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 New York Times reported.
The shots are trapped in a byzantine drug regulatory process at the World Health Organization (WHO), the report noted.
Three years after the last worldwide mpox outbreak, the WHO 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, The New York Times report noted.
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, the report noted.
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 WHO to judge what vaccines and treatments are safe and effective, a process called prequalification.
But the organization is painfully risk-averse, concerned with a need to protect its trustworthiness and ill-prepared to act swiftly in emergencies, Blair Hanewall, a global health consultant who managed the WHO approvals portfolio as a deputy director of the Bill & Melinda Gates Foundation, a key funder, for more than a decade, has been quoted as saying by The New York Times.
“They don’t have flexibility to use alternative approaches,” she said.
There have been more than 15,000 cases of mpox in Congo this year, and at least 550 deaths, although many cases are not diagnosed or treated. Most of those deaths have occurred among children, some of whom starve because agonizing lesions in their mouths and throats have prevented them from eating.
A new variant of the virus, spread by close intimate contact, has now crossed Congo’s eastern border into 13 countries, prompting the WHO to declare a global health emergency on Aug. 14.
In recent weeks, the NYT added, key players in the epidemic response have grown increasingly critical of the WHO for unnecessarily slowing the effort to get vaccines to Africa. It’s a “broken system” that “is not built for emergencies,” said one US scientist who sits on WHO advisory panels but was not authorized to speak publicly.