VIPS Phase I executive summary:
Autodisable sharps - injury protection
syringes
June 2019
Autodisable (AD) sharps -injury protection (SIP)
syringes
About AD SIP syringes
? AD SIP syringes are single -use, disposable syringes with a mechanism that
covers the needle after use to reduce the risk of accidental needlestick
injury .
? Mechanisms include retraction of the needle into the barrel after injection
or a needle shield .
? Some syringes have SIP features that are automatically activated and
others require extra activation steps by the end user.
Stage of development
? AD SIP syringes are commercially available .
? A list of the current AD SIP syringes is available on the World Health
Organization?s (WHO?s) Performance, Quality, and Safety (PQS) catalogue b.
WHO
a
A VanishPoint ? retractable syringe
(Retractable Technologies, Inc.)
PATH
BD Eclipse? syringe (BD, Franklin
Lakes, NJ) with needle shield
ahttp://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/LinkPDF.aspx?UniqueID=f3025136 -636d -4139 -9773 -fdbf82427 6e1&TipoDoc=DataSheet&ID=0 bW HO. PQS catalogue website. Category E008 auto -disable syringe for fixed dose immunization page. http://apps.who.int/immunizatio n_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=37. Accessed April 4, 2019.

12.06.2019 Page 1 of 18
VIPS is a Vaccine Alliance project from Gavi, World Health Organization, Bill & Melinda Gates Foundation, PATH and UNICEF
A utodisable (A D ) sharps -injury protection (SIP)
syringe s
Comparator : AD needle and syringe ( N&S ) without SIP feature


Section 1: Summary of innovation
1.1 Example s of innovation types :

Image source : Provided by PATH
1.2. D escription of innovation:
Unsafe injections cause hepatitis B, hepatitis C, or HIV infections and can result in chronic disease or death
(1). To reduce the risk of unsafe injection, the World Health Organization (WHO) Expanded Programme on
Immunization ca lled for the design of safer injection devices in the 1980s. In 1999, WHO, the United
Nations International Children?s Emergency Fund ( UNICEF ), and the United Nations Population Fund
(UNFPA ) released a joint statement supporting the use of autodisable (AD) syringes for immunization (2),
and UNICEF started phasing out regular disposable syringes for immunization and replacing them with
WHO prequalified AD syringes (3). The 1999 WHO/UNICEF joint statement highlights that AD syringes
should be used for both routine immunization and mass campaigns (fixed dose immunizations) (2), and this
was reaffirmed in a 2019 joint statement that also promotes the use of reuse prevention ( RUP ) syringes for
reconstitution (4).
Safety syringes come in t wo types: RUP and sharps injury protection (SIP) .a AD syringes are considered a
specific subtype of RUP syringes, and RUP and AD syringes can both come with SIP features . AD SIP
syringe s are the focus of this evaluation. According to Gavi?s Vaccine Innovations Lexicon, a SIP
syringe is, ?A single -use, dispos able syringe with a mechanism that covers the needle after use to reduce
the risk of accidental needlestick injury. Mechanisms include retraction of the needle into the barrel after
injection or a needle shield. SIP syringes have an additional feature that helps prevent needle -stick injury
and can increase the safety of immunisation delivery and disposal (5).?
Like AD syringes, AD syringes with SIP features can be used for routine immunization and mass
campaigns for intramuscular, subcutaneous, or intrader mal vaccinations . By 2012 , International
Organization for Standardization (ISO ) standards were developed for SIP syringes (6). WHO also now
recommends the use of syringes with SIP features for health care workers delivering intramuscular,
subcutaneous or i ntradermal injectable medications to patients (6). The WHO Performance, Quality, and
Safety (PQS) group is planning a consultation in 2019 to assess whether SIP features should be required
for all immunization syringes (7,8).
a Unless specifically noted RUP syringes ordinarily refer to non -AD syringes used for reconstitution of freeze -dried vaccines and curative medicine (variable dosing).

