The 2D Vaccine Barcoding Pilot is funded by the Centers for Disease Control and Prevention (CDC) and 

managed under contract by Deloitte Consulting, LLP (Deloitte). A two-year contract to design and 

implement the barcoding pilot was awarded to Deloitte in September 2011.

Centers for Disease Control and Prevention

Two-Dimensional (2D) Vaccine Barcoding 

Manufacturers Forum Report

November 2014

"Reviewed November 2015"
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Version Control

Version Date Changes

0.0 2/29/12 Initial Draft
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Table of Contents

Table of Contents........................................................................................................................3

1.0 Executive Summary ..........................................................................................................4

2.0 Background ......................................................................................................................5

3.0 Forum Goals and Objectives.............................................................................................5

4.0 Forum Agenda ..................................................................................................................5

5.0 Speaker Presentations......................................................................................................7

6.0 Working Sessions............................................................................................................13

7.0 Summary & Follow-ups...................................................................................................19

8.0 Appendices.....................................................................................................................21
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1.0 Executive Summary

The 2D Vaccine Barcoding Manufacturers Forum was conducted January 26, 2012 at the Tom Harkin 

Global Communications Center on the Centers for Disease Control and Prevention (CDC) Roybal Campus 

located at 1600 Clifton Road, Atlanta Georgia. Over 60 industry stakeholders attended in person. 

Attendees included 26 representatives from 10 vaccine manufacturing companies, representing 

functions of packaging, distribution, policy, regulatory affairs, technical services, customer service and 

new products. In addition to the manufacturers, the forum was attended by representatives of retail 

pharmacy supply chain participants, standards bodies, and trade associations such as GS1 and BIO. 

Regulatory and global agencies including World Health Organization (WHO), the Food and Drug 

Administration (FDA), and CDC participated in the event, providing a rare opportunity for the industry 

and regulators to connect and discuss the changing requirements and standards for vaccines. 

The forum was structured to provide information on several key topics including the CDC’s 2D Vaccine 

Barcoding Pilot, current FDA guidance on 2D Vaccine Barcoding, overall industry progress on 2D 

barcoding, and standards development in the 2D barcoding space. Opening remarks were made by Dr. 

Anne Schuchat, CDC—Assistant Surgeon General, United States Public Health Service (USPHS) Director, 

National Center for Immunization and Respiratory Diseases, who emphasized the importance of the 

pilot’s goals of improving information flow and accuracy, and patient safety.

An overview of CDC’s Vaccine Barcode Pilot project was given by Erin Kennedy, DVM, MPH, of the CDC. 

Regulatory guidance for manufacturers was addressed by Captain Vada Perkins, FDA, followed by a 

provider perspective given by Dr. Edward Zissman, MD, FAAP who represented the American Academy 

of Pediatrics (AAP). An overview of the Vaccine Barcoding Report, which was funded by the CDC was 

given by Alan O’Connor of Research Triangle Institute International (RTI), followed by a final 

presentation by John Roberts of GS1, the global standards organization focusing on the need for 

adopting data standards to drive the benefits of 2D vaccine barcoding.

Following the speaker presentations, working sessions were held with forum attendees to discuss the 

benefits and impacts of 2D vaccine barcoding. Topics for the breakout working sessions were standards, 

user adoption and time and cost. Below are highlights from those working sessions. 

 Manufacturers recognize the value of 2D barcoding to the provider community, but struggle 

with implementing in a cost effective way.

 There is confusion and concern about regulatory requirements that is slowing rapid adoption. 

The FDA is willing to address this and work with the manufacturers to resolve the uncertainty. 

 There will be a period of time where all vaccine products will carry both linear and 2D barcodes, 

until there is sufficient uptake of 2D symbology by providers and migration away from linear 

barcodes.

 GS1 is the standard that manufacturers have adopted for use in the supply chain. 

 Forum participants welcome the opportunity to work collaboratively with agencies and peers on 

defining the benefits and seeking ways to solve issues and enhance patient safety.

 There is a need for alignment between vaccine manufacturers and vaccine end-users, or 

immunizers. Manufacturers cannot drive the adoption of 2D barcoding alone.
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2.0 Background

In September 2011, the CDC initiated a pilot designed to evaluate how 2D vaccine barcodes may affect 

the quality, accuracy and timeliness of the exchange of immunization-related information between 

electronic immunization provider recording systems and grantee Immunization Information Systems 

(IIS), among other systems. A two-year contract to design and implement the pilot was awarded to 

Deloitte Consulting.

By moving from a linear to a 2D barcode, vaccine manufacturers can more efficiently provide data about 

vaccine products. It is anticipated that by scanning a 2D barcode into an electronic provider

immunization recording system, immunizers can easily and accurately capture data with a single scan. 

As part of the pilot, a 2D Vaccine Barcoding Manufacturers Forum was organized to bring together 

vaccine manufacturer, regulatory and standards stakeholders to discuss the opportunities, challenges 

and next steps for implementing 2D barcoding on vaccine products. A full list of forum sponsors and 

attendees are displayed in Appendix B and C.

3.0 Forum Goals and Objectives

The goals and objectives of the forum were to engage the vaccine manufacturing community in the 

discussion of the benefits, impacts and challenges of implementing 2D barcoding, to understand the 

regulations and standards landscape in more detail, and to explore the options and considerations for 

moving the industry forward toward the implementation of 2D barcoding of vaccine products.

4.0 Forum Agenda

The agenda was designed to bring together key groups involved in the creation and adoption of 2D 

Vaccine Barcoding. The agenda included presentations about the pilot from CDC representatives as 

well as other speakers who discussed key issues in vaccine barcoding. The FDA was selected to provide 

details on the regulatory process for 2D vaccine barcoding, which was of prime interest to the 

manufacturer attendees. The AAP, the Pilot’s primary industry group sponsor, provided a key voice into 

immunizer (specifically pediatric) adoption considerations. RTI was selected to present as they have 

conducted with CDC support the primary research to date on vaccine barcoding and could provide 

insight on the potential benefits to be achieved by adopting 2D barcoding. GS1 provided insights on the 

latest standards around barcoding to help the manufacturers understand the likely standards that will 

be used as part of 2D Vaccine Barcoding.

