of the Philippines

Republic
Department of Health
OFFICE OF THE SECRETARY
February 23, 2021

DEPARTMENT MEMORANDUM
No. 2021 - 0099

FOR: ALL DEPARTMENT UNDERSECRETARIES AND ASSISTANT

SECRETARIES; CENTERS FOR HEALTH DEVELOPMENT
AND MINISTRY OF BANGSAMORO AUTONOMOUS REGION
IN__MUSLIM_ MINDANAO__(BARMM);__AND__ BUREAU
DIRECTORS; SPECIAL AND SPECIALTY HOSPITAL
DIRECTORS; CHIEFS OF MEDICAL CENTERS, HOSPITALS
AND SANITARIA; AND OTHER CONCERNED OFFICES

SUBJECT: Interim Omnibus Guidelines for the Implementation of the National

Vaccine Deployment Plan for COVID-19

I. RATIONALE
In light of the absence of definitive treatment for COVID-19, it is expected that
COVID-19 morbidity and mortality will continue to increase. The development of vaccines
against COVID-19 is among the solutions that will greatly mitigate the increasing cases in the
country, complemented by already existing measures and practices in place.

The Department of Health (DOH), through the Task Group COVID-19 Immunization
Program, and in consultation with all agencies comprising the COVID-19 Vaccine Cluster,
developed a comprehensive plan for vaccine deployment and vaccination. The National
Deployment and Vaccination Plan (NDVP) for COVID-19 Vaccines seeks to provide the
overall operational guidance in the implementation of the COVID-19 vaccine deployment and
vaccination program in the Philippines. However, there is a need to supplement/update the
National Deployment and Vaccination Plan given new developments.
|
To ensure safety and efficacy of vaccines to be administered to the public, ONLY
vaccines which are granted with Emergency Use Authorization (EUA) the Philippine Food by
and Drug Administration and positive recommendation from the Health Technology
Assessment Council (HTAC) will be purchased by the government.

Likewise, policy decisions and recommendations are informed based on the

recommendations of technical experts, convened to provide independent recommendations to
the DOH, Vaccine Cluster, and IATF on vaccine implementation. These expert groups include
the interim National Immunization Technical Advisory Group (NITAG), Technical Advisory
Group for COVID-19, Health Technology Assessment Council, National Adverse Event
Following Immunization Committee, and Vaccine Expert Panel.

These interim omnibus guidelines on COVID-19 vaccination shall provide the overall
guidance to implementers on vaccine administration of the National Deployment and
Vaccination Plan.

Building |, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 local 1108, 1111, 1112, 1113
Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: fiduque@doh.gov.ph
Ik. GENERAL GUIDELINES
A. Implementation of the Prevention, Detection, Isolation, Treatment, and
Reintegration Strategies shall remain the cornerstone of response to prevent further
transmission, and shall be a shared responsibility of the national government, local
government units (LGUs), private sector, and the public.

. COVID-19 vaccination shall be used as one of the major strategies to complement

the existing measures and practices to mitigate the spread and reduce morbidity and
mortality due to COVID-19.
The external agencies engaged in COVID-19 response shall comply with their
specific roles and corresponding operational guidelines issued by the National Task
Force (NTF) for COVID-19 response.

. Minimum public health standards, which include physical distancing, hand hygiene,
cough etiquette, and wearing of masks and face shields among others, shall be
strictly implemented during the implementation of the NVDP.

General policy directions and program implementation of the vaccination plan shall
be guided by technical expertise of vaccine expert groups, as independent
recommending bodies to the National Government.
As
ageneral rule, only vaccines granted Emergency Use Authorization (EUA) by
the Philippine Food and Drug Administration (FDA) following FDA Circular 2020-
036 and positive recommendations from the Health Technology Assessment
Council (HTAC) shall be procured, distributed, and administered while an FDA-
issued Certificate of Product Registration is unavailable. Separate guidelines
detailing procedures for the acceptance and management of donations shall be
issued.

Specific instructions provided in the EUA of COVID-19 vaccines granted by the

FDA, and recommendations from the HTAC shall be judiciously taken into
consideration in the planning and allocation of the Vaccine Cluster of the NTF
Against COVID-19, distribution and program management of the regional and local
Vaccine Operations Center, and the administration of vaccines by health care
providers.

All vaccine recipients shall be monitored for the manifestation of any adverse
reaction following immunization (AEFI) and referred to the appropriate facility for
management.

