Bavarian Nordic, which recently got approval for its monkeypox vaccine, received FDA and EU regulatory nods to begin producing the shot at its fill-finish facility in Denmark.
With those regulatory boxes checked off, Bavarian Nordic can begin the manufacture and delivery of its treatment—known as Jynneos in the U.S.—from its own facilities. Previously, the vaccine was being produced by an unnamed contract manufacturer.
FDA inspectors conducted a pre-approval inspection of the facility in early July.
Bavarian Nordic’s Jynneos has become a key option since the onset of the monkeypox outbreak and even more so since the World Health Organization declared it a global public health emergency last week.
In making the announcement, Tedros Adhanom Ghebreyesus, the WHO director-general, called for a coordinated response to stop transmission and protect vulnerable groups, as well as efforts to protect affected communities.
Though the WHO assessed that the risk of monkeypox as currently moderate globally, it is high in Europe, which led European regulators to approve the vaccine much faster than the usual six- to nine-month review timeline.