United States: The surprising and much-needed announcement unveiled the news of its mpox vaccine receiving a green flag from the European Union drug regulator for its usage in adolescents amid an outbreak in some African areas.
Mpox has in the past been classified as a public health emergency of international concern by the WHO and is lethal to children and adolescents.
More about the news
JYNNEOS, produced by Bavarian, also only works for people aged 18 and above, while the US FDA authorized its usage in adolescents in the mpox outbreak that occurred in 2022.
CHMP’s approval, depends on the information the Danish biotech firm provided to the European Medicines Agency of which was submitted in the past month.
What more are the experts stating?
“We applaud EMA for their expedited review and decision to recommend approval,” said the company CEO.
The WHO says the vaccine may be given to those below 18 years of age, but it is off-label, an endorsement that has only been restrictedly given to adults.
Approval by the WHO can inform the decisions made domestically as well as enable an international aid organization to purchase and administer a vaccine.
Democratic Republic of Congo (DRC), the hardest affected nation in the current outbreak, does not currently intend to include those below 18 years in its first round of immunization with the Bavarian vaccine.
Another vaccine under development
Another mpox vaccine under development is by Japan’s KM Biologics, and the authorities there say that it can already be administered to children, although it needs a special type of needle.
Though the EMA decision does not orient countries in the rest of the world, which has no Europe, Congo relied on the evaluation of Bavarian’s vaccine while approving the shot locally in June. It also had a nod from the Food and Drug Administration.
The WHO says that there have been almost 25,100 cases and more than 720 deaths of this outbreak that started in January in the African region where the Democratic Republic of Congo is the worst affected country.