Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY
JAN 12 2011

ADMINISTRATIVE ORDER
No.2828=q D005

SUBJECT: National Strategic Policy Framework for COVID-19 Vaccine

Deployment and Immunization

I. RATIONALE

On 30 January 2020, the World Health Organization (WHO) declared Coronavirus Disease
2019 (COVID-19), a disease caused by a novel Severe Acute Respiratory Syndrome - Coronavirus
2 (SARS-CoV?2), as a Public Health Emergency of International Concern (PHEIC).

The Philippines since January 2020, has been responding to the COVID-19 pandemic and
has implemented numerous interventions in response to the pandemic with varying levels of
success.
These interventions are anchored on the National Action Plan Against COVID-19
utilizing the
Prevent-Detect-Isolate/Quarantine-Treat-Recovery/Reintegration (PDITR) strategy. Several months
in its implementation, the Philippines
is
strategically exploring other interventions that will allow
the country to hasten socio-economic recovery and transition to near normal. With
this, countries
including the Philippines, are racing to find a safe and effective vaccine.

Further, the Philippine government has provided a legislative guidance on the

procurement
of COVID-19 vaccines as mandated under Republic Act No. 11494 otherwise known as the
“Bayanihan to Recover as One Act”, Section 12,
Procurement of COVID-19 Drugs and Vaccine. - Notwithstanding
any law to the contrary,
the requirement of Phase IV trials for COVID-19 medication and vaccine
stipulated in the
Universal Health Care Law is hereby waived to expedite the
procurement of said medication
and vaccine; Provided, That these are recommended and approved
by the WHO and/or other
internationally recognized health agencies: Provided, Surther, That the minimum standards
for the distribution of the said medication and vaccine shall be determined
by the Food and
Drug Administration (FDA) and Health Technolo gy Assessment Council (HTAC); Provided
furthermore, That nothing in this Act shall prohibit private entities from conducted research,
developing, manufacturing, importing, distributing or selling COVID-19 vaccine sourced
from registered pharmaceutical companies, subject to the provisions of
this Act and existing
laws, rules and regulations; Provided, finally, That this section shall remain in effect three
(3) months after December 18, 2020.

Vaccines have saved millions of lives in the past and have been used to halt
previous
pandemics (e.g. HINI in 2009). With the COVID-19 pandemic, the national
government is
exploring all means to access COVID-19 vaccines and prepare the country for the implementation
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Department of Health
 it
In light of the absence of definitive treatment for COVID-19, is expected that the morbidity
and mortality associated with COVID-19 will continue to increase, hence the Philippine Government
shall utilize COVID-19 vaccines to complement its existing measures to address the COVID-19
pandemic.

II. OBJECTIVES

General Objective:

This Administrative Order shall provide strategic policy guidance and direction on the selection,
access, deployment of the COVID-19 vaccine and the COVID-19 immunization program.

Specific Objectives:

A. To provide guidance on vaccine delivery strategies, vaccine acceptance, human resource

management and training, supply chain, and management of health care waste, safety and
surveillance, and immunization monitoring systems
B. To guide the implementation and provision of a free, safe, and
effective, high-quality
vaccine/s against SARS-CoV2, prioritizing the most-at-risk and most-vulnerable populations
C. To ensure implementation of risk communication, health education and
community
engagement activities utilizing diverse platforms, and the conduct of strategies and
interventions addressing vaccine hesitancy

III. SCOPE AND COVERAGE

This Administrative Order shall provide guidance and apply to the

Inter-agency Task Force
in the Management of Emerging Diseases (IATF) and their regional
counterparts, National Task
Force Against COVID-19 (NTF) and their regional and local
counterparts, National Government
Agencies and their regional and local counterparts, Centers for Health
Development, Local
Government Units, academe, implementing sectors and agencies, immunization
program managers,
service providers, immunization partners and the private sector, others.
among

IV. DEFINITION OF TERMS

A. Active safety surveillance - is an active system for the detection of adverse events. This is
achieved by active follow-up after vaccination. Events can be detected
by asking patients
directly or by screening patient records. It is best done prospectively.

Adverse Events Following Immunization (AEFI) - any untoward medical occurrence

B.
which follows immunization and which does not necessarily have a causal
relationship with
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 Adverse Events of Special Interest (AESI) - a pre-identified and predetermined medically-
significant event that has the potential to be causally associated with a vaccine product that
needs to be carefully monitored and confirmed by further specific studies.

Causality Assessment - a systematic review of data about the AEFI case(s) to determine
the likelihood of a causal association between the vent and the vaccine(s) received.

Cold Chain - is the system used for keeping and distributing vaccines in good condition.
The cold chain consists of a series of storage and transport links, all designed to keep vaccines
within an acceptable temperature range until they reach the user.

Immunity - is the ability of the human body

to
tolerate the presence of material indigenous
to the “body” (self) and to eliminate “foreign” (non-self) material.

Immunization - the process whereby a person is made immune or resistant to an infectious

disease, typically by the administration of a vaccine. Vaccines stimulate the body’s own
immune system to protect the person against subsequent infection or disease

Immunization Safety -the public health practices and policies dealing with the various
aspects of the correct administration of vaccines, focusing on minimizing the risk of
transmission of disease with vaccination and maximizing the effectiveness of the vaccine.
The term encompasses the spectrum of events from
proper manufacture to correct
administration.

Injection safety - is the safe handling

of all
injection equipment, routine monitoring of the
availability and use of safe injection equipment, and correct disposal of contaminated
infection equipment.

Profiling - the act or process of extrapolating information from a person based on known
past and present medical history, family history and social and employment history.
Social Preparation - is a series of activities designed to prepare communities and identified
population groups for a particular national program and encourage them to actively
participate and prepare them for their societal, community and personal responsibilities in
the immunization program.

Vaccination - is the administration of a vaccine to help the immune system develop

protection from a disease.

