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Drugmakers have supplies ready to ship that are necessary to stop a potential pandemic. But W.H.O. regulations have slowed access.
There are no vaccines for mpox available in the Democratic Republic of Congo, the epicenter of a global health emergency declared last week, even though the country first asked for the shots two years ago and the manufacturers say they have supplies.
“The most important thing we need right now are the vaccines,” said Dr. Samuel-Roger Kamba, health minister of Congo.
So where are the shots? They are trapped in a byzantine drug regulatory process at the World Health Organization.
Three years after the last worldwide mpox outbreak, the W.H.O. still has neither officially approved the vaccines — although the United States and Europe have — nor has it issued an emergency use license that would speed access.
One of these two approvals is necessary for UNICEF and Gavi, the organization that helps facilitate immunizations in developing nations, to buy and distribute mpox vaccines in low-income countries like Congo.
While high-income nations rely on their own drug regulators, such as the Food and Drug Administration in the United States, many low- and middle-income countries depend on the W.H.O. to judge what vaccines and treatments are safe and effective, a process called prequalification.