First doses of mpox vaccines arrive at the heart of Africa's outbreak. What took so long?

How do you tell a mother not to hold her sick child?

This is a dilemma Dr. Dago Inagbe knows well. He’s the head of mission for Doctors Without Borders in the Democratic Republic of Congo — a country in the throes of a major mpox outbreak with more than 20,000 suspected cases so far this year and hundreds of deaths, most of which are children.

“The mothers, they would like to be with their children,” says Inagbe, who worries about their chance of contracting the virus that causes painful skin lesions and can be deadly. “This is why the vaccine would be welcome.”

Yet up until now, there were no mpox vaccines in the country. The 99,100 doses that landed in Kinshasa on Thursday come more than 18 months after Congo declared the situation an epidemic.

It seems as if getting mpox vaccines to Congo should have been straightforward — one country needs vaccines, other countries are willing to give them. The U.S. in fact has been ready to send doses to Africa for two years. But, it turns out, it’s not that simple.

Some blame Congo's government for the delays. Others blame the World Health Organization. Some point to real gaps in scientific knowledge.

“It really is this shell game,” says Rick Bright, former director of the U.S. government's Biomedical Advanced Research and Development Authority. “And in the meantime, people are getting infected, the virus is mutating and spreading more widely, and people are dying.”

Tedros Adhanom Ghebreyesus, the director-general of WHO, pushed back on the notion that anyone is dragging their feet. “We will not take shortcuts,” he said at a press conference last week.

So just who is to blame?

It’s tricky to figure out exactly where to lay the blame because there are so many factors at play from logistical challenges to scientific questions and financial considerations. But some say the biggest first hurdle has been bureaucratic.

Up until June 27, Congo's regulatory body had not authorized mpox vaccines for use. And even after that was done, donations from the U.S. have been held up waiting for the Congolese government to finalize preshipment requirements, including proper storage and handling of the vaccines once they arrive.

The other path for vaccines to get into the country is through the WHO. Many low- and middle-income countries defer to WHO to assess the safety and effectiveness of vaccines. But WHO has not yet given its blessing to any of the mpox vaccines, which are relatively new. Some public health specialists say this should have been done when the U.S. and Europe health authorities allowed the vaccines to be used during the 2022 global mpox outbreak.

WHO, for its part, says it is now reviewing the vaccines but, until very recently, didn’t have complete enough information to make an official decision. Now that the drug companies have submitted all the data and information, “we're working to review those applications as fast as possible,” says Tedros.

Plenty of unknowns

Experts on all sides agree there are still substantial gaps in what’s known about the mpox vaccines and how they will work given the particulars of this outbreak, which has now spread to over a dozen African countries.

For example, most of the vaccine studies were done against the strain of the virus that went global in 2022 and not the more dangerous strain surging in Congo. Complicating matters further is that the mpox virus in Congo has recently evolved and mutated into a whole new strain.

“Will the vaccines work [against this new strain]? I think the honest answer is: ‘We do not know yet,’” says Marion Koopmans, director of the Pandemic and Disaster Centre at the Erasmus Medical Centre in the Netherlands.

Also, most of the existing studies focused on a very different population than those currently at risk. “The vaccine effectiveness studies were done in the Global North and amongst gay and bisexual men,” says Dr. Dimie Ogoina, an infectious diseases physician and researcher at Niger Delta University in Nigeria. But in Congo, he notes, children make up the majority of cases and deaths — and the vaccine the U.S. is donating has yet to be licensed for children.

Vaccines are not the only way to combat the outbreak, says Ogoina. Testing, surveillance and infection control can play major roles. But, he says, vaccines “may be one of the best tools we have available now based on existing knowledge.”

Is this a repeat of COVID pitfalls?

For some in Africa, the mpox vaccine situation is a case of deja vu. At the height of the COVID pandemic, wealthy nations had plenty of COVID vaccines and lower income countries struggled to get doses.

“We faced COVID. We didn't have vaccines, medicines. We didn't have even syringes, gloves. We were abandoned,” said Dr. Jean Kaseya, director-general at the Africa Centres for Disease Control and Prevention, at a press conference last week. “Today, we are in a similar situation where we start to look for vaccine because we don't manufacture vaccine.”

“We can't play that scene out again, and I am concerned [that’s what’s happening],” says William Moss, an epidemiologist and professor of international health at the Johns Hopkins Bloomberg School of Public Health.

Others disagree. “We're not in the same situation we were in when COVID began,” says Dr. Maria Van Kerkhove, the WHO’s interim director of Epidemic and Pandemic Preparedness and Prevention. She argues that many of the systems set up during the COVID era have helped the global community respond. “We need to shift this narrative a little bit and talk about not only the challenges, but the strengths that exist across the continent of Africa,” she says.

One of those strengths, many public health experts say, is the role African leaders are taking in managing the outbreak.

For the first time, the Africa CDC used its authority to declare a “public health emergency of continental security” on Aug. 13 — raising the alarm about the mpox situation and even beating the WHO to the punch by a day. It’s also “the first time that Africa will have one response plan and one budget,” says Africa CDC’s Kaseya.

Placide Mbala Kingebeni has noticed the difference. “This is really good,” says Kingebeni, who is the director of the Clinical Research Center at the National Institute of Biomedical Research in Congo. In the past, he says, outside groups have determined which health situations in Africa merit global attention “and for the first time, the continent has had the courage to say that this is a continental situation.”

Inagbe, head of Doctors Without Borders in Congo, has spent time in the far north of the country caring for mpox patients. He is hopeful that the African leadership and coordination will smooth the vaccine procurement and rollout.

“It looks like there is a new dynamic,” Inagbe says, adding that his “fingers are crossed” that the children, parents, health workers and others who most need the vaccines will start getting their shots soon.