Efficient information systems shall be in place to support operationalization of the

vaccine implementation plan.

Policy cascade shall be facilitated by the NTF, DOH, Department of the Interior
and the Local Government, Philippine Information Agency, and other lead agencies
to ensure that vaccination plans of local government units (LGUs) are in line with
the overall vaccination plan of the National Government.

PhilHealth shall cover individuals who will develop AEFI warranting

hospitalization through new or existing benefit packages. PhilHealth shall publish
relevant guidelines regarding coverage on AEFI.
Wi. IMPLEMENTING GUIDELINES
A. Prioritization Criteria

1. Due to competing global demand, vaccine supply is expected to start low and
gradually increase in the succeeding months. As such,
for the
it
National
is appropriate to adopt
Vaccine Deployment
a phased implementation approach
Program, following the objectives of ensuring reduction of mortality from
COVID-19 and preservation of health system capacity, and strategically
aligning the demand of priority populations to the expected vaccine supply, with
three phases:

a. Phase 1: Potentially limited supply of COVID-19 vaccine doses available

-
Concentrating efforts on critical populations based on risk of exposure and
mortality;

b. Phase 2: Large number of vaccine doses available - Ensuring access for the
general population, particularly to the working population; and

c. Phase 3: Sufficient supply of vaccine doses for entire population (surplus of

doses) - Ensuring equitable access to all populations, monitoring uptake
and coverage, and re-strategizing to increase uptake in populations with low
coverage.
The National Government shall pool all available vaccine supply, regardless of
whether donated, procured or sourced through tnipartite agreements.
Vaccinations shall follow the phased implementation approach and that
vaccines are provided to the identified population groups following the
prioritization schedule in consideration of the recommended age group and/or
sector indicated in the EUA. As such, LGUs and private sector companies that
entered into tripartite agreements shall abide by all relevant NVDP policies
issued by NTF and DOH.

Sub-prioritization shall be determined by the Department of Health upon

recommendation of the iNITAG conducted within a priority population group
through selection of geographic areas if there is insufficient incoming supply of
vaccines. Sub-prioritization shall be based on:

a. COVID-19 burden of disease (current active cases, attack rate per 100,000
population in the past 4 weeks, and population density); and

b. Vaccination site and/or Local Government Unit readiness, in particular, its

supply chain capability, to mount a vaccination campaign.

Further sub-prioritization shall be conducted if there is noted insufficient

incoming supply of vaccines even after employment of the sub-prioritization
criteria. This shall be based on exposure and mortality risk..

As
the needarises, methods of sub-prioritization for other priority groups may
be further developed and threshed out in succeeding issuances after initial roll-
out and consultation with relevant stakeholders.
B. Priority Population Groups

1. The priority population groups for COVID-19 immunization are as follows:

Phase | - Priority Eligible A

Frontline workers in health facilities both national and local, private and
public, health professionals and non-professionals like students in health
Al
and allied professions courses with clinical responsibilities, nursing aides,
janitors, barangay health workers, etc.

A2 Senior citizens aged 60 years old and above

Adults with comorbidities not otherwise included in the preceding

A3
categories

Frontline personnel in essential sectors both in public and private sectors,

including uniformed personnel, and those in working sectors identified by;
A4
the IATF that are directly client facing and cannot dutifully meet
minimum public health standards

Poor population based on the National Household Targeting System for

AS Poverty Reduction (NHTS-PR) not otherwise included in the preceding
categories

Phase 2 - Priority Eligible B

Bl Teachers, Social Workers

B2 Other Government Workers

B3 Other essential workers

Socio-demographic groups at significantly higher risk other than senior

B4
citizens and poor population based on the NHTS-PR

BS Overseas Filipino Workers

B6 Other Remaining Workforce

Phase 3 - Priority Eligible C: Rest of the Filipino population not otherwise

included in the above groups

2. For group A1, all workers in a health facility shall be taken as a group.
priority
Facilities or institutions of prioritization, in the following order of precedence,
may
be sub-prioritized based on (a) historical admission of COVID-19 cases
and (b) allocated and occupied COVID-19 beds:

a. COVID-19 referral hospitals designated by the DOH;

 b. Public and private hospitals and infirmaries providing COVID-19 care, as
prioritized based on service capability, starting from level 3 hospitals, to
level 2 hospitals to level 1 hospitals, and then infirmaries;

c. Among hospitals with a common service capability, the order of priority

shall be from facilities owned by the DOH, then facilities owned by LGUs,
and then facilities owned by private entities;

