The World Health Organization (WHO) announced today that it has approved the monkeypox vaccine produced by Danish biotech company Bavarian Nordic for adolescents aged 12 to 17, a group particularly vulnerable to monkeypox outbreaks. This decision follows a confirmation of the vaccine’s prequalification status on October 8, as reported by Reuters.
A recent wave of monkeypox cases, which spread from the Democratic Republic of the Congo to neighboring countries, led the WHO to declare a “Public Health Emergency of International Concern” (PHEIC) in August, marking the second such announcement in two years.
In September, the WHO authorized the vaccine for adults to facilitate easier access in African countries severely affected by the outbreak. Generally, the monkeypox virus can cause flu-like symptoms along with skin lesions, and children, teenagers, and immunocompromised individuals are particularly at risk.
Last month, the European Union also approved the Bavarian Nordic monkeypox vaccine for use in adolescents. Additionally, Bavarian Nordic is preparing to conduct clinical trials to evaluate the vaccine’s safety in children aged 2 to 12, aiming to expand its potential use.
This clinical trial is partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and is expected to commence in October.
While the U.S. Food and Drug Administration (FDA) has approved the Bavarian Nordic monkeypox vaccine, it is currently only available for adults aged 18 and older. During the monkeypox outbreak in 2022, the FDA had also granted an Emergency Use Authorization (EUA) for this vaccine.
Moreover, Japanese regulatory authorities have confirmed that another monkeypox vaccine, LC16 produced by KM Biologics, is suitable for children, though it requires the use of special needles.
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