Report of the WHO Pandemic Vaccine Deployment Workshop

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Report of the WHO Pandemic Vaccine Deployment Workshop Lagos, Nigeria, 46 November 2019

Transcript of Report of the WHO Pandemic Vaccine Deployment Workshop

Page 1: Report of the WHO Pandemic Vaccine Deployment Workshop

Report of the

WHO Pandemic Vaccine Deployment

Workshop Lagos, Nigeria, 4−6 November 2019

Page 2: Report of the WHO Pandemic Vaccine Deployment Workshop

Report of the WHO Pandemic Vaccine Deployment Workshop, Lagos, Nigeria, 4-6 November 2019

ISBN 978-92-4-001285-1 (electronic version)

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Contents

Acronyms ............................................................................................................................................... iv

Executive summary ................................................................................................................................ v

Introduction ........................................................................................................................................... 1

1. Global mechanisms for effective deployment and vaccination operations during an influenza

pandemic ................................................................................................................................................ 2

The Pandemic Influenza Preparedness (PIP) Framework and the importance of vaccination............... 2

Lessons learned from the 2009 H1N1 pandemic vaccine deployment initiative ....................................... 2

National Deployment and Vaccination Plan guidance, checklist and game introduction ........................ 3

2. Enhancing pandemic influenza deployment and vaccination capacities in Nigeria ...................... 4

Nigeria update: pandemic preparedness and the NDVP ............................................................................ 4

Pandemic influenza risk communication ...................................................................................................... 6

Medical countermeasures (MCM) supply chain plan ................................................................................. 7

Regulatory pathways for pandemic influenza vaccine deployment: overview of the Nigerian system ... 7

3. Learning in action − the PIP Deploy exercise .................................................................................. 9

Mission 1: National Deployment and Vaccination Plan (NDVP) ............................................................... 9

Mission 2: Legal and regulatory planning .................................................................................................. 10

Mission 3: Public communication in a pandemic situation ....................................................................... 11

Mission 4: Communication, supply chain and waste management .......................................................... 11

Mission 5: Post-deployment surveillance system and management of adverse effects following

immunization ................................................................................................................................................. 12

Participants’ feedback on the PIP Deploy game ........................................................................................ 12

4. Group work and next steps ........................................................................................................... 12

Annex 1: Agenda ................................................................................................................................. 13

Annex 2: Recommended activities to facilitate development and implementation of Nigeria’s

NDVP ................................................................................................................................................... 16

Annex 3. PIP Deploy game evaluation ............................................................................................... 20

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Acronyms

AEFI

EOC

FMoH

FMoARD

IHR

MCM

NAFDAC

NCDC

Adverse Events Following Immunization

Emergency Operations Centre

Federal Ministry of Health

Federal Minister of Agriculture and Rural Development

International Health Regulations

Medical countermeasures

National Agency for Food and Drug Administration and Control

Nigeria Centre for Disease Control

NDVP National Deployment and Vaccination Plan for Pandemic Influenza

Vaccines

NEMA

NOA

National Emergency Management Agency

National Orientation Agency

NPHCDA

NSCDC

National Primary Health Care Development Agency

National Security and Civil Defence Corps

PIP

Pandemic Influenza Preparedness

RCTWG Risk Communication Technical Working Group

RI

Routine Immunization

WHO World Health Organization

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Executive summary

Pandemic influenza vaccines play a major role in mitigating the spread of an influenza pandemic and

protecting vulnerable populations. During the 2009−2010 pandemic, Nigeria received 2 880 000

doses of pandemic influenza vaccine which were donated through the WHO Deployment Initiative.

Experience during the 2009 H1N1 pandemic demonstrated the importance of planning for

deployment operations – which span the entire deployment and vaccination process from importing

of vaccines and other supplies, transporting and distributing these products throughout the supply

chain, organizing vaccination campaigns (taking into account all elements that may impact these

activities), and monitoring the safety, quality and efficacy of the medical products administered, up to

the termination of vaccination operations.

The Pandemic Vaccine Deployment Workshop held from 4 to 6 November 2019 in Lagos, Nigeria,

brought together participants from several sectors that play a key role in deployment and vaccination

operations. The aim of the workshop was to initiate the development of Nigeria’s National

Deployment and Vaccination Plan for Pandemic Influenza Vaccines (NDVP). The interactive format

of the workshop included a combination of presentations with the use of PIP Deploy.

Participants emphasized that the workshop allowed them to gain knowledge on key areas that an

NDVP should contain, to identify gaps in current response capacities, and to identify and discuss

roles and responsibilities of different national agencies during an influenza pandemic.

To capitalize on these discussions, further work is envisaged, namely: 1) to clarify coordination

approaches among the different agencies and partnering organizations in the country, so duplication

of work can be avoided; 2) to identify leading agencies on specific components of the deployment

and vaccination operations in view of further development of these operational approaches; and 3) to

develop the NDVP and address the gaps identified throughout the workshop to ensure timely and

efficient response operations.

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Introduction

This report summarizes the results and recommendations of the Pandemic Vaccine Deployment

Workshop held from 4 to 6 November 2019 in Lagos, Nigeria.

