Bavarian Nordic’s mpox vaccine Jynneos generated a similar immune response in adolescents as it did in adults, offering encouraging results that suggest the shot would be similarly effective.
The new data were reported Wednesday by NIH, which ran the Phase 2 study. The vaccine, first approved to prevent smallpox, secured FDA emergency use authorization for mpox in August 2022. Health agencies around the globe have only greenlit the shot in adults, but the World Health Organization says it may be used off-label in areas with high need.
The study is testing two doses of the vaccine in children ages 12 to 17 and comparing the data to adults 18 to 50. The new data assessed antibody levels two weeks after the second dose and monitored safety for 180 days after the second dose. The NIH found that the overall frequency of side effects was similar between the two groups and that while children reported higher rates of dizziness, the figures were comparable to other vaccines administered to adolescents.
The company already snagged European approval last month based on non-inferiority data. The company said then that it was the first time the vaccine had won an adolescent approval.
Another trial testing the vaccine in kids ages 2 to 12 is set to start soon. A record of the trial in a federal database says it has yet to begin recruiting, though Bavarian Nordic previously said it expected to start in October. The estimated study start time is Wednesday, according to the trial record.
Jynneos is one of just a handful of vaccine options that have been relied upon to stem the latest swell of cases in Africa. Emergent BioSolutions has donated tens of thousands of doses of its vaccine to nations where cases were on the rise. That shot, ACAM2000, is not approved for mpox, but is used against smallpox, part of the same virus family.
The first doses of Jynneos began to arrive in the Democratic Republic of the Congo in early September after the WHO declared a public health emergency of international concern. The biotech said then that more than 250,000 doses had been shipped and another 500,000 had been pledged by other countries. It expects to be able to provide up to two million doses by the end of the year.