Skip to comments.CDC: Anthrax Vaccine Not Yet Proven Effective
Posted on 12/01/2001 1:49:07 AM PST by DaRocksMom
Medical researchers at the Centers for Disease Control in Atlanta cannot say with certainty that the current anthrax vaccine would be effective in protecting people against the disease strain recently mailed in terror attacks on members of Congress and the news media, CDC officials tell Inside the Pentagon. But CDC currently has studies under way aimed at determining just that.
The anthrax vaccine has been administered over the past three and a half years to more than 500,000 U.S. military personnel, according to Defense Department data.
The continued uncertainty about the vaccine's effectiveness in the face of a fifth death last week attributed to inhaled anthrax may throw yet another hook into the Pentagon's controversial effort to vaccinate all service members in coming years. Such lingering questions may also put the brakes on proposals to make the anthrax vaccine available more widely to the U.S. public, especially given military complaints about the shots' painful -- and, on occasion, quite serious -- side effects.
Past studies have shown that the vaccine triggers an antibody response in humans and lab animals that would likely protect them from infection if exposed to anthrax. But it remains unclear whether it is the small amount of protective antigen in the vaccine -- or some other factor -- that triggers this immune response (ITP, March 8, p1). Ongoing studies at CDC seek to better understand how the anthrax vaccine works -- with an eye toward shortening the current six-shot regimen over 18 months, among other things -- but this research is just getting under way this year.
The recent anthrax attacks in Florida, New York and Washington were determined to be all of the same, fairly common but relatively virulent Ames strain. At the same time, the powder in the letter to Majority Leader Sen. Tom Daschle (D-SD) appeared to be more finely milled and thus became airborne more easily than that sent to NBC's Tom Brokaw, government officials have said.
"Our current knowledge about the protective antigen for this strain suggests that the vaccine would likely protect against this strain, however further studies are in progress to address this issue," said Dr. Nina Marano and Dr. Jai Lingappa of CDC's anthrax vaccine research program, in written responses to ITP's questions.
"Knowledge of the structure of the protective antigen that is in the strain used in the recent terrorist attacks would help in understanding if the vaccine would likely protect against the disease from that strain," the researchers said.
Toward that end, CDC is undertaking studies to sequence the gene that codes for the protective antigen in the Ames strain, said Marano, a veterinarian, and Lingappa, a physician. Other research is under way to learn "if the antibodies from people who have been vaccinated can attach to the protective antigen from this strain," they said. If the antibodies attach, that would help explain if the anthrax vaccine can protect against the strain used in the terror mailings, according to the two researchers.
Marano and Lingappa say medical studies to date have elicited some understanding of the anthrax vaccine, but there remain many unknowns. Among them is how many shots are really required to achieve protection against anthrax, and how long that protection lasts. That could be of special concern to the growing number of service members whose last shot was more than two years ago, because quality control at its Michigan manufacturer has created a serious shortage in vaccine stocks and severely slowed the Defense Department's vaccination program.
Dr. Sue Bailey, then the Pentagon's top physician, in 1998 recommended that if more than two years has elapsed since a service member's last shot, the patient should restart the entire six-shot series if immunity is to be maintained (ITP, July 20, 2000, p1). The clock is ticking for many military personnel in the midst of their inoculation regimen after several major slowdowns in the Pentagon's anthrax immunization program began in July 2000. Currently very few military members are receiving the shots.
Perhaps more unsettling may be Marano and Lingappa's No. 1 "unknown" about the vaccine, namely whether the current tests researchers use to measure anthrax immunity are even "the appropriate tests to use to measure protection," they said.
Based on animal studies, the researchers believe the immune system may "remember" to fight off anthrax if a person is exposed more than two years after their last shot. Additional research is being performed to "help further refine our understanding of these additional factors contributing to protection and thereby develop the next generation of the anthrax vaccine," the two said.
Meanwhile, based on the recent anthrax scare, CDC is considering whether to recommend a change in the Food and Drug Administration label for the anthrax vaccine that would allow shots to be given more widely to the U.S. population. The labeling currently advises the vaccine be given solely to a small community at increased risk of contracting anthrax, such as those who process animal pelts or work in lab research on the disease.
