Anthrax: Critics Attack Vaccine Treatment Plan
Opponents of a U.S. plan to offer the anthrax vaccine as a post-exposure treatment method yesterday criticized the vaccine’s safety and the lack of information as to who should be inoculated (see GSN, Dec. 19).
U.S. Representative Christopher Shays (R-Conn.), who held hearings last year on the vaccine, said it was dangerous for people “to take a vaccine that hasn’t been approved by the [U.S. Food and Drug Administration] and that was made in a plant that hasn’t been approved either.”
After the Shays hearings, the House Government Reform Committee released a report that criticized the “preposterously low adverse report rates,” issued by the Defense Department. The Pentagon did not monitor safety adequately and had an “institutional resistance to associating health effects with the vaccine,” the report said.
U.S. Postal Service officials said that without information from the U.S. Centers for Disease Control and Prevention, they would be unable to advise postal workers on whether to take the vaccine.
“I am disappointed and frustrated,” said Azeezaly Jaffer, vice president for public affairs for the Postal Service. “I don’t know what is best for me and my health,” Jaffer said. “If I cannot come to a resolution on what is best for me, you can guess how frustrated my employees are” (Rosenbaum/Stolberg, New York Times, Dec. 20).
Washington Mayor Anthony Williams yesterday released a statement saying district officials were not recommending vaccinations. “After discussing this issue at several scientific meetings, and the careful review of the scientific data, and absent a recommendation from the CDC, the District … affirms its previous public health advisory which recommends strict compliance with the 60-day course of antibiotics,” Williams said.
“As such the District Department of Health does not recommend investigational post-exposure prophylactics with anthrax vaccine at this time,” he said.
Bailus Walker, a professor of public health and policy at Howard University in Washington, said the government’s method of handling the anthrax incidents has reinforced long-held suspicions.
“There is a long-standing, deeply ingrained concern in the black community about being used as guinea pigs,” Walker said. “As much as we try, we have not been able to remove from the minds of the black community the Tuskegee episode… We confront it almost monthly as we try to get blacks to participate in clinical trials. This just feeds it.”
U.S. Officials’ Response
CDC Director Jeffrey Koplan yesterday described who might want to consider taking the vaccine as post-exposure treatment, according to the Washington Post. Such people include those who were near tainted mail, those who had contact with any of the five people who died from anthrax and those who were in contaminated buildings, Koplan said. “Those are the individuals at higher risk who may want to consider these more aggressive options,” he said (Connolly/Goldstein, Washington Post, Dec. 20).
Lt. Col. John Grabenstein, deputy director for clinical operations of the Pentagon’s Anthrax Vaccine Immunization Program, defended the safety of the vaccine. “We have conducted 18 human safety studies—short and long term—retrospective and prospective,” Grabenstein said. “In aggregate, what they show is anthrax vaccine has a side effect profile similar as that of other vaccines.”
Severe allergic reactions are visible in 1 per 100,000 people, Grabenstein said. Up to 16 percent of those inoculated may experience rashes, 14 to 25 percent may experience headaches, 12 to 15 percent may experience joint aches and close to a third may experience muscle aches, according to military researchers. Those inoculated have also said they felt painful stinging and burning at the inoculation site, the Washington Post reported.
In response to claims that the vaccine has other, more serious side effects, Grabenstein said, “lots of people are confusing ‘it happened after vaccination’ with ‘it happened because of vaccination’”(Shankar Vedantam, Washington Post, Dec. 20).
BioPort Inspections Completed
Food and Drug Administration officials yesterday said they had finished inspections of laboratories at BioPort, the only U.S. manufacturer of the anthrax vaccine. The company had successfully addressed most of the agency’s complaints, FDA officials said (see GSN, Nov. 21). BioPort will not be fully licensed until the FDA next month completes inspections of another company contracted to decant the anthrax vaccine into vials, FDA officials said.
BioPort has been trying to obtain U.S. approval to ship the anthrax vaccine it produces, according to the Associated Press. BioPort has produced the vaccine since 1988, but has been unable to ship since failing federal inspections in 1999 and 2000, the Associated Press reported.
