WHO Director-General Initiates Emergency Use Listing for Mpox Vaccines Amid Worsening Outbreak
On August 7, 2024, the WHO Director-General announced the initiation of the Emergency Use Listing (EUL) process for mpox vaccines, citing concerning trends in the disease’s spread.
A significant and escalating outbreak in the Democratic Republic of the Congo (DRC) has now extended beyond the country’s borders. Notably, a new viral strain, first identified in September 2023, has been detected outside of the DRC for the first time.
The EUL procedure is a fast-track authorization process designed to accelerate the availability of unlicensed medical products, such as vaccines, during public health emergencies. This temporary recommendation is based on a risk-benefit analysis to address urgent health needs.
The WHO is urging vaccine manufacturers to submit necessary data to ensure the vaccines are safe, effective, high-quality, and appropriate for the target populations.
Approval of an EUL will speed up vaccine access, particularly for lower-income countries that have yet to grant their own national regulatory approvals. It will also allow global partners, including Gavi and UNICEF, to procure and distribute the vaccines.
Mpox, caused by the monkeypox virus, is a viral illness belonging to the Orthopoxvirus genus. It can be transmitted to humans through direct contact with an infected person, contaminated materials, or infected animals.
Lately, there are currently two vaccines in use against the disease, both of which have been recommended for use by the WHO Strategic Advisory Group of Experts on Immunization, or SAGE.
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WHO Director-General Initiates Emergency Use Listing for Mpox Vaccines Amid Worsening Outbreak