Now, with all but one of the five inhaled anthrax fatalities affecting those over 50 years of age, some say older Americans whose immune systems may have weakened should receive the anthrax vaccine. Such proposals are highly contentious, though; several members of Congress are sure to raise concerns about whether the risks of the current vaccine merit the benefits of protecting the very few who might be exposed to this lethal -- but potentially treatable -- disease. A couple recent victims of inhaled anthrax have recovered and were released from the hospital after timely and aggressive treatment with common antibiotics.
CDC's Advisory Committee on Immunization Practices "has been working closely with CDC to review the data from the recent anthrax letters received in several U.S. cities, in order to determine whether a change in the recommendations [on who may receive the vaccine] would be appropriate," Marano and Lingappa said.
The anthrax vaccine labeling also does not yet reflect government officials' belief that it provides immunity against inhaled anthrax; the label accounts for protection against solely the skin form of contracting the disease. But FDA in 1997 allowed the Defense Department's massive immunization program to go forward based on concerns that an enemy bomb or crude weapon could disperse an aerosolized form of anthrax over U.S. troops (ITP, Feb. 17, 2000, p1).
"While there is a paucity of data regarding the effectiveness of anthrax vaccine for prevention of inhaled anthrax, the current package insert does not preclude this use," wrote Dr. Michael Friedman, FDA's lead deputy commissioner at the time. He went on to give his tacit approval for the Pentagon program.
As of the end of October, almost 523,000 service members had received at least one dose of the anthrax vaccine, Lt. Col. John Grabenstein of the Defense Department's Anthrax Vaccine Immunization Program told ITP earlier this month. "Almost all" of those military personnel had received their last shot within the past two years, said Jim Turner, a Pentagon spokesman. But Grabenstein said just 75,000 of those who started the 18-month regime had received all six shots. Annual boosters are also recommended to maintain immunity.
The CDC said nothing during this propaganda campaign.
FDA Citizen Petition/Anthrax Vaccine
I would like to ask that you please take a short minute or two to submit a comment to the FDA in support of the FDA citizen petition.
This petition is a valid and legal instrument that has been filed with FDA. It seeks action by the FDA commissioner concerning the anthrax vaccine. By law, FDA is required to respond to this petition.
All that you need to do is write something on the order of "I support this petition, docket number 01P-0471" Of course, more detailed comments are welcome.
Below is a summary of the petition. To read the Citizen Petition in full please go to Anthrax Vaccine Risks (the petition is above the web site counter)
Here you will also be able to read official documents of the General Accounting Office (GAO) Reports (the latest 10/01: Changes to the Manufacturing Process), FDA Reports and Congressional Testimony.
*When corresponding to the FDA please use the address below and insert in the subject area the following:
Subject: RE: Docket No. 01P-0471
Thank you for your time and concerns regarding the anthrax vaccine.
* * * * * * *
Dockets Management Branch
Department of Health and Human Services
Food and Drug Administration; Room 1-23
12420 Parklawn Drive
Rockville, Maryland 20857
The undersigned submit this petition under Section 360bbb-2 of the Federal Food, Drug and Cosmetic Act, section 553(e) of the Administrative Procedures Act, and Title 21 Subsection 10.30 of the Code of Federal Regulations to request the Commissioner of Food and Drugs to take the administrative actions listed below regarding anthrax vaccine adsorbed.
A. Action requested
(1) Issue a Final Rule on the drug category placement of anthrax vaccine as Category II (unsafe, ineffective, or misbranded) amending the as yet to be finalized Proposed Rule as published in the Federal Register 13 December 1985.
(2) Declare as adulterated all stockpiles of anthrax vaccine adsorbed in the possession of BioPort Corporation and all doses in private, public, U.S. or foreign government possession.
(3) Enforce FDA Compliance Policy Guide, Section 400.200 Consistent Application of CGMP Determinations (CPG 7132.12) with respect to anthrax vaccine adsorbed (license #1260).
(4) Revoke the anthrax vaccine adsorbed license (license #1260) held by BioPort Corporation.
Dunno! We briefly had an "all" feature that got axed... what you can do is pop up a 2nd browser ( control-N ), do a self-search, and copy & paste a pile of names you have flagged before..... like so!
There are reasons to be concerned about the military version of anthrax vaccines:
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Guardian Unlimited | The Guardian | Illegal vaccine link to ...
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July 30, 2001 The Guardian The illness known as Gulf war syndrome looks ...
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