EMA approves Bavarian Nordic's mpox vaccine for teenagers [Yahoo! Finance]
BAVARIAN NORDIC R/I S/ADR (BVNRY)
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Source: Yahoo! Finance
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 type II variation – a route used when a major change is needed in the marketing authorisation for a medicine approved in Europe. Bavarian Nordic applied for the change last month. The Committee for Medicinal Products for Human Use (CHMP) recommended extending the marketing authorisation to teenagers, which the European Commission (EC) then backed, as per a 19 September press release. The decision means that, in addition to adults, adolescents in Europe aged 12 to 17 years can now receive the vaccine. 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). A Bavarian Nordic spokesperson confirmed to Pharmaceutica
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