V. GUIDING PRINCIPLES

A. The COVID-19 vaccines shall be a main prevention

commodity, and shall be made available
to all members of the society as public good, without prejudice to practice of

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measures.
CERTIFIED
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following princ ples:
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 1. National Ownership: the national government shall ensure primary ownership and
responsibility for establishing good governance and provision of quality and effective
immunization services for all.
2. Shared Responsibility and Partnership: COVID-19 immunization is an individual,
community, societal and government responsibility that cuts across borders and
sectors.
3. Integration: the COVID-19 immunization services shall be fully integrated into the
country’s health systems and eventually to the regular immunization services.
4. Innovation: adaption and incorporation of the scientific evidence gathered through
research and innovation on COVID-19 vaccine and immunization is vital to ensure
effective implementation of COVID-19 immunization services.
C. In addition, the allocation of COVID-19 vaccines and prioritization of COVID-19
immunization shall be anchored to the following principles:
1. Human well-being: where health, social and economic security, human rights and
civil liberties of all citizens and individuals are protected and promoted.
2. Equal respect: where all human beings are treated equally and their interests are
considered with equal moral consideration.
3. National equity: where equity in vaccine access is assured nationally and those with
greater burden of COVID-19 pandemic.
4. Reciprocity: where individuals and groups who have greater burden in the COVID-
19 pandemic response and have higher significant risks brought by their
responsibilities and roles in the said response shall be given greater priority.
5. Legitimacy: where decisions are made through transparent processes based on
shared values and scientific evidence.

VI. GENERAL GUIDELINES

A. Recognizing that the COVID-19 vaccine deployment and vaccination program is a huge
national endeavor, an encompassing and comprehensive whole-of-society and whole-of-
government approach shall be executed where all members of the government and society,
in solidarity, are encouraged to participate and take action to achieve collective goals and
objectives.
This policy shall provide guidance on the development of the National COVID-19 Vaccine
Deployment and Vaccination Plan (NDVP), and its implementation plans, including
macroplans and microplans in all organizational levels. Moreover, due to the fast-evolving
developments on the COVID-19 vaccines, the NDVP, and its implementation plans, shall be
flexible and updated regularly based on specific vaccines procured and available, its
characteristics and supply, and the COVID-19 epidemiology of each particular geographical
area.
C. This policy shall adhere to evidence-based recommendations and policy guidance on
COVID-19 vaccines by the National Immunization Technical Advisory Group (NITAG) for
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D. All immunization interventions and strategies shall be anchored in the principles adhered to
by the National Immunization Program (NIP).
E. A strategic approach in optimizing the deployment of COVID-19 vaccines shall be utilized,
without compromising the implementation of regular immunization services under the NIP.
F. The vaccination of COVID-19 vaccines shall be voluntary for all Filipino citizens. Moreover,
all individuals consenting to be vaccinated with COVID-19 vaccine shall be provided with
sufficient information on the COVID-19 vaccine administered, and its possible adverse
reactions.

VI. SPECIFIC GUIDELINES

A. Planning and Coordination

In order to protect national interests and to effectively launch the COVID-19 vaccine
1.

deployment after rigorous scientific review and considering population safety, a multi-
sectoral organizational structure capable of making transparent and robust decision-making,
and organizational processes shall be set in place. The COVID-19 Vaccine organization
structure shall be established to institutionalize a unified command, control, coordination,
and communication mechanism and ensure the implementation of COVID-19 vaccine
access, deployment and immunization of eligible populations.
2. In reference to the WHO’s Vaccine Introduction Readiness Assessment Tool (VIRAT)
where organizational critical activities and work streams were recommended such as the
creation of a National Coordinating Committee and its Technical Working Groups and Sub-
Technical Working Groups, and establishment and institutionalization of the National
Immunization Technical Advisory Group (NITAG) and National Adverse Events Following
Immunization Committee (NAEFIC), a multi-sectoral national organizational structure for
COVID-19 vaccine shall be established, institutionalized and integrated with the existing
COVID-19 response organizational structures and coordination mechanisms. Thus,
a. The Inter-agency Task Force for the Management of Emerging Infectious Diseases
shall serve as the National Coordinating Committee.
b. The COVID-19 Vaccine Cluster under the National Task Force Against COVID-19
shall serve as the National Technical Working Group.
c. The following workstreams shall be subsumed under the COVID-19 Vaccine Cluster:
i. Scientific evaluation and selection
ii. Diplomatic engagement and negotiation
111. Procurement and finance
iv. Cold chain and logistics
v. Immunization program
Co vi. Demand generation and communications.
~~ 3. The NITAG for COVID-19 shall serve as an independent advisory body who shall provide
recommendations to the COVID-19 Vaccine Cluster and its Task Groups and Sub-Task
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 making process and contribute to building public confidence in the COVID-19 vaccine
deployment and vaccination program.

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a. To ensure that appropriate expertise is utilized in the implementation of the COVDI-
19 vaccine deployment and vaccination program, a dedicated NITAG for COVID-19
vaccines shall be established.
b. The NITAG for COVID-19 Vaccines shall serve as a technical advisory role in the
development of vaccine recommendations. It shall have no implementing,
coordinating, nor regulatory function.
c. There shall be two general types of membership for NITAG for COVID-19 Vaccines:
Core Members and Non-core Members, where both participate in the plenary
meetings, however, only the Core Members have the decision-making/voting
capability. Participation of Non-core Members, however, is crucial in providing
necessary information to a decision.
i. Core Members (at least seven (7) members):
1. Do not represent a particular group or a stakeholder. He/She does not
hold any position in DOH nor has any direct indirect supervisory
relationship to the country’s NIP. |

