DoD Smallpox Vaccination
Program
Safety Summary, 17 May 2007
Background:
On December 13, 2002, the President directed smallpox vaccinations for
selected military personnel, government workers, and contracted workers. DoD
vaccinations began immediately for emergency response personnel and hospital
staff members. Comprehensive training programs in vaccination technique,
infection-control safeguards, screening and education methods, adverse event
monitoring, and product storage and handling, aggressively launched in October
2002, made immediate vaccinations possible. In early January 2003, DoD began
smallpox vaccinations of selected US military forces, and
emergency-essential civilians and contractors deployed or deploying in support
of U.S. Central Command missions.
Program Status:
DoD operational forces and healthcare workers vaccinated against smallpox:
over 1,200,000. Another 116,700 personnel were screened for vaccination, but
medically exempted. Details about the DoD program appeared in the June 25, 2003
issue of the Journal of the American Medical Association (JAMA).The abstract of
that article appears after the following summation of the program’s current
status:
In the 53 months between 13 Dec 02 and 17 May 2007, the DoD
administered more than 1,200,000 smallpox vaccinations. Most adverse events
occurred at rates below historical rates.
• 140 cases of
myo-pericarditis developed after smallpox vaccination. These cases have been
followed carefully to evaluate their recovery. Detailed follow-up cardiac
testing is available in 64 cases: all 64 had normal electrocardiograms (ECGs),
echocardiograms (“echos”), and normal treadmill stress test results, suggesting
a high rate of recovery. [See Journal of the American College
of Cardiology. 2004 (Jul 7);44(1):201-5.]
• Another 16 cases of
"ischemic" heart disease (such as heart attacks, atherosclerosis, or
angina) occurred within 6 weeks after smallpox vaccination. This number of
cases is similar to what normally occurs among unvaccinated military personnel
of similar age.
• In no case was vaccinia (the live virus in the
vaccine) transmitted from one person to another in the work place. Among
27,700 smallpox-vaccinated health-care workers, there were no cases of
transmission of vaccinia from worker to patient.
•
61 cases (36 lab-confirmed) of contact transfer of vaccinia virus have
occurred, principally to spouses and adult intimate contacts. During education,
we repeat the warning "Don't let your guard down at home."
• One case of eczema
vaccinatum occurred. No cases of progressive vaccinia. This indicates our
education and exemption process is working well.
• The total number of
treatments with vaccinia immune globulin (VIG) is six: one burn patient, one
eczema vaccinatum patient, one contact transmission, two ocular patients, and
one unconfirmed contact transmission.
• In the 43 cases of possible
generalized vaccinia all were treated primarily as outpatients. This is
discussed in detail in the Journal of the American Academy
of Dermatology 2006;55:23-31. Few of those reported cases meet a strict case
definition.
• Eight deaths due to disease after vaccination
have been reviewed: one following an acute lupus-like illness may have
been caused by vaccination, based on review by two independent panels of
civilian physicians. Additional information on this case appears at
http://www.smallpox.mil/event/panelreport.asp. Another case involved
sudden death in a 26-year-old Soldier given smallpox and influenza
vaccines 16 days earlier; in this case, evidence of parvovirus B19 was
found in his heart tissue. The other deaths involved the following
diagnoses (one each, except as noted): myocardial infarction,
atherosclerotic coronary vascular disease (ASCVD, two), pulmonary
embolism, heat injury, and benzodiazepine overdose. These deaths were
judged unrelated to vaccination, based on individual factors such as
preexisting disease, incidence among unvaccinated people, and lack of
physical evidence to implicate a vaccine.
NOTE:
All appropriate program information is provided regularly to federal health
authorities, including all safety-surveillance data.
The June 25, 2003, issue of the Journal of the American Medical
Association (JAMA) summarizes the DoD experience with smallpox vaccination
to date. Below appears the abstract of this article:
US Military Smallpox Vaccination Program Experience
John D. Grabenstein, RPh, PhD William Winkenwerder, Jr., MD, MBA
Context. The United States recently implemented
smallpox vaccination of selected military personnel in a national program
of preparedness against use of smallpox as a biological weapon. The return
of smallpox vaccinations raises important questions regarding
implementation and safety.
Objective. To describe the US military smallpox
vaccination program.
Design. Descriptive study of the vaccination program
from its inception on December 13, 2002, through May 28, 2003.
Setting. US Department of Defense (DoD) fixed and
field medical treatment facilities on multiple continents and ships at
sea.
Subjects. US service members and DoD civilian workers
eligible for smallpox vaccination.
Main Outcome Measures. Numbers of vaccinations and
rates of vaccination exemptions, symptoms, and adverse events. Data was
collected via reports to headquarters and rigorous surveillance for
sentinel events.
Results. In 5.5 months, the DoD administered 450,293
smallpox vaccinations (70.5% primary vaccinees and 29.5% revaccinees). In
2 settings, 0.5% and 3.0% of vaccine recipients needed short-term sick
leave. Most adverse events occurred at rates below historical rates. One
case of encephalitis and 37 cases of acute myopericarditis developed after
vaccination; all cases recovered. Among 19,461 worker-months of clinical
contact, there were no cases of transmission of vaccinia from worker to
patient, no cases of eczema vaccinatum or progressive vaccinia, and no
attributed deaths.
Conclusions. Mass smallpox vaccinations can be
conducted safely with very low rates of serious adverse events. Program
implementation emphasized human factors: careful staff training,
contraindication screening, recipient education, and attention to
bandaging. Our experience suggests broad smallpox vaccination programs may
be implemented with fewer serious adverse events than previously believed.
JAMA. 2003;289:3278-3282 www.jama.com
Full article at: http://jama.ama-assn.org/cgi/reprint/289/24/3278.pdf
For more discussion of the myo-pericarditis cases, see: http://jama.ama-assn.org/cgi/reprint/289/24/3283.pdf
For the accompanying editorial, see: http://jama.ama-assn.org/cgi/reprint/289/24/3306.pdf
Perspective:
“Within DoD, we know a lot now about smallpox vaccine. We now have
current, good experience with using it. The remarkable news about this
program is that our adverse events do not reflect what history told us to
expect. With proper care and attention, smallpox vaccine can be
administered to large numbers of people safely. Those large numbers of
vaccinated citizens discourage an enemy from using smallpox as a
weapon.”
- William Winkenwerder, Jr., MD, Assistant Secretary of Defense
for Health Affairs