<p><span lang="EN-US"> </span></p><p><span lang="EN-US">JOHANNESBURG,
21 March, 21 (PLUSNEWS) - Almost a century ago, French scientists
discovered the world's only tuberculosis (TB) vaccine. Now the World
Health Organization warns that without a new one, the world will not win
the fight against TB. </span></p><p><span lang="EN-US"></span></p><p><span lang="EN-US">A
new plan, launched in Johannesburg, South Africa, on 20 March ahead of
World TB Day, outlines the gaps and needs in five main areas of TB
vaccine research and development: Innovation in research and discovery;
better understanding of TB immunity; clinical trials; TB vaccine
candidate selection; and advocacy and resource mobilization. </span></p><p><span lang="EN-US"></span></p><p><span lang="EN-US">The
eight-page plan, or blueprint, and related commentaries have been
published in the March 2012 edition of the medical journal,
Tuberculosis. </span></p><p><span lang="EN-US"></span></p><span lang="EN-US"></span><p><span lang="EN-US">Ten
years ago, there were no potential TB vaccines in clinical trials.
Today - and more than US$600 million dollars later - there are 12 TB
vaccine candidates. </span></p><p><span lang="EN-US"></span></p><p><span lang="EN-US">"If
these new vaccines were successful, we need to be prepared to design
the multi-country phase-three clinical trials to get these vaccines
marketed and distributed globally" . "If these
failed, we need to be prepared with the next generation of vaccines in
the pipeline using novel technologies." </span></p><p><span lang="EN-US"> Among
the major issues highlighted in the blueprint are the need to better
understand why some people develop active TB and others do not; develop
appropriate clinical trials for HIV patients and those with drug
resistant TB; and the need for resource mobilization. </span></p><p><span lang="EN-US"> The large, advanced-stage clinical trials needed to show a
TB vaccine's efficacy and safety prior to regulatory approval could cost
up to US$200 million. In 2010, only about US$80 million was going
towards vaccine research and development, according to the latest survey
by the New York-based Treatment Action Group. </span></p><p><span lang="EN-US">[ </span><a href="http://www.plusnews.org/Report/94355/HEALTH-TB-programming-research-slowed-by-inadequate-funding" target="_blank"><span lang="EN-US">http://www.plusnews.org/Report/94355/HEALTH-TB-programming-research-slowed-by-inadequate-funding</span></a><span lang="EN-US"> ] </span></p>
<p><span lang="EN-US"> Thinking globally, acting locally </span></p><p><span lang="EN-US"> Globally,
there are about nine million new TB cases annually and 1.4 million
people lose their lives to active TB each year. In South Africa, TB -
driven by high HIV prevalence rates - is now the leading cause of
natural death. Although many people carry TB, only 10 percent will ever
develop the active disease. However, people with compromised immune
systems, such as those living with HIV or diabetes, are up to 40 times
more likely to develop active TB. </span></p><p><span lang="EN-US"> I
the new National Strategic Plan (NSP) for HIV and AIDS, sexually
transmitted infections and TB 2012-2016, the country has prioritized the
need for innovative research into new TB drugs, diagnostics and vaccine
development, which the government is currently funding. Should a new,
effective TB vaccine be discovered, South Africa's NSP also calls for
the use of novel licensing mechanisms to facilitate rapid uptake. [ </span><a href="http://www.irinnews.org/Report/94365/SOUTH-AFRICA-Country-launches-new-HIV-TB-plan" target="_blank"><span lang="EN-US">http://www.irinnews.org/Report/94365/SOUTH-AFRICA-Country-launches-new-HIV-TB-plan</span></a><span lang="EN-US"> ] </span></p>
<span lang="EN-US"></span><span lang="EN-US"></span><p><span lang="EN-US">This
week, South African researchers and policymakers will meet in
Johannesburg to set - and cost - HIV and TB research priorities that
will ultimately be presented to the South African National AIDS Council
and government. </span></p><p><span lang="EN-US"></span></p><p><span lang="EN-US">In
2010, South Africa made history by becoming the first government to
join a patent pool. As a member of the pool established by
ac pharmaceutical company, South African TB
researchers have access to more than 2,300 existing patents and related
knowledge on neglected diseases like TB. </span></p><p><span lang="EN-US"> Due
to the country's high TB burden, and regulatory and research capacity,
half of all TB vaccine trials are being conducted in South Africa. </span></p><p><span lang="EN-US"> TB vaccine study </span></p><p><span lang="EN-US"></span></p><p><span lang="EN-US">TB
vaccines have to be tested in countries with high TB burdens, like
those in sub-Saharan Africa and Southeast Asia, to show that they work. It is thus important to ensure that these communities would
also reap the benefits of a successful trial. </span></p><p><span lang="EN-US"></span></p><span lang="EN-US"></span><p><span lang="EN-US">"These
efforts have been basically done through a non-profit platform... It
would be very sad that after a success, that non-profit platform was
replaced with a different platform that is profit-driven", "Hopefully we don't have the same issues
as we had with antiretrovirals. We will jealously guard against any
excessive cost that will be linked to making these vaccines available." </span></p><p><span lang="EN-US"> </span><span lang="EN-US">South
Africa has been battling patents on some second and third line
antiretrovirals for years. Still under patent protection and with no
generics available, the cost of these regimens have kept them out of the
public sector. [ </span><a href="http://www.fixthepatentlaws.org/?p=144" target="_blank"><span lang="EN-US">http://www.fixthepatentlaws.org/?p=144</span></a></p><span lang="EN-US"> </span>