The agenda also included breakout “working sessions” to encourage dialogue between attendees to 

highlight perceptions and issues around 2D vaccine barcoding standards, user adoption, and time and 

cost commitment.
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Time Description Presenter

11:00 – 11:05 Welcome 

Opening Remarks

Bonni Kirkwood

Deloitte—PM 2D Vaccine Barcode Pilot Project

Anne Schuchat, MD

CDC—Assistant Surgeon General (USPHS)

Director, National Center for Immunization and 

Respiratory Diseases

11:05 – 11:10 Forum Purpose and Objectives

Antitrust Announcement

Bonni Kirkwood

Ken Gerlach, MPH, CTR

CDC— NCIRD/Immunization Services Division, 

Health Scientist 

11:10 – 11:30 Overview of 2D Vaccine 

Barcoding Pilot

Erin Kennedy, DVM, MPH

CDC— NCIRD/Immunization Services Division, 

Medical Officer

11:30 – 12:00 Overview and Guidance on 

Vaccine 2D Barcoding

Vada Perkins, BSN, MSc, RN 

FDA—Chief, Business Operations Staff

12:00 – 12:30 Lunch

12:30 – 1:15 Industry Goals and Progress for 

Vaccine Barcoding – A 

Perspective from the AAP

Edward Zissman, MD, FAAP 

AAP

1:15 – 2:00 Overview of Vaccine Bar Coding 

Report

Alan O’Connor

RTI—Senior Economist

2:00 – 2:15 Break

2:15 – 3:00 Emerging Standards for Vaccine 

Barcoding – GS1 Overview

John Roberts

GS1—Director, Healthcare

3:00 – 3:05 Overview of Working Sessions Bonni Kirkwood

3:05 - 4:15 Benefit/Impact Working 

Sessions 

3 sessions with facilitators

4:15 – 4:55 Working Session Readouts Bonni Kirkwood

4:55 – 5:00 Close Forum Warren Williams, MPH

CDC— NCIRD/Immunization Services Division, 

Informatics Team Lead, Immunization 

Information Systems Support Branch

Table 1 – Manufacturer Forum Agenda
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5.0 Speaker Presentations 

The slides used for each speaker presentation can be found in Appendix A.

Welcome – Dr. Anne Schuchat, MD CDC – Assistant Surgeon General (USPHS) and Director, National 

Center for Immunization and Respiratory Diseases 

Dr. Schuchat’s opening remarks placed emphasis on the importance of the pilot. She described a recent 

experience in rural Africa where, with a scan of a barcode, a nurse could present information around the 

therapy that a patient was receiving. Dr. Schuchat stated this experience should be motivation for 

improving our efforts in the United States. Dr. Schuchat provided an overview of the vaccine supply 

chain and the use of the CDC vaccine ordering system (VTrckS) in the process. She also touched on the 

impact of 2D barcoding on managing shortages, recalls and safety tracking, decision support and 

meaningful use. 

Overview of 2D Vaccine Barcoding Pilot - Dr. Erin Kennedy

Dr. Kennedy provided an overview of the 2D Vaccine Barcoding Pilot Project, including a description of 

the progress of 2D vaccine barcoding efforts since 2004. 

The key points of Dr. Kennedy’s presentation included:

 Definition of linear vs. 2D barcoding indicating that linear barcodes contain the NDC code only 

and that 2D barcodes can capture additional information like expiration date and lot number

 Potential public health benefits of the 2D Vaccine Barcoding Pilot include improved accuracy of 

patient health records, consistency in information captured in IIS and VAERS reports, increased 

ability to identify safety concerns and a potential reduction in administration errors

 The 2D Vaccine Barcoding Pilot’s objectives are to examine the challenges of implementing 2D 

barcodes on vaccines and to evaluate the use of 2D barcodes via assessing data completeness, 

user experience, and process impacts, and to document best practices and lessons learned

 The Pilot’s timeline begins with manufacturer, grantee, and immunizer enrollment and 

provisioning through mid-2012, continues with immunization tracking through April 2013, with a 

final report following in June 2013

 Current Pilot progress includes two manufacturers enrolled, and 58 immunizers enrolled

 Barcoding will also be introduced on all Vaccine Information Statements (VIS) as part of the Pilot 

in order to achieve the benefits of increasing completeness of data elements, enhancing record 

keeping for providers, and promoting the use of barcoding technology

 The CDC has identified the GS1 Global Document Type Identifier (GDTI) to encode the VIS, added 

the GDTI barcode to all up to date VIS, and developed assistance documents for users

Questions & Answers*

Question Answer

[Zissman, AAP] Concern about nurses knowing 

which bar code to scan if 2D barcodes are on 

vaccine vials and VISs. There is no doubt that 2D 

[Erin Kennedy, CDC] No, VIS codes are generic. We 

aim to offer sufficient training to educate nurses 

about which VIS code to scan. 
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barcodes will lead to accuracy improvements, 

but ‘everything that can be messed up will be 

messed up’. Clear direction needs to be given to 

ensure providers understand the appropriate 

use of 2D barcode scanning. Adopting a change 

in workflow is huge. Workflow changes will be 

an issue for the practices. Do the VIS codes 

contain vaccine specific barcodes? 

[Greg Anderson, Connexin] Nurses often print out 

barcode cheat sheets with multiple barcodes on 

one piece of paper. This makes their life easier to 

scan the barcodes, but causes concern about 

barcode accuracy.

[Melissa Melhame, Dynavax] What is the benefit 

of scanning the VIS?

[Erin Kennedy, CDC] To record and increase 

completeness of version date of the VIS. 

[Zissman, AAP] Is there an interface to the 

Electronic Medical Records (EMR) developed as 

part of this pilot?

[Erin Kennedy, CDC] No interface.

*Questions and Answers captured in this report were not captured verbatim

Overview and Guidance on Vaccine 2D Barcoding – Captain Vada Perkins

Captain Perkins provided an overview on the FDA guidance for the use of 2D barcodes on vaccine 

products. 

The key points of Captain Perkins’ presentation included:

 Current barcoding requirements

o Drugs approved on or after April 26, 2004, have 60 days from their approval date to 

comply with the bar code requirement (21 CFR 201.25)

o All other drugs subject to the bar code requirement, including drugs with applications 

approved before April 26, 2004, must implement the requirements within 2 years of the 

effective date (i.e., no later than April 26, 2006) (21 CFR 201.25)

o A drug manufactured on or after April 26, 2006, must bear a bar code 

 2D barcodes are to include National Drug Code (can support Global Trade Identification Number 

(GTIN)), Lot Number, Expiration Date

 Labeling submission for addition of a 2D barcode requires a Prior Approval Supplement (PAS) 

labeling submission 

 Equipment that already has the capability for 2D barcode and will require validation for 2D 

barcode addition to the label. Manufacturers can contact Industry.Biologics@fda.hhs.gov for 

more information on manufacturing changes

 Manufacturers can request exemptions to the FDA/CBER review process for 2D barcode 

additions

Questions & Answers*

Question Answer

[Tim Marsh, Pfizer] Do we need linear and 2D? [Vada Perkins, FDA].
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Is an exemption possible? There is a process to request an exemption to the 

linear barcode requirement. That being said, 

companies that have submitted 2D barcode 

submissions, to date, were "in addition to" 

requests.