Thirty-one representatives from different national agencies and institutions,1 the WHO country office

and WHO headquarters attended the workshop. Participants included experts in immunization, risk

communications, logistics, immunization, surveillance and influenza.

The overall objective of the workshop was to support the country in drafting an updated National

Deployment and Vaccination Plan for Pandemic Influenza Vaccines (NDVP) and to discuss key

issues that should be addressed before, during and after a future influenza pandemic. Other workshop

objectives included:

• to reinforce the importance of pandemic vaccine deployment in the wider planning of

pandemic influenza preparedness;

• to stress the need to update Nigeria’s NDVP for pandemic influenza;

• to raise awareness of in-country planning in order to ensure capacities and capabilities for

effective and efficient deployment of pandemic vaccines;

• to run the PIP Deploy table-top/simulation game/exercise.

The workshop included critical presentations given by experts in the subject matter plus the

interactive game/table-top exercise – PIP Deploy. The game provided participants with an engaging

environment in which to better understand the main components of an NDVP.

Following this exercise, participants were divided into groups according to their areas of work in

order to reflect on the main aspects that should be addressed in Nigeria’s NDVP. A list of

recommended activities that should be implemented following the workshop was developed and can

be found in Annex 2 of this report.

1 Representatives from the following agencies and institutions attended the workshop: National Primary Health Care Development Agency (NPHCDA); National Agency for Food and Drug Administration and Control (NAFDAC); Nigeria Centre for Disease Control (NCDC); Nnamdi Azikiwe University Teaching Hospital, Nnewi; National Orientation Agency (NOA); Federal Ministry of Humanitarian Affairs, Disaster Management and Social Development (MHADMSD); Federal Ministry of Agriculture and Rural Development (FMoARD); Aminu Kano Teaching Hospital; National Agency for Quarantine Service (NAQS); National Security and Civil Defence Corps (NSCDC); Lagos State University Teaching Hospital (LASUTH); National Emergency Management Agency (NEMA); and WHO.

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1. Global mechanisms for effective deployment and vaccination

operations during an influenza pandemic

The opening session of the workshop stressed the importance of planning for deployment and

vaccination operations in order to enhance Nigeria’s response capacity in the event of an influenza

pandemic. It was highlighted that, when the latest pandemic influenza hit Nigeria in 2009, no

deployment plans were available, which added to the challenges and slowed down the

implementation of vaccination campaigns. Consequently, participants were encouraged to strengthen

collaboration and commit to update and test Nigeria’s NDVP.

The Pandemic Influenza Preparedness (PIP) Framework and the importance of

vaccination

This session presented the PIP Framework, which was adopted by the World Health Assembly in

2011. The framework is an innovative public health instrument that seeks to improve global

preparedness for, and the response to, the next pandemic. The framework’s key goals include

improving and strengthening the sharing of influenza viruses with pandemic potential, and increasing

the access of developing countries to pandemic vaccines and other supplies. Through PIP, some 420

million doses of pandemic vaccines, 10 million treatment courses of antivirals and 250 000

diagnostic kits will be available to countries in most need.

The presentation also highlighted the benefits of pandemic influenza vaccine in decreasing morbidity

and mortality. The 2009 influenza pandemic evaluations showed that vaccination rates were much

higher in high-income countries (16.8%) than in middle-income (8.5%) and low-income countries

(5.7%).2 This led to discussion of the benefits of having a seasonal influenza vaccination programme.

Evidence from the 2009 pandemic demonstrated that countries with seasonal influenza vaccination

programmes were more likely to access vaccines by attaining a state of readiness faster than other

countries and received their shipments earlier as a result of this.

Lessons learned from the 2009 H1N1 pandemic vaccine deployment initiative

This session presented the lessons learned from the WHO pandemic influenza vaccine deployment

processes during the 2009−2010 pandemic as well as WHO’s current efforts to ensure efficient

global deployment operations.

Lessons learned from the global deployment process included:

• Meeting the WHO Deployment Initiative requirements for pandemic H1N1 vaccine

donations, receiving vaccine deliveries and deploying them took longer than anticipated in

most countries.

• Existing immunization systems, infrastructure and education played an important role during

deployment.

2 Mihigo et al., 2012; Tizzoni et al., 2012; WHO, 2013b.

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• Negative media coverage and rumours had less impact on vaccine utilization in countries that

had high-profile government support for deployment.

• Limited influenza surveillance systems (and a lack of infrastructure for seasonal influenza

surveillance in particular) led to public uncertainty about the extent of the pandemic and made

it difficult to rally political support and commitment in some countries.

The main challenges identified at country level during the 2009 WHO pandemic vaccine deployment

process included: 1) national regulatory issues associated with unique regulatory processes for legal

importation and distribution of vaccines; 2) lack of legal agreements with donors and beneficiary

countries and the challenges associated with establishing a single framework that was acceptable to

all parties; and 3) lack of NDVPs in many affected countries.

In the WHO African Region, competing priorities such as measles and polio outbreaks delayed the

pandemic response. Vaccine deliveries occurred mostly during or after the peak of the 2009 H1N1

pandemic, with the utilization of donated vaccines varying widely between countries. Nigeria

received 2 880 000 doses on 24 September 2010.

