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Current Anthrax Vaccine Safe and Effective
National Academies' Institute of Medicine ^ | March 6, 2002 | Vanee Vines

Posted on 03/07/2002 2:47:37 AM PST by VA Advogado

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WASHINGTON -- The current anthrax vaccine is safe and effective, but certain drawbacks - including reliance on older vaccine technology and a six-dose vaccination schedule over 18 months - underscore the need for a better vaccine, says a new report from the National Academies' Institute of Medicine. The current vaccine can continue to be used, but the U.S. Department of Defense should vigorously support research efforts not only to improve the way it is administered, but also to develop an alternative.

The committee that wrote the report did not identify any unexpected short-term adverse reactions to the anthrax vaccine. Furthermore, the rates at which reactions occurred were similar to rates for other vaccines now in use for adults. Scientific data are limited on adverse health effects that might surface months or years following anthrax inoculations, but the evidence available to date does not confirm any long-term health risks among people who have received the vaccine. Because no vaccine is 100 percent safe, however, DOD should create systems to enhance long-term monitoring of health conditions that might be associated with any vaccine given to military personnel.

"The anthrax vaccine should protect against even the inhalational form of the infection, but the lengthy vaccination schedule and the way the shots are physically administered make it far from optimal; it also is manufactured using older technologies that can be improved upon," said committee chair Brian L. Strom, professor of biostatistics and epidemiology, medicine, and pharmacology; and director, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia. "The most prudent course of action is to develop a new vaccine - given the nation's war against terrorism and the domestic attacks where anthrax was used as a deadly weapon. In the meantime, the current vaccine is sufficiently safe and effective to be useful."

The committee pointed out that natural mutations or bioengineered alterations in the anthrax bacteria would not likely produce vaccine-resistant strains. The vaccine acts directly on a toxin from the bacteria, and that toxin must remain unaltered for the bacteria to retain its lethal nature.

ANTHRAX BECOMES A NATIONAL CONCERN

Anthrax primarily is a disease of wild and domestic animals. Historically, humans have contracted it through contact with infected animals or animal products, such as hides contaminated with anthrax spores. Infection occurs when these spores enter the body through inhalation, contact with skin, or ingestion of contaminated meat. However, inhalational anthrax infection had been rare in the United States until the 2001 bioterrorist incidents. Among the people who came in contact with anthrax spores last year, 18 developed confirmed skin or lung infections, leading to five deaths.

Only one anthrax vaccine, referred to as "anthrax vaccine adsorbed" or AVA, is licensed for human use in the United States. At this point, its sole manufacturer is BioPort Corp. in Lansing, Mich. The U.S. Food and Drug Administration approved the vaccine in 1970, largely to protect veterinarians, workers who process animal hair, and scientists working with anthrax. In response to heightened concerns about biological warfare threats during and after the Persian Gulf War, DOD announced in 1997 a plan to vaccinate all U.S. service members to protect them against possible exposure to anthrax bioweapons.

Roughly 2 million doses of the vaccine have been administered, mostly to U.S. military personnel. But some service members have raised concerns about the vaccine's safety and efficacy, and more than 400 military personnel have refused the shots, worried that vaccination could be connected to complaints of chronic fatigue, memory loss, and other health problems. These concerns prompted Congress to request a National Academies study of the vaccine's adverse reactions; long-term health implications; gender differences in reactions; and effectiveness against inhalation exposure.

The report also addresses shortcomings of the manufacturing process and identifies gaps in existing research. It does not examine the military's policy to vaccinate all service members, or consider other populations that could be vaccinated.

A LOOK AT ANTHRAX VACCINE SAFETY

On the whole, the types of reactions associated with the current vaccine and the rates at which they have been observed are comparable to those seen with other vaccines administered to adults, such as the tetanus shot, the report says. Reactions such as skin redness and swelling at the site of the injection are common. Systemic responses - malaise and muscle pain, for example - occur much less often. Reactions may result in time lost from work or brief periods of limited activity, but they do not lead to serious or permanent health impairments. However, women have been more likely than men to experience and report some effects, including swelling and itching at the injection site.

