This presentation illustrates the several steps/activities that are needed during the process of introducing a new vaccine. The MCHIP scale-up map illustrates TA is needed to support countries throughout the process of launching a NV to ensure a smooth process. Steps are required in order to introduce a new vaccine.

1. What does it take to introduce a new vaccine
in Gavi-eligible countries?
Michel Othepa, MD, MPH
JSI Research & Training Institute, Inc.

2. Principles
 Introduction of a new vaccine:
 Is NOT a one time event
 It is a PROCESS of several activities
 This process requires:
 Time and energy
 Additional resources
 Continuous and close follow-up of planned specific tasks
 Involvement of Government, Partners and the
Community

3. African countries where JSI provided TA
on New Vaccine Introduction
• Support provided to MOH/EPI and with partners (e.g. WHO, UNICEF, USAID, etc)
• Two Regional Technical Officers (1 for West & Central Africa; 1 for East & Southern Africa)
• 5 Senior Technical Officers provided periodic backstopping from HQ

4. Inputs required for New Vaccine
Introduction:
1) Planning, partnership, and adequate resources
2) Effective commitment of Government, ICC partners, and community
3) Coordination between MoH and ICC partners and close follow-up for the
introduction process
4) Additional cold chain storage capacity to accommodate new vaccines
5) Ability to deliver increasednumber of vaccines at the vaccination site level
6) Ability to manage & dispose of increasedvaccine waste at immunization site
7) Trained and skilled health workers and community volunteers
8) Revisedtechnical guidelines, recording and reporting tools, IEC materials, etc.
9) Communication with parents to address their concerns regarding introduction of
new vaccines.
10)Surveillance system in place prior to and after NV introduction

5. National
Actions
Global
Actions
Program Implementation
Preparation
(3-6 months before launch)
Vaccine
Launch
Post-Launch
Monitoring and Evaluation
Discuss and reach
consensus to introduce
a new vaccine
Conduct nationwide
assessment of cold
chain storage space
and logistics
 assessment
Update/prepare cMYP
and costing tables.
Incorporate into national
health sector plan
Develop plan for vaccine
introduction plan
Solicit ICC endorsement
and commitment for
implementation
Prepare or revise Gavi
application, obtain
ministerial signatures,
and submit on time.
Country
submits/
re-submits
application
IRC makes
recommend-
ation to the
Gavi Board
Gavi
Secretariat
prioritizes
applications
for approval
Upgrade cold chain
and logistics
Advocate for vaccine
introduction support and
long term funding
Register the vaccine, review
vaccine supply distribution
system, upgrade as needed
Revise, print and distribute
EPI management tools
Develop/adapt learning
materials, conduct technical
training
As needed, improve waste
management system
Implement demand creation
for new vaccine
Initiate AEFI
surveillance for the new
vaccine and strengthen AEFI
reporting system
Develop communications
strategies and key messages
to address concerns of
caregivers and providers
Hold public
relations
events to
launch the
vaccine
Monitoring
and response
to any reported
adverse events
Conduct post-
introduction
evaluation (PIE)
6-12 months
following vaccine
launch
Reduced
morbidity
and
mortality
due to the
targeted
vaccine
preventable
disease
Assess magnitude of
problem: morbidity and
mortality due to target
disease for new vaccine
Scale Up Map for New VaccineIntroduction in Gavi supported countries*
Vaccinatealleligiblepeople
Assess impact on
morbidity and
mortality
Source: MCHIP 2014
Continuous
monitoring,
supervision
capacity building,
and follow up to
ensure full
integration into
the RI system
* MCHIP-assisted
activities are in boxes
outlined in red
Initiate surveillance to
establish baseline.
Select specific vaccine
product suitable for
country context.