2. Shall have the following academic/specialization qualification/s:

clinical medicine (internal medicine or geriatrics), epidemiology,
infectious diseases and/or microbiology, public health, immunology,
vaccinology, health economics, social science, and health systems and
development.
Shall serve as members as long as COVID-19 vaccines are part of the
3.
COVID-19 pandemic response. Once the COVID-19 vaccines are
integrated into the regular services of the NIP, the NITAG for
COVID-19 Vaccines shall then therefore be dissolved.
ii. Non-Core Members (no predetermined number):
1. May represent a specific stakeholder/agency that can be consulted.
They are invited on a per-need basis during the NITAG’s plenary
meetings. They shall provide technical expertise and provide
background information or needed evidence and may participate in
the discussion.
2. They are either an Ex-officio or Liaison Member:
a. The Ex-officio Members are officials from the DOH which
hold key positions on the Offices related to the National
Immunization Program.
b. The Liaison Members are members of various medical
societies and international organizations.
iii. For membership selection, the call for nomination for NITAG for COVID-19
Vaccines Core Members shall be called by the Public Health Services Team.
Experts shall be invited from academic institutions, medical specialty
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 The selection team composed of members determined by the Public Health
iv.
Services Team shall select the NITAG for COVID-19 Vaccines members
through a vetting process considering their academic merits, past working
experiences, technical expertise and strong commitment to support the
immunization program. After vetting, the names shall be forwarded to the
DOH Executive Committee for approval and endorsement to the Secretary of
Health.
v. The Secretary of Health shall then issue a Department Personnel Order for
the final appointment of the NITAG for COVID-19 Vaccines Chair, Co-Chair
and Core Members.
4. The NAEFIC shall serve as an independent body, supported by the NAEFIC secretariat, who
shall review serious and cluster of Adverse Events Following Immunization (AEFI) cases
and ensure evidence-based causality assessment of all AEFIs. Expertise of the NAEFIC shall
include vaccinology, infectious disease, public health. allergology, immunology, pathology,
microbiology, parasitology, geriatrics, and other fields deemed necessary for causality
assessment of AEFI of COVID-19 vaccines.
5. A coordination mechanism shall be set in place to ensure sufficient communication and
information are shared between Task Group, Sub-Task Groups, independent bodies such as
the NITAG, NAEFIC and Health Technology Assessment Council (HTAC), and the Vaccine
Expert Panel.
6. The Vaccine Expert Panel shall provide regular updates to the COVID-19 Vaccine Cluster
Head, HTAC, NITAG, and NAEFIC.
7. An Incident Command System supported by an emergency operations center shall be
established and operationalized at all levels, as follows:
a. National Emergency Operations Center
b. Sub-National Emergency Operations Centers (National Capital Region and Luzon
EOC, and the Visayas and Mindanao EOC) |

c. Regional Emergency Operations Centers

d. Local Emergency Operations Centers.

B. Financing and Funding Mechanisms

1. As part of the national COVID-19 response, the budget and funding for the COVID-19
vaccine shall be integrated and reflected in the national budgets of implementing agencies,
as deemed necessary. However, it is essential that the budget for other essential health
services, including the routine immunization budget, be not affected by the cost and funding
requirements of the COVID-19 vaccine and its ancillary logistics.
2. In addition, with the unparalleled need and the competing demand in the global market, other
funding methods and mechanisms such as multilateral development bank arrangements, local
- bank-facilitated loans, advance market commitments, among others, shall be explored.
3. The
budget proposals for the implementation of the national COVID-19 vaccine deployment
arzafion shall include budgetary requirements at the national, regional, and local
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 4. All participating agencies shall develop a three - year bud geted COVID-19 vaccine roadmap,
consistent with the NDVP. It shall be annually revised in alignment with standardized
budgeting processes and based on the latest updates on COVID-19, COVID-19 vaccines,
epidemiological settings and recommended strategies.
5. Each strategy and activity identified in the NDVP shall be costed and provided with adequate
funding.

C. Identification of Eligible Population

1. The WHO Strategic Advisory Group of Experts (SAGE) Values Framework for the
Allocation and Prioritization of COVID 19 Vaccination principles and the policies and
recommendations of the NITAG of COVID-19 Vaccines shall guide the identification and
finalization of the eligible population, taking into consideration the national context, the
epidemiologic settings and the COVID-19 vaccine characteristics and supply.
2. The identification of the eligible population shall be primarily anchored on the principles of:
human well-being, global equity, reciprocity, equal respect, national equity and legitimacy,
taking in mind that 60-70% of the population are needed to have immunity to break the chain
of transmission.
3. The Philippine government shall ensure equitable access to COVID-19 vaccines and that
groups with high risk of exposure of COVID-19, and groups with high vulnerability risk such
as those with underlying societal, geographic or biomedical factors are provided with
COVID-19 vaccination services.
4. The identification of the eligible population shall be based on the following goals for
vaccination:
a. Primary: direct reduction of morbidity and mortality and maintenance of most critical
essential services.
b. Secondary: substantially control transmission and minimize disruption of social,
economic and security functions.
c. Tertiary: resumption to near normal.
5. Considering all goals, principles and values stated above, a decision matrix shall be
developed to guide decision-making.
6. In the minimum, the Philippine Government shall vaccinate the most-at-risk and most-
vulnerable populations such as: a) frontline health workers, b) senior citizens and c) indigent
population, and d) uniformed personnel. Persons with comorbidities and vulnerable
population groups may be prioritized as soon as developments and information on the
COVID-19 vaccine determines their inclusion.
7. The final determination of the eligible population to be vaccinated shall take into
consideration the characteristics of the COVID-19 vaccine to be administered, including
exclusion and inclusion criteria shared by the vaccine manufacturers.
8. To ensure accurate national estimates of identified eligible population, agencies and sectors
involved are enjoined to conduct profiling and provide accurate information based on
standardized tools and templates provided by the DOH.
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D. Vaccination Delivery Strategies

1. The vaccine delivery strategies shall be tailored based on the vaccine characteristics, risk-
benefit assessment for different population groups, amount and pace of vaccine supply, and
in line with the NIP systems and context.
2. A framework-based strategy shall be developed for each vaccine candidate to ensure
readiness of the system whatever vaccine shall be procured. The details on the vaccine
schedule and administration shall be defined once a COVID-19 vaccine product is authorized
for use by the Food and Drug Administration (FDA), and HTAC recommendations.
3. Other means of delivering the vaccines shall be adopted, including non-traditional,
innovation and perhaps novel immunization strategies in reaching priority eligible
populations.
4. The system shall ensure the inclusion of Infection Prevention and Control (IPC) measures
and implementation of Minimum Health Standards during the provision of vaccination
services, including the use of personal protective equipment (PPE) by health workers,
vaccination teams and implementers.