The future corrections required by the FDA were minor compared to violations found in previous inspections, said BioPort President Bob Kramer (Associated Press/London Guardian, Dec. 20).
Genetic Findings Might Not Solve Investigation
Some scientists said too little is known yet about the genetic makeup of anthrax to be able to differentiate one sample from another, the Associated Press reported yesterday.
“It’s a race against time to get enough genetic information to make these matches precisely,” said Jill Trewhella, bioscience division leader at Los Alamos National Laboratory, which is assisting in the anthrax spores genetic fingerprinting effort (see GSN, Dec. 19). “We want to catch the person.”
Barbara Hatch Rosenberg, of New York State University, said they key to the case would probably involve determining a motive, rather than scientific analysis. FBI investigators are examining political and ideological motives for the attacks, as well as possible financial gain, such as someone involved with an environmental cleanup company, a law enforcement official said (Laura Meckler, Associated Press, Dec. 19).
Anthrax spores used at the University of New Mexico are likely identical to the spores used in the attacks, a university spokesman said. The university expects its anthrax samples to be tested soon for a genetic match with the mailed spores, said university spokesman Sam Giammo. “We would be very surprised if it didn’t match perfectly,” Giammo said.
The university’s anthrax samples came from the U.S. Army Medical Research Institute of Infectious Disease, which also sent out samples to five other laboratories, according to the Albuquerque Journal. The university did not use in its research the finely milled version of anthrax found in the tainted letters, Giammo said (Jackie Jadrnak, Albuquerque Journal, Dec. 19).
Russia Offers Help
Russian scientists have developed a new anthrax vaccine that they are prepared to offer to the United States, Valentin Pokrovskii, president of the Academy of Medical Sciences, said Tuesday. The new Russian vaccine only requires two injections, as opposed to six for the U.S. version, Pokrovskii said.
Russia is also ready to send its stockpiles of anthrax vaccine and spore samples to the United States, said Health Minister Yurii Shevchenko. “If the terrorist origin of the anthrax cases in America is proved, all of us should be ready for a mass vaccination of the population,” Shevchenko said (RFE/RL Newsline, Dec. 19).
U.S. Representative Christopher Shays (R-Conn.), who held hearings last year on the vaccine, said it was dangerous for people “to take a vaccine that hasn’t been approved by the [U.S. Food and Drug Administration] and that was made in a plant that hasn’t been approved either.”
After the Shays hearings, the House Government Reform Committee released a report that criticized the “preposterously low adverse report rates,” issued by the Defense Department. The Pentagon did not monitor safety adequately and had an “institutional resistance to associating health effects with the vaccine,” the report said.
U.S. Postal Service officials said that without information from the U.S. Centers for Disease Control and Prevention, they would be unable to advise postal workers on whether to take the vaccine.
“I am disappointed and frustrated,” said Azeezaly Jaffer, vice president for public affairs for the Postal Service. “I don’t know what is best for me and my health,” Jaffer said. “If I cannot come to a resolution on what is best for me, you can guess how frustrated my employees are” (Rosenbaum/Stolberg, New York Times, Dec. 20).
Washington Mayor Anthony Williams yesterday released a statement saying district officials were not recommending vaccinations. “After discussing this issue at several scientific meetings, and the careful review of the scientific data, and absent a recommendation from the CDC, the District … affirms its previous public health advisory which recommends strict compliance with the 60-day course of antibiotics,” Williams said.
“As such the District Department of Health does not recommend investigational post-exposure prophylactics with anthrax vaccine at this time,” he said.
Bailus Walker, a professor of public health and policy at Howard University in Washington, said the government’s method of handling the anthrax incidents has reinforced long-held suspicions.
“There is a long-standing, deeply ingrained concern in the black community about being used as guinea pigs,” Walker said. “As much as we try, we have not been able to remove from the minds of the black community the Tuskegee episode… We confront it almost monthly as we try to get blacks to participate in clinical trials. This just feeds it.”