[Craig Kemp, Merck] Just to confirm, you would 

like a PAS to be the filing mechanism to ensure 

consistency although at some point it may move 

to a Changes Being Effected in 30 Days (CBE30)?

[Vada Perkins, FDA] Yes. Because there is a timing 

issue with the pilot, we will take quick action on 

those products to turn them around. 

[Craig Kemp, Merck] Do we submit an exemption 

in addition to the PAS?

[Vada Perkins, FDA] An exemption is required only 

if you want to drop the linear.

[Greg Anderson, Connexin] There is not enough 

real estate to use both. Scanner will catch both 

far too easily--have to hold just right. It will be 

very difficult to teach nurses to scan one or the 

other code if both exist on the vial. There is 

interference between the two codes.

[Vada Perkins, FDA] We can only offer a mechanism 

to allow one or both--using the exemption 

processes. 

The exemption process applies only if a 

manufacturer wants to eliminate the linear when 

adding the 2D barcode. Linear in addition to the 2D 

will require a PAS labeling supplement

[Zissman, AAP] The AAP working group was told 

one or other?

[Vada Perkins, FDA] An exemption is only applicable 

if a request to remove the linear barcode is 

submitted.

[Novartis] Is an exemption required for each 

product?

[Vada Perkins, FDA] We will follow up on this.

*Questions and Answers captured in this report were not captured verbatim

Industry Goals and Progress for Vaccine Barcoding - Perspective from AAP – Dr. Edward Zissman

Dr. Edward Zissman, representing the American Academy of Pediatrics, presented a historical and 

forward-looking overview of vaccine barcoding. 

The key points of Dr. Zissman’s presentation included:

 Pediatricians provide the majority of vaccinations in the U.S. leading the AAP to have a 

continued interest in barcoding on immunization vials and syringes

 Environmental changes such as an increase in the number of recommended childhood vaccines, 

an increase in vaccine data recording requirements, and an increase in the number of private 

practices using electronic systems have created greater need for improved vaccine tracking

 Guidance on how to track combination vaccines (vaccines with more than one vial that need to 

be combined for administration (e.g. Pentacel)) is needed

 Involvement and agreement of stakeholders is critical and AAP’s ongoing task will be to educate 

stakeholders including vaccine administrators, software vendors, and immunization registries
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Overview of Vaccine Bar Coding Report – Alan O’Connor

Alan O’Connor of RTI provided an overview of the Vaccine Bar Coding Project commissioned by the CDC 

in October of 2010. 

The key points of Mr. O’Connor’s presentation included:

 2D barcodes are technically feasible and expected by stakeholders to enhance safety via 

automated product verification (right product, right patient) and improve accuracy and 

completeness of records

 Scanning 2D barcodes saves about 35 to 39 seconds per dose for documentation

 When made aware of estimated scanner, workflow redesign, and training costs, 

o

o

79.5% of pediatric practices said they would use the barcode or would use it if they had 

an electronic health record (EHR) system

69.8% of family medicine practices agreed

 Estimated net economic benefits to Primary Care Providers , Local Health Departments, 

manufacturers, and some public-sector organizations

o

o

o

o

$326M to $349M, between 2011 and 2023

Net Present Value of $176M to $197M (7% discount rate)

Benefit-to-cost ratio of 2.7 to 2.8

Internal rate of return of 43% to 49%

 A mapping of GTIN to NDC to Manufacturers of Vaccines (MVX) and Vaccine Administered (CVX) 

codes is necessary for IT systems. 

Questions & Answers*

Question Answer

[Unknown] Does the study focus on all 3 

barcodes required. (Serialization etc.)?

[Alan O’Connor, RTI] The study looked at primary 

packaging only. Secondary packaging was not 

considered.

[Unknown] Guidelines good for Pediatricians but 

need to make sure that serialization is fully 

inclusive for track and trace.

[Unknown] Cost? Does it include outside 

package too? 
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[Zissman, AAP] Inventory control is very 

important. A large selling point is inventory 

control to reduce wastage. Reporting for fraud 

and abuse would be a huge selling point.

Note: [Zissman, AAP] The cost to the 

Pediatrician. Electronic Medical Records (EMR) 

upgrades and interfaces are not included.

[Alan O’Connor, RTI] RTI looked into this: We 

engaged EHR vendors about requirements to 

incorporate scanners. The cost adoption was fairly 

low. The majority of vendors did not perceive 

incremental costs simply because of increased 

automation and barcoding. With respect to the 

comments about pediatrics and family practice 

markets, this was considered a key market driver 

for EHR vendors to push more.

[Alan O’Connor, RTI] The cost was very small.

[Alan O’Connor, RTI] Functionality could come as a 

push, as part of the yearly lease.

[Jay Crowley, FDA] Cautioned against parsing 

numbers. Parsing the NDC out of a GTIN is 

dangerous. It might work in the short term, but 

it will get us in trouble in the long term.

[Alan O’Connor, RTI] There are so many decision 

rules that need to be considered that a mapping is 

preferable. 

[Jay Crowley, FDA] Even mapping can cause 

trouble, we must be careful to acquire the 

information without parsing NDC to get it.

Note: [Zissman, AAP] Remember that billing uses a different form. Don't just think about medical 

records, also think about billing. If CDC takes ownership of the NDC mapping then they should consider 

other implications like billing and associated codes.

*Questions and Answers captured in this report were not captured verbatim

Emerging Standards for Vaccine Barcoding - GS1 Overview – John Roberts

John Roberts, Director of Healthcare for GS1 US provided an overview of the GS1 organization, GS1 

standards and the nuances of barcoding using 2D symbology. 