To facilitate deployment operations at national level, countries were advised to develop, revise and

test NDVPs for pandemic influenza vaccines. This is mandatory for countries interested in accessing

pandemic influenza vaccines donated by WHO. Looking back at the 2009−2010 experience, the

development of NDVPs required significant assistance and financial resources, leading to delays in

the delivery process.

To increase deployment preparedness and learning from the challenges observed in the 2009

pandemic, it was recommended to: 1) tailor NDVPs to serve context-specific needs; 2) build and

maintain global and national operational readiness; 3) ensure effective global and country

communication channels; 4) sustain capacity to execute legal agreements; 5) ensure appropriate

regulatory pathways suitable for pandemic response; and 6) map and continuously update cold-chain

capacity at both global and country levels.

National Deployment and Vaccination Plan guidance, checklist and game introduction

In this session participants were introduced to two documents designed to support Member States to

develop/update their NDVPs, namely: 1) Guidance on development and implementation of a

National Deployment and Vaccination Plan for Pandemic Influenza Vaccines and (2) Checklist for

development and implementation of a National Deployment and Vaccination Plan for Pandemic

Influenza Vaccines.

According to WHO recommendations, an NDVP should contain 10 main chapters with consideration

of: 1) vaccination strategies; 2) management and organization; 3) legal and regulatory planning for

vaccine deployment; 4) communication and information management; 5) human resources and

security; 6) public communication; 7) supply chain management; 8) waste management;(9) post-

deployment surveillance and management of adverse events following immunization (AEFI); and 10)

termination of deployment and vaccination operations.

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Participants were invited to reflect on the 10 chapters of Nigeria’s NDVP during the exercise – PIP

Deploy.

2. Enhancing pandemic influenza deployment and vaccination

capacities in Nigeria

Nigeria update: pandemic preparedness and the NDVP

This presentation provided an overview of Nigeria’s investigation and response efforts in both animal

and human populations and the environment.

In the area of surveillance, Nigeria is enhancing its national influenza sentinel surveillance by: 1)

conducting influenza surveillance at four sentinel sites; 2) investigating and responding to all

outbreaks related to influenza (including avian influenza outbreaks) in collaboration with the Federal

Ministry of Agriculture and Rural Development (FMoARD); 3) conducting regular coordination and

collaboration meetings under the One Health concept with FMoARD; and 4) coordinating the

influenza technical working group at national level.

With regard to pandemic influenza preparedness, Nigeria has initiated the revision of its National

Pandemic Influenza Preparedness Plan which was developed in 2013. It is also working on the

implementation of the Pandemic Influenza Severity Assessment (PISA)3 and planning a simulation

exercise to test the updated NDVP when it becomes available.

It was highlighted that the country does not have a seasonal influenza immunization programme.

Discussion on this session highlighted the need for stronger synergies among government agencies

involved in outbreak/pandemic responses. Additionally, participants stressed that the country’s

human resources capacity should be better assessed, and that the Nigeria Centre for Disease Control

(NCDC) is currently working on a database of emergency responders.

3 See: https://www.who.int/influenza/surveillance_monitoring/pisa/en/, accessed 4 January 2020.

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Leveraging routine immunization structures to support immunization campaigns in

Nigeria

This session presented the routine immunization structure in Nigeria, encompassing coordination

mechanisms at national, state, local government and ward levels.

The following challenges and corresponding potential solutions to address them were highlighted:

Area Key challenges Current efforts to address

identified challenges

Security

Volatile and fluid nature of the

security challenge across the

country

Innovative strategies, “hit and

run”, “Reaching Every

Settlement“ and Reaching

Inaccessible Children”

Micro-planning

Obtaining accurate population

data (denominators) for

immunization

- Household-based

enumeration

- Geographic Information

System mapping

- Use of house-to-house

mobilization and line listing

teams

Cold Chain/logistics

Achieving timely last mile

vaccine distribution

- Implementation of Cold

Chain equipment

optimization platform

- Deployment of faster Cold

Chain equipment

- Construction of three hubs

and system redesign

Human resources

Human resource gaps for large

campaigns requiring skilled

health workforce

- Campaign phasing and

staggering of intra-country,

state and local government

authorities

- Ad hoc recruitment of

qualified volunteers (retirees,

etc.)

Funding at operational level Funding gaps, especially for

unexpected outbreaks - Advocacy for early budgeting

and release of funds

Vaccine hesitancy

Vaccine hesitancy in some

localities

- Revised communication plan

to address hesitancy

- Community engagement

strategy for routine

immunization extended

during campaigns

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Additionally, the presentation stressed some of the lessons learned from previous immunization

campaigns in the country. These included:

• With a fluid security situation, especially in the north-east of Nigeria, adequate contingency

plans with innovative approaches are required to reach target cohorts.

• Although progress has been made, determining an accurate denominator still remains a

challenge in a number of locations.

• Cold Chain equipment and capacity assessment is important prior to deployment. Use of

vaccine accountability officers has been a game changer, improving vaccine security and

accountability.

• Where disease outbreaks transcend country borders, cross-border collaboration is an essential

component of responses to outbreaks.

• The new Community Engagement Strategy instituted by the National Emergency Routine

Immunization Coordination Centre has been useful in house-to-house mobilization for

immunization campaigns.

