In August 2024 WHO issued an invitation for manufacturers of mpox vaccines to submit an Expression of Interest for Emergency Use Listing (EUL). This came shortly after the Director-General, Dr Tedros Adhanom Ghebreyesus, announced that he has decided to convene an Emergency Committee under the International Health Regulations to advise on the need to categorise the outbreak as a public health emergency of international concern (PHEIC). As the outbreak evolves and cases are reported in previously unaffected regions, WHO is making efforts to ensure resources are available to address the situation.
Director-General’s comments
At a media briefing on 7th August 2024, Dr Tedros Adhanom Ghebreyesus stated that the DRC has reported more than 14,000 mpox cases and 511 deaths since the beginning of the year. Although DRC has been reporting outbreaks of mpox “for decades”, the number of reported cases has been “increasing steadily” every year. The number of cases reported in the first six months of this year “match the number reported in all of last year”. Additionally, recent confirmed and suspected cases have been reported in DRC-neighbouring countries that have previously not reported cases: Burundi, Kenya, Rwanda, and Uganda.
The Director-General noted that the current outbreak in the Eastern DRC is caused by a “new offshoot” of mpox clade I, known as clade 1b. This causes “more severe disease” than clade 2, which caused the 2022 global outbreak. In other parts of DRC, along with Central African Republic and the Republic of Congo, cases of clade 1a have been reported. Clade 2 is reported in Cameroon, Côte d’Ivoire, Liberia, Nigeria, and South Africa.
While WHO works with governments in the affected countries, Africa CDC, and partners, to “understand and address the drivers” of the outbreaks, Dr Tedros highlighted the need for a “comprehensive”, community-centred response. Dr Tedros elected to convene an Emergency Committee, setting the date for Wednesday 14th August. This step will bring expert advice on whether the outbreak is a public health emergency of international concern. From there, Dr Tedros will be advised on temporary recommendations for prevention and disease management.
Vaccines to the fore
Two mpox vaccines have been approved by WHO-listed national regulatory authorities and are recommended by WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE). Dr Tedros has “triggered the process” for Emergency Use Listing (EUL) of both vaccines to accelerate vaccine access, particularly for lower-income countries. EUL also allows partners like Gavi and UNICEF to procure vaccines for distribution.
WHO also issued an invitation for mpox vaccine manufacturers to submit an Expression of Interest for EUL. The procedure is “specifically developed to expedite the availability of unlicensed medical products” for use in public health emergency situations. WHO requests that manufacturers submit data to demonstrate that their vaccines are safe, effective, of assured quality, and suitable for target populations.
At the Congress in Barcelona this October, we will hear from vaccine safety experts about post-authorisation safety and effectiveness evaluation of vaccines that are deployed through emergency use authorisation. To join us, do get your tickets here, and don’t forget to subscribe to our weekly newsletters here.
