GSK announces Rollout of U.S.-Licensed Vaccines with 2D Barcodes

- Advanced Information Technology Supports Efforts to Improve Understanding of Vaccine Usage

Issued: August 2, 2013, Philadelphia, PA     

GlaxoSmithKline plc [LSE/NYSE: GSK] announced today it will place two-dimensional (2D) barcoding on both the inner containers and outer boxes of the majority of its U.S. vaccines, a step that supports electronic-medical record keeping.  A 2D barcode is a small square that takes up less space than the current linear barcodes, and can hold more information.

The additional capacity of 2D Data Matrix technology allows for product identification, expiration date, and lot number to be encoded on each vaccine product.  With the necessary hardware and software for this technology, healthcare providers can update their inventory management system, patient records, and vaccination reports automatically, reducing the need for manual entry of information, which can be susceptible to administrative errors and incomplete record keeping.

"We're committed to being one of the early adopters of this technology," said Dr. Leonard Friedland, VP, Scientific Affairs and Public Policy, GSK Vaccines, North America.  "Through regular electronic scanning of information contained in 2D barcodes, we believe that a more accurate and complete picture of U.S. vaccine usage could emerge."

Today's announcement reflects GSK's commitment to implement 2D barcoding beyond the pilot initiative, which the Centers for Disease Control and Prevention (CDC) began in 2011 with support from key organizations, including the U.S. Food and Drug Administration (FDA), the American Academy of Pediatrics (AAP) and other manufacturers.  GSK sought and has received approval from the FDA to add the 2D technology to our labelling.

"The American Academy of Pediatrics applauds efforts to place 2D barcodes on vaccines," said Edward Zissman, MD, FAAP, co-chair of the AAP Vaccine Barcoding Project. "The move to scan vaccines electronically is an important step in helping to facilitate accurate and uniform records of immunization for children across the U.S."

The AAP championed discussions on the feasibility of 2D barcoding in 2009 and, as a primary advocate of 2D barcoding, continues to work with stakeholders to create standards and provide office implementation guidance. GSK was one of two principal vaccine manufacturers to enlist in the pilot, the results of which are currently being analyzed.

GSK has already piloted the 1440 EL.U. vial presentation of Havrix® (Hepatitis A Vaccine) with 2D barcoding and will phase in the additional vaccines with FDA-approved 2D barcoding, meeting globally recognized GS1 standards, from Q3 2013 - Q2 2014.  They are:

  • BOOSTRIX® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
  • CERVARIX® [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant]
  • ENGERIX-B® [Hepatitis B Vaccine (Recombinant)], 20 mcg/mL and 10 mcg/0.5mL formulations
  • FLUARIX® (Influenza Virus Vaccine)
  • FLUARIX® QUADRIVALENT (Influenza Virus Vaccine)
  • HAVRIX® (Hepatitis A Vaccine), 1440 EL.U./mL and 720 EL.U./0.5mL formulations
  • INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)
  • KINRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed and Inactivated Poliovirus Vaccine)
  • PEDIARIX® [(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)]
  • TWINRIX® ([Hepatitis A and Hepatitis B (Recombinant) Vaccine])

For more information about the CDC's 2D barcoding pilot project, including the CDC's initiative to add 2D barcoding to Vaccine Information Statements, please visit http://www.cdc.gov/vaccines/programs/iis/2d-vaccine-barcodes/.

In addition, healthcare providers can visit http://www2.aap.org/immunization/pediatricians/barcoding.html for the AAP's clinical guidance to help implement the necessary technology to use 2D barcoding. Having 2D barcodes on vaccines, while an important piece, is only the first step of many that practices will need to fully utilize 2D barcoding in the office.

About the American Academy of Pediatrics

The American Academy of Pediatrics is an organization of 60,000 primary care paediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.  For more information, visit www.aap.org.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit http://us.gsk.com/

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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.