Why Mpox vaccines are only just arriving in Africa after two years
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 vaccines 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 the 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 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 and Japan's KM Biologics. Bavarian Nordic's 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 – 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."
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 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 contacts, 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.
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 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 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 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 on 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.
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.
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