Homeland Security Watch

News and analysis of critical issues in homeland security

October 31, 2011

Test anthrax vaccine on children: A bad biodefense policy idea

Filed under: Biosecurity,WMD — by Alan Wolfe on October 31, 2011

I was surprised, last week, to see this story in the Washington Post about the efforts of a working group of the National Biodefense Science Board. Seems that, back in April, the board decided to examine whether children should receive the standard anthrax vaccine in the event of a wide-area anthrax attack on the nation. Although it’s not explained well in the story, it is assumed that this would be a post-treatment administered under emergency matters after an attack, rather than as a pre-treatment.

“At the end of the day, do we want to wait for an attack and give it to millions and millions of children and collect data at that time?” said Daniel B. Fagbuyi of Children’s National Medical Center in Washington, who chaired the group. “Or do we want to say: ‘How do we best protect our children?’ We can take care of Grandma and Grandpa, Uncle and Auntie. But right now, we have nothing for the children.”

Yes, oh who will think of the children? As the article explains, the vaccine has been tested for safety for the military, but it doesn’t explain that the vaccine’s efficacy is sometimes in question. Critics of the vaccine note that it hasn’t been tested against humans who have been exposed to a weaponized form of anthrax. And that’s true. There have been animal models that show the airborne vaccine should be both safe and efficacious for humans. And all of our researchers and veterinarians who work with anthrax use the vaccine, without any losses. Both the airborne vaccine and the natural form of vaccine work in the same way on the human body. So we’re pretty sure it’s a very good vaccine.

But back to the children. Medical experts and emergency responders have always been concerned about the “sensitive population” and how they are treated in the event of an emergency. Yes, it’s possible that an anthrax vaccine developed for adults might be too powerful for children or have detrimental side effects. We don’t know. But the chance of a wide-area anthrax attack affecting thousands, let alone “millions and millions of children,” is almost zero. Close enough to zero to not worry about it.

Except for this National Biodefense Science Board.  They decided, on a vote of 12-1, that in fact, we do need to have the vaccine tested on children in order to prepare for that day that is “not a matter of if, but when.”

“We need to know more about the safety and immunogenicity of the vaccine as we develop plans to use the vaccine on a large number of children in the event of a bioterrorist’s attack,” said Ruth L. Berkelman of Emory University, a panel member.

Now these are smart people. I don’t doubt their sincerity or intelligence. I do question their common sense and rationality. The absolute possibility of a transnational terrorist attack involving kilograms of anthrax to cause such an event are just insignificant compared to the storm of controversy and outcry if the US government starts testing the anthrax vaccine on kids.

It doesn’t matter if the side effects of the anthrax vaccine are far less severe than nearly any other vaccine. It doesn’t matter if the U.S. government has been using this vaccine for over a decade and has literally millions of health records to study. The critics will argue that the government hasn’t proven the vaccine’s efficacy for adults, let alone children. And they’d be right, technically; but it still works. This is a lousy argument.

The recommendation to test the vaccine for use on children is just wrong.

Any sensible mayor or governor would suggest that the appropriate risk-management approach would be to plan and resource for the widespread use of Cipro or other antibiotics on the population, to include children and other sensitive population types, as a first course of action. And then if, and only if, an actual anthrax attack occurred, the parents would be asked if they want to take the chance on the vaccine – and sign a release form for its use. It needs to be explained that this is a post-treatment, and without its use, the affected patient may die a very horrible and sudden death. This testing is unnecessary because the scenario too remotely theoretical.

It’s really that simple. How our community responds to bioterrorism is too important to be left to the doctors. Let’s get some public policy analysts involved and make better decisions.


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Comment by Anderson

October 31, 2011 @ 12:33 pm

I saw this comment someone added to Friday’s Washington Post story:

Is the idea of this study to identify parents who should not be raising children?

That is to say, you ask a bunch of parents if they’d let their kids be given drugs to see if they’re safe for other children, because they have no idea, and in return for putting their kids at risk they get what… free ice cream?

And then if the parents say yes, you know you have irresponsible parents?

Comment by Alan Wolfe

October 31, 2011 @ 2:07 pm

I love that comment. I really do. Thanks.

Comment by Terry O'Sullivan

November 1, 2011 @ 8:14 pm

This just amazed me, Alan (et al.). And the most ridiculous thing of all is that anthrax is not a communicable disease (person to person). By the time a unique anthrax attack is discovered, the spores will have blown into the next county or beyond, and given the documented very low probability of secondary environmental exposure, would make post-attack administration of vaccine for children, especially, silly at best, and dangerous at worst.

Even if there were more attacks to come after that, unless the U.S. govt is planning to vaccinate half the urban population of the country (neither feasible nor desirable, given the uncertainties of the current vaccine), there would be no guarantee of vaccinating the right population — and to do so for that which had already been attacked would likely be pointless. And for those already exposed, prophylactic antibiotics are far more likely and less problematic than a vaccine.

And, as the comment passed on by Anderson illustrates, given the risk variables, it would be both clinically unethical and parentally irresponsible to administer such vaccine tests to children, given the potential for severe adverse effects. Not only for those potentially injured by vaccine side effects, but to the whole U.S. prophylactic biosecurity development program. Not as unethical as inoculating human subjects with a deadly viral disease (such as smallpox) to test anti-viral drugs, but given the population in question, not far out of the ballpark.

See: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm

Comment by A Government Gone Too Far....

November 3, 2011 @ 6:12 am

A Government gone too far….

Around here in New England, local community governments came in and “cancelled” Haloweeen because of safety risks posed by downed trees and wires – however instead of rescheduling this next week when conditions vastly improved and temp’s to be near 60, no, local government flexed its muscles and interferred in children’s Life – government had no right to cancel a holiday and take the candy away from the kids though it did have the Right to caution kids and parents of the safety risks and use their discretion or as many preferred, move the holiday up a week…

Well, kids and parents, not only is government led by this Goldman Sachs administration and its local governments as subsidiaries supported by federal bankrupt coffers willing to take candy from the kids, but this ever imposing – government – we are to “entrust” now willing to use kids by testing vaccine on the population…

Our forefathers warned us – pay heed to their wisdom. Stand up when you see wrong and at the polls, your precious vote has never been more important – be independent, never mind these party affiliations which were so much a part of my older generation for many reasons not applicable today…demand accountability and transparency. Demand that local governments place their budget and expenditures – line by line – on the internet and take them to task…

Terry O’Sullivan, continue to speak out for our children…there are many more who are in an uproar not only with local communities who chose to “cancel” a kids festivities and fun instead of rescheduling to the next week…after all, for most of these politicians from the WH to town hall, every day they stand at our door with their tricks….

Christopher Tingus
PO Box 1612
Harwich (Cape Cod), MA 02645 USA

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