Bavarian Nordic’s Chikungunya Vaccine Candidate Granted Accelerated Assessment by European Medicines Agency
BAVARIAN NORDIC R/I S/ADR (BVNRY)
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bavarian-nordic.com/investor.aspx
Company Research
Source: GlobeNewswire
Accelerated assessment allows for a shorter review period with EMA.Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024. COPENHAGEN, Denmark, February 23, 2024 – Bavarian Nordic A/S (OMX: BAVA) (“the Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming Marketing Authorisation Application (MAA) for CHIKV VLP, the Company’s investigational chikungunya vaccine. The accelerated assessment, which is granted based upon CHMP’s decision that the vaccine candidate is of major interest for public health and therapeutic innovation, may reduce the timeframe for the review of the MAA from 210 days under the standard review procedure to 150 days, not counting clock stops when applicants must provide additional information1. Bavarian Nordic is on track and plans to submit its MAA for CHIKV VLP to the
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- Morris & Dickson is the First U.S. Distributor for Bavarian Nordic's JYNNEOS®, the Only FDA-approved Mpox Vaccine [Yahoo! Finance]Yahoo! Finance
- Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the U.S. [Yahoo! Finance]Yahoo! Finance
- Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the U.S.GlobeNewswire
- Mpox cases in the US are on the rise as vaccination rates lag and new threats loom [CNN]CNN
- Mpox cases in the US are on the rise as vaccination rates lag and new threats loom [CNN]CNN