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2011)
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31 May 2011
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SciDev.net - Mico Tatalovic
International tuberculosis
(TB) experts are gathering today World TB Day in
But the reason there is no
effective vaccine to prevent the roughly ten million new cases and two million
deaths from TB each year has little to do with the science. There are already 11
vaccines in clinical trials whose progress has slowed or stalled because the
funding has dried up.
That is why the
TuBerculosis Vaccine Initiative (TBVI), an independent organisation that
promotes the development of TB vaccines, is launching a new funding model today.
Joris Vandeputte, senior
vice-president of advocacy and resource mobilisation at TBVI, tells SciDev.Net
that US$1.5 billion is urgently needed to translate basic research into
market-ready vaccines over the next decade. A single TB vaccine can cost up to
US$300 million to develop.
Funding gap
Basic research has been
adequately funded, he says, resulting in around 40 candidate vaccines because of
a huge research effort over the past decade. In addition to the 11 in the
faltering trials, a further 30 are languishing in laboratories, some of them in
developing countries, waiting to be tested.
But the "second
chunk" of funding, needed to get the candidate vaccines through clinical
trials, is missing so vaccine development has effectively stopped, he says.
Under the new funding
model, the European Union would provide loans to fill the gaps, possibly through
the European Investment Bank. The loans would be administered by the TBVI and
paid back once the vaccines start making money.
The model takes into
account various logistical difficulties facing the researchers, such as the
bottleneck caused by the lack of capacity in clinical trials, by calculating in
the costs needed to tackle such issues.
"We will have to look
to the east
Around 90 per cent of
countries currently vaccinate their children against TB with the Bacillus
Calmette-Guιrin (BCG) vaccine, using 100 million doses each year. BCG protects
children from severe forms of TB but does not protect adults from pulmonary TB
the most common and infectious form of the disease.
A more effective vaccine
would save huge amounts on treatment, which costs European countries alone about
US$3 billion a year.
Low take-up
But even if the money for
trials becomes available and an effective vaccine emerges, further problems may
await. Data to be published later this year in a special vaccines issue of the
journal Tuberculosis show that some developing countries may be reluctant to
accept new TB vaccines.
Several factors seem to
determine whether countries are prepared to shoulder the costs of a new vaccine
campaign, including whether the vaccine has been tested in their own country.
The study's authors
conducted 86 structured interviews with public health clinicians, politicians
and senior civil servants from health and finance ministries in countries with
the highest burden of the disease:
Lew Barker, senior medical
advisor at the Aeras Global TB Vaccine Foundation in the
"None of the
respondents, when asked about the most important public health issues and needs
of their country, spontaneously mentioned TB," Barker says. Instead,
primary, rural and mother-and-child healthcare, as well as HIV/AIDS, were
identified as the most pressing issues.
"However, when TB was
mentioned [by the interviewer], they uniformly said this is a very serious
problem and, by and large, they said it's also a neglected problem that needs
and deserves more attention then it gets," Barker adds.
Respondents in the survey
welcomed the development of better TB vaccines, but around 20 per cent said it
was unlikely that such vaccines would be taken up in their countries, and many
more were undecided. In most of the vaccine roll-out scenarios presented, less
than half said they were willing to commit to a new vaccine and provide funding.
One of the main reasons was that they wanted to see strong efficacy data from
clinical trials in their own country.
Political priorities
Vaccine deployment might
take 2030 years to reap healthcare benefits because 95 per cent of cases are
latent and may take years to show up, and most vaccines only target people who
have not been exposed to TB (around one third of the world's population has been
exposed), so there will be a long tail of cases before the hoped-for elimination
of TB in 2050, Barker says. This explains why other issues such as HIV are given
political priority.
Barker concludes that
robust data showing efficacy of 90 per cent, rather than a more realistic 60 per
cent, and from studies in the countries concerned, are likely to be needed for
the introduction of new TB vaccines.
Opokua Ofori-Anyinam,
senior clinical development manager at GSK Biologicals, a vaccine manufacturer,
said researchers should engage with policymakers to make sure that, after
spending millions of dollars on trials and testing vaccines in thousands of
individuals, they end up with vaccines that policymakers will want to deploy.
"These are the things
we have to think about ahead of time," Ofori-Anyinam tells SciDev.Net.
Vandeputte says the TB
research community must engage with the media and policymakers to put TB onto
national political agendas.
But he points out that
Aeras' market research, presented by Barker, found a mixed response and that the
proportion of decision-makers who would go for a new vaccine is bigger than
those who would not. Engagement and advocacy before a new vaccine reaches the
market may also help convince the undecided.
Focus on the vaccine
Michel Greco, chair of the
working group on new TB vaccines at the Stop TB Partnership, says: "I am
not one of those people who think that as soon as we have a good TB vaccine it
would be taken up. Countries are very wary of potential problems, so they go
slowly."
But he adds that although
studies are needed to address uptake issues and pave the way for the future
deployment of TB vaccines, the priority should be on designing and testing
vaccines rather than worrying about their subsequent uptake.
