New Anthrax Vaccine Shows Promise
By MARILYNN MARCHIONE
The Associated Press
Wednesday, September 27, 2006; 8:49 PM
http://www.washingtonpost.com/wp-dyn/content/article/2006/09/27/AR2006092701381.html
SAN FRANCISCO -- Five years after anthrax attacks left five dead and terrified America, scientists are reporting progress on developing a new vaccine they hope will work faster and with fewer side effects than the current one.
The experimental vaccine cleared two big hurdles in its first round of human tests, involving two doses given in a single month: No safety problems emerged, and it produced responses that suggest people were developing immunity to anthrax, its British manufacturer reported Wednesday.
The federally funded study involved 111 healthy adults and tested a vaccine developed by Avecia, a suburban London company, and the Defense Science and Technology Lab, part of the British Ministry of Defense.
More study is needed, but the early results are a good sign because problems continue to plague the California company with the main contract to develop a new vaccine, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
"We want to make sure we cover ourselves. You want to make sure you don't have everything invested in one particular product," especially one for a potential bioterrorism threat, he said.
Inventing a better vaccine has been a top goal since anthrax spores were sent through the mail five years ago, killing five, sickening 17, and causing a near panic nationwide. Many troops have refused to get the current vaccine, which is based on 1950s technology and requires six shots over 18 months to provide protection. Some soldiers sued to keep it from being required in the military.
To jump-start work on a new vaccine, scientists at the Army's research lab at Fort Detrick, Md., engineered a key ingredient they believed would make a vaccine less likely to cause skin irritations and other problems.
The government gave a California company, VaxGen Inc., an $877 million federal contract to produce vaccine based on the new approach, using three doses in six months. But the company has missed many deadlines and has pushed back delivery until at least 2008.
The government then gave Avecia a $71 million contract to develop an alternative vaccine using the same approach.
Results of Avecia's early human tests were reported Wednesday at a meeting of the American Society for Microbiology.
Volunteers were given two shots _ one at the start of the study and another three or four weeks later. Each shot contained one of various levels of the new vaccine or one of two levels of the current one.
At all doses, the new vaccine produced signs that people were developing immunity to the germ, though the early results suggest they may be a little weaker than the current vaccine's protection, said Dr. Andrew Simpson, a scientist at the British defense lab.
"The implication ... is that the immune response was not as good," said Dr. Arthur Friedlander, a senior scientist at the Army lab who did early work that led to the vaccine.
However, no one knows whether it is good enough, because even the current vaccine was never really tested against anthrax. It would be unethical to deliberately expose people to such a deadly germ, so scientists have relied on animal research to suggest what levels of immunity might protect people.
larger study of the Avecia vaccine, testing two or three doses and over longer time periods, is under way on 600 people in London and the United States, Simpson said.
"It is safe. We'd be quite happy to give it to more people in a larger trial," he said. "It's encouraging."
"They're making progress," Friedlander said. "It's certainly good having an alternative manufacturer."
The Associated Press
Wednesday, September 27, 2006; 8:49 PM
http://www.washingtonpost.com/wp-dyn/content/article/2006/09/27/AR2006092701381.html
SAN FRANCISCO -- Five years after anthrax attacks left five dead and terrified America, scientists are reporting progress on developing a new vaccine they hope will work faster and with fewer side effects than the current one.
The experimental vaccine cleared two big hurdles in its first round of human tests, involving two doses given in a single month: No safety problems emerged, and it produced responses that suggest people were developing immunity to anthrax, its British manufacturer reported Wednesday.
The federally funded study involved 111 healthy adults and tested a vaccine developed by Avecia, a suburban London company, and the Defense Science and Technology Lab, part of the British Ministry of Defense.
More study is needed, but the early results are a good sign because problems continue to plague the California company with the main contract to develop a new vaccine, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
"We want to make sure we cover ourselves. You want to make sure you don't have everything invested in one particular product," especially one for a potential bioterrorism threat, he said.
Inventing a better vaccine has been a top goal since anthrax spores were sent through the mail five years ago, killing five, sickening 17, and causing a near panic nationwide. Many troops have refused to get the current vaccine, which is based on 1950s technology and requires six shots over 18 months to provide protection. Some soldiers sued to keep it from being required in the military.
To jump-start work on a new vaccine, scientists at the Army's research lab at Fort Detrick, Md., engineered a key ingredient they believed would make a vaccine less likely to cause skin irritations and other problems.
The government gave a California company, VaxGen Inc., an $877 million federal contract to produce vaccine based on the new approach, using three doses in six months. But the company has missed many deadlines and has pushed back delivery until at least 2008.
The government then gave Avecia a $71 million contract to develop an alternative vaccine using the same approach.
Results of Avecia's early human tests were reported Wednesday at a meeting of the American Society for Microbiology.
Volunteers were given two shots _ one at the start of the study and another three or four weeks later. Each shot contained one of various levels of the new vaccine or one of two levels of the current one.
At all doses, the new vaccine produced signs that people were developing immunity to the germ, though the early results suggest they may be a little weaker than the current vaccine's protection, said Dr. Andrew Simpson, a scientist at the British defense lab.
"The implication ... is that the immune response was not as good," said Dr. Arthur Friedlander, a senior scientist at the Army lab who did early work that led to the vaccine.
However, no one knows whether it is good enough, because even the current vaccine was never really tested against anthrax. It would be unethical to deliberately expose people to such a deadly germ, so scientists have relied on animal research to suggest what levels of immunity might protect people.
larger study of the Avecia vaccine, testing two or three doses and over longer time periods, is under way on 600 people in London and the United States, Simpson said.
"It is safe. We'd be quite happy to give it to more people in a larger trial," he said. "It's encouraging."
"They're making progress," Friedlander said. "It's certainly good having an alternative manufacturer."
