Mpox vaccine maker seeks approval for use in teens
LOOK: (FILES) This file photo taken on 10 August 2022 shows a pharmacist administering a dose of Imvanex, a vaccine to protect against Monkeypox virus, at a pharmacy in Lille, northern France. Shares of the pharmaceutical laboratories of Bavarian Nordic in Denmark, which manufactures a specific vaccine against the mpox, jumped up on 15 August 2024 following the decision of the World Organization of Health WHO to consider the resurgence of monkeypox cases together with an urgent need for health care in the world. A surging mpox outbreak in Africa, which was declared an emergency by the continent's health agency on 13 August, is being driven by a new, more transmissible strain of the virus. The Africa Centres for Disease Control and Prevention (Africa CDC) declared its first-ever Public Health Emergency of Continental Security (PHECS) for the deadly disease. Bavarian Nordic mainly supplies its mpox vaccine - called Jynneos in the US, Imvanex in the European Union - to governments and international organisations but began marketing it in the US market in April.
📸 FRANCOIS LO PRESTI / AFP
Danish drugmaker Bavarian Nordic said Friday it was seeking European approval to use its mpox vaccine in children aged 12 to 17, after the WHO declared the current virus surge a global public health emergency.
The World Health Organization (WHO) this week declared the rapid spread of the new, more dangerous mpox strain, dubbed Clade 1b, a public health emergency of international concern -- the highest alarm the UN agency can sound.
Bavarian Nordic's vaccine is currently only approved for people 18 years and older.
"Children and adolescents are disproportionately 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," Bavarian Nordic chief executive Paul Chaplin said in a statement.
The company said it had presented the European Medicines Agency with clinical data from a study which showed "non-inferiority of immune responses from mpox/smallpox vaccination in adolescents and (a) similar safety profile compared to adults."
The US Food and Drug Administration (FDA) granted the vaccine an "emergency use authorisation" for adolescents during the 2022 global mpox outbreak.
The virus has swept through the Democratic Republic of Congo, killing 548 people so far this year.
Sweden and Pakistan have this week reported the first cases of the virus outside of Africa, with the WHO warning further imported cases of the new strain in Europe were likely.
The infectious disease is caused by a virus transmitted to humans by animals but can also spread human-to-human through close physical contact.
It causes fever, muscular aches and large boil-like skin lesions.
On Thursday, Bavarian Nordic said it was ready to produce 10 million vaccine doses by 2025 but was waiting for countries to place orders.
It said it has some 500,000 doses in stock.