Skip to main content

Main menu

  • Home
  • COVID-19
    • Articles & podcasts
    • Blog posts
    • Collection
    • News
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • Classified ads
  • Authors
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
  • CMA Members
    • Overview for members
    • Earn CPD Credits
    • Print copies of CMAJ
    • Career Ad Discount
  • Subscribers
    • General information
    • View prices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN

User menu

Search

  • Advanced search
CMAJ
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN
CMAJ

Advanced Search

  • Home
  • COVID-19
    • Articles & podcasts
    • Blog posts
    • Collection
    • News
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • Classified ads
  • Authors
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
  • CMA Members
    • Overview for members
    • Earn CPD Credits
    • Print copies of CMAJ
    • Career Ad Discount
  • Subscribers
    • General information
    • View prices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
  • Visit CMAJ on Facebook
  • Follow CMAJ on Twitter
  • Follow CMAJ on Pinterest
  • Follow CMAJ on Youtube
  • Follow CMAJ on Instagram
News

US delays testing anthrax vaccine for children

Cal Woodward
CMAJ June 11, 2013 185 (9) E369-E370; DOI: https://doi.org/10.1503/cmaj.109-4463
Cal Woodward
Washington, DC
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Responses
  • Metrics
  • PDF
Loading

Federal advisers have laid down a rigorous regimen that must be met before the United States government approves anthrax vaccine trials on children, all but ensuring no such tests will enlist youngsters any time soon.

It’s but one sign that once-rampant fears of another catastrophic terrorist assault on US soil are receding, more than a decade after the attacks of Sept. 11, 2001.

The Presidential Commission for the Study of Bioethical Issues weighed in Mar. 19 on a question that vexes policy-makers as they consider how to protect children from a bioterrorism attack that might never happen, but could be devastating if it did.

In a report certain to carry clout with Health and Human Services Secretary, Kathleen Sebelius, who requested it, the commission said no anthrax vaccine trials involving children should take place until future studies confirm that the children would face no more than “minimal risk” — roughly equivalent to the danger from a routine medical checkup (http://bioethics.gov/cms/sites/default/files/PCSBI_Pediatric-MCM_2.pdf).

Prevailing ethical standards call for children to be the subjects of medical trials only if those same youngsters stand to benefit. That’s not the case with anthrax, a killer unlikely to emerge except in a particularly audacious act of mass violence.

Just a week after the 2001 terrorist attacks on the World Trade Center and Pentagon, anthrax spores sent through the mail killed 5 people, sickened 17 and scared practically everyone. The murders were blamed years later on a disturbed federal scientist, not on terrorists from abroad. Yet the episode showed the capacity to distribute lethal amounts of the bacteria widely and cheaply.

In one plausible doomsday scenario the US government has calculated, an anthrax attack theoretically exposed nearly two million children and five million adults.

Figure1

A US commission recommends that no anthrax vaccine trials involving children take place until future studies confirm that the children would face no more than “minimal risk” — roughly equivalent to the danger from a routine medical checkup.

Image courtesy of © 2013 Thinkstock

Proponents of trials argue the country cannot wait until an attack happens before figuring out whether a vaccine already approved for adults is also effective and safe for kids — and in what doses.

All of that prompted the commission to carve a careful path.

Commissioners recommended that researchers gather thorough information from tests on young adults before going any farther. After that, experimental vaccination carried out by the US government, or approved and funded by it, might be justified on the oldest children, then, in time, on progressively younger children.

As for where children might be found for trials should the studies go ahead in some form, the report suggests researchers turn to locations where participants are likely to be at an elevated risk of exposure to anthrax, such as urban areas near potential bioterrorism targets.

Researchers might also consider the children of emergency responders, the report says, because their parents are alert to the risks of terrorism and are more apt to want protection for their families that average citizens don’t think about.

But the report cautions against selectively enrolling children in military families. Some soldiers already get the adult anthrax vaccine. But given the chain-of-command culture, military parents might take a request to include their children in a vaccine trial as an order. While service members have volunteered to be exposed to higher risks than most civilians, the report says, “their children have not.”

The anthrax issue parallels a debate that unfolded in 2002 — when fears of a bioterrorism attack were acute — over a protocol to test smallpox vaccine in 40 children aged two to five. In that case, evidence of adverse reactions and secondary infections in adults suggested that a pediatric smallpox trial would subject children to more than minimal risk. The protocol was rejected, which means the vaccine Dryvax would not be available to children in an emergency.

Before children are enlisted for anthrax vaccine trials, the report says, “ethically sound modeling, testing with animals, and testing with the youngest adults must be completed to identify, understand, and characterize research risks.”

Authorities are vigilant to the dangers of weaponized anthrax but, after years without a domestic terrorist attack, ordinary Americans aren’t. “Respectable members of the public do not believe in the threat,” Dr. John S. Parker, chairman of the National Biodefense Science Board, told the commission in earlier hearings.

People who are exposed to the spores are not without defences. In an attack using weaponized anthrax, potent antibiotics could deal with immediate exposure and a vaccine administered later could protect against pathogens lingering in a dormant state.

But what dosage children should get and what that would do to them — and for them — are questions that may not be answered until that chaos comes, if it ever does.

PreviousNext
Back to top

In this issue

Canadian Medical Association Journal: 185 (9)
CMAJ
Vol. 185, Issue 9
11 Jun 2013
  • Table of Contents
  • Index by author

Article tools

Respond to this article
Print
Download PDF
Article Alerts
To sign up for email alerts or to access your current email alerts, enter your email address below:
Email Article

Thank you for your interest in spreading the word on CMAJ.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
US delays testing anthrax vaccine for children
(Your Name) has sent you a message from CMAJ
(Your Name) thought you would like to see the CMAJ web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
US delays testing anthrax vaccine for children
Cal Woodward
CMAJ Jun 2013, 185 (9) E369-E370; DOI: 10.1503/cmaj.109-4463

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
‍ Request Permissions
Share
US delays testing anthrax vaccine for children
Cal Woodward
CMAJ Jun 2013, 185 (9) E369-E370; DOI: 10.1503/cmaj.109-4463
Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
  • Responses
  • Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • Trudeau promises to boost federal health transfers when the pandemic is over
  • Does shaming have a place in public health?
  • Should Canada aim for #CovidZero?
Show more News

Similar Articles

Collections

  • Topics
    • Medical consequences of conflict
    • Emergency medicine

Content

  • Current issue
  • Past issues
  • Collections
  • Sections
  • Blog
  • Podcasts
  • Alerts
  • RSS
  • Early releases

Information for

  • Advertisers
  • Authors
  • Reviewers
  • CMA Members
  • Media
  • Reprint requests
  • Subscribers

About

  • General Information
  • Journal staff
  • Editorial Board
  • Governance Council
  • Journal Oversight
  • Careers
  • Contact
  • Copyright and Permissions

Copyright 2021, Joule Inc. or its licensors. All rights reserved. ISSN 1488-2329 (e) 0820-3946 (p)

All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association or its subsidiaries.

Powered by HighWire