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New TB Vaccines in Could Protect Against All Drug Resistant Strains

New tuberculosis (TB) vaccines in development have the potential to provide protection against all strains of TB, including multidrug-resistant (MDR) and extensively drug- resistant (XDR) TB , Dr. Jerald C. Sadoff, president and CEO of the Aeras Global TB Vaccine Foundation, said here today at the International Conference on Global Health.

Aeras, the only non-profit organization dedicated solely to creating new TB vaccines, is working to develop at least one new TB vaccine regimen for infants and one for adolescents within seven to nine years and to ensure they are available worldwide to all who need them.

Aeras and its partners have the largest TB vaccine pipeline in the world with six vaccine candidates in or expected to be in Phase I-II trials in 2007.

Dr. Sadoff cited the rise of the new, deadlier strains of TB -- including MDR and XDR -- which are spreading around the world, including to the United States. This week the U.S. Centers for Disease Control and Prevention (CDC) quarantined a patient in Atlanta who is infected with XDR, and who had been traveling on transatlantic flights. XDR TB is resistant to many of the first and second line drugs, severely limiting treatment options. At least 37 nations have reported cases of XDR.

"TB is second only to HIV/AIDS as the world's most deadly infectious disease and is the leading cause of death among individuals infected with HIV. TB takes a victim every 20 seconds, which adds up to more than 1.5 million people every year," Dr. Sadoff said.

"The rise of MDR and XDR TB, which has a particularly high fatality rate in people with HIV, makes our mission even more critical. The vaccines under development by Aeras and its partners are intended to protect against all strains of TB and to be safe for use in people infected with HIV."

Dr. Sadoff noted that there has not been a new TB vaccine since the current vaccine, Bacille Calmette-Guerin (B CG), was developed more than 86 years ago. It provides some protection against severe forms of TB in children but is unreliable against pulmonary TB, which accounts for most TB worldwide.

"New vaccines, along with new drugs and diagnostics, are essential to the elimination of TB as a public health threat," he said. "The work that we are doing will help save millions of lives."

Aeras operates as a Product Development Partnership (PDP), developing candidate vaccines in its own laboratory and manufacturing facility and pursuing partnerships with public, private, academic and philanthropic sector organizations to promote rapid development and distribution of a more effective TB vaccine. It has a dual role -- to develop new vaccines and to ensure access to those around the world with the least ability to pay.

Aeras' largest source of funding is the Bill & Melinda Gates Foundation. It also receives support from the Dutch Ministry of Foreign Affairs, the Danish International Development Agency, and the U.S. Centers for Disease Control and Prevention.

This support has enabled Aeras to build a new facility in Rockville, MD, opened in 2006, that has the capacity to produce 150 million to 200 million vaccine doses a year of a modified BCG vaccine.

Despite the very generous contributions from the Gates Foundation and others, considerably more funding is needed to create a vaccine and bring it to market, Dr. Sadoff said.

The Global Plan to Stop TB puts the research and development costs of new vaccines, in 2006-20015, at $2.08 billion, with a current funding gap of $1.5 billion. The plan was created by the Stop TB Partnership, a network of more than 500 international organizations, countries, public and private sector donors, and nongovernmental and governmental organizations.

"We still need help from governments, foundations, other philanthropic organizations and the private sector to put a stop to this terrible disease," Dr. Sadoff said. "This is a global issue and it's going to require a global commitment to solve it."

Dr. Sadoff has worked in vaccine development for more than 30 years. He was involved in efforts to develop and obtain licensure for nine currently licensed vaccines and has been involved in the research and development of numerous other vaccines.


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