Bavarian Nordic submits data to EU regulator for adolescent Mpox vaccine extension.

Danish biotech company Bavarian Nordic has submitted data to the European Union's drug regulator for approval to extend the use of its Mpox vaccine (JYNNEOS, also known as IMVANEX) for adolescents aged 12-17. The vaccine is currently approved for use in adults aged 18 and over. CEO Paul Chaplin stated that the expanded approval for teenagers would be crucial in tackling the outbreak, which primarily affects adolescents and young children. The World Health Organization declared an escalating Mpox outbreak in Africa as a public health emergency, with more than 15,000 cases and at least 537 deaths reported this year. Bavarian Nordic plans to conduct a study of the vaccine in children aged 2 to 12 years old in the Democratic Republic of the Congo and Uganda later this year.

August 16, 2024
54 Articles