Why are Mpox vaccines not reaching African countries where they are desperately needed?

There are no vaccines available for mpox, also known as monkeypox, in the Democratic Republic of Congo, the epicenter of a global health emergency declared on Aug. 14, even though the country first requested the shots two years ago and manufacturers say they have stocks.

So where are the vaccines? They are stuck in a byzantine drug regulation process at the World Health Organization.

Three years after the last global outbreak of mpox, the WHO has yet to officially approve the vaccines — though the United States and Europe have — or issue an emergency use license that would speed up access.

One of these two approvals is needed for UNICEF and Gavi, the group that helps facilitate immunizations in developing countries, to purchase and distribute mpox vaccines in countries like Congo.

While high-income nations rely on their own drug regulators, many low- and middle-income countries rely on the WHO to judge which vaccines are safe and effective.

There have been more than 15,000 cases of mpox in the Congo this year and at least 550 deaths. Most of these deaths have occurred among children, some of whom are starving to death because lesions in their mouths prevent them from eating.

A new variant of the virus, transmitted through close intimate contact, has crossed Congo’s eastern border into 13 countries, prompting the WHO to declare a global emergency.

Paul Chaplin, chief executive of Bavarian Nordic, which makes the Jynneos vaccine used in North America and Europe during the 2022 outbreak, said the company can produce 10 million doses by the end of 2025, but there are no orders. Under pressure from member states, WHO told Gavi to start a purchasing negotiation with Bavarian Nordic even though the vaccine’s approval is still pending.

The WHO says it has not had the data needed to conduct a full review for approval of Jynneos, and that the emergency licensing process can only take place after a public health emergency of international concern (known as a PHEIC) has been declared, which has happened.

But Bavarian Nordic first met with the WHO in August 2022 to discuss Jynneos and submitted a dossier of information on the vaccine in May 2023, Chaplin said.

Studies showed that the vaccine provided a high level of protection against mpox.

Critics question why the WHO did not act sooner to approve a vaccine against MPOX, given that the virus has never stopped circulating in Congo. They ask why it has not been possible to grant the injections an emergency license based on the US and European authorizations of the Jynneos vaccine.

The vaccine was created to prevent smallpox and was kept in biosecurity stockpiles after the disease was eradicated. Because mpox, like smallpox, is part of the orthopoxvirus family, researchers thought that smallpox vaccines might work to block mpox. Small animal studies showed it was effective.

This year, as the number of cases in Congo grew, the WHO decided to activate the emergency licensing process even as it declared a global emergency. Most of the data collected on the Jynneos vaccine evaluated it for use on the Clade 2 mpox virus, a less lethal version that caused the 2022 global outbreak. But the Clade 1 virus is circulating in Congo and across East Africa, and the vaccine has not been tested against it.

There are reasons to be cautious. Placide Mbala, director of the clinical research centre at the National Institute for Biomedical Research in Kinshasa, said he was hopeful for the vaccines, but it was an open question how well they would work against the virus variant now circulating in Congo.

Mbala was an investigator on a large, US-funded clinical trial in Congo of the antiviral tecovirimat, which was used to treat mpox in high-income countries in 2022. In August, Maryland’s National Institute of Allergy and Infectious Diseases announced that the drug did not improve resolution of mpox in Congolese patients with Clade 1 infections.

“As we see with tecovirimat, in different contexts the drug or vaccine can act differently,” Mbala said. “We can’t be sure until we can test them.”