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Lessons from COVID about inequities haven't yet brought

change

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WHO's slow process delayed vaccine access for Congo

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First 10,000 doses in Africa going to Nigeria, not Congo

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Conflict and slow Congo response also delayed vaccines

By Jennifer Rigby

LONDON, Aug 24 (Reuters) - The first 10,000 mpox

vaccines are finally due to arrive next week in Africa, where a

dangerous new strain of the virus - which has afflicted people

there for decades - has caused global alarm.

The slow arrival of the shots - which have already been made

available in more than 70 countries outside Africa - showed that

lessons learned from the COVID-19 pandemic about global

healthcare inequities have been slow to bring change, half a

dozen public health officials and scientists said.

Among the hurdles: It took the World Health Organization

(WHO) until this month to start officially the process needed to

give poor countries easy access to large quantities of vaccine

via international agencies.

That could have begun years ago, several of the officials

and scientists told Reuters.

Mpox is a potentially deadly infection that causes flu-like

symptoms and pus-filled lesions and spreads through close

physical contact. It was declared a global health emergency by

the WHO on Aug. 14 after the new strain, known as clade Ib,

began to proliferate from Democratic Republic of Congo to

neighbouring African countries.

In response to Reuters questions about the delays in vaccine

deployment, the U.N. health agency said on Friday it would relax

some of its procedures on this occasion in an effort to now

accelerate poor countries' access to the mpox shots.

Buying the expensive vaccines directly is out of reach for

many low-income countries. There are two key mpox shots, made by

Denmark's Bavarian Nordic ( BVNKF ) and Japan's KM Biologics. Bavarian

Nordic's ( BVNKF ) costs $100 a dose; the price of KM Biologics' is

unknown.

The long wait for WHO approval for international agencies to

buy and distribute the vaccine has forced individual African

governments and the continent's public health agency - the

Africa Centres for Disease Control and Prevention (CDC) - to

instead request donations of shots from rich countries. That

cumbersome process can collapse, as it has before, if donors

feel they should keep the vaccine to protect their own people.

The first 10,000 vaccines on their way to Africa - made by

Bavarian Nordic ( BVNKF ) - were donated by the United States, not

provided by the U.N. system.

Helen Rees, a member of the Africa CDC's mpox emergency

committee, and executive director of the Wits RHI Research

Institute in Johannesburg, South Africa, said it was "really

outrageous" that, after Africa struggled to access vaccines

during the COVID pandemic, the region had once again been left

behind.

In 2022, after a different mpox strain spread outside

Africa, smallpox shots were repurposed by governments within

weeks, approved by regulators and used in roughly 70 high and

middle income countries to protect those most at risk.

Those vaccines have now reached 1.2 million people in the

United States alone, according to the U.S. Centers for Disease

Control and Prevention (CDC).

But no shots have been available in Africa outside clinical

trials. A key reason: Vaccines needed to be greenlit by the WHO

before they could be bought by public healthcare groups

including Gavi, the Vaccine Alliance.

Gavi helps poorer countries buy shots, supplying childhood

vaccines in this way routinely. It administered a global scheme

for all vaccines during COVID-19 and has up to $500 million to

spend on mpox vaccines and logistics.

The Africa CDC has said 10 million doses may be needed

across the continent.

But the WHO only this month asked vaccine manufacturers to

submit the information needed for the mpox shots to receive an

emergency licence - the WHO's accelerated approval for medical

products. It urged countries to donate shots until the process

was finalised, in September.

The WHO said it is working with the authorities in Congo to

put together a vaccination plan, and on Friday said Gavi could

start talks while it finalised its emergency approval.

Sania Nishtar, chief executive of Gavi, said the WHO's aim

to now act quickly on approvals and improvements in funding

showed "the somewhat brighter side of where we are compared to

COVID." Asked to comment on the approval delays, she said,

"hopefully this is another learning moment for us."

WHO CRITICIZED

The WHO's role in approving medical products has

revolutionised supply in low-income countries, which often lack

the facilities to check new products themselves, but it has also

faced criticism for its slow speed and complexity.

The Geneva-based U.N. health agency said on Friday it did

not have sufficient data during the last mpox emergency in 2022

to start an approval process for the vaccine, and it has been

working with manufacturers since then to see if the available

data warranted an approval.