U.S. Officials’ Response
CDC Director Jeffrey Koplan yesterday described who might want to consider taking the vaccine as post-exposure treatment, according to the Washington Post. Such people include those who were near tainted mail, those who had contact with any of the five people who died from anthrax and those who were in contaminated buildings, Koplan said. “Those are the individuals at higher risk who may want to consider these more aggressive options,” he said (Connolly/Goldstein, Washington Post, Dec. 20).
Lt. Col. John Grabenstein, deputy director for clinical operations of the Pentagon’s Anthrax Vaccine Immunization Program, defended the safety of the vaccine. “We have conducted 18 human safety studies—short and long term—retrospective and prospective,” Grabenstein said. “In aggregate, what they show is anthrax vaccine has a side effect profile similar as that of other vaccines.”
Severe allergic reactions are visible in 1 per 100,000 people, Grabenstein said. Up to 16 percent of those inoculated may experience rashes, 14 to 25 percent may experience headaches, 12 to 15 percent may experience joint aches and close to a third may experience muscle aches, according to military researchers. Those inoculated have also said they felt painful stinging and burning at the inoculation site, the Washington Post reported.
In response to claims that the vaccine has other, more serious side effects, Grabenstein said, “lots of people are confusing ‘it happened after vaccination’ with ‘it happened because of vaccination’”(Shankar Vedantam, Washington Post, Dec. 20).
BioPort Inspections Completed
Food and Drug Administration officials yesterday said they had finished inspections of laboratories at BioPort, the only U.S. manufacturer of the anthrax vaccine. The company had successfully addressed most of the agency’s complaints, FDA officials said (see GSN, Nov. 21). BioPort will not be fully licensed until the FDA next month completes inspections of another company contracted to decant the anthrax vaccine into vials, FDA officials said.
BioPort has been trying to obtain U.S. approval to ship the anthrax vaccine it produces, according to the Associated Press. BioPort has produced the vaccine since 1988, but has been unable to ship since failing federal inspections in 1999 and 2000, the Associated Press reported.
The future corrections required by the FDA were minor compared to violations found in previous inspections, said BioPort President Bob Kramer (Associated Press/London Guardian, Dec. 20).
Genetic Findings Might Not Solve Investigation
Some scientists said too little is known yet about the genetic makeup of anthrax to be able to differentiate one sample from another, the Associated Press reported yesterday.
“It’s a race against time to get enough genetic information to make these matches precisely,” said Jill Trewhella, bioscience division leader at Los Alamos National Laboratory, which is assisting in the anthrax spores genetic fingerprinting effort (see GSN, Dec. 19). “We want to catch the person.”
Barbara Hatch Rosenberg, of New York State University, said they key to the case would probably involve determining a motive, rather than scientific analysis. FBI investigators are examining political and ideological motives for the attacks, as well as possible financial gain, such as someone involved with an environmental cleanup company, a law enforcement official said (Laura Meckler, Associated Press, Dec. 19).
Anthrax spores used at the University of New Mexico are likely identical to the spores used in the attacks, a university spokesman said. The university expects its anthrax samples to be tested soon for a genetic match with the mailed spores, said university spokesman Sam Giammo. “We would be very surprised if it didn’t match perfectly,” Giammo said.
The university’s anthrax samples came from the U.S. Army Medical Research Institute of Infectious Disease, which also sent out samples to five other laboratories, according to the Albuquerque Journal. The university did not use in its research the finely milled version of anthrax found in the tainted letters, Giammo said (Jackie Jadrnak, Albuquerque Journal, Dec. 19).
Russia Offers Help
Russian scientists have developed a new anthrax vaccine that they are prepared to offer to the United States, Valentin Pokrovskii, president of the Academy of Medical Sciences, said Tuesday. The new Russian vaccine only requires two injections, as opposed to six for the U.S. version, Pokrovskii said.
Russia is also ready to send its stockpiles of anthrax vaccine and spore samples to the United States, said Health Minister Yurii Shevchenko. “If the terrorist origin of the anthrax cases in America is proved, all of us should be ready for a mass vaccination of the population,” Shevchenko said (RFE/RL Newsline, Dec. 19).
