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The World Health Organization (WHO) has invited Mpox vaccine makers to submit expression of interest (EOI) and subsequently, dossiers for evaluation leading to Emergency Use Listing (EUL).

This move has been occasioned by a multi-country outbreak of the Monkeypox (Mpox) virus, which since the beginning of this year (up to 28 July) has claimed a total of 456 lives in Africa, representing a 19% rise in fatalities in 2024 compared to the same period in 2023.1

Although endemic in the Democratic Republic of Congo (DRC)- where there have already been more than 450 fatalities this year- the virus is increasingly becoming a major public health concern both continentally and globally.

The current outbreak is more widespread than any previous DRC outbreak and countries like Kenya and Côte d'Ivoire that have not previously reported outbreaks are now starting to feel the effects of the virus.2

 

Importance of Emergency Use Listing

Emergency use listing (EUL) was created specifically to speed up the availability of unlicensed medical products required in emergency situations involving public health.

Such as this one experienced with the Mpox outbreak.

It does this by applying a risk-benefit analysis to offer a time-limited recommendation for unlicensed vaccines when the available data on their efficacy, safety, and quality outweighs the anticipated risks and uncertainties.

The granting of an EUL will expedite the availability of the Mpox vaccines, especially for lower-income nations that do not currently possess national regulatory approval. Additionally, the EUL makes it possible for partners like UNICEF and Gavi to acquire the vaccines for distribution.

For the presented vaccines to be deemed suitable for listing, they have to be developed and manufactured in accordance with internationally recognized standards, including Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).

They also need to meet mandatory characteristics for programmatic suitability.

Additionally, the national regulatory authority overseeing the vaccine has been assessed and documented as a "WHO listed authority."

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About the Monkeypox virus

Monkeypox is a disease caused by the Mpox virus, a genus of the Orthopoxvirus and having two distinct subtypes referred as genetic clades I and II.

Clade I is endemic in Central Africa, while II in West Africa.

Notably, the ongoing global outbreak is due to the clade II subtype.3

Typical symptoms of the disease include mucosal lesions, rash, muscle aches, headache and fever. Transmission occurs through physical contact with infected humans or animals, as well as contact with infected surfaces.4

Currently 2 vaccines have been licensed for use in protection against mpox; Imvamune® and ACAM2000® manufactured by Bavarian Nordic and Emergent Bio Solutions respectively.5

WHO clarified that “Only those EOIs that are considered acceptable to proceed with the submission of a dossier, will be assessed according to the EUL procedure, prequalification standards and relevant guidance in the WHO Technical Report Series “Recommendations for the production and quality control of smallpox vaccine, revised 2003, Annex 1, TRS No 926”

 

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References

1.        Outbreak Report, 30 July 2024: Mpox Situation in Africa. Africa CDC. Accessed August 12, 2024. https://africacdc.org/news-item/mpox-situation-in-africa/

2.        WHO seeks support to end Mpox as disease hits 17 African countries. The East African. August 9, 2024. Accessed August 12, 2024. https://www.theeastafrican.co.ke/tea/science-health/who-seeks-support-to-end-mpox-as-disease-hits-african-countries-4720190

3.        Ongoing 2022 Mpox Clade II Outbreak | Mpox | Poxvirus | CDC. July 12, 2024. Accessed August 12, 2024. https://www.cdc.gov/poxvirus/mpox/outbreak/2022-ongoing-global.html

4.        Mpox (monkeypox). Accessed August 12, 2024. https://www.who.int/news-room/fact-sheets/detail/monkeypox

5.        Vaccination | Mpox | Poxvirus | CDC. June 28, 2024. Accessed August 12, 2024. https://www.cdc.gov/poxvirus/mpox/interim-considerations/overview.html

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