VLA

Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15

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星期一, 十二月 4, 2023
DSMB, Food, Șaeș, Euronext Paris, BLA, Data monitoring committee, Marketing, PFE, FDA, EMA, MAA, Lyme disease, Disease, Research, Biologics license application, European Medicines Agency, VLA, Safety, Development, Senior, Vaccine

Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15

Key Points: 
  • Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15
    9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic
    Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026
    New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15.
  • The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.
  • “We are pleased that the Phase 3 trial recruitment is complete.
  • Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.3,4

Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ®

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星期一, 十二月 4, 2023
Interest group, Licensure, Șaeș, U.S. FDA, Euronext Paris, Antibody, EMA, FDA, Ageing, Trial of the century, Vaccination, Public, Health Canada, Chikungunya, VLA, Safety, Vaccine

These persistence data are intended to supplement the existing approval by U.S. FDA and ongoing regulatory approval processes.

Key Points: 
  • These persistence data are intended to supplement the existing approval by U.S. FDA and ongoing regulatory approval processes.
  • 97% of the 316 healthy adults still enrolled in the trial retained neutralizing antibody titers above the seroresponse threshold2 twenty-four months after the single-dose vaccination.
  • Being the world's first approved vaccine against chikungunya, each positive outcome further strengthens the defense against this significant and expanding public health threat.”
    Valneva was granted U.S. FDA approval4 for its chikungunya vaccine IXCHIQ® in November 20235.
  • A clinical study in adolescents is also ongoing in Brazil for which the Company reported positive pivotal Phase 3 data in November 20236.

EMA Accepts Valneva’s Chikungunya Vaccine Marketing Authorization Application for Accelerated Assessment

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星期一, 十一月 27, 2023
Licensure, Food, Risk, Euronext Paris, Saint-Herblain, Marketing, EMA, MAA, FDA, Disease, MD, Chikungunya, European Medicines Agency, Public, VLA, CHMP, Pharmaceutical industry

Saint-Herblain (France), November 27, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has performed a technical validation of the Marketing Authorization Application (MAA) for Valneva’s single-shot chikungunya vaccine candidate VLA1553 and has determined that all essential regulatory elements required for scientific assessment were included in the application.

Key Points: 
  • Saint-Herblain (France), November 27, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has performed a technical validation of the Marketing Authorization Application (MAA) for Valneva’s single-shot chikungunya vaccine candidate VLA1553 and has determined that all essential regulatory elements required for scientific assessment were included in the application.
  • The MAA was granted accelerated assessment1 last month by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”2.
  • Accelerated assessment reduces the timeframe for EMA’s CHMP to review a MAA once it is accepted for review from 210 days under the standard review procedure to 150 days.
  • The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations.

Valneva Announces the Availability of Documentation for its Extraordinary General Meeting including Planned Changes to its Future Board of Directors

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星期三, 十一月 15, 2023
VLA, Annual general meeting, Lyme disease, EGM, Euronext Paris, Supervisory board, Saint-Herblain, Chikungunya, Radisson Blu Hotel Hamburg, Bulletin, CET, Documentation, Supervision, Management, Valneva SE

As part of the proposed changes, three current Supervisory Board members will not join the future Board of Directors, Ms. Johanna Pattenier, Ms. Sharon Tetlow and Mr. Frederic Grimaud, current Chairman of the Supervisory Board.

Key Points: 
  • As part of the proposed changes, three current Supervisory Board members will not join the future Board of Directors, Ms. Johanna Pattenier, Ms. Sharon Tetlow and Mr. Frederic Grimaud, current Chairman of the Supervisory Board.
  • I wish Valneva every success in the future,” said Frederic Grimaud, Valneva’s Chairman of the Board and Groupe Grimaud’s President and Chief Executive Officer.
  • The future Board of Directors is expected to elect a new chairperson during its constitutional post EGM meeting.
  • The Company also intends to propose additional, complementary Board of Directors members to its shareholders at its Annual General Meeting in June 2024.

Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate

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星期一, 十一月 13, 2023
VLA, CEPI, Epidemic, Euronext Paris, Adolescence, Licensure, Safety, Saint-Herblain, Food, European Medicines Agency, GMT, Ageing, CHIKV, Valneva SE, Clinical trial, Vaccination, EMA, History, European, FDA, Coalition, Instituto Butantan, Geometric mean, Antibody, Food and Drug Administration, Vaccine

Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.

Key Points: 
  • Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.
  • These results complement the initial Phase 3 safety data the Company reported for the trial in August 20231.
  • The pivotal immunogenicity data showed that a single-dose vaccination with VLA1553 induced a robust immune response in adolescents aged 12 to
  • An independent Data Safety Monitoring Board has continuously evaluated safety data during the trial and has not identified any safety concerns.

Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ®

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星期五, 十一月 10, 2023
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Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

Key Points: 
  • Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.
  • As sponsor of the first chikungunya vaccine approved in the U.S., Valneva has received a Priority Review Voucher (PRV) from the FDA, which it intends to monetize to help finance its research and development (R&D) programs.
  • With this U.S. approval, IXCHIQ® becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva1 has brought from early R&D to approval.
  • Initial safety data from this trial were included in the submission to the European Medicines Agency (EMA) in October 202313.

Valneva to Present and Hold Investor Meetings at the Jefferies London Healthcare Conference

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星期二, 十一月 7, 2023
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Saint-Herblain (France), November 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference, to take place November 14-16, 2023 in London, UK.

Key Points: 
  • Saint-Herblain (France), November 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference, to take place November 14-16, 2023 in London, UK.
  • Chief Executive Officer Thomas Lingelbach and Chief Financial Officer Peter Bühler will host a fireside chat at 2:30pm GMT on November 14 to discuss Valneva’s commercial business and pipeline of infectious disease vaccines.
  • A replay of the webcast will be available following the live events in the “Investor” section of the Valneva website at www.valneva.com .
  • To request a meeting at the event, please contact your representative at Jefferies.

Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Announces CHMP Accelerated Assessment

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星期三, 十月 25, 2023
FDA, Chikungunya, Biologics license application, VLA, PDUFA, Food, CHMP, Priority, Prescription Drug User Fee Act, European Directive on Traditional Herbal Medicinal Products, MD, Health Canada, European Medicines Agency, Regulation of tobacco by the U.S. Food and Drug Administration, Valneva SE, Euronext Paris, Saint-Herblain, CHIKV, Risk, EMA, Public, Fast track (FDA), BLA, Lancet, Pharmaceutical industry

Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553.

Key Points: 
  • Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553.
  • Valneva was also granted accelerated assessment1 for the application by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”.
  • VLA1553 is currently the first and only chikungunya vaccine candidate worldwide for which regulatory review processes are underway.
  • Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s accelerated assessment and will work closely with them to bring this vaccine to market.

Valneva to Present on Chikungunya at Several Leading Scientific Conferences

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星期三, 十月 11, 2023
ISPOR, Vaccine, CDT, Central Time Zone, Tropical medicine, Disease, Donald Mackay Medal, International Society, CHIKV, Pharmacoeconomics, Cost, VLA, Systematic, European Congress of Mathematics, Society, IDSA, Climate, Infectious Diseases Society of America, CEST, Meta-analysis, Vaccination, Pulse vaccination strategy, Pregnancy, Disability-adjusted life year, EDT, Patient, Central European Summer Time, Euronext Paris, Global Burden of Disease Study, Valneva SE, Saint-Herblain, Pharmaceutical industry, Immunodeficiency, Chikungunya, Hygiene

Saint-Herblain (France), October 11, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today it will present on the mosquito-borne chikungunya disease at several leading scientific conferences during the fourth quarter of 2023.

Key Points: 
  • Saint-Herblain (France), October 11, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today it will present on the mosquito-borne chikungunya disease at several leading scientific conferences during the fourth quarter of 2023.
  • At IDWeek, the annual meeting of the Infectious Diseases Society of America (IDSA), Valneva will support the roundtable discussion “Chikungunya is an Increasing Global Threat: The Need for Better Protection” taking place on October 14, 2023 at 6:00 pm Eastern Daylight Time (EDT) in Boston, Massachusetts.
  • At the American Society of Tropical Medicine and Hygiene (ASTMH) 2023 Annual Meeting in Chicago, Illinois, Valneva will hold two chikungunya presentations on October 20, 2023 at 11:00 am and 12:15 pm Central Daylight Time (CDT).
  • At the International Society of Vaccines Annual Congress taking place in Lausanne, Switzerland Valneva will present on chikungunya on October 24, 2023 at 09:45 am Central European Summer Time (CEST).

Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32 Million

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星期一, 九月 25, 2023
Travel, JE, United States Department of Defense, Valneva SE, Walter Reed Army Institute of Research, Military personnel, Euronext Paris, VLA, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Department of Defence, Food, Pharmaceutical industry, Research

Saint Herblain (France), September 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of a new $32 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®.

Key Points: 
  • Saint Herblain (France), September 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of a new $32 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®.
  • Under this new one-year contract, the DoD will buy a minimum of $32 million worth of IXIARO® vaccines and has the possibility to purchase additional doses during the coming twelve months.
  • Dipal Patel, Chief Commercial Officer of Valneva commented, “We are excited to continue our long-term relationship with the DoD.
  • In the U.S., Valneva markets and distributes IXIARO® directly to the military and private travel market.