Drugs / VLA2001
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | UK (MHRA) | — | COVID-19 | 2021-08-23 | “today commenced rolling submission, for initial approval of its COVID-19 vaccine candidate, VLA2001, with the Medicines and Healthcare products Regulatory Agency (MHRA)” valneva.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04671017 | Dec 2020 → Feb 2021 | COVID-19 | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05298644 | Oct 2022 → Jul 2023 | COVID-19 | Valneva Austria GmbH | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT05364242 | May → Sep 2022 | Orthocoronavirinae infectious disease | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT05545683 | Dec 2022 → Mar 2023 | COVID-19 | Centro de Estudios en Infectogía Pediatrica | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04956224 | Aug → Nov 2021 | COVID-19 | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT04864561 | Apr → Jul 2021 | COVID-19 | Valneva Austria GmbH | Completed | Met primary |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2023-03-02 | Valneva Austria GmbH | Results Valneva Provides Clinical and Regulatory Updates for its COVID-19 Vaccine VLA2001 valneva.com ↗
In dieser Studie waren die neutralisierenden Antikörper am Tag 208 (sechs Monate nach der zweiten Dosis der Primärimmunisierung mit VLA2001) im Vergleich zum aktiven Vergleichsimpfstoff AZD1222, einem adenoviralen Vektorimpfstoff, nicht unterlegen. |
| 2022-12-30 | Valneva Austria GmbH | Results Valneva Reports Further Heterologous Booster Data for its Inactivated COVID-19 Vaccine valneva.com ↗ |
| 2022-09-06 | Valneva Austria GmbH | Results Valneva Announces Publication of its COVID-19 Vaccine Phase 3 Data in The Lancet Infectious Diseases valneva.com ↗
Valneva gibt die Veröffentlichung der Phase 3-Daten seines COVID-19 Impfstoffs in The Lancet Infectious Diseases bekannt |
| 2022-08-29 | Valneva Austria GmbH | Results Valneva Reports Further Positive Phase 3 Immunogenicity and the First Heterologous Booster Results for its Inactivated, Adjuvanted COVID-19 Vaccine VLA2001 valneva.com ↗
Des données supplémentaires provenant de l’essai pivot VLA2001 -301, « Cov-Compare », de la Société ont montré une immunogénicité persistante et des premiers résultats positifs d’utilisation comme rappel hétérologue après une primovaccination avec ChAdOx1-S (AstraZeneca). |
| 2022-08-23 | Valneva Austria GmbH | Regulatory Valneva Confirms WHO Recommendations for its Inactivated COVID-19 Vaccine valneva.com ↗ |
| 2022-06-24 | Valneva Austria GmbH | Regulatory Valneva Receives Marketing Authorization in Europe for Inactivated Whole-Virus COVID-19 Vaccine VLA2001 valneva.com ↗
gab heute bekannt, dass die Europäische Kommission die Marktzulassung für Valnevas inaktivierten COVID-19-Ganzvirusimpfstoff VLA2001 zur Verwendung als Erstimpfung bei Menschen im Alter von 18 bis 50 Jahren in Europa erteilt hat. |
| 2022-06-23 | Valneva Austria GmbH | Regulatory Valneva Receives Positive CHMP Opinion for Marketing Authorization of its Inactivated COVID-19 Vaccine Candidate in Europe valneva.com ↗ |
| 2022-05-19 | Valneva Austria GmbH | Regulatory EMA accepts filing of marketing authorization application for Valneva’s inactivated COVID-19 Vaccine Candidate valneva.com ↗
L’acceptation du dossier signifie que VLA2001 sort du processus de revue progressive des données pour rentrer dans le processus formel d’évaluation par le comité des médicaments à usage humain (CHMP) de l’EMA. |
| 2022-05-16 | Valneva Austria GmbH | Regulatory Valneva Receives Emergency Use Authorization from the United Arab Emirates for its Inactivated COVID-19 Vaccine valneva.com ↗
annonce aujourd'hui que les Émirats arabes unis ont accordé une autorisation pour l’utilisation d’urgence du vaccin inactivé et adjuvanté de Valneva contre la COVID-19, VLA2001. |
