Using anthrax vaccine in children: first steps completed. And approved by the American Academy of Pediatrics!

Will anthrax vaccine eventually become part of the childhood vaccine schedule?  When we are now vaccinating children for many diseases that they have less than a million in one chance of catching, why not add anthrax vaccine?

Those diseases American children aren't being exposed to are diphtheria, rubella, and polio.  There were only 8 meningitis A,C,W and Y cases in the 11-23 age group in the entire country last year.  And while children might be exposed to Hepatitis A, spread is due to oral-fecal contamination of water or food and is rare with modern plumbing and food handling.  There were just 2 deaths in a year from Hepatitis A in the 0-34 age group.

The American Academy of Pediatrics has already approved anthrax vaccine for children as young as six weeks old, given a declared anthrax emergency, despite the fact it is not approved or licensed for children.  In case you think that won't happen, the Secretary of HHS has already declared an anthrax emergency.  Twice since 2004.  It does not take much to declare one.

So, anthrax vaccine for kids?  It could happen.  Anthrax vaccine was just approved for any civilian for the first time, last week, if the civilians had previously received the initial 5 dose series.

It gets worse.  The current anthrax vaccine manufacturer has an experimental anthrax vaccine in development, possibly even more dangerous than the licensed one--but has already applied for an Emergency Use Authorization for it.  FDA charges $2.5 million for a priority review for emergency use authorizations.  The manufacturer bought themselves a priority review, with a decision expected in the first half of 2019.

Vaccine. 2015 May 15;33(21):2470-6. doi: 10.1016/j.vaccine.2015.03.071. Epub 2015 Apr 5.

Evaluation of anthrax vaccine safety in 18 to 20 year olds: A first step towards age de-escalation studies in adolescents.

King JC Jr1, Gao Y2, Quinn CP3, Dreier TM4, Vianney C5, Espeland EM2.

Author information

1

Tunnell Contracting, Serving the Mission of: Health and Human Services (HHS)/Assistant Secretary for Preparedness and Response(ASPR)/Biomedical Advanced Research and Development Authority(BARDA), Thomas P. O'Neill Federal Building (FOB8), 200 C Street, SW, Washington, DC 20024. Electronic address: james.king@hhs.gov.

2

Health and Human Services (HHS)/Assistant Secretary for Preparedness and Response(ASPR)/Biomedical Advanced Research and Development Authority(BARDA), United States.

3

MPIR Laboratory, MVPD/DBD/NCIRD, Centers for Disease Control & Prevention, MS-D01, Bldg. 23, Room 8-161, 1600 Clifton Road, Atlanta, GA 30333, United States.

4

Tunnell Contracting, Serving the Mission of: Health and Human Services (HHS)/Assistant Secretary for Preparedness and Response(ASPR)/Biomedical Advanced Research and Development Authority(BARDA), Thomas P. O'Neill Federal Building (FOB8), 200 C Street, SW, Washington, DC 20024.

5

GAP Solutions Inc. Supporting the Mission of Health and Human Services (HHS)/Assistant Secretary for Preparedness and Response(ASPR)/Biomedical Advanced Research and Development Authority(BARDA), United States.

Abstract

BACKGROUND/OBJECTIVES:

Anthrax vaccine adsorbed (AVA, BioThrax(®)) is recommended for post-exposure prophylaxis administration for the US population in response to large-scale Bacillus anthracis spore exposure. However, no information exists on AVA use in children and ethical barriers exist to performing pre-event pediatric AVA studies. A Presidential Ethics Commission proposed a potential pathway for such studies utilizing an age de-escalation process comparing safety and immunogenicity data from 18 to 20 year-olds to older adults and if acceptable proceeding to evaluations in younger adolescents. We conducted exploratory summary re-analyses of existing databases from 18 to 20 year-olds (n=74) compared to adults aged 21 to 29 years (n=243) who participated in four previous US government funded AVA studies.

METHODS:

Data extracted from studies included elicited local injection-site and systemic adverse events (AEs) following AVA doses given subcutaneously at 0, 2, and 4 weeks. Additionally, proportions of subjects with ≥4-fold antibody rises from baseline to post-second and post-third AVA doses (seroresponse) were obtained.

RESULTS:

Rates of any elicited local AEs were not significantly different between younger and older age groups for local events (79.2% vs. 83.8%, P=0.120) or systemic events (45.4% vs. 50.5%, P=0.188). Robust and similar proportions of seroresponses to vaccination were observed in both age groups.

CONCLUSIONS:

AVA was safe and immunogenic in 18 to 20 year-olds compared to 21 to 29 year-olds. These results provide initial information to anthrax and pediatric specialists if AVA studies in adolescents are required.