The key points of Mr. Roberts’ presentation included:

 GS1 is a not-for-profit organization dedicated to the design and implementation of global 

standards to improve the efficiency and visibility of supply chains globally and across sectors

 GS1 standards focus on patient “rights”: Right Patient (location) – Global Location Number 

(GLN), Right Drug/Device – GTIN, Right Dose – GTIN, Right Route – GTIN

 One data structure (GTIN) will be used to reference the item by all members of the supply chain

(hospital & retail, manufacturer, distributor, Group Purchasing Organization (GPO)/Payer)

 There is “perfect standards storm” upcoming with the 2012 voluntary GTIN Sunrise, FDA Unique 

Device Identification, and California pedigree in 2015 amongst others, creating a strong case for 

standards adoption
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 The 2012 GTIN Sunrise goal is to have GTINs assigned to all healthcare products, marked on all 

appropriate packaging levels, used in business transactions, scanned at point of delivery, used in 

product returns and recalls, and registered in a GDSN certified data pool

 GS1 offers education forums, webinars, toolkits, and case studies to help stakeholders get 

educated and increase adoption of GS1 standards

Questions & Answers*

Question Answer

[Greg Anderson, Connexin] What is the likelihood 

that serials are going to show up at unit of use 

when it comes to vaccines?

[John Roberts, GS1] I can't talk about vaccines, but I 

know that some manufacturers will send serials not 

to just California, but everywhere too.

[Alan O’Connor, RTI] GTIN + Serial number: what 

packaging level will we see a serialized GTIN?

[John Roberts, GS1] For Pedigree/California, it will 

go down to unit of use. I have seen both. 

Serialization is difficult due to real estate 

requirements.

[Jay Crowley, CDC] Serial number: Just because it [a 

product] has a serial number, does not mean that it 

[the product] does not have a lot number. It is 

easier to recall a lot than 10,000 serial numbers. 

Packaging: it becomes a necessity to serialize higher 

levels of packages in my opinion (not speaking for 

FDA). In order to make this work for distribution 

and traceability, you need to put a serial number on 

the outer level of packaging. Use inference to 

determine serial levels of interior packages.

[Warren, CDC] Is there a requirement related to 

the order of the data within the barcode e.g. 

GTIN, Lot Number, and Expiration Date)?

[John Roberts, GS1] No GTIN has to be first and the 

rest come after. It is an art and it depends. There 

should be fixed size fields such as GTIN and 

expiration date up front.

*Questions and Answers captured in this report were not captured verbatim
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6.0 Working Sessions 

Prior to the Manufacturers Forum, the registrants were asked to identify three opportunities or 

challenges that the implementation of 2D barcoding presented for the manufacturer and immunizer 

community. Three common themes emerged as the primary areas of interest: 

 Standards – Both opportunities and challenges were identified with respect to standards. While 

the GS1 standard has emerged as the industry-accepted standard for barcoding, there were 

various levels of understanding and use of the standards and implementation timeframes.

 User Adoption – User Adoption was interpreted not only as adoption by the providers and 

customers of manufacturers, but also trading partners. While education and benefits will need 

to be a focus in the future, working through some of the current processes in place will take 

time.

 Cost and Time Commitment – It will take time for manufacturers to upgrade lines, redesign 

labels and purchase and reconfigure equipment in order to begin applying 2D barcodes to 

vaccine products. Ensuring use in the field is of utmost importance to help manufacturers invest 

in 2D barcoding.

The disproportionate number of submissions for these three areas made them the logical choice to be 

topics for the forum working sessions. Detailed responses received by attendees prior to the forum can 

be found in Appendix E. Appendix E also lists the additional areas of interest submitted by registrants. 

The following section provides notes from each of the working sessions. Many of these notes are 

captured in bullet points or sentence fragments and are included to provide context and background for 

the opportunities and challenges summarized in Figure 2 in Appendix E. A full listing of working session 

groups and their associated attendees can be found in Appendix D.

Group 1 – Standards

The focus of Group 1 was to discuss the benefits and the challenges of adopting and implementing GS1 

standards for vaccine products. Participants of this group can be found in Appendix D-Forum Working 

Session Groups. The questions asked of the group and the related discussion points are below:

1. What are the benefits of switching from market-specific product and location identification 

numbers to global identifiers (specifically GTIN and GLN proposed by GS1)?

 Group members agreed that the use of global identifiers increases patient safety and 

outcomes.

 The group also agreed that there should be no universal GTIN across the globe. The scope

should be confined to U.S.; use the same packaging line but different label.

 Cost savings from peel-off labels is minimal hence not a significant monetary incentive.

 Supply chain integrity and management can improve with this program.

2. What challenges revolve around switching to the common GS1 identifier types (e.g. NDC to 

GTIN)?
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 The scope of this conversation was significant because of the pending California Pedigree 

law. There was discussion of where the 2D barcode should be located. Should linear/2D or 

both be used?

 The group ruled serial number discussions to be out of scope because of volatile changes in

secondary packaging.

 There is no forecast of use serial number on unit of use.

 The group agreed that the 2D barcode will be on the packaging in addition to the linear, so 

you will have both.

3. What standards are currently used in the US in addition to or instead of GS1?

 The concern was that the industry is spending significant time discussing the GS1 standards 

– is there a potential that these standards could change?

 The group felt that while Health Industry Business Communications Council (HIBCC) is 

another standard that is used, it is not likely that this would be where the industry will 

move.

4. If all manufacturers and distribution channels do not harmonize on 2D barcode standards and 

timing for implementation, how will the industry be impacted? What are the benefits of being 

an early adopter?

 Pediatricians have a limited choice – they must use one of 3-4 companies – GlaxoSmithKline, 

Sanofi, or Pfizer. You will see an impact when all of these companies provide 2D barcodes.

 Discussed the PAS process and the desire to try to move these through quickly, especially if 

a manufacturer is part of the Pilot program. This is assuming that the PAS does not bundle 

many other labeling changes in with the request to change to a 2D barcode, because those 

will need a full review. 

5. Do you believe there is a common understanding of the 2D barcoded fields and sequence to 

be encoded (GTIN/Expiration date/Lot number)? If not, what needs to be clarified?

 Yes. 2D on unit of use: encode the GTIN -> Exp. -> Lot (Agreement among group).

There was one item captured in the parking lot and it was suggested that working groups be formed 

to continue the discussion (see below paragraph). There are existing GS1 workgroups to address 

encoding standards. FDA suggested making packaging guidance more explicit and defining 

regulations and how to implement.

