EXTON, Pa., Oct. 10, 2017 /PRNewswire/ -- West
Pharmaceutical Services, Inc. (NYSE: WST), a global leader in
innovative solutions for injectable drug administration, today
shared the results of a study highlighting the benefits of West's
ID Adapter for improving the intradermal administration of polio
vaccines. The study results were presented at the Fourth Skin
Vaccination Summit in May 2017 by Dr.
Ondrej Mach, Clinical Trials and
Research Team Lead, Polio Department, World Health Organization
(WHO), and recently published in the journal
Vaccine.i
The two-phase field campaign evaluated the feasibility of using
fractional inactivated poliovirus vaccine (fIPV) in remote
locations where polio outbreaks have persisted. The study
demonstrated that fIPV delivered via West's ID Adapter, used in
conjunction with a staked needle syringe by Helm Medical GMBH,
offers a safe, effective, dose-sparing option for drug
delivery.
"We are pleased that our ID Adapter performed so well in this
critical research study that addresses a vital medical need," said
Karen A. Flynn, Senior Vice
President & Chief Commercial Officer, West. "West is proud to
offer a solution that can help improve the reliability and
performance of intradermal injections while also extending the
limited supply of IPV."
Polio (poliomyelitis) is a highly infectious disease that mainly
affects children under five years of age. Caused by a virus, polio
invades the nervous system and can cause partial to total paralysis
in a matter of hours. There is no cure for polio; it can only be
prevented through administration of the polio vaccine.ii
Fortunately, a 20 percent fractional dose of intradermal IPV has
been proven just as effective as a full dose of intramuscular
inactivated poliovirus vaccine, while allowing significant dose
sparing.iii,iv,v,vi,vii,viii,ix,x And while intradermal
administration has been proven to be a safe, effective method for
delivering fractional doses of many vaccines, greater technical
skill is required to deliver the dose. West's ID Adapter addresses
this problem.
Conducted in Pakistan, where
polio outbreaks have persisted, this study sought to evaluate the
use of fIPV in conjunction with two types of intradermal devices
for outbreak response and routine immunizations of children. The
study was led by researchers from Aga Khan
University with funding from the WHO and support from the
Centers for Disease Control and Prevention (CDC). The study was
comprised of two phases:
- Phase 1 assessed the usability and immune response of fIPV
administration in children ages 6-12 months with two novel
intradermal adapters: one of which was developed by West with a
syringe from Helm Medical GMBH.
- Phase 2 evaluated the feasibility of conducting a door-to-door
vaccination campaign to administer the fIPV to children under 5
years old.
The study results showed that the immune response achieved with
one dose of fIPV administered via the Helm syringe with West's ID
Adapter was similar to that achieved by fIPV administered with
conventional needle and syringe. The data also demonstrated the
safety and usability of intradermal devices in difficult field
conditions and showed that fIPV can be used successfully for both
primary immunization and as an alternative to full-dose IPV.
For more information about West, visit us online at
www.westpharma.com.
About the ID Adapter
West's ID Adapter is a novel injection guide designed for use
with 1mL 1/2 inch fixed needle allergy syringes. The ID Adapter can
help make intradermal injection easier and more consistent by
guiding the angle and limiting the depth of needle insertion. The
ID Adapter consists of a sterile, disposable, single-use,
injection-molded part that snaps onto a syringe. The ID Adapter
provides for consistent ID injections, is convenient and easy to
use, and requires minimal end-user training.
About West
West Pharmaceutical Services, Inc. is a leading manufacturer of
packaging components and delivery systems for injectable drugs and
healthcare products. Working by the side of its customers from
concept to patient, West creates products that promote the
efficiency, reliability and safety of the world's pharmaceutical
drug supply. West is headquartered in Exton, Pennsylvania, and supports its
customers from locations in North and South America, Europe, Asia
and Australia. West's 2016 net
sales of $1.5 billion reflect the
daily use of approximately 112 million of its components and
devices, which are designed to improve the delivery of healthcare
to patients around the world.
Forward-Looking Statements
Certain forward-looking statements are included in this release.
These statements reflect management's current expectations
regarding future events and operating performance and speak only as
of the date of this release. There is no certainty that West's ID
adapter will achieve any level of commercial success. These
forward-looking statements involve a number of risks and
uncertainties. For a description of certain additional factors that
could cause West's future results to differ from those expressed in
any such forward-looking statements, see Item 1A, entitled "Risk
Factors," in West's Annual Report on Form 10-K for the year ended
December 31, 2016. Except as required
by law or regulation, we undertake no obligation to publicly update
any forward-looking statements, whether as a result of new
information, future events, or otherwise.
West and the diamond logo and By your side for a healthier
world™ are registered trademarks or trademarks of West
Pharmaceutical Services, Inc., in the
United States and other jurisdictions.
i Saleem AF et al. Needle adapters for intradermal
administration of fractional dose of inactivated poliovirus
vaccine: Evaluation of immunogenicity and programmatic feasibility
in Pakistan. Vaccine 2017
May 31; 35(24): 3209–3214. doi: 10.1016/j.vaccine.2017.04.075
ii World Health Organization. Poliomyelitis Fact Sheet.
April 2017. Retrieved from:
http://www.who.int/mediacentre/factsheets/fs114/en/
iii Mohammed A.J., AlAwaidy S., Bawikar S. Fractional
doses of inactivated poliovirus vaccine in Oman. N Engl J Med. 2010;362:2351–2359.
doi: 10.1056/NEJMoa0909383.
iv Nirmal S., Cherian T., Samuel B.U., Rajasingh J.,
Raghupathy P., John T.J. Immune response of infants to fractional
doses of intradermally administered inactivated poliovirus vaccine.
Vaccine. 1998;16:928–931.
v Resik S., Tejeda A., Mach O. Immune responses after
fractional doses of inactivated poliovirus vaccine using newly
developed intradermal jet injectors: a randomized controlled trial
in Cuba. Vaccine.
2015;33:307–313. doi: 10.1016/j.vaccine.2014.11.025. Epub 2014 Nov
22.
vi Estivariz C.F., Jafari H., Sutter R.W. Immunogenicity
of supplemental doses of poliovirus vaccine for children aged 6–9
months in Moradabad, India: a
community-based, randomised controlled trial. Lancet Infect
Dis. 2012;12:128–135. doi: 10.1016/S1473-3099(11)70190-6. Epub
2011 Nov 7.
vii Soonawala D., Verdijk P., Wijmenga-Monsuur A.J.
Intradermal fractional booster dose of inactivated poliomyelitis
vaccine with a jet injector in healthy adults. Vaccine.
2013;31:3688–3694. doi: 10.1016/j.vaccine.2013.05.104. Epub 2013
Jun 13.
viii Nelson K.S., Janssen J.M., Troy S.B., Maldonado Y.
Intradermal fractional dose inactivated polio vaccine: a review of
the literature. Vaccine. 2012;30:121–125. doi:
10.1016/j.vaccine.2011.11.018. Epub 2011 Nov 17.
ix Resik S., Tejeda A., Lago P.M. Randomized controlled
clinical trial of fractional doses of inactivated poliovirus
vaccine administered intradermally by needle-free device in
Cuba. J Infect Dis.
2010;201:1344–1352. doi: 10.1086/651611.
x Resik S., Tejeda A., Sutter R.W. Priming after a
fractional dose of inactivated poliovirus vaccine. N Engl J
Med. 2013;368:416–424. doi: 10.1056/NEJMoa1202541.
Media Contact:
Emily
Denney
Global Communications
West Pharmaceutical Services, Inc.
+ 1-610-594-3035
Emily.Denney@westpharma.com
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