• Financial and political commitment are key to a successful immunization campaign.

To conclude, the presenter emphasized that Nigeria has the capacity to carry out immunization

campaigns using existing structures. However, the changing landscape of the country should be

considered, especially due to the security situation in some regions. In this regard, detailed

reassessments are essential for closing gaps when rapid deployment is required.

Pandemic influenza risk communication

This presentation stressed the importance of risk communication activities before, during and after a

pandemic. It emphasized how building trust among stakeholders and communities can support the

acceptance of public health interventions, including vaccination campaigns.

Participants discussed the main challenges concerning communication of the introduction of a new

pandemic vaccine and highlighted important aspects which should be considered, including: 1) the

high speed of information and multiple communication channels; 2) the analysis of risk perception of

targeted and non-targeted groups and their attitudes towards vaccination; and 3) the importance of

health-care workers as both recipients and advocates of the pandemic influenza vaccine.

A successful risk communication strategy should consider a mix of communication and engagement

strategies, such as media and social media communications, mass awareness campaigns, health

promotion, social mobilization, stakeholder engagement and community engagement. The strategy

should consider enhancing five key areas, as recommended by the WHO Joint External Evaluation

tool,4 namely: 1) risk communication systems for unusual/unexpected events and emergencies; 2)

internal and partner coordination; 3) public communication for emergencies; 4) communication

engagement with affected communities; and 5) addressing perceptions, risky behaviours and

misinformation.

4 WHO Joint External Evaluation tool, p. 88. See: https://extranet.who.int/sph/joint-external-evaluation-tool-2nd-edition, accessed 4

January 2020.

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Participants discussed some of the lessons learned from the Ebola outbreak which demonstrated that

greater understanding of beliefs and practices and engagement with the community is needed. They

highlighted the importance of local governments in this regard and emphasized that interventions to

tackle stigmatization should be strengthened.

It was highlighted that risk communication activities in Nigeria are led by the Risk Communication

Technical Working Group (RCTWG) located in the NCDC. The working group consists of

communication experts from different ministries, and its terms of reference are tailored to addressing

risk communication needs regarding infectious disease in the country. The RCTWG is guided by a

set of guidelines, protocols and standard operating procedures that define activities at national and

subnational levels.

Risk communication messages are developed at national level and then adapted and translated at

subnational level. At the subnational level, a social mobilization committee performs a similar role to

that of the RCTWG, leading the risk communication and community engagement efforts.

Medical countermeasures (MCM) supply chain plan

This session presented Nigeria’s efforts to advance its medical countermeasures (MCM) supply chain

plan which is being developed by the NCDC in collaboration with national partners. The objectives

of the MCM plan are to:

• provide a framework for managing MCM supply chain operations in response to public health

emergencies in Nigeria;

• describe supply chain operational procedures such as requesting, procurement, receipt,

stockpiling and distribution of MCM assets from the NCDC, MDAs, state and local

governments and other partners in preparation for, and response to, infectious disease

outbreaks and emergencies of public health importance;

• provide a coordinated supply chain operations strategy between national, state and local

government incident management authorities and partners during public health emergencies.

The presentation highlighted the importance of inter-agency collaboration and coordination for

effective deployment of MCMs, including vaccines.

Discussion during this session emphasized the need to assess the number of functional incinerators

available in the country, as some have become a burden to states which are not able to sustain their

high maintenance costs. Other solutions, such as outsourcing this service to external

institutions/companies, may be considered.

Additionally, participants mentioned that an assessment of Cold Chain storage should be performed

to identify gaps in the current infrastructure.

Regulatory pathways for pandemic influenza vaccine deployment: overview of the

Nigerian system

This presentation provided an overview of the regulatory pathways available in the country to

support the approval for use and importation of pandemic influenza vaccines. Participants learned

about the National Agency for Food and Drug Administration and Control (NAFDAC) role in

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regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale

and use of drugs, including vaccines.

It was highlighted that the deployment of pandemic influenza vaccines in Nigeria will require the

directorates of NAFDAC to provide input to a number of processes, namely:

Drug Evaluation and Research – Ensuring clinical trial oversight, Good Manufacturing Practice

inspection of manufacturing facilities producing vaccines that are not prequalified by WHO, and

Cold Chain monitoring of storage facilities at federal, state and local levels.

Registration and Regulatory Affairs – Granting licensure for medicinal products. Pandemic

influenza vaccines may not require licensure but authorizations/waivers can be provided to facilitate

clearance processes at ports of entry.

Vaccine Laboratory – Testing and conducting vaccine lot release.

Ports Inspection Directorate − Import document verification, inspection, sampling and other

clearance procedures while coordinating with other government agencies, including the customs

offices located at the ports of entry. The Ports Inspection Directorate also monitors transportation,

including the type of vehicle, in order to ensure that the Cold Chain is not broken during local transit.

Pharmacovigilance/Postmarketing Surveillance – Postmarketing surveillance and monitoring of

AEFI for some vaccines – especially vaccines distributed through the National Immunization

Programme – which is done in collaboration with the National Primary Health Care Development

Agency (NPHCDA).

Investigation and Enforcement − Coordination of the disposal of vaccines/empty vials, usually by

incineration and burial.