Side effects of the anthrax vaccine, coupled with the required long series of doses, are among the realities that underscore the need for a new and improved alternative, the committee emphasized. Some of the bodily reactions likely stem from the vaccine being injected under the skin rather than into a muscle - which is the typical injection procedure for most vaccines. The anthrax vaccine is given in six shots over 18 months, and an annual booster dose is required. DOD should expedite its research on the anthrax bacteria and disease, and on ways to improve on the current vaccine. A new and improved vaccine should not cause any severe reactions. And among other characteristics, it should require only two or three injections; provide immunity within 30 days that lasts for at least a year; and remain potent for a long period of time so that it can be stockpiled to ensure ample supplies when needed.

The committee evaluated population studies as well as case reports about the safety of the anthrax vaccine. It also heard testimony from those who believe that they or their family members have been harmed by the vaccine. The studies available did not examine vaccination effects in children or the elderly. Although a study is now under way regarding pregnancy outcomes following use of the anthrax vaccine, only limited information exists in this area. The military prohibits giving the vaccine to a woman who knows she is pregnant.

BioPort recently received FDA approval to distribute newly produced anthrax vaccine for the military. Until then, vaccine lots manufactured in the company's renovated facility and filled at another site had not been released pending government approval of plant renovations and satisfactory documentation of the production process. As with all vaccines, government authorities should continue to monitor the company's new batches of anthrax vaccine, the report says.

BROADER RESEARCH EFFORTS NEEDED

More studies using animals are essential for further investigation of the current vaccine's effectiveness and to evaluate any new anthrax vaccines, the committee said. Human studies would not be feasible or responsible.

DOD also should support additional research with laboratory animals on the effectiveness of combining the current anthrax vaccine with antibiotics following inhalation exposure to anthrax spores. These studies should focus on establishing an appropriate time frame for supplemental antibiotic treatment. Limited scientific data now suggest that the vaccine in combination with a 30-day treatment of antibiotics could provide post-exposure protection against inhalational anthrax.

In addition, the report urges the agency to shift its efforts and resources away from specialized programs that review individual reports about adverse events following anthrax inoculations. Instead, the emphasis should be on a broader program for regular analysis of data from the Defense Medical Surveillance System to monitor potential health effects of any vaccine - including the one for anthrax - administered to military personnel. Because these data may point to possible areas of concern and frequently are useful for follow-up analyses of information from civilian reporting systems, DOD also should explore ways to make this information available to civilian researchers.

The study was sponsored by the U.S. Department of Defense. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows.


Read the full text of THE ANTHRAX VACCINE: IS IT SAFE? DOES IT WORK? for free on the web. Printed copies are available for purchase from the National Academy Press Web site or by calling (202) 334-3313 or 1-800-624-6242. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).


TOPICS: Announcements; Front Page News; Government
KEYWORDS: anthraxscarelist

1 posted on 03/07/2002 2:47:37 AM PST by VA Advogado
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To: VA Advogado;DaRocksMom
Hope this puts to bed some of the lies being spread about this vaccine.
2 posted on 03/07/2002 2:48:31 AM PST by VA Advogado
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To: VA Advogado
Hope this puts to bed some of the lies being spread about this vaccine.

Unfortunately this horrible vaccine will never have the truth told about it in any real sense now that there is Anthrax hysteria out there. Those who look to the government and shriek for their action will all be persueded that this vaccine is the savior of their lives.

That is a risk they will take. One that I will not. I testified in congress about this vaccine, I did my homework and I will not take it. Even if it means they lose this pilot from the ranks.

3 posted on 03/07/2002 3:42:49 AM PST by ICE-FLYER
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To: ICE-FLYER
That is a risk they will take. One that I will not. I testified in congress about this vaccine, I did my homework and I will not take it. Even if it means they lose this pilot from the ranks.

