International regulators have published a report highlighting their considerations on the development, clinical trials and availability of vaccines and therapeutics for mpox. The report presents the outcomes of a workshop that was organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
In August 2024, the World Health Organisation (WHO) declared mpox a public health emergency of international concern (PHEIC). The viral illness caused by the monkeypox virus is endemic in certain parts of Central and West Africa. The surge in cases in the Democratic Republic of Congo and several neighbouring countries is driven by the mpox clade I strain which has been evolving into a new sub-clade Ib similarly to what happened with the clade II mpox strain that was circulating during the 2022/2023 public health emergency. The availability of medicines has been one of the biggest challenges during these outbreaks…