E. Cold Chain, Supply and HealthCare Waste Management

1. A cold chain and logistics plan with diverse vaccine deployment strategies shall be developed
to guarantee efficient deployment of COVID-19 vaccines to eligible populations groups. The
plan shall be linked to the overall National Immunization Program cold chain and
management plan, and shall utilize the evidence gathered from readiness assessments to
contextualize implementation of strategies and interventions.
2. The plan shall include potential variations in storage temperature requirements of different
COVID-19 vaccine products, and information on the available cold chain capacity, including
surge capacity of DOH storage facilities and warehouses, and those from other government
agencies and private sectors. Specifically, it shall include consideration of COVID-19
vaccine requiring ultra-cold storage (UCC) temperature (e.g. -70 °C), and identification of
practical interventions, such as commissioning logistic service providers to deploy the UCC
equipment and facilitate vaccine transportation and reverse logistics.
3. The plan shall ensure the inclusion of security and safety measures and interventions,
especially for vaccine storage facilities and transportation platforms, in order to ensure
integrity of vaccines during transport, and the safety of all staff responsible for managing the
supply and implementing the vaccination.
4. Due to high global demand, first batches of COVID-19 vaccine supply may be limited, have
shorter shelf-life, and not have vaccine vial monitors. A strengthened supply chain
information system on stock management and distribution shall be implemented, including
monitoring and reporting of vaccine utilization and wastage rates, and use of online or digital
platforms, to guide appropriate allocation of subsequent supply.
5. Therreshall be a robust mechanism to track COVID-19 vaccine distribution from the national
down’ 10 service points to avoid risk of diversion and falsification. This mechanism
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 6. A healthcare waste management plan shall be developed and shall cover reverse logistics, to
guarantee the health and safety of vaccinators and the community.

F. Human Resource Management and Training

1. A human resource management and training plan shall be developed to ensure sufficient
number of human resources (including Barangay Health Workers) are available for the
implementation of the COVID-19 vaccine deployment and immunization, and to determine
capacity building requirements of human resources. The plan shall consider various scenarios
and frameworks as several unknowns still persist, and shall include identification of human
resource needs, training modalities, and details on supportive supervision.
Utilization of health human resource and training for the COVID-19 vaccine deployment and
vaccination program shall not be limited to the DOH and LGU health human resource. The
Philippine Government shall ensure that health human resources of government agencies and
the private sector shall be effectively utilized and extensively trained. There shall be clear
coordination and mobilization of human resources from other government agencies, such as
Armed Forces of the Philippines (AFP) and Philippine National Police (PNP), Departments
of Interior and Local Government, Social Welfare and Development, Education, health
personnel and support staff among others, and the private sector.
The opportunity to develop innovative systems, such as online or digital tools, for modules,
training and supportive supervision shall be set in place.
The WHO and other partner agencies shall be tapped to support the capacity building
activities and initiatives.
A plan on intensified supportive supervisory or monitoring visits for the duration of vaccine
introduction is recommended.

G. Vaccine Acceptance and Uptake

As this is a novel vaccine, risk communication and community engagement plan including
1.
comprehensive assessment and monitoring mechanisms such as perception surveys and
qualitative and quantitative assessments are significant to ensure strategies on acceptance
and confidence to the vaccination program by mustering a whole-of-society approach.
2. The following is needed to be adopted as an integrated demand approach:
a. Listening to and understanding eligible populations, to generate behavioural and
social data on the drivers of uptake and to design targeted strategies to respond;
b. Building a supportive and transparent information environment, and addresses
misinformation through social listening and assessments that inform digital
engagement initiatives;
c. Building trust and acceptance of the vaccines through engagement of communities
by social mobilizers, partners and civil society organizations, particularly for
vulnerable target populations;
d. Providing health workers with the requisite knowledge of COVID-19 vaccines as
first; adopters, trusted influencers and vaccinators, giving them the skills to
with eligible populations and
CERTIFIED TRUE €@Giunicate effectively and persuasively
communities; and
 e. Utilizing Barangay Health Workers and Barangay Health Emergency Response
Teams (BHERTS) as social mobilizers to ensure that communities are engaged,
informed, appraised and thus, possibly translating their interventions and actions to
social preparation and community buy-in and action.
f. Preparing to respond to any reports of AEFI/AESI and ensuring that plans in place to
mitigate any resulting crises of confidence.
. Education of policymakers, health professionals, and implementers, both public and private,
on COVDI-19 vaccine and its development shall be prioritized to ensure vaccine acceptance
and improve vaccine confidence. The academe and the medical societies are encouraged to
support these initiatives.

H. Vaccine and Immunization Safety Monitoring, AEFI/AESI and Postmarketing Surveillance

and Management, and Pharmacovigilance

1. There shall be a comprehensive plan on vaccine safety monitoring and management of AEFI
and AESI to be led by FDA and its regional counterparts and supported by the Epidemiology
Bureau (EB), Regional and Local Epidemiology and Surveillance Units.
Surveillance and monitoring of AEFIs / AESIs shall be up until one year post-vaccination.
. All health facilities shall perform AEFI/AESI and post-marketing surveillance activities
(active and passive) based on the Phillippine Integrated Disease Surveillance and Response
(PIDSR) flow and Event-based Surveillance and Response (ESR) system.
The NAEFIC/RAEFICs should be established with explicit terms of reference to serve as an
independent body for AEFI and AESI causality assessment.
Responding to AEFIs and AESIs including case management and other programmatic
support activities shall utilize the healthcare service delivery network of the Universal Health
Care (UHC) where appropriate, while those without shall use the existing health systems
referral network.
The importance of injection and immunization safety based on NIP recommendations and
current policies shall form an integral part of the vaccination program.
The Department of Health, upon recommendation from the NITAG and NAEFIC, shall have
the authority to suspend the vaccination program following iminent efficacy and safety
concerns of the COVID-19 vaccines which may be subjected to a product recall as ordered
by the FDA.
The FDA shall continuously monitor the quality, safety and efficacy of the vaccines through
its existing rules and regulations.