Helen McShane, a TB
vaccine researcher at the University of Oxford, United Kingdom, whose vaccine
MVA85A is currently in phase IIb clinical trials, told SciDev.Net: "The
more effective a vaccine is, the more likely that it will be taken on. It will
also depend on cost I think if you have a very effective vaccine at
affordable prices for the developing areas of the world then it will be taken
on."
She adds: "There may
be certain countries where you have to do some studies in that country to get
some safety data but, although those are all important factors, I don't see them
as the biggest challenge the biggest challenge is that we need to get a
vaccine that works."
(Reuters) - Here
is some new global data on HIV and AIDS from an updated report by the Joint U.N.
Programme on HIV/AIDS (UNAIDS).
THE GLOBAL PICTURE:
* More than 34 million people worldwide had
the human immunodeficiency virus (HIV) that causes AIDS at the end of 2010,
according to the latest figures issued by (UNAIDS). There were 26.2 million in
1999.
* There were an estimated 1.8 million
AIDS-related deaths around the world in 2009.
* Since the AIDS pandemic started in the
early 1980s, more than 60 million people have been infected with HIV and nearly
30 million have died of HIV-related causes.
* The number of girls aged 10-14 living with
HIV grew from about 50,000 in 1999 to more than 300,000 in 2010.
-- Young women aged 15-24 account for 26
percent of all new HIV infections globally.
-- In southern
* ANTIRETROVIRAL THERAPY AND PLANNING:
-- An estimated 6.6 million people in low-
and middle-income countries were receiving antiretroviral therapy at the end of
2010, a nearly 22-fold increase since 2001.
-- About 9 million people in low- and
middle-income countries who were eligible for antiretroviral treatment were not
receiving it, as of end-2010.
* Between 2001 and 2009, the global annual
rate of new HIV infections declined by nearly 25 percent.
* In 2010, 94 percent of countries (162 of
172 countries reporting) had national HIV strategic plans, up from 87 percent in
2006.
* Despite dramatic gains in treatment
access, 9 million people who were eligible for treatment were not receiving it,
as of December 2010.
-- Up to 460,000 children were receiving
antiretroviral therapy at the end of 2010. Treatment coverage for children (28
percent) was lower than for people of all ages (36 percent) in 2009.
* INVESTMENT AND ACCOUNTABILITY:
-- Between 2001 and 2009, investments in the
HIV response in low- and middle-income countries rose nearly 10-fold, from $1.6
billion to $15.9 billion.
-- In 2010, international AIDS resources
declined for the first time in a decade. Financial challenges in many countries
have put downward pressure on funding sources.
-- A 2011 investment framework proposed by
UNAIDS and partners found that a more focused annual investment of at least $22
billion is needed by the year 2015, $6 billion more than is available today.
-- The estimated return on this investment:
12 million more HIV infections averted and 7.4 million more deaths averted by
the year 2020.
SOURCE: UNAIDS/Reuters
(Writing by David Cutler,
Jun 1, 2011
By Kate Kelland
Dramatic scientific
advances since HIV was first discovered 30 years ago this week mean the virus is
no longer a death sentence. Thanks to tests that detect HIV early, new
antiretroviral AIDS drugs that can control the virus for decades, and a range of
ways to stop it being spread, 33.3 million people around the world are learning
to live with HIV.
People like Vuyiseka
Dubula, an HIV-positive AIDS activist and mother in
Nonetheless, on the 30th
birthday of HIV, the global scientific community is setting out with renewed
vigour to try to kill it. The drive is partly about science, and partly about
money. Treating HIV patients with lifelong courses of sophisticated drugs is
becoming unaffordable.
Caring for HIV patients in
developing countries alone already costs around $13 billion (7.9 billion pounds)
a year and that could treble over the next 20 years.
In tough economic times,
the need to find a cure has become even more urgent, says Francoise Barre
Sinoussi, who won a Nobel prize for her work in identifying Human
Immunodeficiency Virus (HIV). "We have to think about the long term,
including a strategy to find a cure," she says. "We have to keep on
searching until we find one."
The
THE CURE THAT WORKED
Timothy Ray Brown was
living in
"We really didn't
know when we started this project what would happen," Huetter, an
oncologist and haematologist who now works at the
Most experts say it is
inconceivable Brown's treatment could be a way of curing all patients. The
procedure was expensive, complex and risky. To do this in others, exact match
donors would have to be found in the tiny proportion of people -- most of them
of northern European descent -- who have the mutation that makes them resistant
to the virus.
Dr Robert Gallo, of the
Sinoussi is more
expansive. "It's clearly unrealistic to think that this medically heavy,
extremely costly, barely reproducible approach could be replicated and scaled-up
... but from a scientist's point of view, it has shown at least that a cure is
possible," she says.
The International AIDS
Society will this month formally add the aim of finding a cure to its HIV
strategy of prevention, treatment and care.
