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25. Okt. 2023 · Valneva, ein spezialisiertes Impfstoffunternehmen, hat einen Zulassungsantrag für VLA1553, den ersten und einzigen Chikungunya-Impfstoffkandidaten weltweit, bei der Europäischen Arzneimittel-Agentur (EMA) eingereicht. VLA1553 ist ein PRIority MEdicine (PRIME) und hat einen Fast-Track Status bei der FDA.
4. Juni 2024 · Valneva is a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.
- Standard Marketing Authorisation
- Where to Find More Information
- How Covid-19 Vaccine (inactivated, Adjuvanted) Valneva Works
- Monitoring The Safety of Covid-19 Vaccine (inactivated, Adjuvanted) Valneva
- Assessment of Covid-19 Vaccine (inactivated, Adjuvanted) Valneva
The dossier for the vaccine includes the results from an immunobridging trial. Although efficacy placebo-controlled trials have been the gold standard for authorising COVID-19 vaccines so far, EMA considers that a well-justified and appropriately designed immunobridging study is adequate for authorising future COVID-19 vaccines at this point in the...
The product information for COVID-19 Vaccine (inactivated, adjuvanted) Valneva contains COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Product information, a package leafletfor members of the public and details of the vaccine’s authorisation. An assessment report with details of EMA’s evaluation of COVID-19 Vaccine (inactivated, adjuva...
COVID-19 Vaccine (inactivated, adjuvanted) Valneva works by preparing the body to defend itself against COVID-19. The vaccine contains whole particles of the original strain of SARS-CoV-2 that has been inactivated (killed) and cannot cause the disease. It also contains two ‘adjuvants’, substances that help strengthen the immune responses to the vac...
In line with the EU’s safety monitoring plan for COVID-19 vaccines, COVID-19 Vaccine (inactivated, adjuvanted) Valneva will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines. Although large numbers of people have received COVID-19 vaccines in clinical trials, certain side effects may only emerge whe...
During the assessment of COVID-19 Vaccine (inactivated, adjuvanted) Valneva, the CHMP had the support of EMA’s safety committee, the PRAC, who assessed the risk management plan of the vaccine, and the COVID-19 EMA pandemic task force (COVID-ETF), a group that brings together experts from across the European medicines regulatory networkto facilitate...
1. Juli 2024 · Valneva gibt Ergebnisse für das erste Quartal 2024 und aktuelle Unternehmensinformationen bekannt.
1. Juli 2024 · Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP Global Communications & European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelot-fontaine@valneva.com
1. Juli 2024 · Valneva SE gab bekannt, dass die Europäische Kommission (EK) die Marktzulassung für Valnevas Einzelimpfstoff IXCHIQ zur Vorbeugung von Erkrankungen durch das Chikungunya-Virus bei Personen ab 18 Jahren in Europa erteilt hat.
Vor einem Tag · Valneva SE VALN recently announced that the European Commission (EC) has given it the marketing authorization for Valneva’s single-dose Chikungunya vaccine, IXCHIQ, in Europe. This approval ...
