Bavarian Nordic Gets EMA Approval Of Mpox Vaccine
EMA approves Bavarian Nordic’s mpox vaccine for teenagers
Bavarian Nordic’s MVA-BN vaccine is called Imvanex in Europe but is known as Jynneos in countries such as the US and Singapore. Currently, the vaccine is only approved for adults by the US Food and Drug Administration (FDA).
Bavarian Nordic Receives EMA Approval of Mpox Vaccine for Adolescents
MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMARepresents the second EMA approval of an MVA-BN-based vaccine for a younger population COPENHAGEN,
Bavarian Nordic Gets EMA Approval Of Mpox Vaccine For Adolescents
(RTTNews) - Bavarian Nordic A/S (BAVA) Thursday said that the European Commission has adopted the Committee for Medicinal Products for Human Use (CHMP) recommendation for the approval of a type II variation for IMVANEX smallpox and mpox vaccine. This extends the current marketing authorization to include adolescents 12 to 17 years of age.
Bavarian says mpox vaccine approved by EU regulator for adolescents
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 using the shot in the 12 to 17 age group to contain an outbreak in parts of Africa.
Bavarian Nordic mpox shot gains approval for adolescents in EU
The European Commission has approved Bavarian Nordic's (OTCPK:BVNRY)(OTCPK:BVNKF) mpox shot for adolescents between 12 and 17 years old. Approval was based on data from a clinical study of more than 300 adolescents and 200 adults that found non-inferior immune responses and similar safety profile between both age groups after two standard doses
Bavarian Nordic stock jumps 16% on EMA mpox vaccine update
Bavarian Nordic said the vaccine could receive EMA authorization for adolescents in Q4. The company is also preparing ...
Nasdaq1mon
Bavarian Nordic Submits Data To EMA To Approve Use Of Mpox/Smallpox Vaccine In Adolescents
(RTTNews) - Bavarian Nordic (BVNKF.PK) has submitted clinical ... The company said, following review of the data by EMA, the Marketing Authorisation for IMVANEX could be extended to include ...
KRQE Blogs1mon
Bavarian Nordic Submits Data to EMA to Extend Mpox/Smallpox Vaccine Approval to Adolescents
Following review of the data by EMA, the Marketing Authorisation for IMVANEX could be extended to include use of the vaccine for adolescents during the fourth quarter of 2024. Bavarian Nordic is ...
Pharmabiz1mon
Bavarian Nordic submits clinical data to EMA to extend mpox/smallpox vaccine approval to adolescents
Bavarian Nordic A/S has submitted clinical data to the European Medicines Agency (EMA) to support the extension of the Imvanex (MVA-BN) smallpox and mpox vaccine indication to include ...
Finanznachrichten1d
Bavarian Nordic A/S: Bavarian Nordic Receives EMA Approval of Mpox Vaccine for Adolescents
Paul Chaplin, President & CEO of Bavarian Nordic, said: "We applaud EMA for their expedited review and decision to recommend approval of MVA-BN for adolescents. This represents an important ...
Yahoo Finance1mon
Bavarian Nordic Submits Data to EMA to Extend Mpox/Smallpox Vaccine Approval to Adolescents
COPENHAGEN, 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 ®) ...