ↗
On 12 September, within the framework of the scientific symposium “A New Generation of Influenza Vaccines: the Future of Influenza Vaccination”, Marina Abramova, Petrovax Pharm’s Vice President for R&D, presented clinical trial results for Grippol® Quadrivalent, the first Russian quadrivalent influenza vaccine. |
| 2017-08-16 | FluGen Inc | Results M2SR, a novel live influenza vaccine, protects mice and ferrets against highly pathogenic avian influenza flugen.com ↗
All M2SR vaccinated mice survived lethal challenge with influenza A/Vietnam/1203/2004 (H5N1), whereas 40% of mice vaccinated with recombinant H5 HA and none of the naïve controls survived. |
| 2017-04-27 | ModernaTX, Inc. | Results Moderna Announces Positive Interim Phase 1 Clinical Data Demonstrating First mRNA Vaccine Candidate, mRNA-1440, Induces High Levels of Immunogenicity modernatx.com ↗ |
| 2016-11-18 | GlaxoSmithKline | Regulatory GSK receives FDA approval for expanded indication for FluLaval® Quadrivalent (Influenza Vaccine) for infants 6 months and older gsk.com ↗
GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research expanding the indication for FluLaval® Quadrivalent (Influenza Vaccine) to include use in children 6 months and older. |
| 2016-10-27 | GlaxoSmithKline | Results GSK presents new data for shingles candidate vaccine at IDWeek scientific conference gsk.com ↗
The data examined co-administration of GSK’s candidate vaccine with the flu vaccine; a flexible dosing schedule; and the vaccine’s impact on quality of life. |
| 2016-10-07 | Merck Sharp & Dohme LLC | Regulatory Merck Animal Health Announces USDA Approval of Innovative Canine Flu Bivalent Vaccine merck.com ↗ |
| 2016-03-22 | NPO Petrovax | Regulatory Russia’s immunobiological industry has made a great progress in import substitution and mastering of cutting-edge vaccine technologies petrovax.com ↗
Petrovax Pharm has been authorised by the Ministry of Health to manufacture Grippol ® Plus, Russian flu vaccine, using flu antigens produced by the Saint Petersburg Research Institute for Vaccines and Sera of the Federal Biomedical Agency of Russia. |
| 2016-02-02 | GlaxoSmithKline | Regulatory GSK announces US regulatory submission seeking expanded indication for FluLaval® Quadrivalent (Influenza Vaccine) for infants 6 mos+ gsk.com ↗
GSK today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for FLULAVAL® QUADRIVALENT (Influenza Vaccine). |
| 2015-11-20 | Merck Sharp & Dohme LLC | Regulatory Merck Animal Health Pioneers H3N2 Canine Influenza Vaccine merck.com ↗
today announced the U.S. Department of Agriculture (USDA) has issued a conditional product license for a vaccine to protect against this newly identified strain of CIV. |
| 2013-04-03 | GlaxoSmithKline | Regulatory GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK gsk.com ↗
Following a decentralised procedure, Germany’s Paul Ehrlich Institut (PEI) was the first national regulatory authority in Europe to grant marketing authorisation for this influenza vaccine, followed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. |
| 2013-03-25 | GlaxoSmithKline | Regulatory Regulatory update: GlaxoSmithKline receives complete response from FDA for candidate pandemic H5N1 adjuvanted influenza vaccine gsk.com ↗
In this case, the Complete Response letter was triggered due to an administrative matter that has recently been rectified. |
| 2013-02-20 | FluGen Inc | Results FluGen’s flu vaccine shows up well in early tests, CEO says flugen.com ↗ |
| 2013-02-06 | FluGen Inc | Results FluGen’s Universal Flu Vaccine REDEE FLU™ Showcased at World Health Organization Influenza Meeting flugen.com ↗
The FluGen data suggest that REDEE FLU™ could be the universal vaccine that dramatically improves the effectiveness of global vaccination initiatives and the world’s population health. |
| 2012-12-17 | GlaxoSmithKline | Regulatory FDA Approves GlaxoSmithKline’s four-strain seasonal influenza vaccine for use in the US gsk.com ↗