A group of
scientist-activists is also launching a global working group to draw up a
scientific plan of attack and persuade governments and research institutions to
commit more funds. Money is starting to flow. The U.S. National Institutes of
Health is asking for proposals for an $8.5 million collaborative research grant
to search for a cure, and the Foundation for AIDS Research, or amfAR, has just
announced its first round of four grants to research groups "to develop
strategies for eradicating HIV infection."
THE COST OF TREATMENT
Until recently, people in
HIV and AIDS circles feared that to direct funds towards the search for a cure
risked detracting from the fight to get HIV-positive people treated. Even today,
only just over five million of the 12 million or so people who need the drugs
actually get them.
HIV first surfaced in
1981, when scientists at the U.S. Centers for Disease Control and Prevention
discovered it was the cause of acquired immunodeficiency syndrome (AIDS). An
article in the CDC's Morbidity and Mortality Weekly Report of that June referred
to "five young men, all active homosexuals" from
In the subsequent three
decades, the disease ignorantly branded "the gay plague" has become
one of the most vicious pandemics in human history. Transmitted in semen, blood
and breast milk, HIV has devastated poorer regions, particularly sub-Saharan
Treatment costs per
patient can range from around $150 a year in poor countries, where drugs are
available as cheap generics, to more than $20,000 a year in the
The overall sums are huge.
A recent study as part of a non-governmental campaign called AIDS2031 suggests
that low and middle-income countries will need $35 billion a year to properly
address the pandemic by 2031. That's almost three times the current level of
around $13 billion a year. Add in the costs of treatment in rich countries and
experts estimate the costs of HIV 20 years from now will reach $50 to $60
billion a year.
"It's clear that we
have to look at another possible way of managing of the epidemic beyond just
treating everyone forever," says Sharon Lewin, a leading HIV doctor and
researcher from
In some ways, we have been
here before. Early AIDS drugs such as AZT came to market in the late 1980s, but
within a decade they were overtaken by powerful cocktail treatments known as
HAART, or highly active antiretroviral treatment. HAART had a dramatic effect --
rapidly driving the virus out of patients' blood and prompting some to say a
cure was just around the corner.
But then scientists
discovered HIV could lie low in pools or reservoirs of latent infection that
even powerful drugs could not reach. Talk of a cure all but died out.
"Scientifically we
had no means to say we were on the way to finding a cure," says Bertrand
Audoin, executive director of the Geneva-based International AIDS Society.
"Scientists ... don't want to make any more false promises. They didn't
want to talk about a cure again because it really wasn't anywhere on the
horizon."
GENE THERAPY
The ultimate goal would
allow patients to stop taking AIDS drugs, knocking a hole in a $12
billion-a-year market dominated by Californian drugmaker
It's unlikely to happen
anytime soon, but Brown's case has opened the door to new ideas. "What it
proved was that if you make someone's cells resistant to HIV...then all the last
bits of HIV, that hang around for a long time in patients on treatment, did in
fact decay and disappear," says Lewin.
Now scientists working on
mimicking the effect of the
At an HIV conference in
Boston earlier this year, American researchers presented data on six patients
who had large numbers of white blood cells known as CD4 cells removed,
manipulated to knock out the existing CCR5 gene, and then replaced.
"It works like
scissors and cuts a piece of genetic information out of the DNA, and then closes
the gap," says Huetter. "Then every cell arising from this mother cell
has this same mutation."
Early results showed the
mutated cells managed to survive inside the bodies of the patients at low
levels, remaining present for more than three months in five. "This was a
proof of concept," says Lewin. Another potential avenue is a small group of
patients known as "elite controllers", who despite being infected with
HIV are able to keep it under control simply with their own immune systems.
Researchers hope these patients could one day be the clue to developing a
successful HIV/AIDS vaccine or functional cure.
Scientists are also
exploring ways to "wake up" HIV cells and kill them. As discovered in
the late 1990s, HIV has a way of getting deep into the immune system itself --
into what are known as resting memory T-cells -- and going to sleep there.
Hidden away, it effectively avoids drugs and the body's own immune response.
"Once it goes to
sleep in a cell it can stay there forever, which is really the main reason why
we can't cure HIV with current drugs," says Lewin. Her team in
WHAT ABOUT PREVENTION?
As scientists begin to
talk up a cure, the old question of whether that's the right goal has
re-emerged. Seth Berkley, a medical epidemiologist and head of the U.S.-based
International AIDS Vaccine Initiative (IAVI) is concerned.
"From a science point
of view, it's a fabulous thing to do. It's a great target and a lot of science
will be learned. But from a public health point of view, the primary thing you
need to do is stop the flow of new infections," says
Vuyiseka Dubula agrees.
The South African activist finds talk of a cure for HIV distracting, almost
disconcerting. "This research might not yield results soon, and even when
it does, access to that cure is still going to be a big issue," she says.
"So in the meantime, while we don't have the answer on whether HIV can be
cured or not, we need to save lives."
(Additional reporting by
Julie Steenhuysen in