During a pandemic, the NCDC will be responsible for surveillance, data collection and reporting and

will act as the International Health Regulations (IHR) focal point. Moreover, it will be the authority

responsible for declaring the event in the country, triggering partner coordination at the Emergency

Operations Centre (EOC). Based on the outcome of the EOC meeting on the need to import

pandemic influenza vaccine, the NPHCDA is the responsible agency for raising a request to the

NAFDAC which will authorize/waive the regulatory review. The Federal Ministry of Health (FMoH)

will also be notified of this request.

For emergency use of vaccines, it is expected that the NAFDAC will waive the need for a review and

will accept the WHO prequalification certificate of the manufacturer. WHO should provide a

certificate of donation, which allows the NAFDAC to inform its officers at the ports of entry to fast-

track the clearance process. The Import Duty Exception Certificate is also submitted to the Nigeria

Customs Service to facilitate clearance.

Currently, the NAFDAC is developing regulations on new licensing regulatory pathways for

emergency situations. The agency also implements reliance approaches and recognizes approvals

granted by stringent regulatory authorities.

Vaccine labelling, patient leaflets and other documentation are required in English, in accordance

with NAFDAC regulations. Documents that need to be enclosed in the shipment of vaccines are:

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− certificate of analysis

− certificate of lot release

− certificate of WHO prequalification

− packing list

− shipment temperature

− certificate of origin

− certificate of donation/proforma invoice and other certification as may be required.

3. Learning in action − the PIP Deploy exercise

The second part of the workshop was dedicated to the PIP Deploy simulation exercise which

encouraged participants to reflect on key processes and activities that should be in place in Nigeria

for effective and timely deployment of pandemic influenza vaccines.

The learning objectives of PIP Deploy include:

1. To provoke discussion on key gaps in preparation for, or updating of, national pandemic

influenza deployment plans.

2. To enable conversations on best practices on in-country governance and operations for pandemic

influenza vaccine deployment.

3. To better understand country training needs and barriers to future participation in simulation

exercises.

The game consists of five missions which are presented with fictitious scenarios of pandemic vaccine

deployment which could also happen in a real-life setting. Throughout the missions – which involve

brainstorming, presentations and board-game sessions – players are invited to discuss and reflect

about the 10 NDVP chapters. Participants were divided into four teams.

Mission 1: National Deployment and Vaccination Plan (NDVP)

On this mission, participants were invited to reflect on the NDVP structure and chapters, according to

the WHO NDVP template.5 Additionally, they were asked to think about the management,

organization, human resources and vaccination strategies that should be considered in Nigeria in the

event of a pandemic influenza.

Key discussion points

• In addition to the 10 chapters recommended in the WHO guidance, it was recommended that

Nigeria should include consideration of security as a separate chapter, covering important

issues regarding how to reach conflict zones, especially in the north-east part of the country.

5 Guidance on development and implementation of a National Deployment and Vaccination Plan for Pandemic Influenza Vaccines

Geneva: World Health Organization, 2012:67

(https://apps.who.int/iris/bitstream/handle/10665/75246/9789241503990_eng.pdf?sequence=1&isAllowed=y, accessed 4 January

2020).

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• Regarding vaccination strategies, participants stated that the ultimate responsibility for

determining the priority vaccination groups rests with the FMoH. Additionally, the NPHCDA

has operational responsibility and works with various partners to establish a national technical

working group on immunization to decide which groups should be prioritized in the

vaccination campaign, following recommendations provided by WHO Strategic Group of

Experts (SAGE) on Immunization.6 There was discussion on whether the composition of the

such a technical working group on immunization should be revised to better support a

response to pandemic influenza.

• Participants stressed that a comprehensive workforce strategy, ensuring continuous training of

health-care workers as well as incentivized career paths, should be developed. A package of

incentives should be established for health-care workers involved in a pandemic influenza

response. According to participants, this proposed package should consider providing

responders with: 1) 70% of the per diem in advance; 2) a communication allowance to enable

communication with their families during the response; and 3) physical, medical and

psychosocial support.

• With regard to management and organization, it was highlighted that the NCDC’s EOC will

oversee coordination of the response. The Director General of the NCDC will appoint the

Incident Manager who will then notify the NPHCDA, WHO, UNICEF, FMoH, FMoARD and

other relevant stakeholders about the event and associated needs for coordination. All key

stakeholders are expected to report in the EOC within 24 hours or not more than 48 hours of

notification. The National Influenza Technical Working Group will also be activated and will

be subsumed into the structure of the EOC.

• Participants highlighted the importance of involving security personnel in the deployment

process.

Mission 2: Legal and regulatory planning

The objective of Mission 2 was to encourage participants to discuss existing international and

national legal and regulatory requirements and procedures for importing and receiving pandemic

influenza vaccines and other supplies.

Key discussion points

• Participants mentioned that the donation agreement between WHO and the country should

include not only vaccines but also the same number of syringes, as well as safety boxes,

because Nigeria may not have the capacity to cover the cost of these products without

external support. Participants recognized the importance of well-defined procedures to

expedite the importation of vaccines and other supplies during an influenza pandemic.

