First MPOX vaccine arrives in epidemic epicenter in Africa. Why did it take so long?

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

It's a dilemma well known to Dr. Dago Inagbe, Doctors Without Borders' head of mission in the Democratic Republic of Congo, a country in the midst of a massive MPOX outbreak that has reported more than 20,000 suspected cases and hundreds of deaths, most of them children, so far this year.

“Mothers want to be with their children,” said Inagbe, who worries about contracting the virus, which causes painful skin lesions and can be deadly, “which is why the vaccine is welcome.”

However, until now there has been no MPOX vaccine available in Japan. Thursday's cases in Kinshasa come more than 18 months after the Congolese government declared the situation an epidemic.

Getting the MPOX vaccine to Congo seemed like an easy thing to do: one country needed the vaccine, and another was ready to provide it. In fact, the United States had been ready to send the vaccine to Africa for two years. But in reality, it's not that simple.

Some blame the Congolese government for the delay, others the World Health Organization, and still others say there are genuine gaps in the scientific knowledge.

“It's really a shell game,” said Rick Bright, a former director of the US 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.”

WHO Director-General Tedros Adhanom Ghebreyesus rejected the idea that anyone was dilly-dallying, telling a press conference last week that “we will not take any shortcuts.”

So who is to blame?

There are so many factors at play, from logistical challenges to scientific questions to financial considerations, that it's hard to pinpoint exactly who is to blame, but some say the biggest initial hurdle was bureaucracy.

Congolese regulators had not approved the MPOX vaccine for use until June 27. Even after approval, the U.S. donation is on hold pending the Congolese government's finalization of pre-shipment requirements, including proper storage and handling of the vaccine once it arrives.

Another way to bring a vaccine into a country is through the WHO. Many low- and middle-income countries rely on the WHO to evaluate the safety and effectiveness of vaccines. But the WHO has not yet given its approval to any of the relatively new MPOX vaccines. Some public health experts say the agency should have done so when U.S. and European health authorities cleared the vaccine for use in the event of a global MPOX outbreak in 2022.

The WHO, meanwhile, says it's currently reviewing the vaccine but didn't have enough information to make a formal decision until recently. Now that pharmaceutical companies have submitted all their data and information, “we are working to review the application as quickly as possible,” Tedros said.

There are many unknowns

Experts across the board agree that given the specifics of this outbreak, which has now spread to more than a dozen African countries, there are still significant gaps in what is known about the MPOX vaccine and how well it works.

For example, most of the vaccine research has been done on the strain of the virus that spread globally in 2022, not the more dangerous strain surging in Congo. Further complicating things, the Congo's MPOX virus has recently evolved and mutated into an entirely new strain.

“Does the vaccine work? [against this new strain]”I think the honest answer is: we don't know yet,” said Marion Koopmans, director of the centre for pandemics and disasters at the Erasmus Medical Centre in the Netherlands.

And most of the existing research has focused on populations entirely different from those currently at risk. “The vaccine efficacy studies were done in the Global North and among gay and bisexual men,” he said. Dr. Dima OgoyinThe infectious disease specialist and researcher at Nigeria's Niger Delta University noted that most infections and deaths in Congo are among children, and the vaccine the U.S. is donating is not yet approved for use in children.

Ogoyna says a vaccine isn't the only way to fight an outbreak — testing, surveillance and infection control can play big roles — but he says “based on existing knowledge, a vaccine may be one of the best tools we have available right now.”

Is this a repeat of COVID's pitfalls?

For some in Africa, the MPOX vaccine situation is a case of deja vu: At the peak of the COVID pandemic, wealthy countries had enough COVID vaccines, while lower-income countries struggled to access them.

“We were faced with COVID-19. We had no vaccines, no medicines. We didn't even have syringes or gloves. We were abandoned,” Jean Kaseya, director of the Africa Centers for Disease Control and Prevention, said at a press conference last week. “Today, we are in a similar situation where we are starting to look for vaccines because we don't manufacture them.”

“I can't replay that scene and I'm worried. [that’s what’s happening]” said William Moss, an epidemiologist and professor of global health at the Johns Hopkins Bloomberg School of Public Health.

There are dissenting voices. “We’re not in the same situation we were when COVID started,” says Dr. Maria Van Kerkhove, WHO’s interim director for infectious diseases and pandemic preparedness and prevention. She argues that many of the systems built during COVID have helped the international community respond. “We need to shift this story a bit and talk about not just the challenges but also the strengths that exist across the continent,” she says.

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

first time, Africa CDC exercised its authority The WHO acted one day earlier than the WHO, sounding the alarm about the situation in MPOX by declaring a “continental security public health emergency” on August 13. “This is the first time Africa has one response plan and one budget,” says Africa CDC's Kaseya.

Placido Mbala Kingebeni Africans are the first to notice the difference. “This is really amazing,” says Kingebeni, director of the Clinical Research Center at Congo's National Biomedical Institute. Until now, outside groups have decided which African health conditions merit global attention, but “for the first time, the continent has the courage to say this is a continental problem,” he said.

Inagbe, MSF representative in Congo, who has treated MPOX patients in the north of the country, is hopeful that African leadership and collaboration will help smooth the procurement and deployment of the vaccine.

“There appears to be new momentum,” Inagbe said, adding that he was “praying” that those who need the vaccine most – children, parents and health workers – would start receiving them soon.

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