Mpox, which includes several different strains, has caused

99,000 confirmed cases and 208 deaths worldwide since 2022,

according to the WHO. The tally is likely an underestimate as

many cases go unreported.

Infections have been brought under control in rich regions

by a combination of vaccines and by behaviour change among the

highest-risk groups.

With the main earlier mpox strain, men who have sex with men

were most at risk, but the new clade Ib variant seems to spread

more easily through other close contact, including among

children, as well as through sexual contact among heterosexual

people.

The country currently hardest hit by mpox is Congo. Since

January 2023, there have been more than 27,000 suspected cases

and 1,100 deaths there, according to government figures, mainly

among children.

But the first 10,000 vaccines donated by the United States

are not destined for Congo but for Nigeria, as a result of

several years of talks between both governments, according to a

source involved in the process who was not authorised to speak

to the media. Nigeria has had 786 suspected cases this year, and

no deaths.

The Nigerian health ministry did not respond to a request

for comment; the U.S. Agency for International Development

(USAID) said it has also donated 50,000 doses to Congo but the

arrival date is not yet finalised.

CHILDREN AT RISK

In Congo, the country's administration is another part of

the problem. Grappling with conflict and multiple competing

disease outbreaks, its government has yet to ask Gavi officially

for vaccine supplies and took months to talk to donor

governments. Its medicines regulator only approved the two main

vaccines in June.

Neither Congo's health ministry nor Japan's, which is

working to donate large amounts of KM Biologics vaccines,

responded to requests for comment for this story.

Bavarian Nordic ( BVNKF ) said this week it needs orders now to

produce vaccines in volume this year.

Congo's government has told reporters it hopes to receive

vaccine donations next week, but three donor sources told

Reuters it is not clear if that will happen. Europe's pandemic

preparedness agency said by email its 215,000 doses will not

arrive before September at the earliest.

Bavarian Nordic ( BVNKF ) and Congo are still discussing pre-shipment

requirements necessary to ensure proper storage and handling,

said a spokesperson for USAID. The vaccines have to be kept at

-20C, for example.

In eastern Congo, around 750,000 people are living in camps

after fleeing conflict, including seven-year-old Sagesse

Hakizimana and his mother Elisabeth Furaha. He is one of more

than 100 children to have been infected by mpox in one area near

the city of Goma, in north Kivu, according to doctors.

"Imagine fleeing a war and then losing your child to this

illness," said Furaha, 30, rubbing ointment on her son's rash

and adding that his symptoms were easing. He was being treated

last week in a repurposed Ebola treatment centre.

"We need a vaccine for this disease. It's a bad disease that

weakens our children."

Even when shots arrive, questions remain about how to use

them: Bavarian Nordic's ( BVNKF ) vaccine - the most widely used worldwide

- is only available for adults. The KM Biologics vaccine can be

given to children but is more complex to administer.

Adding to those questions, scientists have not yet agreed

what groups should be vaccinated first, although a likely

strategy is ring vaccination, where contacts of known cases are

prioritised.

"We saw with COVID-19 that the vaccine was available but the

population didn't want it," says Jean Jacques Muyembe,

co-discoverer of the Ebola virus and director of the Institut

National de Recherche Biomédicale (INRB) in Kinshasa.

He and other scientists said other public health measures

like awareness raising in Africa and better diagnosis were also

key to stopping the spread of mpox; vaccines are not the only

solution.

PRIORITIES

Some global health experts say the WHO and others should

have focused earlier on improving access to mpox vaccines as

well as tests for the disease and treatments.

"The processes [at WHO for vaccines] and funding for

diagnostics for mpox should have started a few years ago," said

Ayoade Alakija, who co-chairs a global health partnership aiming

to make the mpox response more egalitarian.

She said her comment was not a critique of the WHO, which

can only prioritise what its member states want. "It is a matter

of what the world considers to be a priority, and [that is not]

diseases that primarily affect black and brown people."

In a statement, the WHO said it was "urging all partners

including countries, manufacturers and communities to mobilize

efforts, increase vaccine donations, reduce prices and provide

other necessary support to protect people at risk during this

outbreak".

Jean Kaseya, head of the Africa CDC, said he is working to

get African vaccine manufacturers involved to boost supply and

lower prices, but that will take time.