the U.S. Food and Drug Administration (FDA) has approved FLUARIX® QUADRIVALENT (Influenza Virus Vaccine) |
| 2012-10-22 | GlaxoSmithKline | Results Results from five phase III studies presented for GSK’s two candidate quadrivalent influenza vaccines gsk.com ↗
Four immunogenicity and safety studies in children and adults showed that both QIVs are highly immunogenic against all four influenza strains contained in the vaccine. |
| 2012-09-06 | NPO Petrovax | Regulatory Russian flu vaccine Grippol® Plus now approved for infants and children aged 6 months and up petrovax.com ↗
The pharmaceutical company Petrovax Pharm is proud to announce that on 17 July 2012 the Russian Ministry of Healthcare expanded the Grippol® Plus indications to include infants and children aged 6 months and up. |
| 2012-03-05 | GlaxoSmithKline | Regulatory Regulatory Update: GSK announces submissions for two influenza vaccines gsk.com ↗
GlaxoSmithKline [GSK] announced today that it has submitted regulatory files for two of its influenza vaccines currently in development. |
| 2011-07-21 | GlaxoSmithKline | Regulatory GlaxoSmithKline European regulatory update on Pandemrix™ gsk.com ↗
GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an update to the product label for the H1N1 influenza vaccine, Pandemrix. |
| 2011-03-09 | FluGen Inc | Results FluGen Scientists Publish in the Journal Vaccine (29:2308-12) flugen.com ↗
The mutant virus elicited sterile immunity in mice, completely protecting them from challenge with a pandemic (H1N1) 2009 virus. |
| 2010-10-22 | AstraZeneca | Regulatory European regulator backs nasal spray vaccine FLUENZ for the prevention of seasonal influenza in children astrazeneca.com ↗
AstraZeneca announced today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the marketing authorisation application for FLUENZ Influenza Vaccine (Live attenuated, nasal), its nasally administered live attenuated influenza vaccine (LAIV) for prevention of seasonal influenza. |
| 2009-11-22 | GlaxoSmithKline | Results Pandemic 2009 Influenza Update: Pandemrix™ data in children and adolescents from 3 to 17 years of age gsk.com ↗
The trial, which is ongoing, shows that after the first dose of adjuvanted vaccine, a strong immune response was demonstrated in all age groups. |
| 2009-11-09 | GlaxoSmithKline | Regulatory Pandemic 2009 Influenza Update: US FDA approves GSK’s pandemic H1N1 vaccine gsk.com ↗
GlaxoSmithKline (GSK) today announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. |
| 2009-11-09 | GlaxoSmithKline | Results Pandemic 2009 Influenza Update: Pandemrix™ data on co-administration with annual seasonal influenza vaccine (Fluarix®) gsk.com ↗
The trial showed that co-administration of one dose of both vaccines in separate arms, induced a strong response in adults for both the H1N1 pandemic vaccine as well as the seasonal vaccine. |
| 2009-10-27 | GlaxoSmithKline | Results Pandemic 2009 Influenza Update: Pandemrix™ data in an elderly population gsk.com ↗
The trial, which is ongoing, shows that after the first dose of adjuvanted vaccine, a strong immune response was demonstrated, inclusive of the over 60 age group. |
| 2009-10-23 | GlaxoSmithKline | Results Pandemic (H1N1) 2009 Influenza Update: Experience of GSK’s H1N1 adjuvanted vaccine, Pandemrix™, and preliminary paediatric results gsk.com ↗
Also announced today are preliminary results from the first paediatric clinical trial assessing use of Pandemrix. |
| 2009-10-15 | GlaxoSmithKline | Results Pandemic (H1N1) 2009 Influenza Update: Results from second clinical trial of GSK’s H1N1 adjuvanted vaccine confirm immune response and tolerability gsk.com ↗
In 100% of the subjects receiving the adjuvanted vaccine the resulting hemagglutination-inhibition titres exceeded the regulatory threshold of 1:40 seroprotection after the first dose. |
| 2009-09-24 | GlaxoSmithKline | Regulatory Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives positive opinion from European Regulators gsk.com ↗
