LONDON, Sept 19 (Askume) – Bavarian Nordic AG (BAVA.CO) said on Thursday its Mpox vaccine has been approved by the European Union’s drug regulator for use in teenagers to help curb outbreaks in parts of Africa. The power is more powerful.
The World Health Organization (WHO) has declared ampox a global public health emergency, with children and adolescents particularly vulnerable to the disease.
Bavaria’s JYNNEOS is also approved by the US Food and Drug Administration (FDA), but only for adults 18 years and older, although emergency use authorization was granted for use in adolescents during the 2022 Mpox outbreak.
Approval by the Committee for Medicinal Products for Human Use (CHMP)The report is based on data submitted by the Danish biotech to the European Medicines Agency (EMA) last month .
“We applaud the EMA’s decision to recommend accelerated review and approval,” Bavaria CEO Paul Chaplin said.
Although the World Health Organization says the vaccine may be used “off-label” in people under 18 , it only supports its use in adults.
WHO approval could guide domestic choices and allow international aid organizations to purchase and distribute the vaccine.
The Democratic Republic of Congo (DRC), which has been worst hit by the current outbreak, is not planning to give the Bavarian vaccine to people under 18 in the first phase of vaccination.
Another Mpox vaccine, made by Japan’s KM Biologics, can already be given to children, according to Japanese regulators, but it requires a special type of needle.
Although the EMA decision is not official guidance for countries outside Europe, Congo cited its evaluation of the Bavarian vaccine when approving domestic emergency use in June. The FDA approval is also mentioned.
The WHO said there have been nearly 25,100 cases and more than 720 deaths in Africa since the outbreak began in January, with the Democratic Republic of Congo reporting the most cases.