VIPS Phase I executive summary:
Barcodes
June 2019
Barcodes
About Barcodes
? Barcodes are symbols that encode information such as product numbers, serial numbers,
supplier data, batch numbers and expiry dates which can be scanned electronically using two
dimensional (2D) scanners, laser or mobile device cameras to automatically capture information.
? Barcodes enable tracking and monitoring of vaccine products in supply chains, providing
information to manufacturers, transport providers, health facilities and other relevant parties
involved in the logistics management systems, assuming the supporting infrastructure is in place.
? 2D barcodes can hold a significant amount of information and there is a possibility to automatically
import data into patient electronic medical records (EMRs).
? This assessment is based on barcode placement on vaccine primary and higher packaging levels.
Stage of development
? 2D Barcodes are commercially available and pilots have been introduced in a number of countries.
? WHO currently recommends GS1 compliant barcodes for secondary and tertiary packaging of
vaccines containing the Global Trade Item Number (GTIN), vaccine expiry date and vaccine batch/lot
number. This recommendation is anticipated to soon become a critical characteristic necessary
for WHO prequalification.
Newswire.ca
a
a https://www.newswire.ca/news -releases/sanofi -pasteur -moves -national -immunization -strategy -forward -with -new -bar -code -technology -509575151.html
PATH
Barcode on primary packaging
Barcode on secondary packaging

12.06.2019 Page 1 of 18
VIPS is a Vaccine Alliance project from Gavi, World Health Organization, Bill & Melinda Gates Foundation, PATH and UNICEF
Barcodes
Comparator: Use without innovation (i.e. no barcodes )


Section 1: Summary of innovation
1.1 Example images :
Primary package barcode a




Secondary package
barcode b




Tertiary package barcode c




1.2. D escription of innovation:

? Barcodes are symbols that encode information such as product numbers, serial numbers, supplier data,
batch numbers and expiry dates which can be scanned electronically using 2 dimensional ( 2D )
scanners, laser or mobile device cameras to automatically captu re information.
? Barcodes can be placed on vaccine primary, secondary, and tertiary packaging. This evaluation
assumes barcode placement down to the primary packaging level.
? 2D barcodes are a Data Matrix capable of holding a significant amount of informati on (more than the
linear one -dimensional barcodes) in a smaller space. The 2D barcodes currently available on some
vaccines contain the vaccine product identification information, expiration date and lot number d.
? Barcodes enable tracking and monitoring of vaccine products in supply chains, providing information to
manufacturers, transport providers, health facilities and other relevant parties involved in the logistics
management systems, assuming the supporting infrastructure is in place.
? Providers can use barcode scanners to read the 2D barcodes on primary packaging and automatically
import data into patient electronic medical records (EMRs), if these EMRs are in place.

a Photo source: https://www.newswire.ca/news -releases/sanofi -pasteur -moves -national -immunization -strategy -forward -with -new -bar -code - technology -509575151.html
b Photo source: PATH/Matt Morio c Photo source: https://ediacademy.com/blog/freds -barcode -requirements/ d About Two -Dimensio nal (2D) Vaccine Barcodes, CDC. https://www.cdc.gov/vaccines/programs/iis/2d -vaccine -barcodes/about.html

VIPS Phase I executive summary:
Blow - fill - seal primary containers
June 2019
Blow -fill -seal (BFS) primary containers
About BFS primary containers
? BFS is a single, continuous, aseptic filling process in which a polymer resin is melted, blown into
a blister, filled with vaccine product, and sealed.
? BFS containers can be packaged either as separate single dose containers or conjoined as
multi -mono -dose (MMD) containers.
? Two sub -types of single dose presentation primary container BFS have been assessed:
? Ampoule formats: to withdraw the contents, the container has to be opened by twisting
off the top of the container.
? Vial formats: contents are withdrawn by inserting a needle and syringe through the septum.
Stage of development
? BFS containers are widely used to produce a variety of pharmaceuticals in polymer primary
containers.
? GlaxoSmithKline?s oral rotavirus vaccine is available in a BFS 5 -dose MMD strip and Serum
Institute of India, Pvt, Ltd uses BFS ampoules for packaging diluent for their influenza
vaccine .
PATH
Rommelag BFS ampoule
PATH
Rommelag BFS vial

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