Combination vaccine products (vaccine with more than one vial that need to be combined for 

administration) were discussed and which of the lot numbers should be captured. No clear 

answer emerged. This topic could be part of a future focus group. 
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Group 2 - User Adoption

The focus of Group 2 was to discuss the benefits and the challenges of user adoption and how to 

educate the provider community to embrace 2D barcoding to enhance their processes. It was important 

to remember that users come in several types – the immunizer community is more than just 

administrators of vaccines. The questions asked of the group and the related discussion points are 

below:

1. What demonstration of user benefits, if any, are manufacturers anticipating by adopting 2D 

barcoding?

 Different users will have different priorities (public vs. private)

 Patient safety 

 Inventory control and management

 Cost Savings (e.g. important for Pediatricians) – efficiencies 

 Clearly distinguish practices with high-low VFC product volume

2. What are the major vehicles for manufacturers to enhance user adoption and create customer 

pull through the use of 2D barcodes? How will these communications be managed?

 Can manufacturers alone really drive adoption? Support from EMR vendors is needed to 

drive initial adoption because doctors can’t implement if systems don’t have a place for the 

barcode information to go.

 There is a need to enlist a critical mass of manufacturers and users to jump start adoption. 

If it is too piecemeal or drawn out, it will be difficult to get any energy behind it.

 There is a need to assist practices with variable levels of automation –some just have 

practice management systems, some have EMR. The approach we should take during the 

pilot should be to develop different guidance for each type and size of practice, including:

o

o

Target practices that already using EMRs

Develop guidance specific to each segment of practices

 Do not overpromise – talk about what is coming, but be realistic to limit some from jumping 

ahead because they are very excited to do this. 

 Incentives for stakeholders will vary – there will need to be a different way to design 

incentives for each stakeholder group. 

 The pilot should assist with removing barriers to adoption like cost for EMR upgrades.

3. What are the benefits and drawbacks of using linear and 2D barcodes on vaccines until the 

industry transitions to 2D? What is preventing the complete transition to 2D barcodes now?

 Drawbacks: 

o Confusion/errors on the part of those who administer vaccines which could lead to

data capture errors. Since the goal is to get rid of errors, introducing barcodes may 

temporarily introduce errors during the learning period.
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o

o

o

Real estate concern is what goes on the label and where and making sure there is 

room for the barcode.

There are unanswered questions right now about the general regulatory 

environment, how the waiver process will work, and how quickly manufacturers can 

move through the process.

Logistical considerations that come from combination product – what do you 

scan/not scan? How do you ignore scans of things not intended to be scanned– 

multiple scanning? 

 Benefits: There will be an easier transition for customers who might not have the hardware 

or are reliant on linear codes – Do not cut customers off of linear codes, they will need some 

time for them to transition.

 What is preventing transition to 2D barcodes completely? 

o

o

o

There is a focus on customer needs and what they need to do their work today.

Some manufacturers in the group would be able to change all of their lines 

immediately to 2D if the users were ready to adopt and that the process was ready 

to go, although this was not universal across all manufacturers.

Some integration with EMR/ Practice Management Software (PMS) is needed. 

Manufacturers need to adopt this at once. It does no good to have a scanner gun if 

the system has no place to put the values. A majority of packages do not have the 

ability to support locally and that is going to need some time to come around.

 Note: How many users are scanning/using linear codes on the primary packages?

4. Where would the 2D barcode need to be located to drive maximum benefit? 

 Unit of use? Yes. 

 Consider placing the barcode so that you do not introduce safety issues relating to how the 

user/nurse is handling the vial/syringe.

 It will be important to solicit perspectives from all different kinds of users during the pilot. 

This should be discussed this at the future educational forum to define what the most 

convenient location to place the bar code would be and to ensure it works for larger 

packaging etc.

 Provide manufacturers with clear direction from the user community on where the best 

placement is for the bar codes.

 What works best at the secondary packaging level – in terms of users bringing inventory into 

the system as well as individual administration?

5. What educational campaigns will increase adoption?

 CDC and the National Vaccine Program Office (NVPO) should champion the significant 

improvement in safety. Need to be leaders to promote the concept.
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 Payers, EMR and PMS Vendors need to be involved and may require setting performance 

thresholds (Healthcare Effectiveness Data Information Set (HEDIS)) and that credit will not 

be provided unless you submit a complete record instead of a partial record.

 Greater level of requirements around Stage 2 meaningful use (vaccine safety). Need a little 

more teeth because that stick will drive the EMR vendor community to incorporate into 

products if it is a requirement to stay certified under those programs.

 AAP/others can provide continuing education (C&E) opportunities to communicate financial 

savings to members (webinars etc.). AAP section about improving practice management.

 Timing is important (not too quick and not too late). Don’t want to educate now before you 

are ready to go because people get excited and they cannot do anything with it. Don’t want 

to be too late because you want a chance to build up momentum.

User adoption parking lot:

 Note ICD 10 conversion Oct 2013 will be a major distraction for vendors/providers. 

Whatever happens needs to precede this because there will be a lot of noise around that 

and we want to avoid fighting for attention. Don’t want to get lost in the noise.

 Packaging form? – is it worth exploring alternate solutions for inventory? Putting barcode 

on a package slip?

 Considerations around serialization – track and trace.

Group 3 -Time and Cost 

The focus of Group 3 was to discuss the time and cost considerations and challenges facing 

manufacturers when considering adoption of 2D barcoding. The questions asked of the group and the 

related discussion points are below:

1. What are the benefits for manufacturers to adopt 2D barcoding? What is preventing the 

complete transition to 2D barcodes?

 Eliminating peel off labels could be a factor, and eliminating linear would simplify labeling. 

 2D is a heavy foundation for larger implementation of data and followed by serialization. 

Once implemented at the primary container level then expanding to secondary package or

case will be a good transition for manufacturers.

 Conversion is limited by the slowest adopter – manufacturers have their reasons for not 

moving this forward, such as unit volume. Packaging lines are busy between May and 

October because of seasonality, and freeing up lines to validate would be a significant risk.

 Knowing that you need to plan ahead for other adjustments as part of a larger, strategic 

plan.

 Concern about investing in 2D but users lagging in adoption.

 2D could be replaced by a new technology – radio frequency identification (RFID) was set 

aside, but at some point 2D could lead to another answer.
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2. Where would the 2D barcode need to be located (packaging – primary/secondary) to drive 

maximum use and benefit? To distributors/wholesalers? To providers? 

 Greater flexibility to change secondary packaging. 

 A federal date would increase action – realm of coverage leaves off with manufacturer 

because hospitals and users don’t fall under FDA realm. Question about the impact that the 

FDA could have, given that they don’t control all the way down to the patient, like other 

countries do.