I. Immunization Registration, Monitoring and Data Management Systems

1. A robust and comprehensive data management system, preferably a digital system, shall be
established and utilized to monitor progress of vaccination activity, including monitoring of
~

vaccine safety and effectiveness. The data management system shall be use to:
a: Measure real-time and equitable uptake and coverage over time by geography and
~eligible population groups.
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 Monitor implementation of national policies to identify eligible populations and
b.
various settings.

~~
¢. Retrieve personal vaccination records or certification as deemed required.
d. Monitor safety, disease surveillance and vaccine effectiveness.
2. A nationwide profiling of eligible population groups shall be conducted prior to the
implementation of the vaccination activity utilizing an electronic immunization registry. This
shall be utilized to determine the eligibility of the priority groups receiving the vaccine. In
the same way, a nationwide registry of vaccination team members, composite team members,
supervisors and planning officers and individuals shall be conducted prior to the
implementation of vaccination activity. The Philippine Government may utilize existing
registries of government agencies.

VII. ROLES AND RESPONSIBILITIES:

A. COVID-19 Vaccine Cluster

1. The roles and responsibilities for the COVID-19 Vaccine Cluster are:
a. To provide institutionalize end-to-end vaccines delivery system for COVID-19
vaccines, including, but not limited to:
i. Possibility of local production, and participation therein of public or private
entities.
ii. Demand forecasting, target setting, and budget allocation.
iii. Supply chain and logistics management, and participation of private sector or
other government entities with competencies.
iv. Information systems that will enable real-time tracking of supplies and linelist
of recipients of vaccines, the latter critical if vaccines will be in multiple
doses.

B. Task Group on Vaccine Evaluation and Selection

1. The Task Group on Vaccine Evaluation and Selection shall be led by the Department of
Science and Technology (DOST) with the following members: DOH (HRT), FDA, Research
Institute for Tropical Medicine (RITM), and selected vaccine experts.
2. The roles and responsibilities of the Task Group on Vaccine Evaluation and Selection are:
a. To review results of clinical trials of all vaccines for COVID-19.
b. To coordinate with NITAG and HTAC while following the usual FDA vaccine
regulation processes which shall be facilitated for the COVID-19 vaccine without
compromising safety and efficacy.

C. Task Group on Diplomatic Engagement and Negotiation

The Task Group on Diplomatic Engagement and Negotiation shall be led by the Department

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 (BIHC), National Task Force for COVID-19, and Department of Science and Technology
(DOST).
2. The roles and responsibilities of the Task Group on Diplomatic Engagement and Negotiation
are:
a. To engage and negotiate with international parties and entities on COVID-19
vaccines on behalf of the Philippine government.
b. To provide feedback and updates to the other respective Technical Groups (TG)
pertaining to vaccine development in the global market.
c. To coordinate and collaborate with TG Procurement and Finance in identifying viable
global market vaccine manufacturers and entities.

D. Task Group on COVID-19 Vaccine Procurement and Financing

1. The Task Group on COVID-19 Vaccine Procurement and Financing shall be led by the DOF
with the following members: DOH and Department of Budget and Management (DBM).
The roles and responsibilities of the Task Group on COVID-19 Vaccine Procurement and
Financing are:
a. to facilitate procurement through various mechanisms allowed under existing laws,
rules, and regulations through bilateral, multilateral and other financial modalities.
b. To facilitate advanced market commitment and/or framework contracting and/or
procurement through international facilities such as the COVAX facility.
c. To activate price negotiation board subject to Health Technology Assessment’s cost-
effective price.
d. To coordinate with legislators, as may be necessary on budget and co-payment
|

ceilings.
e. To explore the possibility of local vaccine production.

E. Task Group on Cold Chain and Logistics Management

1. The Task Group on Cold Chain and Logistics Management shall be led by the DOH
(PSCMT) and the National Task Force for COVID-19’s Technical Group on Resource
Mobilization and Logistics with the following members: DBM, Department of Interior and
Local Government (DILG)/Philippine National Police (PNP), Department of National
Defense (DND)/Armed Forces of the Philippines (AFP) and Office for Civil Defense (OCD).
2. The roles and responsibilities of the Task Group on Cold Chain and Logistics Management
are:
a. To develop a cold chain and logistics plan and provide a budgetary plan to the
COVID-19 vaccine clusters for cold chain and logistics management.
b. To map the potential port(s) of entry, points of storage (stores), and fallback facilities
in the country with their respective cold chain and transportation/distribution capacity
for vaccines, and ancillary products and assess dry storage and cold chain capacity at
all levels.
° c. To facilitate acceptance and inventory of vaccines and logistics.
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4y
 d. To facilitate and ensure storage, distribution and delivery of vaccines and logistics to
target areas.
e. To monitor cold chain practices and ensure that vaccines are handled and disposed
correctly and properly, including reverse logistics.

F. Task Group on COVID-19 Immunization Program

1. The Task Group on COVID-19 Immunization Program shall be led by DOH (PHST) with
the following members: Department of Justice (DOJ), FDA, DILG, Department of Social
Welfare and Development (DSWD), Department of Education (DepEd), AFP, Department
of Transportation (DOTr), Department of Information and Communication Technology
(DICT).
2. The roles and responsibilities of the Task Group on COVID-19 Immunization Program are:
a. To develop a strategic roadmap for the COVID-19 deployment and vaccination
program.
b. To initiate the drafting of the National COVID-19 Vaccine Deployment and
Vaccination Plan.
c. To plan and craft policies, guidelines and standard operating procedures, and
Monitoring and Evaluation (M&E) plans related to the COVID-19 vaccine
deployment and program implementation (e.g. vaccine deployment and vaccination
operational plan, human resource management and training plan, data management
system, vaccine safety, surveillance and response plan, among others).
for
‘d. To estimate potential numbers of eligible populations that shall be prioritized
access to vaccines stratified by sectoral group and geographic location.
e. To identify potential COVID-19 vaccine delivery strategies.
f To create a data information system for all vaccine recipients and implementation.
To provide capacity building and training to policymakers, health professionals and
implementers.
h. To ensure the implementation of a quality vaccination campaign against COVID-19.
i. To develop or adapt existing and implement AEFI/AESI and post-marketing
surveillance, and a monitoring and evaluation framework.
j. To craft guidelines, procedures and tools for planning and conducting vaccine
pharmacovigilance activities.
|

