Reasonable Rascal
07-10-02, 12:40
SMALLPOX VACCINATION (02)
*******************************
A ProMED-mail post
Date: 9 Jul 2002
From: ProMED-mail
Source: AP Online [edited]
Volunteers Undergo Vaccine Trials
---------------------------------
SAN FRANCISCO -- With the jab of a needle, volunteers are being injected with a smallpox vaccine as part of government-sponsored experiments that come amid heightened fear of biological terrorism.
About 330 volunteers will be inoculated with diluted doses of the vaccine over the next two weeks at 4 sites across the nation. On Monday, the Oakland Medical Center began vaccinating 50 volunteers.
Researchers will test 2 vaccines. One, known as Dryvax, was made 20 years ago; there are 15 million doses available. There are more than 70 million doses of the other vaccine, which Aventis Pasteur Inc. donated to the government, who now must determine whether the vaccines are still usable.
For decades, Aventis' doses sat nearly unnoticed in a walk-in freezer at a remote mountainside lab in Pennsylvania. The firm thought the contents of its freezer were so worthless they were planning to destroy the stockpile.
Then came Sept. 11 and the ensuing anthrax attacks. Suddenly the nation's available supply of vaccine for smallpox, a disease that had been declared eradicated worldwide in 1980, was deemed crucial.
"In the past year, I think we've all become more aware of the possibility of a bioterrorist attack in the United States," said Steve Black, co-director of the Vaccine Research Center at Oakland Medical Center.
"I hope we never need to use this vaccine again, but it's important to make certain that if we do it will be available and it will work,'' Black said. "If we can show that this vaccine stock is still effective, it will go a
long way toward making a dose of smallpox vaccine available for everyone in the U.S.''
Volunteers have already begun receiving the vaccine at Vanderbilt University in Nashville, Tenn., and the University of Iowa. Baylor College of Medicine, in Houston, also is enrolling volunteers. Results are expected by mid-August 2002.
The tests are part of a $12.6 million National Institutes of Health grant awarded last year to Vanderbilt, which is overseeing the experiment and will enroll about 90 volunteers of its own.
Federal officials at the Centers for Disease Control and Prevention now are considering vaccinating as many as 500 000 health care workers and emergency personnel who would be first to see any smallpox cases. Because the vaccine carries significant risks -- including death -- officials do not want to resume mass vaccinations.
Bioterrorism experts consider the possibility of a smallpox attack one of the most frightening (albeit unlikely) threats, because one infected patient could infect many others.
Health workers will inject the vaccine, the area will be bandaged, and the area will be checked. Subsequent blood tests will determine whether the test subjects develop the antibodies needed to fight off the disease.
Two studies released in March 2002 by The New England Journal of Medicine found that out of the 700 previously unvaccinated young adults who received some of the Dryvax vaccine, one-third had pain bad enough to miss school, work, or other activities after being inoculated. While no one in the study fell seriously ill, some experienced fever, headache, nausea, muscle aches, lesions, and swelling.
On the Net:
National Institutes of Health: <http://www.nih.gov>
Centers for Disease Control and Prevention: <http://www.cdc.gov>
[Byline: Paul Elias]
--
ProMED-mail
[According to this article, there will be 330 volunteers involved in the smallpox vaccination trials described above. In addition, there is reference to an earlier vaccine trial involving approximately 700 volunteers. The sample sizes involved in these trials will be sufficient to study the efficacy of the vaccine in terms of antibody production. However, any conclusions drawn about the side effects must be conditional, as the sample size is very small and would theoretically only detect those side effects with a high incidence (greater than 1 in 1000). All of these studies are critical to determine the efficacy of vaccines currently in stock. - Mod.MPP]
*******************************
A ProMED-mail post
Date: 9 Jul 2002
From: ProMED-mail
Source: AP Online [edited]
Volunteers Undergo Vaccine Trials
---------------------------------
SAN FRANCISCO -- With the jab of a needle, volunteers are being injected with a smallpox vaccine as part of government-sponsored experiments that come amid heightened fear of biological terrorism.
About 330 volunteers will be inoculated with diluted doses of the vaccine over the next two weeks at 4 sites across the nation. On Monday, the Oakland Medical Center began vaccinating 50 volunteers.
Researchers will test 2 vaccines. One, known as Dryvax, was made 20 years ago; there are 15 million doses available. There are more than 70 million doses of the other vaccine, which Aventis Pasteur Inc. donated to the government, who now must determine whether the vaccines are still usable.
For decades, Aventis' doses sat nearly unnoticed in a walk-in freezer at a remote mountainside lab in Pennsylvania. The firm thought the contents of its freezer were so worthless they were planning to destroy the stockpile.
Then came Sept. 11 and the ensuing anthrax attacks. Suddenly the nation's available supply of vaccine for smallpox, a disease that had been declared eradicated worldwide in 1980, was deemed crucial.
"In the past year, I think we've all become more aware of the possibility of a bioterrorist attack in the United States," said Steve Black, co-director of the Vaccine Research Center at Oakland Medical Center.
"I hope we never need to use this vaccine again, but it's important to make certain that if we do it will be available and it will work,'' Black said. "If we can show that this vaccine stock is still effective, it will go a
long way toward making a dose of smallpox vaccine available for everyone in the U.S.''
Volunteers have already begun receiving the vaccine at Vanderbilt University in Nashville, Tenn., and the University of Iowa. Baylor College of Medicine, in Houston, also is enrolling volunteers. Results are expected by mid-August 2002.
The tests are part of a $12.6 million National Institutes of Health grant awarded last year to Vanderbilt, which is overseeing the experiment and will enroll about 90 volunteers of its own.
Federal officials at the Centers for Disease Control and Prevention now are considering vaccinating as many as 500 000 health care workers and emergency personnel who would be first to see any smallpox cases. Because the vaccine carries significant risks -- including death -- officials do not want to resume mass vaccinations.
Bioterrorism experts consider the possibility of a smallpox attack one of the most frightening (albeit unlikely) threats, because one infected patient could infect many others.
Health workers will inject the vaccine, the area will be bandaged, and the area will be checked. Subsequent blood tests will determine whether the test subjects develop the antibodies needed to fight off the disease.
Two studies released in March 2002 by The New England Journal of Medicine found that out of the 700 previously unvaccinated young adults who received some of the Dryvax vaccine, one-third had pain bad enough to miss school, work, or other activities after being inoculated. While no one in the study fell seriously ill, some experienced fever, headache, nausea, muscle aches, lesions, and swelling.
On the Net:
National Institutes of Health: <http://www.nih.gov>
Centers for Disease Control and Prevention: <http://www.cdc.gov>
[Byline: Paul Elias]
--
ProMED-mail
[According to this article, there will be 330 volunteers involved in the smallpox vaccination trials described above. In addition, there is reference to an earlier vaccine trial involving approximately 700 volunteers. The sample sizes involved in these trials will be sufficient to study the efficacy of the vaccine in terms of antibody production. However, any conclusions drawn about the side effects must be conditional, as the sample size is very small and would theoretically only detect those side effects with a high incidence (greater than 1 in 1000). All of these studies are critical to determine the efficacy of vaccines currently in stock. - Mod.MPP]