Years ahead of having a new product, a foundation set up to develop a tuberculosis vaccine opened its first factory on Thursday.
The Aeras Global TB Vaccine Foundation cut the tape on a research and production facility in Rockville, Md., that Chief Executive Officer Dr. Jerald Sadoff predicts will be able to produce 150 million doses of vaccine a year — perhaps eventually 300 million a year.
Sadoff is not disturbed that there actually is no modern tuberculosis vaccine yet.
"We are going to be using it for making replacement BCG for the world," said Sadoff, a former Merck and Co. vaccine executive, describing the Bacille Calmette-Guerin vaccine which has "been around for 80 years."
"It sort of works but it doesn't really work very well," Sadoff said in an interview.
"One of the things we think we can do is replace this very old vaccine with a modern vaccine using some modern technology."
The World Health Organization estimates that 2 billion people, one-third of everybody alive, are infected with tuberculosis. Of these, about 8 million become ill every year and 1.75 million die.
TB is the biggest killer of people with HIV, causing about 13 percent of AIDS deaths. The HIV pandemic has caused a resurgence in TB, which thrives in people with weak immune systems.
Best hope for cure
Intensive use of antibiotic cocktails for weeks on end can cure TB, but experts say a vaccine has better hope of controlling the bacterial-caused disease.
"Vaccination with BCG still remains the standard for TB prevention in most countries because of its efficacy in preventing life-threatening forms of TB in infants and young children, and also because it is the only vaccine available, is inexpensive, and requires only one encounter with the baby," WHO says in a statement on its Web site.
While a new TB vaccine is still seven to 10 years away, the nonprofit Aeras wants to hit the ground running with an $80 million grant from the Bill and Melinda Gates Foundation.
It also has projects going with Dutch biotechnology company Crucell NV, Denmark's Statens Serum Institut, the University of Cape Town in South Africa, GlaxoSmithKline and others.
"In private industry you really have to start building your factory early so there is no gap between time regulatory agencies allow you to sell it and the time you go to market," Sadoff said.
"You need to be able to do your clinical trials with a final product. So we can have all that ready."
Aeras has been running human, clinical trials since 2004 with rBCG30, a jazzed-up version of the original BCG vaccine.
The BCG vaccine used a weakened version of M. bovis, the cattle version of Mycobacterium tuberculosis, which causes most cases of human TB.
For its interim vaccine, Aeras genetically engineered the BCG bacteria to secrete large amounts of a protein of M. tuberculosis.
"With more than 4,700 people dying every day from TB, the world needs an effective TB vaccine as soon as possible," Sadoff said. "This new facility can deliver a TB vaccine to the world as soon as one is available."
Aeras is working on newer technology using Shigella, a bacteria that causes diarrhea. The new vaccine weakens Shigella so it does not cause illness, but instead delivers a tiny nanoparticle containing genetic material from M. tuberculosis. Like BCG, it would be an oral vaccine, Sadoff said.
U.S. vaccine plant
A vaccine plant on U.S. soil, like the Aeras facility, is a rare thing. Corporate vaccine makers have been fleeing the U.S. market, citing difficult regulations, fear of lawsuits and low profits. Nearly all U.S. vaccines are made in factories in other countries.
Sadoff said the plant could be adapted to make other types of vaccines if needed.
"We are confident this technology can be applied to just about any important vaccine -- such as malaria, HIV and flu and biodefense ones," he said.
He is not afraid of competition.
"For TB there just is not a market, let's face it," Sadoff said.
"Even though it is the world's most widely used vaccine, the market is small compared to a new HPV virus (a vaccine against cervical cancer) or rotavirus (a vaccine against a common cause of fatal childhood diarrhea) or pneumococcal conjugate vaccine."
Such vaccines can earn tens of millions of dollars for their makers.