Well that is certainly your choice, and I admire you for your willingness to take the consequences. However, I despise the efforts of some of the people associated with the anti-vaccine movement. The lies, propaganda and evil efforts to shut down the manufacturing of this vaccine and preventing anyone else from having the same choice as you is just evil.

4 posted on 03/07/2002 3:59:26 AM PST by VA Advogado
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To: VA Advogado
This is what I saw on USA TODAY: Anthrax Vaccine Found Safe For Troops

By Anita Manning, USA Today

The anthrax vaccine is effective and safe enough to use to protect U.S. soldiers, says a panel of medical experts. But there are not enough studies to assure its safety for wide use by the public, and a better vaccine is needed, according to a report released Wednesday by the Institute of Medicine.

"The issue takes on particular urgency since the recent use of anthrax spores in the mail system," says Brian Strom of the University of Pennsylvania, who chaired the institute committee that investigated the anthrax vaccine.

The vaccine has been given to about 2 million people, mostly U.S. military personnel. In the USA, only one manufacturer, BioPort Corp. of Lansing, Mich., is licensed to produce it.

Some service men and women have reported disabling and chronic illnesses — including joint pain, vision and skin problems, and chronic fatigue — that occurred after they received anthrax shots. Fears of vaccine reactions have led more than 400 to refuse the shots, often ending their military careers.

But the panel, which advises the government on scientific issues, found no evidence that the vaccine was responsible for those ills, saying it is as likely to cause side effects as any other shot given to adults. Unlike other vaccines, anthrax shots are given six times over 18 months, followed by annual boosters.

"The anthrax vaccine, like any other drug, has risks associated with it," Strom says. Because the disease is not passed from person to person, and the number of people at risk is limited, "there is no reason for broad use of it," he says.

"Its side effects, coupled with the long series of doses required, are among the realities that underscore the need for a new and improved alternative," Strom says.

The Department of Defense sponsored the study, and Strom points out that the panel was not asked to review military policy or recommend whether the public should be vaccinated. That said, "it is effective, it is safe enough to use in populations at high risk."

Most of the information on the vaccine pertains to preventing anthrax before exposure to the bacteria's spores. Strom says the information on its effectiveness after exposure is limited, but he would advise its use, along with antibiotics, by anyone exposed to the microbe.

After postal workers, Capitol Hill employees and others were potentially exposed to anthrax sent through the mail last fall, those at high risk for exposure were given antibiotics and were offered anthrax vaccine. Most postal workers refused, citing safety concerns, but the report says that as of Feb. 25, 192 people had begun receiving the vaccine.

The report states that more data are needed on long-term health problems.

Physician Meryl Nass of Freeport, Maine, who is a critic of the DOD's anthrax vaccine program, says research unconnected to DOD is needed.

Until that happens, she says, "the public will not receive valid scientific data."

____________________________________

"...safe enough to use to protect U.S. soldiers, says a panel of medical experts. But there are not enough studies to assure its safety for wide use by the public, and a better vaccine is needed."

If a better vaccine is needed, then why is it still considered "safe" for the military?

5 posted on 03/07/2002 8:17:44 AM PST by bkwells
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To: VA Advogado;*Anthrax_Scare_list;backhoe
Check the Bump List folders for articles related to the above topic(s) or for other topics of interest.
6 posted on 03/07/2002 9:07:52 AM PST by Free the USA
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To: Free the USA
Anthrax_Scare_list:

Anthrax_Scare_list: for Anthrax_Scare_list . 

Other Bump Lists at: Free Republic Bump List Register



7 posted on 03/07/2002 10:24:57 AM PST by backhoe
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To: VA Advogado
Well that is certainly your choice, and I admire you for your willingness to take the consequences. However, I despise the efforts of some of the people associated with the anti-vaccine movement. The lies, propaganda and evil efforts to shut down the manufacturing of this vaccine and preventing anyone else from having the same choice as you is just evil.