6. Steps for New Vaccine Introduction
 Step 1: Decision making process at country level (Ministry
of Health Officials with support from ICC partners):
 Morbidity and mortality due to target disease
 Identification of product (vaccine) and its formulation
 Step 2: Application process & preparation (Technical staff
from EPI , ICC partners, and TA from external partners):
 Planning process: Prepare / update cMYP with costing tools,
develop new vaccine introduction plan, CCL assessment &
improvement plan, as needed
 Application form: Complete the Gavi application form according
to Gavi guidelines
 Update national EPI policy / technical EPI guidelines

7. Steps for New Vaccine Introduction
(continued)
 Step 3: Submission to Gavi Secretariat (Government and
ICC partners)
 Call ICC meeting and present the proposal for NV application to
MOH, MOF, heads of agencies for endorsement (signatures)
 Submit application and required supporting documentation to the
Gavi Alliance
 Gavi response to application:
– If aproved: technical , CCL, communication, etc. preparation
will be needed to introduce the new vaccine
– If not approved: clarify the conditions or re-do the application

8. Steps for New Vaccine Introduction
(continued)
 Step 4: Detailed preparations for NVI (Technical, CCL,
Communication & social mobilization and Surveillance
preparations): Working groups from technical ICC members & TA from
external partners.
 Advocacy for implementation of improved CCL plan
 Upgrade cold chain equipment, if needed, to accommodate new vaccine
 Revise vaccine supply and distribution and upgrade as needed
 Develop / adapt learning materials; conduct TOT and training of Health
Workers
 Revise, print and distribute EPI recording and reporting tools
 Strengthen AEFI reporting system & AEFI surveillance for the new vaccine
 Strengthen Communication strategies, key messages and IEC materials
 Develop check-list and activity plan for each technical working group

9. Steps for New Vaccine Introduction
(continued)
 Step 5: Launching ceremony -
important political event that needs
to be well-prepared:
 Negotiate the date and place of
launch event and help MoH to
prepare the site : posters, banners,
chairs, etc.
 Assist Ministry of Health to invite
donors, political leaders, partners and
decision makers, community leaders,
and mothers with children
 Assist with messages to be
communicated during the ceremony
(e.g. appropriate messages for the
parents on the target ages, vaccine,
disease (s) prevented, etc)
New Vaccine Introduction (Media):
PCV, Kenyan President, 2011

10. Steps for New Vaccine Introduction
(continued)
 Step 6: Post-introduction
activities and NVI roll-out to
ensure that all eligible children
are being immunized:
 Supportive supervision
 Monitoring and use of data for
action
 Follow-up to training (particularly
if done in cascade)
 Post Introduction Evaluation 6-12
months after the introduction of
the vaccine
NewVaccineIntroduction:Rotavirus,Tanzania2012

11. Examples of support provided to the
countries by JSI:
1) Provided specialized TA to the following countries: DRC, Kenya,
Rwanda, Tanzania, Zimbabwe to help with:
 Development of NUVI country proposals, including:
 cMYP and costing tables
 NUVI plan
 Cold chain assessment, etc.
 Support to satisfying the conditions of approval
2) Extensive TA provided with preparedness using scale-up map to guide
NUVI efforts in DRC, Rwanda, Tanzania, Zimbabwe, Kenya, Malawi:
 Check-lists of key activities with roles, responsibilities and timelines
 Revisionof EPI management and reporting tools and key policy documents
 Adaptation of learning materials, training of trainers, training roll-out all levels
 Development of key messages, etc.

12. Examples of support provided to the
countries by JSI (continued):
 Shared NUVI experience from other
countries to establish working
groups, e.g. on CCL, social
mobilization, M&E and training.
 Provided TA to revise the
immunization schedule in
Zimbabwe and Tanzania
 Intensified supportive supervision
visits in countries after launching
ceremony
 Participated in PIE in some
countries
Link: http://www.mchip.net/sites/default/files/N
UVI%20Monograph%20LE%20formats.pdf

13. Conclusion
 Introduction of new vaccines takes time and effort.
In some countries, the entire process (pre-
application, application, and implementation) took
more than 8 months.
 Countries need technical support for new vaccine
introduction. Technical support provided to
countries from partners helped in having a smooth
process for new vaccine introduction.

14. Thank you!
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