G. Task Group on Demand Generation and Communications

The Task Group on Demand Generation and Communications shall be led by Presidential
1.
Communications Operations Office (PCOO) with the following members: DOH (HPCS),
National Telecommunications Center (NTC) and Philippines Information Agency (PIA).
2. The roles and responsibilities of the Task Group on Demand Generation and
Communications are:
a. To design a demand and risk communication plan.
~ ——Fotmplement advocacy, social mobilization and community engagement activities.
CERTIFIED TRUE COPY 1
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Department of -Héalth ;
 C. To ensure social preparation of target population groups and geographical areas prior
to vaccination.

H. National Immunization Technical Advisory Group (NITAG) on COVID-19 Vaccines

1. The roles and responsibilities of the NITAG on COVID-19 Vaccines are:
a. To review the latest position papers, studies, international guidelines and
recommendations from internationally acknowledged resources (i.e., WHO SAGE)
for possible adoption in the country policies and plans.
To conduct existing policy analysis, review of the program data and evidence in order
to provide evidence-based technical advice and recommendations for the
development of appropriate and sustainable immunization policies, guidelines,
strategies and approaches related to immunization program
To advise the COVID-19 Vaccine Cluster and its TGs and STGs, in the formulation
of policies, plans and strategies for research and development of existing and new
vaccines and the vaccine delivery technology.

A. National Adverse Events Following Immunization Committee (NAEFIC)

1. The roles and responsibilities of the NAEFIC are:

a. To review all reported serious and cluster of AEFI cases presented for expert opinion
and provide a final causality assessment of the AEFI cases as well as the cases that
were not classified by the Regional AEFI Committee.
To ensure evidence-based causality assessment by recommending further
investigation and data collection as needed.
To make final decisions on causality assessment of inconclusive investigations.
To ensure standard protocols for AEFI surveillance and investigation are correctly
followed.
To engage with other national and international experts when requirements arise in
establishing causality and vaccine quality issues.
To provide recommendations to the COVID-19 Vaccine Cluster, FDA, EB and
National Cold Chain Manager on improving immunization service delivery,
compliance with injection safety and effective vaccine management based on lessons
from the AEFI cases.
To serve as a technical advisory group on vaccine and immunization safety-related
issues of highest consideration such as immediate recall of vaccines from the market
or temporary/permanent withdrawal of a vaccine from the immunization program.
To serve as resource person in other AEFI related meetings, conferences or capacity
building activities as requested.

J. Health Technology Assessment Council (HTAC)

ad-responsibilities of the HTAC are:
1
|
J
15

i
 b. To review and assess existing evidence of COVID-19 vaccines
undergoing/undergone clinical trials. |

c. To coordinate and provide recommendations to the TG Vaccine Evaluation and

Selection.

VIII. REPEALING CLAUSE

Provisions from previous and related issuances inconsistent or contrary with the provisions of this
Administrative Order are hereby revised, modified, and rescinded accordingly. All other provisions
of existing issuances which are not affected by this Administrative Order, still remain valid and in
effect.

IX. EFFECTIVITY

This Administrative Order shall take effect immediately after publication in the Official Gazette or
a newspaper of general circulation.

Secretary of Health
Annex A. COVID-19 Vaccine Cluster Organizational Structure

COVID-19 Vaccine Cluster Organizational Structure

InterAgency Task Force onthe Management of Emerging Diseases
Chain:Secretary Francisco T.Duque,

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National Task Force Against COVID-19
Chair: Secretary Delfin N, Lorenzana -
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Response Cluster
Chair: Usec, Leopoldo J. Vega

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Chair:

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Carlito Galvez
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Chair: NEDA

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for Local Travel |
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Management & Logistics | 0 Procurement Finance. 1 Demand
Generations
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COVID-19 Vaccine Cluster Organizational Structure

DETAILS

COVID-19 Vaccine Cluster Organizational Structure

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Negotiations Lead: DOH
Lead: DFA Members: DOJ, FDA, DILG, DSWD,

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‘Members; DOF, DOH, NTF, DOST ~~
DepEd, AFP, DOT, DICT

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TG Demand Generation &

TG Procurement and Finance
Communications
Lead: DOF
Lead: PCOO

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Members: DOH, DBM Members: DOH,NTC,PIA
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CERTIFIED TRUE Copy

8
INA P. RIVERA/L
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COVID-19 Vaccine Cluster Organizational Structure

DETAILS

& ,
Sub - Task Groups under the TG COVID-19 Immunization Program

STG Planning, Policy & Technical

Support
I £2 Reglstry, Data Management
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Lead: DOH (Dir. Arevalo) Lead: DOH (Dirs Albornoz, Tayag)
Member: DOJ, OCPLC, DepEd, Member: DICT, DSWD, DepEd
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DSWD, DepEd, DND (AFP), DOJ Member: DOH (EB, DPCB, FICT)

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CERTIFIED TRUE COPY

Annex B. WHO - World Bank Vaccine Introduction Readiness Assessment Tool / Vaccine
Readiness Assessment Framework

A.1 Establish {or engage an existing committee) a |

National Coordinating Committee (NCC) for COVID-19

vaccine introduction with terms of reference, roles and
responsibilities and regular meetings. The body and its
leadership should be accountable and functional.
A.2 Establish (orengage an existing working group) a
National Technical Working Group (NTWG) for COVID-19
vaccine introduction with terms of reference, roles and
responsibilities and regular meetings.