So you despise my efforts and think I want YOUR choic restrained and that it is "EVIL" that I do so.

What you are falling prey to is that the DOD has been your only source of information, or that of the CDC or the NIH. The funny thing is they are ALL federal institutions and thus must protect each other. Look at the CDC, they say it is a good vaccine, for the military, NOT, the civilian population.

What does this tell you?? Why is it that the DOD makes ALL civilians who want to take this (Fed workers and Postal Workers and Government Staffers and State dept workers) sign a 5 page WAIVER???

Why is it that former Secretary of the Army, Louis Caldera, actually granted INDEMNIFICATION to Bio Port? If you look at the Memo it was for a whole host of significant problems that if experienced by the civilian sector they could not even come close to bringing the product to market.

This vaccine was a good one in 1950. Back the Merck developed it for the DOD and was used solely for those working in textile mills whose job was one in which they handled hides of animals. They were routinely suffering from Cutaneous Anthrax (Skin only). It helped some of them, but not all. And the vaccine was weak. Comparitivly speaking. The manufacture of this then went to a different company and then to Michigan Biologic Health Products Inc. This was a state owned company that the DOD contracted with. It became Bio Port.

The filtering process changed, the potency of the vaccine was racheted up to almost 6 times. The dosage was arbitrarly doubled to six shots instead of the three. There was weak and scant evidence that it even did what it said it would do fo cutaneous Anthrax infection let alon inhalation Anthrax.

One Rhesus Monkey study was done and it helped some live through aerosol challenge, but not all. And Rhesus Monkeys do not have a simular human lung to verifiably prove their testing.

the whole thing is that the proof lacks integrity.

VAERS (Vaccine Advers Event Reporting System) is another problem. The DOD said that they experienced a safe and effacious vaccine with thei administration of this vaccine due to the fact that they have a .07 reaction rate under VAERS. I will clue you into a couple of important things that are easily verifiable. VAERS is NOT proactive. It is COMPLETLY passive. If you do not report a reaction, it is not known. Administrations of this program filtered all reports before being sent to VAERS. As a result they had a very artifically low number. Add to this that GAO did confirm that VAERS is under reported system wide by a factor of 100. This is stunning. The DOD had terrible reactiosn with this vaccine. And many members are being told that their newly experianced maladies are NOT Anthrax vaccine related. It was cart blanche denial. they were not even allowed to look at that avenue.

Finally, you are very wrong that ANY of us against this vaccine are somehow ANTI-Vaccine. Not at all. On the contrary, we are excited about the 2nd generation vaccine being developed by 2 other companies. I will be the first to line up, roll up and take it.

There is a lot more to this than superfiucial information you get from www.osd.mil

8 posted on 03/07/2002 11:15:08 AM PST by ICE-FLYER
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To: Free the USA
Thanks. However, I was directing my comments more directly to the people that want to put our troops in harm's way by denying them this vaccine and promoting lies to the FDA. Its a lot bigger than just anthrax.
9 posted on 03/07/2002 2:10:33 PM PST by VA Advogado
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To: backhoe
Thanks hoe! :)
10 posted on 03/07/2002 2:10:52 PM PST by VA Advogado
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To: ICE-FLYER
I am sorry for your choice, but am glad you have one. Please don't deny me mine.
11 posted on 03/07/2002 2:13:06 PM PST by VA Advogado
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To: VA Advogado
You betcha!
12 posted on 03/07/2002 2:53:18 PM PST by backhoe
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To: VA Advogado
I am sorry for your choice, but am glad you have one. Please don't deny me mine.

This is a foolish reply. You obviously did not read one thing I said to you. Its not about "Choice". And stop making it a liberal argument as though I am denying you something good. It is not a good vaccine. It is not anti-vaccine to say that either. When the vaccine is a medical failure that could cause you great harm due to lack of good and proper procedure in its making it does not matter that it could be curing aids, cancer, or a childs lukemia. It is still bad.

