- The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a "positive opinion" recommending Bavarian Nordic A/S's BVNRY smallpox vaccine, Imvanex, be authorized to include protection against monkeypox on its label.
- The vaccine is approved for use against monkeypox in the U.S. and Canada, where it is marketed as Jynneos and Imvamune, respectively. It is only authorized for use against smallpox in Europe.
- But the company has supplied the vaccine to several EU countries during the current monkeypox outbreak for "off-label" use, Reuters reported.
- Bavarian Nordic said the regulator asked it to submit more data to expand its market authorization in light of the growing monkeypox outbreak.
- Related Content: Bavarian Nordic Inks Multiple Supply Pact For Its Monkeypox Vaccine, Updates FY22 Guidance.
- Paul Chaplin, President & CEO of Bavarian Nordic, said the extension of the vaccine's label "will help to improve access to the vaccine throughout Europe and strengthen the future preparedness against monkeypox."
- Earlier this week, Bavarian Nordic said that a non-disclosed European country ordered an additional 1.5 million doses of Imvanex.
- While deliveries under this contract will start in 2022, most of the doses will be delivered during 2023.
- According to data from the European Center for Disease Prevention and Control and the World Health Organization, 10,604 cases of monkeypox have been identified throughout the European region.
- Price Action: BVNRY shares closed higher by 4.38% at $14.65 on Thursday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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