A.3 Establish or engage existing NTWG subcommittees, if

required, to cover the following workstreams: 1) service
delivery 2) vaccine, cold chain & logistics, 3) demand
generation & communication (4) prioritization, targeting
and COVID-19 surveillance, (5) Monitoring and
Evaluation: determination and proof of eligibility, proof
of vaccination, monitoring of coverage among at-risk
groups, and monitoring of vaccine impact (6) Safety,
AEFI detection and
A. PLANNING & |including injury prevention and
COORDINATION |Fesponse.

A.4 Brief key ministries, NITAG, stakeholders and

partners about COVID-19 vaccine introduction and their
expected roles. Inform regularly disseminate global
&

and regional guidance (i.e. SAGE) with NITAGs & RITAGs

and support NITAG working groups on COVID-19
vaccines.

A.5 Identify and plan for the national vaccine

access/procurement approach (e.g. COVAX Facility,
bilateral purchase agreement, procurement through UN
agency, self-procurement), including costs of items, due
diligence mechanisms; identify key needs, ensure
regulatory compliance, and complete required
paperwork. Ensure that the procurement plan and
purchasing strategy includes vaccines, ancillary supplies,
and Personal Protective Equipment. Budget has been
approved; and monitoring arrangements are agreed and-- CH.

A
:

EN
updated as needed.
~

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Department
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 A.6 Plan andprocure waste management supplies and
equipment for appropriate implementation of waste
management protocols.

A.7 Ensure that program objectives are defined and

agreed to by key stakeholders at the central and sub-
national levels, including representatives of target
populations, community leaders, religious leaders, etc.,
and reflect the epidemiological situation and are
adaptable to vaccine supply scenarios (protection of
vulnerable populations, continuity of essential services,
equity).

A.8 Develop the National Deployment and Vaccination

Plan (NDVP) with input from relevant bodies (National
COVID-19 Response Coordinating Committee, CNCC,
CTWG, NITAG, National Immunization Programme,
National Regulatory Authority, AEFI committee and
other relevant groups such as private sector). The NDVP
should be in line with WHO guidance and SAGE
recommendations (plan can be developed by adapting
the Pandemic Influenza NDVP, if existing).
B.1 Include COVID-19 vaccine program costs (vaccine,
operating costs, HR and capital costs) in government
budgetary and/or planning documents approved by the
appropriate authority; in addition, include appropriation
B. BUDGETING or allocation (from MOF/treasury) in the cash planning
as an additional means to ensure that financing is indeed
readily available.

management aspects of appropriations from

B.2 Ensure
the MOF/Treasury are in place.
C.1 Confirm the existence of any expedited regulatory
pathway for approval of COVID-19 vaccines (i.e.
emergency use authorization, exceptional
approval/approval mechanism based on
reliance/recognition, abbreviated procedure, fast track,
etc.). Time lines and maximum number of days should be
mentioned.
C.2 Ensure the national regulatory authority or other
C. REGULATORY
concerned authority has clarified the regulatory
requirements, and documents needed for regulatory
approvals of COVID-19 vaccines and related supplies.

C.3 Ensure that regulatory procedures are in place for

import permit of COVID-19 vaccines and related supplies,
and identify the requirements and documents needed to
import COVID-19 vaccines and related supplies, including
for taxes and tariffs.
 C.4 Confirm to the existence of an expedited
WHO
import approval from appropriate authorities. Time lines
and maximum number of days should be mentioned.
(expected timeline: maximum 5 working days).

C.5 Ensure COVID-19 vaccines can be released (lot

release) in less than two days by reviewing the summary
lot protocol only (testing is not required). Identify the
requirements and documents needed for NRA lot release
for COVID-19 vaccines. Time lines and maximum number
of days for lot release/waiver process should be
mentioned.
D.1 Monitor progress of NITAG working groups on
COVID-19 vaccines and interim recommendations
focusing on prioritization and risk groups.

D.2 Identify potential target populations that will be

D. prioritized for access to vaccines, estimate their
PRIORITIZATIO |numbers, and identify their geographic location, i.e.
N, TARGETING |Prepare first to define, identify and estimate no. of
|HCWs.
& covip1g
SURVEILLANCE
D.3 Coordinate with national COVID-19 disease
surveillance group to ensure relevant epidemiological
data will be collected to inform planning of subsequent
rounds of COVAX vaccination, if applicable, including
outbreak responses.
E.1 Update protocols for infection prevention and
control measures including adequate personal
|

protection equipment (PPE) to minimize exposure risk

during immunization sessions.

E.2 Identify potential COVID-19 vaccine delivery

strategies and outreach strategies leveraging both
E. SERVICE existing vaccination platforms and non-vaccination
DELIVERY delivery approaches to best reach identified target
groups. Develop a master list and strategy of service
providers, points of delivery, including fixed and
outreach (e.g. health facilities, community centers, by
appointments, house-to-house) and associated medical
supplies that could effectively deliver COVID-19 vaccine
to target populations, and ensure that the necessary
planning for locations and logistics is carried out.
-
mmr A =. ~
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 E.3 Identifyimplementing agencies and establish
contractual agreements to prepare for vaccine
introduction (e.g., vaccine warehousing, transport, waste
management, cold chain capacity, etc.) where applicable.
For delivery through private facilities, develop and
approve Standard Operating Procedures, including
service quality and performance and reporting standards
and mechanisms for complaints-handling, certification of
facilities, financing, performance monitoring and
integrity checks.

E.4 Ensure existence of protocols regarding consent to

vaccinations, process for agreeing to or refusing to be
vaccinated, and measures to protect those that refuse to
be vaccinated are in place.

F.1 Develop a training plan across all participating

facilities to prepare for COVID-19 vaccine introduction
that includes key groups of participants, content topic
areas (including safe injection practices), key training
partners and training methods (in-person or virtual).
WHO will provide a template for guidance.

F.2 Adapt and translate training materials developed by

WHO and develop additional training materials as
outlined in the training plan.

