Bavarian Nordic Receives EMA Approval of Mpox Vaccine for …
WEB1 day ago · Bavarian Nordic A/S. MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA. Represents the second EMA approval of an MVA-BN-based ...
Bavarian Nordic Receives EMA Approval of Mpox Vaccine for
WEB1 day ago · Bavarian Nordic is preparing for a clinical trial (NCT06549530) to assess the immunogenicity and safety of MVA-BN in children 2-12 years of age, aiming to further extend the indication of the ...
EMA approves Bavarian Nordic’s mpox vaccine for teenagers
WEB13 hours ago · Adolescents in Europe aged 12 to 17 years can now receive the vaccine. Image credit: Shutterstock / ZaitsevMaksym. The European Medicines Agency (EMA) has approved the use of Bavarian Nordic ’s mpox vaccine in adolescents, increasing the chances for its use in this age group in Africa. The label extension is via a …
News | Bavarian Nordic
WEBAug 16, 2024 · Bavarian Nordic Submits Data to EMA to Extend Mpox/Smallpox Vaccine Approval to Adolescents. Interim results from clinical study show non-inferiority of immune responses from mpox/smallpox vaccination in adolescents and similar safety profile compared to adults, supporting the extension of current approval in Europe later in 2024.
Bavarian says mpox vaccine approved by EU regulator for …
WEB2 days ago · Thu, Sep 19, 2024, 10:30 AM 2 min read. LONDON (Reuters) -Bavarian Nordic said on Thursday its mpox vaccine was approved by the EU's drug regulator for use in adolescents, bolstering the case for ...
News | Bavarian Nordic
WEBJul 26, 2024 · After a systematic review and analysis of data from real-world observational studies conducted in vaccine-eligible individuals and published after the onset of the global mpox outbreak in 2022, Bavarian Nordic submitted an application to EMA in late 2023 for a type II variation, representing a major change to the marketing authorization for MVA-BN.
EU drugs watchdog backs Bavarian Nordic’s mpox vaccine for
WEB1 day ago · Bavarian Nordic’s mpox shot is the first approved in Europe for anyone under the age of 18. The decision comes a week after the World Health Organization approved the vaccine for adults. A clinical study, in 211 adults and 312 adolescents aged 12 to 17, found a “similar safety profile” and “non-inferiority of the immune responses” in ...
Bavarian Nordic Receives EMA Approval of Mpox Vaccine for …
WEB2 days ago · Del. MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA. Represents the second EMA approval of an MVA-BN-based vaccine for a younger population. COPENHAGEN, Denmark, September 19, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today that the European Commission has adopted the ...
News - Bavarian Nordic
WEBJun 26, 2024 · Bavarian Nordic Submits Marketing Authorization Application for its Chikungunya Vaccine Candidate to EMA. Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older is …
Bavarian Nordic Submits Data to EMA to Extend Mpox/Smallpox …
WEBCOPENHAGEN, Denmark, August 16, 2024 – Bavarian Nordic A/S (OMX: BAVA) has submitted clinical data to the European Medicines Agency (EMA) to support the extension of the IMVANEX ® (MVA-BN ®)...