• Legal and regulatory aspects were recognized as a main barrier to a successful deployment

operation.

6 The Strategic Advisory Group of Experts (SAGE) on Immunization was established by the Director-General of WHO in 1999 to

provide guidance on the work of WHO. See: https://www.who.int/immunization/policy/sage/en/, accessed 4 January 2020.

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• National agencies involved in importation of pandemic supplies and other regulatory work

that accompanies the deployment process should have well defined roles and responsibilities.

Mission 3: Public communication in a pandemic situation

For Mission 3, participants were asked to reflect on risk communications systems and activities in

order to address communication challenges during an influenza pandemic.

Key discussion points

• Participants noted that special consideration should be given at the subnational level to

engagement with different community leaders who should be involved in the response

through the existing epidemic preparedness committee.

• Throughout the pandemic, a preliminary and dynamic risk assessment should be performed,

including a risk perception analysis. If there are rumours or misconceptions, the source will

be identified and then a community dialogue can be initiated to understand the perceptions

and to engage in educational activities on the importance and safety of the vaccine.

• Cultural and religious beliefs can be barriers to seeking medical treatments. In addition to

community leaders, it is important also to consider social or community-level mobilizers.

Mission 4: Communication, supply chain and waste management

The objective of Mission 4 was to encourage participants to identify the supply chain management

processes for vaccine deployment within 7 days, to discuss steps to ensure safe disposal of hazardous

medical waste, and to identify the communication systems and mechanisms for ensuring efficient

operations.

Key discussion points

• Participants emphasized that Nigeria needs to consider security issues when developing its

NDVP so that vaccines can be delivered to populations in hard-to-reach areas. Associated

challenges to this operation should be foreseen and addressed.

• Participants suggested that the country should conduct an estimate of the volume of waste that

is likely to be generated during a pandemic. Additionally, an assessment of the availability of

well-functioning incinerators across the country was recommended. Public−private

partnerships should be leveraged for waste management, considering that several incinerators

have become a burden to some of the states in the country due to their high maintenance

costs.

• A Cold Chain storage assessment should be performed to identify gaps in the current

infrastructure. Plans should be made to identify the shortest transportation routes and the

conditions of the transportation and storage.

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Mission 5: Post-deployment surveillance system and management of adverse effects

following immunization

For Mission 5, participants were asked to discuss the post-deployment surveillance mechanisms to

ensure the monitoring of the safety of the pandemic vaccine and the detection of AEFI.

Key discussion points

• Two agencies − NPHCA and NAFDAC − are currently responsible for the surveillance of

AEFI in Nigeria. Participants suggested the need for a better understanding of their

interactions and the differences in their work.

• A reporting format should be developed in order to capture termination activities. Post-

campaign evaluation should be done through after-action reviews or workshops and should

involve partners and stakeholders who were part of the vaccination campaign.

• Participants mentioned the need to establish baseline data for AEFI and adverse events of

special interest in the country.

• Participants highlighted the need to advance the active surveillance system in the country.

Participants’ feedback on the PIP Deploy game

Participants highlighted that the game combined with the presentations given during the workshop

provided an interactive and engaging method to brainstorm and reflect on gaps that should be

addressed in the country. It was mentioned that the game contributed to creating a stress-free

environment in which to discuss critical elements of Nigeria’s deployment and vaccination

operations.

Feedback from the evaluation forms included:

“This was a great and intensive exercise with a lot of brainstorming.”

“The game allowed us to do a lot of work in a stressless environment.”

“The discussions during the game made us realize that stronger coordination is needed across the

different agencies involved in pandemic influenza deployment and vaccination operations.”

Participants stressed the usefulness of using games as a learning method for adults and suggested

adapting PIP Deploy’s approach and method to other workshops and training on other global health

threats such as Ebola and Lassa fever.

4. Group work and next steps

Following the PIP Deploy exercise, participants were divided according to their technical areas of

work. They were asked to reflect on the key recommendations and activities that should be

implemented according to the 10 different components of an NDVP. This list of recommendations

and activities can be found in Annex 2 of this report.

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Annex 1: Agenda

WORLD HEALTH ORGANIZATION NIGERIA COUNTRY OFFICE

WORKSHOP ON NATIONAL PANDEMIC INFLUENZA VACCINE DEPLOYMENT AND

VACCINATION PLANNING TO STRENGTHEN PANDEMIC PREPAREDNESS

Lagos, Nigeria

4-6 November 2019

AGENDA

DAY ONE – 4 November 2019

09:00 – 09:30 Registration

09:30 – 09:45 Welcome and opening remarks

WCO and NCDC

09:45-10:15 PIP Framework and IPPP activities in the AFRO region

WCO

10:15-10:30 Why planning for pandemic influenza vaccine deployment now? Lessons learned

from the 2009 H1N1 pandemic vaccine deployment initiative and the importance

of planning for deployment in the interpandemic phase

WHO HQ

10:30-10:45 Group photo and Coffee break

10:45 – 11:00 National Deployment and Vaccination Plan guidance, checklist and game

introduction

WHO HQ

11:00 – 11:30 Nigeria update: recent outbreaks and country’s level of preparedness, status of

pandemic preparedness planning, including current vaccine deployment plan

NCDC

11:30-12:15 Pandemic Influenza Risk Communication

WHO

12:15-13-15 Lunch

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13:15– 13:30 Immunization structures and approaches to emergency immunization campaigns

in Nigeria: “Routine immunization programme – challenges and lessons learnt”