 Allowing a single regulatory submission for multiple products would facilitate transition, but

o

o

o

This is likely unrealistic because vaccine products are looked at individually, 

therefore putting together a group’s submission would not necessarily have a 

positive response. FDA review is not set up that way.

Most submissions will be highly similar.

An issue with a single part of a multiple submission could delay approval – if 

submitting 2D barcoding changes with other changes to labeling or package insert. 

3. How are federal regulations or lack thereof, impacting the adoption of 2D barcoding?

 All changes in the production process bring a regulatory process—this adds additional time 

to the impact timeline – not only do you have manufacturing changes, but regulatory 

submissions after the manufacturing changes. A complete validation package needs to be 

finished prior to notification of the FDA. If lumped together with other changes, the FDA 

would not necessarily give approval upon notification.

 User adoption is necessary to realize benefits. Both sides should work towards goal. 

o

o

o

Manufacturers often face regulation even when users are not using changes. 

Manufacturers make submission as a lever to drive the future. Whether or not 

other users decide to implement is not a regulatory function – this may be done 

piecemeal – but not something that can be leveraged.

Florida is a case study of this – there was a demanding pedigree system and because 

users were not using the system, this fell apart.

Can we create a carrot for users? For EMRs?

 Regulatory notice facilitates planning.

4. What cost and time impacts should be considered when transitioning from linear to 2D 

barcoding?

 Planning phase is essential because changes implicate capacity.

o High opportunity cost of shut downs and seasonal changes (400 vaccines/minute)

o Planned downtime is often already allocated.

o Time estimate: 3-4 weeks of downtime for installation and validation of equipment.
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o Seasonality of product (May-September is high burn) – has to do with immunization 

plans for kids.

 Suboptimal options exist (e.g. offline labeling) where labels are applied in high speed and 

then brought to labeling after the fact. 

 Implementing validation online with current capacity and current products is complicated – 

interweave with upgrading and validation plan.

 Changes are often global moves.

5. How will software/hardware vendors that are not supporting 2D barcoding factor into your 

adoption?

 Enterprise Resource Planning (ERP) systems are capable of handling 2D barcodes because 

information is not changing – Universal Product Code (UPC) is transitioning to GTIN with lot 

and expiration date and these fields exist today in ERP systems.

 Serialization is driving bigger changes.

The use of contract manufacturing was not openly discussed but this was a consideration.

7.0 Summary & Follow-ups

Summary

There were many key lessons learned from the forum and the Pilot team identified several which will 

continue to be focal points for the industry. As the discussions continued throughout the day, it was 

clear that:

 Manufacturers recognize the value of 2D barcoding to the provider community, but struggle 

with implementing in a cost effective way.

 There is confusion and concern about regulatory requirements slowing rapid adoption. The FDA 

is willing to address and work with the manufacturers to resolve.

 There will be a period of time where all vaccine products will carry both linear and 2D barcodes, 

until there is sufficient uptake of 2D symbology by providers and migration away from linear 

barcodes.

 GS1 is the standard that manufacturers have adopted for use in the supply chain. 

 Forum participants welcome the opportunity to work collaboratively with agencies and peers on 

defining the benefits and seeking ways to solve issues and enhance patient safety. Additional 

forums are suggested which also include providers and EMR vendors.

 There is a need for alignment between vaccine manufacturers and vaccine end-users, or 

immunizers. Manufacturers cannot drive the adoption of 2D barcoding alone.

A survey was also distributed to all attendees in order collect feedback on the forum and what could be 

done to enhance the education and insight gained from the event. Results from the surveys are 

displayed in Appendix F.
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Follow-ups

Several items throughout the forum were noted with a need for follow-up. These items were:

 Barcodes on VIS: Determine the optimal training and technical assistance approach for 

instructing health practitioners when to scan VIS barcodes. 

 2D Barcode Exemptions: CDC/FDA needs to communicate to manufacturers whether a 2D 

barcode exemption will be required for each product they offer or if only one exemption 

required that would apply to all products.

 Combination Products: No clear answer emerged during the forum on which of the lot number

for a combination vaccine product should be captured. This could be a topic for a future focus 

group or a future forum. 

 Location for Barcode Placement: Discuss location at the future education forum to define what 

the most convenient location to place the bar code would be and to ensure it works for larger 

packaging etc.
8.0 Appendices 

Appendix A – Web Links to Speaker Presentations 

Welcome - Dr. Anne Schuchat, MD CDC 

Overview of 2D Vaccine Barcoding Pilot - Dr. Erin Kennedy 

Overview and Guidance on Vaccine 2D Barcoding - Captain Vada Perkins 

Industry Goals and Progress for Vaccine Barcoding - Perspective from AAP - Dr. Edward Zissman 

Overview of Vaccine Bar Coding Report - Alan O’Connor

Emerging Standards for Vaccine Barcoding - GS1 Overview - John Roberts 
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Appendix B – Forum Sponsors 

For the Manufacturers Forum, sponsorship was defined as providing support and endorsement of the 

overall objectives of the Manufacturers Forum as well as the 2D Vaccine Barcoding Pilot. Each of the 

sponsoring organizations provides a critical link in the vaccine supply chain and is dedicated to the 

health and safety of patients. The organizations below were not compensated for the use of their logo 

or for participation. A summary about each of the participating organizations is provided below. 

• American Academy of Pediatrics (AAP) 

• Association of Immunization Managers (AIM) 

• American Immunization Registry Association (AIRA) 

• GS1 

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Appendix C –Attendees 

In Person Attendees 

Attendee Organization Role 

Adamusik, John Thomas Celgene Corporation Director, Package Development 

Anderson, Gregory H. Connexin Software Inc. CIO 

Bennett, Laurie B. McKing Consulting Corp Consultant 

Bridges, Carolyn B CDC Assoc Dir Adult Immunizations 

Charles-Rennie, Trisha McKing Consulting Corp Mtg. Planner 

Chen, Robert CDC HIV Vaccine & Special Studies Team Leader 

Crowley, John Jay FDA Senior Advisor for Patient Safety 

Durbin, Joseph F McKing Consulting Corp Project Manager 

Esbitt, Deborah CDC Health Scientist 

Fish, Rebecca J. GlaxoSmithKline Senior Director, US Vaccines 

Flynn, Raymond Novartis Vaccines & Diagnostics Head of Distribution and Customer Service 