d. Isolation and quarantine facilities such as temporary treatment and

monitoring facilities and converted facilities (e.g. hotels, schools, etc) that
cater to COVID-19 suspect, probable, and confirmed cases, close contacts,
and travellers in quarantine;

e. Remaining hospitals including facilities of uniformed services not catering

to COVID-19 cases;

f. Government owned primary care based facilities such as Urban Health

Centers, Rural Health Units and Barangay Health Stations, birthing homes,
and Local Health Offices to include members of BHERTS, contact tracers,
social workers;

g. Stand-alone facilities, clinics and diagnostic centers, and other facilities

otherwise not specified (e.g. clinics, dialysis centers, dental clinics, and
COVID-19 laboratories), dealing with COVID-19 cases, contacts, and
specimens for research purposes, screening and case management
coordinated through their respective local government units; and

h. Closed institutions and settings such as, but not limited to, nursing homes,
orphanages, jails, detention centers, correctional facilities, drug treatment
and rehabilitation centers, and Bureau of Corrections.

Sub-prioritization for other priority groups, and their respective exhaustive lists,
shall be released in succeeding issuances.

C. Zoning Allocation Process for Vaccines with Sensitive Handling

1. Based on prioritization criteria and indicative supply by batch, allocation of

vaccines for vaccination sites shall be by geographic zones incorporating
pragmatic considerations such as availability of appropriate storage facilities,
vaccination sites, or access roads.

Centers for Health Development (CHD), as well as the Ministry of Health -

Bangsamoro Autonomous Region in Muslim Mindanao, guided by the Field
Implementation and Coordination Team (FICT), shall determine the appropriate
zoning for each region.

Each zone shall jointly develop micro plans for the joint undertaking of the
vaccination program, especially regarding choice of vaccination sites or storage
facilities, designation of human resources for vaccination and adverse event
monitoring, transport of potential vaccine recipients, scheduling, health care
provider referral for AEFI and follow-up processes, among others.
 4. Each health facility, local government, or institution shall submit an attestation
of the total numberof potential vaccine recipients to the CHD for file keeping.
Attestation forms must be in official letterheads signed by the head of the
institution and must include total number of eligible vaccine recipients, total
number of validated vaccine recipients willing to be vaccinated, their quick
substitution list and rationale for choice of alternate facility, and confirmation
that identified recipients and sites are consistent with national guidelines for the
COVID-19 immunization program.

CHDs, with the guidance of FICT, shall allocate vaccines per zone in
accordance with tray, batch, and logistic considerations.

If there are remaining stocks for delivery, FICT shall identify next eligible
facilities using the prioritization framework.

D. Preparation of the Quick Substitution List (QSL)

1. To minimize vaccine wastage, vaccination sites or zones shall prepare a quick

substitution list (QSL) in case of non-attendance of the initially identified
eligible recipients of the vaccines.

QSLs shall include eligible recipients from facilities or sites within the same
zone, province, highly urbanized city, or independent component city, provided
that identification of recipients is based on the same priority group. QSLs shall
not include eligible recipients from vaccination sites included in the allocation
list of the current batch of vaccines.

During the vaccination day, and in case of non-attendance, the hospital should
first attempt to vaccinate its healthcare workers that are scheduled in the
succeeding days.

If the initial list of identified recipients is exhausted, the vaccination site can
then tap the recipients from the QSL. Vaccination of eligible recipients from the
next priority group shall be the option of last resort.

It should be noted that no patient in active disease or with COVID-19

symptoms, as defined in Department Memorandum No. 2020-0512 entitled
“Revised Omnibus Interim Guidelines on the Prevention, Detection, Isolation,
Treatment, and Reintegration Strategies for, should be vaccinated.

Preparations for transporting vaccines to the QSL should be part of

microplanning.

E. Masterlisting
1. The COVID-19 Vaccine Information Management System - Immunization
Registry (VIMS-IR) shall be the official platform for master listing and pre-
registration of individuals for COVID-19 vaccination.

Data standards and masterlisting processes shall be reviewed after the Phase 1
pilot in workers in frontline health services before implementation in
succeeding phases. This includes the ability for External systems to be used to
 submit the necessary information following the Minimum Required Data Fields
for Vaccine Registration Systems.

DOH CHDs shall consolidate a list of eligible potential vaccine recipients.

Compliance to the data privacy act in processing personal information shall be

ensured by the CHDs.