GlaxoSmithKline (GSK) announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommends approval of GSK’s candidate pandemic (H1N1) adjuvanted vaccine Pandemrix™. |
| 2009-09-14 | GlaxoSmithKline | Results Pandemic (H1N1) 2009 Influenza Update: Initial results from first clinical trial of GSK’s H1N1 adjuvanted vaccine gsk.com ↗
The results demonstrate that after one dose the candidate vaccine can provide a strong immune response which exceeds the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine. |
| 2009-09-09 | NPO Petrovax | Regulatory Petrovax Group receives MA for Grippol Neo, an innovative flu vaccine petrovax.com ↗
Petrovax Group, a Russian developer and manufacturer of innovative pharmaceuticals and vaccines, received Grippol Neo marketing authorization (No. LSR-006029 /09) and manufacturing certificate. |
| 2009-01-06 | AstraZeneca | Regulatory MedImmune Submits Marketing Authorisation Application in European Union for Intranasal Vaccine to Prevent Seasonal Influenza astrazeneca.com ↗
MedImmune, the global biologics unit of AstraZeneca, announced today that it has submitted a Marketing Authorisation Application (MAA) for its nasal spray live attenuated influenza vaccine (LAIV), which is now being reviewed by the European Medicines Agency (EMEA). |
All press releases naming this drug 114 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 114 releases opens the full record — a long page | ||
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 80 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Influenza vaccine | “Participants received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV...” NCT05705440 ↗74“Influenza Vaccine recommended by World Health Organization(WHO) in that year and imported 23-Valent Pneumococcal Polysaccharide Vaccine approved by China Food and Drug...” NCT03449459 ↗ “Participants >= 12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.” NCT00880893 ↗ “Influenza vaccine” NCT01072734 ↗ |
| Known as | Flulaval | “Experimental group given influenza vaccine (Flulaval)” NCT05654441 ↗ |
| Known as | FluVac | “influenza vaccine (FluVac)” PMID 40432084 ↗ Apr 2025 |
| Known as | IIV3 | “BACKGROUND: Few data exist on the immunogenicity and safety of an inactivated enterovirus 71 vaccine (EV71 vaccine) coadministered with trivalent split-virion inactivated...” PMID 36569946 ↗ Dec 20221“standard-dose trivalent inactivated influenza vaccination (IIV3)” PMID 30277500 ↗ Jun 2019 |
| Known as | influvac | “surface antigen, inactivated, prepared in egg (influvac ®)” NCT01013675 ↗ |
| Known as | MF59-adjuvanted vaccine | “MF59-adjuvanted vaccine (Sub/MF59, n = 130)” PMID 19561422 ↗ Jul 2009 |
| Known as | QIV | “This study evaluated coadministration of 20-valent pneumococcal conjugate vaccine (PCV20) and an adjuvanted quadrivalent inactivated influenza vaccine (QIV).” PMID 36828719 ↗ Feb 2023 |
| Known as | Sequiris Fluad Quad | “Influenza vaccine (Sequiris Fluad Quad)” NCT07587801 ↗ |
| Known as | SIIV | “Seasonal inactivated influenza vaccine (SIIV)” NCT04526574 ↗ |
| Known as | split vaccine | “nonadjuvanted split vaccine (split, n = 139)” PMID 19561422 ↗ Jul 2009 |
| Known as | Sub/MF59 | “MF59-adjuvanted vaccine (Sub/MF59, n = 130)” PMID 19561422 ↗ Jul 2009 |
| Known as | trivalent split-virion inactivated influenza vaccine | “BACKGROUND: Few data exist on the immunogenicity and safety of an inactivated enterovirus 71 vaccine (EV71 vaccine) coadministered with trivalent split-virion inactivated...” PMID 36569946 ↗ Dec 2022 |
| Known as | VaxigripTetra | “Name of investigational treatment: Influenza vaccine (VaxigripTetra, Sanofi Pasteur MSD).” NCT02831608 ↗ |
| Action | Activate | “influenza vaccine, to directly activate NK cells” NCT02998736 ↗ |
| Modality | Vaccine | “Influenza vaccine” NCT00214071 ↗ |
| Route | Intramuscular | “0.5 mL intramuscular injection” NCT00231816 ↗ |