Friedman, David Deloitte Consulting LLP Principal 

Gerlach, Kenneth Allen CDC - NCIRD Health Scientist 

Glauser, Geoffrey HHS/ASPR/BARDA Program Manager 

Hill, J. Howard CDC-MCKING Sr. Management Consultant 

Hosbach, Phil Sanofi Pasteur Vice President, Immunization Policy 

Jurrens, Erika Leigh GlaxoSmithKline Vaccine Futures Manager 

Kemp, Craig Charles Merck Vaccines Leader, Customer Solutions 

Kennedy, Erin D CDC Medical epidemiologist 

Kewson, Karl Andrew Novartis Vaccine & Diagnostics Sr. Packaging Engineer 

Kiefer, Brian Deloitte Consulting LLP Senior Consultant 

Kirkwood, Bonni Deloitte Consulting LLP 2D Barcoding Vaccine Pilot PM/ SCI Lead 

Lease, Christian Novartis Vaccines Director, Immunization Policy 

Lee, Brian E. Merck Technical Service manager 

Malhame, Melissa Dynavax Technologies Sr. Director 

Maloney, Diane Marilyn FDA/CBER Associate Director for Policy 

Masland, Duncan Deloitte Consulting LLP Business Analyst 

McDaid, Kenneth B. Merck Customer Manager 

O'Connor, Alan C. RTI Senior Economist 

Papageorgiou, Nikos Deloitte Consulting LLP Sr. Consultant 

Patel, Anita CDC Health Scientist 

Paster, Jennifer L. Sanofi Pasteur Deputy Dir., New Products, U.S. 

Perkins, Vada A. FDA/CBER Staff Chief, Business Operations, 

CBER/ADRM 

Rieker, Denise Sanofi Pasteur Director, Regulatory Affairs 

Roberts, John Joseph GS1 US Director-Healthcare 

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Attendee Organization Role 

Robinson, Paul Deloitte Consulting LLP Manager 

Scally, Mark Joseph McKing Consulting Corp Project Manager 

Schuchat, Anne CDC Dir. NCIRD, RADM/USPHS, Ast. Surg. Gen. 

Shimabukuro ,Tom T CDC Senior Medical Officer 

Simmons, Anne Louise GlaxoSmithKline Manager 

Singh, Rajesh Deloitte Consulting LLP Manager 

Snyder, Michael Sanofi Pasteur Equipment Engineer 

Squires, Robert Elliott MedImmune Director Supply Chain Logistics 

Tusavitz, Elysia L. GlaxoSmithKline Assoc Director, Reg Affairs, Vaccines 

Williams, Warren G. CDC Health Analyst 

Zissman, Edward Neal Altamonte Ped. Assoc. Pediatrician CEO 

Webcast Attendees 

Attendee Organization Role 

Ast, Robert Deloitte Consulting LLP Senior Manager 

Clark-Gagne, Julie L. Deloitte Consulting LLP Public Health Analyst 

Das, Sharnali Deloitte Consulting LLP Consultant 

DeLuca, Ruth A. BIO Mgr, Science and Regulatory Affairs 

Garman, Patrick M. Military Vaccine Agency Deputy Director, MILVAX 

Gellin, Bruce Dept of Health & Human Serv. Deputy Assistant Sec for Health and 

Director 

Granados, Gil C. Sanofi Pasteur Director Regulatory Labeling 

Hay, Catherine Ann MassBiologics Assoc. Deputy Director, Reg. Affairs 

Hoover, Bethany Dalton BioMarin Pharmaceutical Sr. Manager Supply Chain Integrity 

Kerls, Daniel CVS Caremark Director of Ambulatory Operations 

Laymon, Barbara Deloitte Consulting Public Health Analyst 

Lundrigan, Karen Ann Alberta Health and Wellness Provincial Coordinator, Biologics 

Lynch, Michael John Pfizer Vaccines Product Director 

Marsh, Timothy Robert Pfizer Senior Manager 

Meek, Drew WHO Doctor 

O'Leary, Melinda Lu GlaxoSmithKline Packaging Manager 

Rivera, Wilfredo MedImmune Secondary Process Industrial Engineer 

Svaby, SueAnn NextGen Design Analyst 

Sumner, Chris Pfizer Vaccines Product Director 

Weiss, Holly M. GlaxoSmithKline Dir. Service/Solutions/Cust. Experience 

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Appendix D – Forum Working Session Groups 

Standards Group 1 User Adoption Group 2 Cost and Time Group 3 

John Roberts, GS1 Edward Zissman, MD – AAP Rebecca Fish, GSK 

Raymond Flynn, NVD Greg Anderson, Connexin Andrew Kewson, NVD 

John Adamusik, Celgene Mike Chaney, AAP Kenneth McDade, Merck 

ElysiaTusavitz, GSK Erika Jurrens, GSK Anne Simmons, GSK 

Brian Lee, Merck Craig Kemp, Merck Phil Hosbach, Sanofi 

Jennifer Paster, Sanofi Christian Lease, NVD Alan O’Connor, RTI 

Melissa Malhame, Dynavax Denise Rieker, Sanofi Ken Gerlach, CDC 

Warren Williams, CDC Erin Kennedy, CDC Deborah Esbitt, CDC 

Anita Patel , CDC Robert Squires, Medimmune Michael Snyder, Sanofi 

Facilitators and Scribes 

Rajesh Singh Joe Durbin Paul Robinson 

Brian Kiefer Nikos Papageorgiou Duncan Masland 

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Appendix E – Challenges Suggested by Forum Registrants 

Standardization User Adoption Cost and Time Commitment 

• Standardization of barcode 

information content 

Opportunities 

• Extending standards from US 

to worldwide given global use 

of vaccines 

 Consistency of provider data 

capturing and sharing 

Challenges 

 Consistency of 

implementation across 

manufacturers 

 Alignment with US and global 

serialization (i.e. GTIN) and 

technology standards 

 Master data management, 

structure and ownership 

 Understanding a timeline and 

expected rollout for universal 

adherence 

 Will there be a standardized 

information requirement that 

all companies need to adhere 

to? 

