EMA Recommends Mpox Vaccine for Adolescents

The European Medicines Agency (EMA) announced on Sept. 19, 2024 that it recommends that the indication for the use of the smallpox and mpox vaccine, Imvanex, be extended to adolescents from 12 to 17 years of age. Imvanex contains a live, weakened form of “modified vaccinia virus Ankara” (MVA-BN) and is currently authorized in the European Union for smallpox and mpox in adults.

The agency’s Committee for Medicinal Products for Human Use (CHMP) decided to extend the indication after interim results of a study that compared the vaccine’s immune response in 515 adolescents to 211 adults showed the response was similar in both groups.

“Therefore, it is inferred that the vaccine will provide similar protection in adolescents to that expected in adults,” the agency said in the press release (1). “According to the submitted data, the safety profile of Imvanex in adolescents was comparable to that seen in adults and no additional risk has been identified.”

The marketing authorization holder has been asked by EMA to provide the agency with the final results of the study by May 30, 2025.

The World Health Organization (WHO) declared mpox a public health emergency of international concern in August 2024 (2).

"The emergence of a new clade of mpox, its rapid spread in eastern DRC [Democratic Republic of the Congo], and the reporting of cases in several neighboring countries are very worrying,” said WHO Director-General Tedros Adhanom Ghebreyesus, in a press release (2). “On top of outbreaks of other mpox clades in DRC and other countries in Africa, it’s clear that a coordinated international response is needed to stop these outbreaks and save lives.”

WHO announced the MVA-BN vaccine as the first vaccine on its prequalification list in September 2024.

“This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future,” said Ghebreyesus in the press release regarding that announcement (3). “We now need urgent scale-up in procurement, donations, and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission, and save lives.”

According to EMA, this assessment to extend the indication may impact the global response to the mpox outbreak in the DRC and other countries; EMA is the regulatory agency responsible for prequalification of this mpox vaccine (3).

“This means that CHMP’s assessment constitutes the basis for WHO prequalification approval to facilitate timely and increased access to this vaccine in communities with urgent need. Previously, EMA’s assessment was also taken into account by the national regulatory authority of the DRC in the fast-track approval of the vaccine. In addition, WHO has cooperated in EMA’s assessment of the extension of indication in adolescents, a population that is particularly vulnerable to mpox,” the agency said in the press release (1).

References

1. EMA. EMA Recommends Extending Indication of Mpox Vaccine to Adolescents. Press Release. Sept. 19, 2024.
2. WHO. WHO Director-General Declares Mpox Outbreak a Public Health Emergency of International Concern. Press Release. Aug. 14, 2024.
3. WHO. WHO Prequalifies the First Vaccine against Mpox. Press Release. Sept. 13, 2024.