NPHCDA

13:30 – 13:45 Regulatory pathways and capacity building for pandemic vaccine deployment

NAFDAC

13:45- 14:00 Active and passive surveillance

NPHCDA and WCO

14:00-14:30 Coffee break

14:30-16:00 PIP Deploy game

Mission 1: National Deployment and Vaccination Plan

• Video

• Challenge M1

o Brainstorming

o Team presentation

• Discussion

• Board game

DAY TWO – 5 November 2019

9:00 – 09:15 Recap of Day 1 and overview of Day 2

09:15-10:30 PIP Deploy game

Mission 2: Legal and regulatory planning

• Video

• Challenge M2

o Brainstorming

o Team presentation

• Discussion

• Board game

10:30-11:00 Coffee break

11:00-12:00 PIP Deploy game

Mission 3: Public communication

• Video

• Challenge M3

o Brainstorming

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o Team presentation

• Discussion

• Board game

12:00-13:00 Lunch

13:00-14:00 PIP Deploy game -

Mission 4: Supply chain and waste management

• Video

• Challenge M4

o Brainstorming

o Team presentation

• Discussion

• Board game

14:00-15:00 PIP Deploy game

Mission 5: Post-deployment surveillance system and management

• Video

• Challenge M5

o Brainstorming

o Team presentation

• Discussion

• Board game

15:00-15:30 Coffee break

15:30-16:30 Hotwash

16:30-17:00 Stakeholder mapping for NDVP development and implementation

DAY THREE – 6 November 2019

9:00 - 09:05 Recap of day 2 and day 3 overview

9:05 - 10:00 Outlining Nigeria’s NDVP: Populating NVDP chapters and defining next steps

10:00-10:30 Coffee

10:30-12:00 Group presentations and next steps

12:00-12:30 Summary and conclusions

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12:30-13:30 Lunch

Annex 2: Recommended activities to facilitate development and

implementation of Nigeria’s NDVP NDVP chapter Recommendation Suggested activities Estimated

time

frame

Lead Potential

partners

Vaccination

strategy

Constitute a technical

advisory or strategy group

to coordinate and plan for

the processes of

vaccination

Invite the relevant

stakeholders from various

agencies/partners across

various areas of expertise

December

2019

FMoH WHO,

UNICEF,

US CDC etc.

Target population:

Prioritize first respondent

to human or animal cases

of outbreaks, elderly,

under-5s, health workers,

security personnel,

persons with comorbidity,

close contacts of cases,

pregnant women and any

other group that may

appear to be at risk within

the outbreak period

Map the different registries or

sources of data such as

demographics from National

Population Commission,

federal and states MDAs,

which may enable calculating

the denominator for various

risk groups

February

2020

FMoH (PRS,

Responsible

officer)

WHO,

UNICEF,

US CDC etc.

How each target group

will be vaccinated: Fixed

and temporary/mobile

posts should be used to

vaccinate each target

group. For security

compromised areas, the

innovative vaccination

strategies existing should

be used to deliver the

vaccines

Detail microplanning to be

done at all levels, utilizing

data from the nonpolio SIAs

and vaccination coordinating

structures

March

2020

NPHCDA

(Director

Disease

Control)

WHO,

UNICEF,

US CDC etc.

Table listing target: Results of MP March

2020

NPHCDA

(Director

Disease

Control)

WHO,

UNICEF,

US CDC etc.

Cost of plans: Results of MP March

2020

NPHCDA

(Director

Disease

Control)

WHO,

UNICEF,

US CDC etc.

Management

and

organization

Development of an

organigram and table with

the roles and

responsibilities of

different actors involved

in the deployment and

vaccination response

February

2020

NCDC National TWG

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Legal and

regulatory

planning

Review, update,

adapt/finalize suitable

regulatory pathways for

approval of medicinal

products such as pandemic

influenza vaccines during

emergency (consider

implementation of WHO’s

2017 Guidelines on

regulatory preparedness

for provision of marketing

authorization of human

pandemic influenza

vaccines in non-vaccine-

producing countries)7

1. Relevant stakeholders’

workshop for the review of

regulatory pathways

2. Modification of existing

laws and regulations

3. Evaluation of the

deployment plan

4. Budgeting

1. Two

years

2. Five

years

3. Two

years

4. One

year

1. NAFDAC

2. NAFDAC

3. NAFDAC

4. NAFDAC

1. NCDC,

NPHCDA,

FMoARD,

MoJ,

Nigeria

Customs,

WHO

5.

Communication

and information

Finalize the linking of

logistics with

epidemiological data to

identify which vaccine

vial has been administered

to which person.

June 2020 NPHCDA NCDC,

NEMA,

NERIC

Human

resources and

training

Map the current existing

capacities in the system

when it comes to human

resources.

Develop a training plan/

curriculum based on

different roles

Develop a plan for

reaching security-

compromised areas.

Develop a deployment

plan for the security

officers to security-

compromised areas

Provide training/Briefing

on Basic security tips for

Health workers.