 Prepping the market for 

successful implementation in 

the face of many different 

platforms, including multiple 

EMR systems and multiple 

state registries with various 

data 

 Coordinated education 

campaign to increase HCPs 

adoption 

 Communication of the 

benefits realized 

 Enabling 2D scanning at HCP 

sites 

 Consistency of data 

capturing and sharing across 

providers 

 Existing stockpiles delay the 

adoption of the new 

technology 

 Defining success with the 

customer: managing 

customer expectations with 

a phased launch approach 

while still encouraging 

adoption 

 Production capacity loss due to 

speed reduction 

 Manufacturers’ investment in 

2D enabling equipment 

 Low utilization of newly 

purchased (non-2D enabled) 

equipment 

 Cost of provider technology 

adoption 

 Online grading and line speed 

equipment manufacturers are 

still not supporting 2D 

barcoding 

 Label real estate 

Figure 1 – Most often identified challenges and opportunities identified by forum registrants 

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Supply Chain Improvements – Supply chain improvements include gaining efficiencies, reducing 

errors, and increasing visibility to product and inventory across and between all supply chain 

partners. 

• Information Exchange – Described as increased data and information sharing and integration 

which enable more efficient and accurate transactions and patient safety information. 

• Internal Consensus – Often mentioned by manufacturers when developing strategy and
 

implementation plans to incorporate 2D barcoding on vaccine products. This involves 

communicating to internal stakeholders, identifying the associated costs and benefits and
 

prioritizing the capital expenditures towards supporting needs.
 

• Regulatory Requirements –Regulatory requirement challenges are often mentioned in the context 

of changes and complexity. Regulations may be open to interpretation and costly/difficult to 

implement when misaligned with current technology capabilities and standards. The extended 

approval timeframes of labeling also creates challenges for quick turnaround and implementation. 

In general, vaccine providers are not familiar with regulatory requirements and their impact on 

processes and patients. 

• Miscellaneous – Marketing and the enhanced use of barcoding beyond administration and 

inventory were mentioned as opportunities. 

Figure 2 depicts the balance of the opportunities and challenges submitted by Forum participants as 

described above. 

Opportunities 

Supply Chain 

Improvements 

 Increased immunization coverage and public health levels 

 Reduced provider vaccination errors 

 Increased traceability of batches 

 Improved AEFI reporting (adverse event reporting) 

 Enhanced inventory control 

Information 

Exchange 

 Integration of vaccination records into clinical information systems (EMRs/EHRs) 

 Quick, paperless data sharing 

 More efficient tracking of immunizations that can be downloaded into registries 

 Elimination of human error such as transposing digits 

 Improve tracking of vaccine exposure information for epidemiologic studies of 

vaccine safety and efficacy 

Miscellaneous 

 Marketing to pediatricians and other immunizers 

 Enabling use of cell phones for scanning barcodes 

 Enhanced customer service 

Challenges 

Internal 

Consensus 

(Manufacturers) 

 Communicate to corporate partners the need to ramp up quickly 

 Business value for manufacturers to adopt 2D codes is still unclear 

 What are the additional benefits beyond patient administration 

 Costs in terms of time and resources can be prohibitive 

 Implementing online printing equipment at all contract packagers used 

Regulatory 

Requirements 

 Technical alignment with FDA requirements is lagging 

 FDA regulations on barcoding are not enforceable at the hospital, pharmacy or 

clinician office 

 Ability of providers to abide with evolving requirements 

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Developing clear steps for filing a waiver with the FDA and creating a clear 

definition of the change category 

 Labeling approval 



Figure 2 – Additional challenges and opportunities identified by forum registrants 

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Agree 

31% 

Strongly 

Agree 

69% 

 

Appendix F – Forum Evaluation Feedback Results 

A survey was distributed to all attendees of the forum in order collect feedback on the forum and what 

could be done to enhance the education and insight gained from the event. The survey document is 

included below: 

Manufacturers 

Forum Survey 

A total of 16 surveys were completed and collected. While many of the attendees left before the forum 

ended, the feedback from the surveys received has been aggregated. 

Results Summary: Forum Content and Materials 

Survey results showed that overwhelmingly, the attendees were satisfied with the content and structure 

of the Forum with the breakout sessions universally acknowledged as one of the most useful portions of 

the event. In terms of attendees’ understanding of key concepts presented at the Forum, there is a fair 

amount of work to be done in the standards area, especially around combination vaccine packaging and 

placement of barcodes. While there is significant expectation on clear FDA guidance on packaging 

standards, overall the attendees felt that they gained a better understanding of opportunities and 

challenges around 2D Vaccine Barcoding from the Forum. 

Question1: This forum provided an effective 

opportunity to discuss the implications, 

opportunities, and challenges of implementing 2D 

barcoding technology on vaccine products. 

Agree 

19% 

Strongly 

Agree 

81% 

Question 2: The forum materials were clear, helpful 

and easy to follow. 

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Neutral 

6% 

Agree 

31% 

Strongly 

Agree 

63% 

6% 

Agree 

38% Strongly 

Agree 

56% 

Neutral 

Neutral 

6% 

Agree 

25% 

Strongly 

Agree 

69% 

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Question 3: The breakout sessions allowed for 

productive discussion and provided appropriate 

interaction. 

Question 4: The facilitators effectively 

presented workshop materials and led group 

discussions. 

Question 5: I have a better understanding of 

industry standards relevant to 2D barcoding 

technology on vaccine products. 

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Question 6: The forum clarified the FDA 

expectations for linear barcode review and 

acceptance process. 

Neutral 

19% 

Agree 

25% 

Strongly 

Agree 

56% 

Question 7: I have a better understanding of the 

standards available related to 2D barcoding 

technology on vaccine products. 

Agree 

56% 

Strongly 

Agree 

44% 

Question 8: I have gained a greater understanding 

of the opportunities and challenges of 

implementing 2D barcode technology on vaccine 

products. 

Neutral 

6% 

Agree 

25% 

Strongly 

Agree 

69% 

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Breakouts: 11 

Eleven of the 16 surveys included additional free form responses capturing the benefits attendees saw 

from the forum as well as opportunities for improvement. 

 Patient Safety: 2 

 Supply Chain Integrity: 1 

 Competitive Advantage: 2 

 Agency Alignment: 1 

 Foundation for Serialization: 1 

What are the greatest benefits? 

 User Adoption: 4 

 Contract Manufacturer: 2 

 Regulatory & Guidance: 4 

 Line Impact: 3 

 Serialization Conflict: 3 

What are the greatest challenges? 

What aspects need further investigation?  Co-packaging/placement: 6 

 Drivers for user adoption: 2 

What was the most valuable part of the 

forum? 



 Nothing: 7 

 Should have been longer: 3 

 Bring in other stakeholders (Immunizers, EMR 

Vendors): 2 

What could have been better? 

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