PHM-Exch> Blueprint for future TB vaccines unveiled

[Claudio Schuftan]

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.

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.

The eight-page plan, or blueprint, and related commentaries have been
published in the March 2012 edition of the medical journal, Tuberculosis.

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.

"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."

 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.

 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.

[
http://www.plusnews.org/Report/94355/HEALTH-TB-programming-research-slowed-by-inadequate-funding]

 Thinking globally, acting locally

 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.

 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. [
http://www.irinnews.org/Report/94365/SOUTH-AFRICA-Country-launches-new-HIV-TB-plan]

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.

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.

 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.

 TB vaccine study

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.

"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."

 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. [ http://www.fixthepatentlaws.org/?p=144
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