Bavarian Nordic's mpox vaccine safe and effective in children

Bavarian Nordic's mpox vaccine, Jynneos, has shown promising results in adolescents, indicating a similar immune response as seen in adults. This encouraging data was announced by the NIH, which conducted a Phase 2 study of the vaccine. Initially approved for smallpox, Jynneos received emergency use authorization from the FDA for mpox in August 2022. While global health agencies have only approved the vaccine for adults, the World Health Organization (WHO) has suggested its use off-label in high-need areas.

The study involved administering two doses of the vaccine to children aged 12 to 17 and comparing the results with those from adults aged 18 to 50. Data revealed that antibody levels two weeks after the second dose were comparable between the two groups. Safety was monitored for 180 days post-second dose, with findings indicating a similar frequency of side effects in both age groups. Although adolescents reported higher rates of dizziness, these figures were in line with other vaccines given to this age group.

Last month, Bavarian Nordic received European approval based on non-inferiority data, marking the first time the vaccine was approved for adolescents. The company plans to begin another trial for children aged 2 to 12 soon. According to a federal database, recruitment for this trial is yet to start, but Bavarian Nordic had anticipated an October commencement, with the estimated start date being a Wednesday.

Jynneos is among the limited vaccine options combatting the recent surge of cases in Africa. Emergent BioSolutions has also donated tens of thousands of doses of its vaccine, ACAM2000, to countries experiencing rising cases. Although ACAM2000 is not approved for mpox, it is used against smallpox, which belongs to the same virus family.

The Democratic Republic of the Congo began receiving the first doses of Jynneos in early September after the WHO declared a public health emergency of international concern. Bavarian Nordic revealed that over 250,000 doses had been shipped, with another 500,000 doses pledged by various countries. The biotech company aims to deliver up to two million doses by the end of the year.