You, by the way, could not take this vaccine even if you wanted to. The DOD would not allow you to. Unless you were one of the identified government workers who signed the 5 page waiver listing all the real difficulties you are highly likely to experience, you can not take it at all.

Don't make the intelectually dishonest and ignorant decision to think that because it has the word "Vaccine" attached to it it is good, at least be true to yourself and do homework on it. Your trust of the DOD's old, out of date and outright misleading information on this issue is about as good as having ENRON investigate itself to find out whats wrong with the company.

13 posted on 03/07/2002 3:12:32 PM PST by ICE-FLYER
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To: ICE-FLYER
And stop making it a liberal argument as though I am denying you something good. It is not a good vaccine.

That is not your call my friend. That is up to the individual. You talk about liberalism, you and that DA (ROCKS IN THE HEAD) MOM are trying to use the cooersive power of the federal government to not only stop the vaccine, but put out of business the company that sells it. You're a shill for the nanny state.

14 posted on 03/07/2002 3:42:22 PM PST by VA Advogado
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To: VA Advogado
That is not your call my friend. That is up to the individual.

No, its not, its up to the DOD, and they will tell you no. Yet you gripe at me. Classic situation of you don't know what you are talking about though you have been told twice or more.

You talk about liberalism, you and that DA (ROCKS IN THE HEAD) MOM are trying to use the cooersive power of the federal government to not only stop the vaccine, but put out of business the company that sells it.

Well, nice to know your real personality. Rocks in the head mom? Do you stick out your tongue and say nahh nahh na nahh nahh too? How illuminating you must be in any serious debate. You claim I have a choice but I do not. Its take it or go to jail and lose a career having served your country. You are an idiot to believe that this represents choice for me. I stand on my research, you demand your ignorance. In the end you will be angrily dis-satisfied if you got this vaccine.

You're a shill for the nanny state.

On the contrary, you are. You are the one here demanding I shut up and inject into my body something I know is bad. You are the type that supports some liberal demogogue in their payback efforts to help an old buddy by simply making a program up, force it on the military and when it makes so many people sick you don't care. You are demanding it. You are the power. I am the servant, Make me do it all in the name of your "Choice".

While the US Military is a benevolant distatorship where I do lose at my own choice a very few civil rights, I do not surrender my health with the exception of going into harms way for war. I will do that, and have been doing that. This vaccine is demonstratably deliterious to my health and YOU demand I take it? Right.

15 posted on 03/07/2002 4:36:13 PM PST by ICE-FLYER
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To: ICE-FLYER
On the contrary, you are. You are the one here demanding I shut up and inject into my body something I know is bad.

When did I ever say that you inaccuate conveyor of information? If you're so wrong in citing me, how can ANYONE believe a thing you say? Earlier I said I respected but did not agree with your choice to NOT take the shot. Let our other soliders exercise the same choice.

16 posted on 03/08/2002 3:11:48 AM PST by VA Advogado
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To: ICE-FLYER;VA Advogado
Ice-Flyer, there is no talking to this guy VA Advogado. I have sent him well documented information and yet he does not read it. I figure he works for the VA and wants to keep his job. Hell, its all in the money, right! He has not a clue, so there is no point in trying to have an intelligent debate. He has the "my mind is made up, don't bore me with the FACTS" syndrome.
17 posted on 03/12/2002 4:54:41 PM PST by DaRocksMom
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To: DaRocksMom
Sorry. The NIH has proved you incredibly wrong. That's all I need.
18 posted on 03/12/2002 5:39:17 PM PST by VA Advogado
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To: VA Advogado
Sorry. The NIH has proved you incredibly wrong. That's all I need.

No, to the contrary, the NIH has said it is ok for the military but recommends the second generation vaccine. Geeee, just like the CDC. Oh, gee, they also reviewed the 5 page waiver you would have to sign were you to be offered this bad vaccine.

19 posted on 03/13/2002 12:17:54 PM PST by ICE-FLYER
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