F.3 Ensure availability of plans to safeguard the security

F. TRAINING & of staff (e.g. during an emergency or major campaign) as
SUPERVISION well as security at the central and/or regional storage
facilities and for in-transit of products. Ensure
regulations are in place regarding personnel who will be
carrying out vaccinations, including all
staff/personnel/consultants etc. engaged in such
activities (cover military personnel also, if
relevant), and
include requirements relating to chemical, physical and
biological substances, not engaging in sexual exploitation
and abuse and sexual harassment, participation in
training, reporting and non-retaliation.

F.4 Conduct virtual and/or in person trainings as outlined ERTIFIED T7

in the training plan.
G.1. Develop or adapt existing surveillance and
monitoring framework with a set of recommended
indicators (coverage, acceptability, disease surveillance
etc. for COVID-19 vaccine including gathering
information from facilities and contractors participating
G.
in vaccine delivery, and ensuring necessary human
MONITORING &
resource capacity is in place. Determine whether
EVALUATION
registration and reporting will be individual or aggregate,
 and to what extent existing tools and systems can be
used.

G.2 Develop or adapt necessary paper-based and/or

electronic monitoring tools and appropriate institutional
arrangements, including vaccination cards/certificates,
facility-based nominal registers and/or tally sheets,
vaccination reports, medical records, immunization
records, systems entry and analytical tools to monitor
progress and coverage among different at-risk categories
and facilitate vaccine delivery and timely reporting.

G.3 Ensure measures are in place for data protection,

and appropriate data governance regulation is in place to
monitor legitimate, appropriate and proportionate use
and processing of data which may be routinely collected
and managed in health information systems.

G.4 Produce and distribute monitoring tools to eligible

vaccination providers, develop, test and roll-out any
changes to electronic systems, provide training for use of
these tools and processes to traditional and new
providers.

G.5 Ensure a mechanism with multiple intake points has

been designed and is in place, and is operational for
feedback and grievances in relation to the vaccine
program.
H.1 Establish/strengthen the national logistics working
group with appropriate terms of reference and standard
operating procedures to coordinate COVID-19 vaccines
and ancillary products deployment.

H.2 Map key roles and responsibilitiesneeded for

H. VACCINE, vaccine and ancillary products deployment; collect and
COLD CHAIN, confirm contact information for key personnel and
LOGISTICS & facilities.
INFRASTRUC-
H.3 Create a distribution strategy, including mapping the
TURE
potential port(s) of entry, points of storage (stores) and
stocking, and fallback facilities in the country with their
respective cold chain storage (2-8C, -20C, -60/70C) and
transportation capacity for vaccines and ancillary
products, and ensure necessary human resource capacity
is in place.
|

J ad
 H.4 Map and develop plan to provide for infrastructure
needs, including for energy (primary and back-up power,
especially in cold chain), IT/communications (including
internet connectivity) and water.

H.5 Assess dry storage and cold chain capacity and

infrastructure needs at
all levels with regards to the
COVID-19 vaccines characteristics and fill the identified
supply and logistics gaps.

H.6 Provide COVID-appropriate standard operating

procedures (SOPs), protocols, or guidelines for collection
and disposal of medical waste, both hazardous and non-
hazardous, to the relevant stakeholders. Assure that
properly-licensed waste management providers
(especially for hazardous waste storage, transportation
and disposal) are identified and can be operationalized.

H.7 Update and implement systems and protocols for

tracking and monitoring the stock management and
distribution of vaccines and key supplies through the
Government's existing Vaccine Logistics Management
and Information System (VLMIS), including operating
procedures to reflect the characteristics of COVID-19
vaccines (i.e. vial size, VVM,...).

H.8 Disseminate delivery and acceptance protocols,

ensure monitoring arrangements are in place, and
identify supervisory focal points at each facility. Establish
security arrangements to ensure the integrity of COVID-
19 vaccines and ancillary products throughout the supply
chain.

1.1Ensure that guidelines, documented procedures and

tools for planning and conducting vaccine
pharmacovigilance activities (i.e. AEFI reporting,
investigation, causality assessment, risk communication
and response), have been developed and disseminated
to surveillance facilities/sites.

I. SAFETY [.2 Ensure adequate and trained human resources are

SURVEILLANCE available to conduct surveillance of events attributable
to vaccination.

|.3 Expedite appropriate representation, well defined

ToRs and training the AEFI committee to review COVID-
19 Vaccine safety data (e.g., causality assessment of

i
serious AEFI, clusters of AEFI, emerging safety concerns-—
—_ eo =
etc.).
i TSAGRE

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a
~~ -—
~~
 1.4Identify provisions that require manufacturers to
implement risk management plans and collect and
report COVID-19 vaccine safety data to the NRA.

1.5Plan active surveillance of specific COVID-19 vaccine

related adverse events. If this is not possible, develop
provisions that allow reliance on active surveillance data,
decisions, and information from other countries or
regional or international bodies.

1.6Define roles and responsibilities and establish a

coordination mechanism between relevant stakeholders
(NRA, EPI, MAH, MOH, WHO and others) for exchange of
COVID-19 Vaccine safety information.

Identify and secure channels of data sharing

1.7

mechanisms to share COVID-19 vaccine safety data and

findings with relevant regional and international
partners.

.8 Establish compensation schemes in the event that

there are unintended health consequences as result of
vaccines, including no-fault liability funds, and ensure
that associated policies are in place.
J.1 Design and distribute a social mobilization and
engagement strategy/demand plan and information
awareness program (including advocacy,
communications, social mobilization, risk and safety
comms, community engagement, and training) to
generate confidence, acceptance and demand for
COVID-19 vaccines, including for engaging with national
and local media, NGOs, social platforms, etc. and human
J. DEMAND resources for community outreach and risk
GENERATION & communication management that also explains how
COMMUNICA- complaints may be lodged and how they will be resolved,
TION are available at all levels. Must include crisis
communications preparedness planning.
J.2 Establish data collection systems, including 1) social
media listening and rumor management, and 2)
assessing behavioral and social data.

).3 Develop key messages and materials for public

communications and advocacy, in alignment with _ —
-
4~
demand plan.
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