Bavarian Nordic, the manufacturer of the only mpox vaccine, is seeking to extend the shot’s license in Europe to include adolescents aged 12 to 17 years, as a more deadly version of the virus — formerly known as monkeypox — spreads largely through young children in Africa.
The Danish drugmaker has submitted further data to support its shot, Imvanex, to the European Medicines Agency, it said in a statement Friday. This comes from early results from a U.S.-sponsored trial in 315 adolescents and 211 adults that shows the immune response and side-effects are similar between the two age groups, at two standard doses.
On Wednesday, the World Health Organization declared a global health emergency as the mpox virus fast spread within the Democratic Republic of the Congo (DRC) and neighboring countries.
The first case in Europe was reported in Sweden on Thursday, prompting several countries to issue emergency procedures to health workers on how to detect and contain the spread of the virus. China is already taking surveillance and sanitation measures for arrivals from affected countries, reported Reuters.
This more deadly strain is known as clade I, and it appears to be disproportionately affecting children. In June, the WHO reported that 39 percent of cases and 62 percent of deaths were in children under 5 years old.
Bavarian Nordic also said Friday that a study of the vaccine in children aged 2 to 12 years-old will take place in DRC and Uganda later this year.
“Children and adolescents are disproportionally affected by mpox in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to vaccines and therapies for this vulnerable population,” said Paul Chaplin, Bavarian Nordic’s CEO.
Africa’s disease agency has asked for 10 million vaccine doses. To date, the EU has offered 215,000 from the 2 million doses it bought during the last outbreak, declared in 2022.
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