WHO approves Bavarian Nordic’s mpox vaccine for teenagers

• The WHO says it has given a vaccine default for teenagers on October 8.
• The Danish biotech company is also preparing to conduct a clinical trial.
• The US federal health agency has approved the Bavarian vaccine for adults.

The World Health Organization (WHO) said on Monday it had approved Bavarian Nordic’s mpox vaccine for teenagers aged 12 to 17, an age group considered particularly vulnerable to outbreaks of the disease that has caused global concern.

The WHO said in a statement that it had given a pre-qualification for the Jynneos vaccine for teenagers on October 8.

The WHO declared mpox a global public health emergency for the second time in two years in August after a new strain of the virus spread from the Democratic Republic of Congo to its neighbors.

The United Nations agency approved the vaccine’s use in September as the first mpox vaccine in adults, making it easier for hard-hit countries in Africa to access the vaccine.

Children, teenagers and people with weakened immune systems are especially vulnerable to mpox, a viral infection that usually causes flu-like symptoms and pus-filled skin lesions.

The latest WHO decision comes after the EU approved the drug for the vaccine for teenagers in September.

The Danish biotech company is also preparing to conduct a clinical trial to assess the safety of the vaccine in children aged two to 12, possibly expanding its use.

The trial, which is funded in part by the Coalition for Epidemic Preparedness Innovations, is expected to begin in October.

The US Food and Drug Administration has also approved the Bavarian vaccine, but only for use in adults 18 and older, although it granted an Emergency Use License for use in teenagers during the 2022 mpox outbreak.

Another mpox vaccine, LC16, made by Japan’s KM Biologics, can already be given to children, according to the Japanese regulator, although it requires a special kind of needle.

Bavarian Scandinavia did not immediately respond to a request for comment on the default.

Confirmed cases of the new mpox strain have been identified in the Democratic Republic of the Congo, Sweden, Thailand, Burundi, Kenya, Rwanda and Uganda.