Answer given by Ms Kyriakides on behalf of the European Commission
29.10.2024
The Commission authorises medicines based on a recommendation by the European Medicines Agency (EMA).
The vaccine Imvanex[1] is authorised in the EU to protect against smallpox, mpox and diseases caused by vaccinia virus in individuals aged 12 and older.
The product information[2] includes advice on the use of Imvanex in vulnerable populations, such as immunocompromised, pregnant women or children.
The recommendation to extend the use of Imvanex to adolescents is based on the interim results of a study[3] showing its ability to generate an immune response in adolescents similar to that in adults.
No additional risk was identified for the use of Imvanex in adolescents compared to adults. EMA requested the marketing authorisation holder to submit the study final results by 30 May 2025 to further characterise the safety information for adolescents[4].
As for all medicines, data on the use of Imvanex are continuously monitored. Side effects reported with Imvanex are evaluated, and any necessary action taken to protect patients.
On 13 September 2024, Imvanex was prequalified by the World Health Organisation (WHO)[5], with EMA as regulatory agency of record, i.e. EMA’s assessment was the basis for WHO prequalification to facilitate timely and increased access to this vaccine in communities with urgent need.
WHO also cooperated in EMA’s assessment of the extension of indication to adolescents, a population particularly vulnerable to mpox.
The Commission will continue to strive for the greatest transparency possible by complying with Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents[6] when applicable.
- [1] Union Register of medicinal products https://ec.europa.eu/health/documents/community-register/html/h855.htm
- [2] IMVANEX II-108 https://ec.europa.eu/health/documents/community-register/2024/20240919164097/anx_164097_en.pdf
- [3] A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox https://www.clinicaltrials.gov/study/NCT05740982
- [4] EMA recommends extending indication of mpox vaccine to adolescents https://www.ema.europa.eu/en/news/ema-recommends-extending-indication-mpox-vaccine-adolescents
- [5] https://www.who.int/news/item/13-09-2024-who-prequalifies-the-first-vaccine-against-mpox
- [6] https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32001R1049