7 Guidelines on regulatory preparedness for provision of marketing authorization of human pandemic influenza vaccines in non-

vaccine-producing countries. In: WHO Expert Committee on Biological Standardization, sixty-seventh report. Geneva: World Health

Organization; 2017: Annex 7 (WHO Technical Report Series, No. 1004;

http://apps.who.int/medicinedocs/documents/s23326en/s23326en.pdf, accessed 4 January 2020).

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Risk

communication

and community

engagement

RCTWG to develop and

adapt all infectious disease

risk communication plans

for pandemic influenza

risk communication

Train RCTWG members

and other communicators

at subnational level on

pandemic influenza

communication.

Conduct workshop to adapt

all infectious disease risk

communication plans and

develop key messages

Carry out pre-test of IEC

materials.

Conduct training at national

and subnational levels on

pandemic influenza response

communication and

vaccination

January

2020

February

2020

April to

June 2020

NCDC NOA,

FMI,

FME,

NYSC,

FMHADMSD,

NEMA,

WHO,

UNICEF,

NSCDC,

AFENET,

FMENV,

FMoH,

FMoARD,

NPHCDA,

US CDC

Supply chain

management

Develop a comprehensive

supply chain and logistics

costed plan

Update the Cold Chain

inventory and determine

gaps. Develop detailed plans

to address the gaps (This

should be part of the MP and

be presented in a table

format)

March

2020

NPHCDA

(Director

Logistics)

WHO,

UNICEF,

CHAI

Develop a detailed vaccine

distribution plan based on the

target population

April 2020 NPHCDA

(Director

Logistics)

WHO,

UNICEF,

CHAI

Identify means of vaccine and

supply transportation and

map routes at all levels for

effective delivery within 7

days

April 2020 NPHCDA

(Director

Logistics)

WHO,

UNICEF,

CHAI

Conduct supply chain human

resource mapping and build

capacities for surge

deployment and management

April 2020 NPHCDA

(Director

Logistics)

WHO,

UNICEF,

CHAI

Review the exiting data tools,

ledgers and logistics

management information

system for adaptability

April 2020 NPHCDA

(Director

Logistics)

WHO,

UNICEF,

CHAI

Develop a comprehensive

budget based on the outlined

activities on the detailed

plans

May 2020 NPHCDA

(Director

Logistics)

WHO,

UNICEF,

CHAI

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Managing

waste

1. Assessing existing

capabilities

2. Deciding on methods of

waste collection, transport,

treatment and disposal

3. Establish a risk

management strategy

1. List national and state

regulations for proper

collection and disposal of

medical waste

2. Identify all existing waste

disposal facilities and routes

for collecting and

transporting

3. Estimate the daily amount

of waste each immunization

site will generate

4. Devise simple indicators to

monitor the quality of waste

management standards and

practices

5. Budgeting

Post-deployment

surveillance and

management of

AEFI

Clarify different areas of

work of NAFAC and

NPHCDA around AEFI

Making provisions to

ensure active surveillance

in the event of a pandemic

Termination of

the deployment

and vaccination

operations

Develop an M&E

framework for vaccine

deployment

Develop a reporting

format for the campaign

Track milestones and

changes

Establish AEFI

surveillance

Conduct post-vaccination

review

Conduct workshop to develop

reporting format for the

campaign

Carry out inventory and

documentation of resources

utilized

Document, publish and

disseminate

Conduct monitoring of

activities and results

Conduct AEFI surveillance

Post-event NPHCDA WHO

FMoARD

FMENV

NOA

NCDC

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Annex 3. PIP Deploy game evaluation

Total of 20 responders.

(Numbers in red indicate the number of responses in each category).

Please express your opinions

The game play met my individual objectives and was relevant to my job:

Yes: 15 No: 0 Missing response: 4 Somehow: 1

The duration of the exercise was: (please circle your answer): correct: 18 too short: 1 too long: Missing

response: 1

Rate from 1 to 4: 1 indicating strong disagreement with the statement and 4 strong agreement

Statement Do not Strongly

agree agree

The game play was well organized and structured 1 2 3: 7 4: 13

The instructions were clear and comprehensive 1 2 3: 7 4: 13

The exercise scenario was adequately designed for its use 1 2 3: 12 4: 7

Participants were encouraged to play an active role in the

game 1 2: 1 3: 5 4: 14

The videos and briefings helped me understand and become

engaged in the scenario 1 2 3: 6 4: 14

The game documents (injects, scenarios, cards) are adequately

designed for their use 1 2 3: 9 4: 10

Handouts were relevant 1 2 3: 7 4: 13

The exercise helped me to identify some of my strengths as

well as some of the gaps in my understanding of response

systems, plans and procedures

1 2 3: 10 4: 10

The level and mix of disciplines and participants included the

right people for this game play 1 2 3: 9 4: 12

The exercise improved my understanding of my role and

function during an emergency response 1 2 3: 6 4: 14

At the end of the exercise, I learned one or more things which

will allow me to increase preparedness and readiness for

deployment of pandemic influenza vaccine in my country

1 2 3: 5 4: 15

I would recommend playing this game to my colleagues 1 2 3: 4 4: 17

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