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 Because it is not yet licensed, the Merck & Co vaccine has been
offered to Congo under a "compassionate use" protocol agreed by
national and international health and ethics authorities.
This means fully informed, signed consent is needed from every
person who wants the shot. And in the current Ebola outbreak, that
makes logistical, cultural and language barriers the ultimate
challenges, global health specialists say.
The hurdles illustrate how hard it can be to move from laboratory to
real life, especially in remote communities with no functioning
health systems. The Congo outbreak is a chance to reality-test a
vaccine against a disease epidemic that can't be replicated in
controlled environments.
"This is going to need a highly sophisticated operation in one of
the most difficult places on earth," said Peter Salama, the World
Health Organization's deputy director-general for emergency
preparedness and response.
"It's very hot and very humid, and we're talking about hundreds of
kilometers of densely forested areas."
The shot is designed for use in a so-called "ring vaccination". When
a new Ebola case is diagnosed, all people who might have been in
recent contact with them are traced and vaccinated to try and
prevent the disease's spread.
The vaccine supplies so far will be enough to vaccinate 50 rings of
150 people, according to the WHO. It said that as of May 15, 527
contacts of Ebola cases and suspected cases had been identified and
were being followed up.
Health workers will need to use translators for several local
languages and explain the vaccine to leaders from different
communities, Salama said. Limited communications, health facilities
and electricity, as well as the need to keep the vaccine in a "cold
chain" at -60 to -80 degrees Celsius will also present challenges.
If any of these elements fails, the vaccine's potential to protect
100 percent of those immunized will go unrealized.
"These are make or break issues," said Salama, who visited Congo
last weekend. "There's a lot of complex logistics and social science
here."
CONTACTS
Results of a trial using the ring vaccination technique with the
Merck shot, which is known as VSV-EBOV, in Guinea in West Africa in
2015 showed 100 percent protection in those vaccinated immediately.
Health experts working to contain the Congo outbreak, which was
first reported on May 8, say a cold chain will be in place to get
the vaccines from Congo's capital Kinshasa to the affected areas
within a few days. Then the shot could be given to local frontline
medical, burial and hospital workers who volunteer for it as early
as next week.
There have been 44 suspected, probable or confirmed Ebola cases in
this outbreak in Congo's Equateur province, and 23 people have died.
The WHO said on Thursday it became more concerned when a case was
confirmed in Mbandaka, a city of about a million people which is
connected to Kinshasa by the Congo River.
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Jeremy Farrar, a specialist in infectious diseases and director of
the Wellcome Trust global health charity, told Reuters the epidemic
now had "all the features of something that could turn really
nasty".
"You can't overrespond in this scenario," he said. "But the vaccine
must be seen in the context of an overarching public health
response. Critically that means early diagnosis, early isolation,
safe burials and understanding the social context. The vaccine can
only be a part of the solution."
ACCEPTANCE
Experts also caution that acting too hastily could jeopardize the
potential success of a vaccine deployment.
Micaela Serafini, a medical director for the international charity
Medecins Sans Frontières (MSF) who is helping coordinate the
response to the Congo outbreak, said its teams are planning for at
least 45 minutes of discussion and information-sharing with each
person, with a translator present, before signed consent would be
obtained.
Then, she told Reuters, medical teams would probably return the
following day to administer the vaccine.
"What we need to avoid at all costs is an uncontrolled situation in
the communities affected," she said.
Even though the vaccine has still yet to get a license, the
emergency response teams say its safety and efficacy data is strong.
And despite lingering suspicions in some of the more remote parts of
Africa of western medicines, experts anticipate widespread public
acceptance.
Congo's health minister Oly Ilunga signaled on Thursday that his
government was fully behind the shot's use.
"The vaccine will help us save lives in the Equateur province, in
the DRC and in neighboring countries. The vaccine allows us to limit
the virus, so we must use it," he said.
Merck and the GAVI vaccine alliance have said a stockpile of more
than 300,000 doses of the shot is available for emergency use in an
epidemic.
Salama and Serafini said one tricky task may be managing a scenario
where larger groups of people not identified as high-risk contacts
of a Ebola case might demand the vaccine for themselves or their
family.
"We want to make sure we are engaging whole communities so that the
broader community understands what we are doing and why," said
Salama. "That is particularly important when you're not targeting
everyone, because naturally people will ask: 'How come you're
vaccinating that person but not me?'"
(Additional reporting by Tom Miles in Geneva and Patient Ligodi in
Kinshasa; Editing by Nick Tattersall and Pravin Char)
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