| 2022-04-25 | Valneva Austria GmbH | Regulatory Valneva Provides Regulatory Update on its inactivated COVID-19 Vaccine Candidate valneva.com ↗
Suite à la réunion du CHMP la semaine dernière, Valneva a reçu une nouvelle Liste de Questions (LoQ). |
| 2022-04-14 | Valneva Austria GmbH | Regulatory Valneva Receives Conditional Marketing Authorization from UK MHRA for its Inactivated COVID-19 Vaccine valneva.com ↗ |
| 2022-03-11 | Valneva Austria GmbH | Regulatory Valneva Provides Regulatory Update on its COVID-19 Vaccine Candidate valneva.com ↗
Valneva a maintenant reçu un faible nombre de questions supplémentaires et prévoit d’y répondre dans les prochains jours. |
| 2022-03-01 | Valneva Austria GmbH | Regulatory Valneva Receives Emergency Use Authorization from Bahrain for its Inactivated COVID-19 Vaccine VLA2001 valneva.com ↗
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), ein spezialisiertes Impfstoff -Unternehmen, gab heute bekannt, dass die Nationale Gesundheitsbehörde (NHRA) des Königreichs Bahrain eine Notfallzulassu ng für den inaktivierten, adjuvantierten COVID -19-Impfstoff VLA2001 von Valneva erteilt hat. |
| 2022-02-25 | Valneva Austria GmbH | Regulatory Valneva Receives Initial CHMP Assessment of its Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001 valneva.com ↗ |
| 2022-01-19 | Valneva Austria GmbH | Results Valneva’s Inactivated COVID-19 Vaccine Candidate Shown to Neutralize Omicron Variant valneva.com ↗
La totalité des 30 échantillons (100 %) ont présenté des anticorps neutralisants contre le virus historique et le variant Delta, et 26 é chantillons (87 %) contre le variant Omicron. |
| 2021-12-16 | Valneva Austria GmbH | Results Valneva Announces Positive Homologous Booster Data for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001 valneva.com ↗ |
| 2021-12-03 | Valneva Austria GmbH | Results Valneva Comments on COV-Boost Clinical Trial Data valneva.com ↗
Valneva estime probable que le court intervalle entre la deuxième injection et l'injection de rappel ait pu avoir un impact négatif sur les résultats de VLA2001 |
| 2021-12-02 | Valneva Austria GmbH | Regulatory Valneva Confirms Initiation of Rolling Review with EMA and Provides Updates on its COVID-19 Vaccine Program VLA2001 valneva.com ↗
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirmed that the European Medici nes Agency (EMA) has started a rolling review of VLA2001, its whole-virus inactivated , adjuvanted COVID-19 vaccine candidate. |
| 2021-10-18 | Valneva Austria GmbH | Results Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001 valneva.com ↗
VLA2001 hat beide co-primären Endpunkte erfolgreich erreicht |
| 2021-08-23 | Valneva Austria GmbH | Regulatory Valneva Commences Rolling Submission to MHRA for its Inactivated, Adjuvanted COVID-19 Vaccine valneva.com ↗
We are pleased to begin the regulatory review process for our COVID-19 vaccine with the MHRA. |
| 2021-04-06 | Valneva Austria GmbH | Results Valneva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001 valneva.com ↗
VLA2001 was generally well tolerated across all dose groups tested, with no safety concerns identified by an independent Data Safety Monitoring Board . |
All press releases naming this drug 32 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VLA2001 | “VLA2001 is a highly purified whole virus, inactivated, adjuvanted vaccine, using the manufacturing platform of Valneva's encephalitis (JE) vaccine” NCT05545683 ↗ |
| Known as | Valneva COVID-19 vaccine | “The Valneva COVID-19 vaccine (VLA2001; Valneva Austria, Vienna, Austria) is an inactivated whole-virus, adjuvanted SARS-CoV-2 vaccine.” PMID 36075233 ↗ Sep 2022 |
| Modality | Vaccine | “whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide” NCT04671017 ↗ |
| Route | Intramuscular | “All participants will received a total of two vaccinations intramuscularly, on day 1 and day 22.” NCT04671017 ↗ |