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WHO invites mpox vaccine manufacturers to submit dossiers for urgent evaluation
/regulation-and-prequalification-(rpq)/prequalification-(pqt)/sharing-information-on-mpox.tmb-1200v.jpg?sfvrsn=e2d83a8d_1 "WHO invites mpox vaccine manufacturers to submit dossiers for urgent evaluation")
WHO issued today invitation to mpox vaccine manufacturers to submit an expression of interest for the emergency list (EUL).
Director General of WHO announced on August 7, 2024 that it initiated the procedure for the EUL of the measles vaccine in view of the worrying trends in the spread of the disease. There is a serious and growing epidemic in the Democratic Republic of Congo (DRC) that has now spread outside the country. The new virus strain, which first appeared in September 2023, was first detected outside the DRC.
The EUL procedure is an emergency use authorization procedure, specifically developed to accelerate the availability of unlicensed medical products such as vaccines that are needed in public health emergencies. This is a time-limited recommendation, based on a risk-benefit approach.
WHO asks manufacturers to provide data to ensure that vaccines are safe, effective, of guaranteed quality and suitable for the target population.
The granting of an EUL will accelerate access to the vaccine, especially for those lower-income countries that have not yet issued their own national regulatory approval. The EUL also enables partners, including Gavi and UNICEF, to procure vaccines for distribution.
Mpox is a viral disease caused by the monkeypox virus, a species of the genus Orthopoxvirus. Mpox can be transmitted to humans through physical contact with someone who is contagious, with contaminated materials, or with infected animals.
There are currently two vaccines against this disease, and both have been recommended for use by the WHO Strategic Advisory Group of Experts on Immunizationor SAGE.
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