The
Unintended Consequences
of Vaccine Delivery
Devices Used to
Eradicate Smallpox:
Lessons for Evaluating
Future Vaccination
Methods
B. G.
Weniger 1,
T. S. Jones2, R. T.
Chen3
1Associate Editor,
Vaccine, CAPT, USPHS
(ret.), Atlanta, GA,
2CAPT, USPHS (ret.),
Florence, MA, 3National
Center HIV/AIDS,
Viral
Hepatitis, STD, & TB,
Centers for Disease
Control and Prevention,
Atlanta, GA
Objective: Review
the actual and
theoretical evidence for
transmission of
bloodborne pathogens
between consecutive
vaccines by
multi-use-nozzle jet
injectors (MUNJIs) and
bifurcated needles (BNs)
without intervening
sterilization.
Background: After
smallpox eradication,
evidence emerged that
its vaccine-delivery
devices could transmit
bloodborne pathogens
such as hepatitis B (HBV)
through inherent design
defect or unsafe use.
Learning from past
mistakes might prevent
future ones with novel
delivery methods.
Methods:
Published literature
and unpublished CDC data
on high-speed,
multi-use-nozzle jet
injectors (MUNJIs) and
bifurcated needles (BNs)
were reviewed, along
with standards for
auto-disabling
needle-syringes and
related policies on
vaccine safety and
nosocomial disease.
Smallpox eradication
experience of authors
and others was recalled,
and novel vaccination
technologies assessed.
Results:
Laboratory and
animal model studies,
epidemiologic
investigations and
analyses, and human
trials of the Ped-O-JetR
and similar MUNJIs once
used in smallpox
campaigns demonstrated
these “jet guns” capable
of HBV transmission,
even when nozzles were
alcohol-swabbed between
injections per
manufacturer
instructions. In the
1990s, the Ped-O-JetR
was recalled, its use
abandoned by the U.S.
military, and
contraindicated by WHO
and CDC. The latest 2008
study detected HBV
contamination by PCR
after 8% of MUNJI
injections of HBV-carrier
volunteers. The BNs were
sometimes re-used in
eradication without
sterilization by
minimally-trained
vaccinators in
challenging field
environments. Without
health officer
supervision to assure
sterilization and
lacking auto-disabling
features, BNs would not
satisfy current WHO and
UNICEF policies for safe
injection. Although HBV
transmission during
smallpox eradication
cannot be documented
retrospectively, many
involved countries have
moderate-to-high
prevalence of chronic
infection, suggesting
transmission
opportunities.
Conclusion: Some
iatrogenic infections
with HBV likely occurred
in countries where
unsafe MUNJIs and
unsterile BNs were used.
Nonetheless, the overall
benefits of eradication
are overwhelmingly
positive and lasting.
Modern emphasis on
injection safety should
apply to future vaccine
delivery systems now in
development which re-use
vaccine pathways.
References:
1.
Weniger BG, Papania MJ.
Alternative Vaccine
Delivery Methods
[Chapter 61]. In:
Plotkin SA, Orenstein
WA, Offit PA, eds.
Vaccines, 5th ed.
Philadelphia:
Elsevier/Saunders;
2008;1357-1392.
2. Kelly
K, Loskutov A, Zehrung
D, et al. Preventing
contamination between
injections with
multiple-use nozzle
needlefree injectors: A
safety trial.
Vaccine.
2008;26(10):1344-1352.
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