All health facilities and LGUs shall submit required data for masterlisting to the
province/ highly urbanized cities/independent component cities, through any of
the following methods:

a. Vaccine Information Management System - Immunization Registry (VIMS-

IR);

b. Information system of the LGU linked to the VIMS-IR through an

application program interface (API) or through the secured file transfer
protocol (SFTP) of VIMS-IR;

c. Dataset consistent with prescribed formats for bulk uploading through the
information system; or

d. Dataset consistent with prescribed formats for bulk uploading through the
assistance of DOH CHDs.

e. For areas without connectivity, individuals within the priority sectors can
manually fill out a physical form and submit it to the Human Resource
Office of the facility. The HR Office shall consolidate it for submission to
the LGUs. The LGU shall then encode the forms to the system and submit
it to the CHDs. HR Offices of hospitals, CHDs, and LGUs shall dedicate a
personnel to accommodate manual submissions, although electronic
submissions are most preferred for the VIMS-IR

F. Microplanning
1. Microplanning shall be conducted by all LGUs and implementing units, after
submission of masterlists, QSLs and/or training of health workers. A readiness
assessment tool shall be used to assess and monitor the implementation of the
plan, and determine and address identified issues and gaps
(www.tinyurl.com/covidvaccineRA & www.tinyurl.com/microplanningcl19).

2. The following critical steps in microplanning shall be conducted:

a. Determination of the number of eligible populations for COVID-19

vaccination in
the facilities. Alternatively, upon guidance of the DOH CHD
Director IV, a QSL shall be provided to the implementing facility;

b. Identification of implementing departments/units in the facility, of the

number of vaccination sites/posts, and of an operational spot map;

c. Designation of supervisors, vaccination teams, Adverse Events Following

Immunization (AEF])/ Adverse Events of Special Interest (AESI) composite
teams, and other personnel needed and available for the vaccination activity;
 d. Identification of vaccination teams needed based on the number of eligible
population;

e. Listing of all vaccination posts/geographic sites, including non-health

facilities (e.g. schools, covered courts), with updated addresses, geographic
coordinates, and landmarks;

f. Assignment of potential vaccine recipients and teams to an implementing

unit / vaccination post/site;

g. Assessment of cold chain capacity at all levels and cold chain equipment
needed;

h. Estimation of eligible population groups, either willing or not willing to be

vaccinated;

i. Estimation of the vaccine requirement, AEFI emergency kit and ancillary

supplies needed;

j. Timely delivery of vaccines and ancillary logistics;

k. Training of human resources for health;

1. Preparation of a Daily Vaccination Session Plan (daily itinerary);

m. Development of a communication plan for facility and/or community

advocacy, social mobilization, partnership and engagement;

n. Development of a supervision and monitoring plan and schedule;

o. Preparation of an AEFI/AESI management, surveillance and response plan.

This includes training on how to manage AEFI, risk communication and
reporting; and

p. Development of a waste management plan, clearly describing how, when,

where, and who will collect, transport and discard immunization waste,
including PPE wastes, consistent with Department Memorandum 2021-
0031 entitled “Interim Guidelines on the Management of Health Care
Wastes generated from COVID-19 vaccination”.

. Micro plans shall be validated and consolidated per zone, province, highly
urbanized city, or independent component city, ensuring collection and
consolidation from levels of municipalities. The province/ HUC/ ICC shall
submit consolidated microplans to the CHDs for concurrence, assessment of
gaps, technical assistance, and finalization.
Status of micro plans shall be consolidated nationally through the FICT for
progress and performance monitoring. Local government readiness shall be
considered in allocation and distribution plansof
the national government.

. Local governments and health care provider networks in zones shall ensure that
designated vaccination sites fulfill standards set by the Department of Health.
The Regional Vaccine Operations Center (RVOC) shall ensure readiness of
identified vaccination sites by providing technical assistance, corrective actions,
 and conduct of simulation. Allocation of vaccines shall be dependent on
readiness of the vaccination sites for vaccine-specific requirements. A separate
issuance shall be provided to outline the standards and quality assurance for
sites.
vaccination

All LGUs shall designate referral hospitals within their health care provider
networks for the management of AEFI/AESI. All vaccination sites shall be
linked to a licensed health facility for accountability, with clearly identified
health care provider network relationshipsfor referral, and case management.

All CHDs and the Ministry of Health - Bangsamoro Autonomous Region in

Muslim Mindanao shall establish and regularly convene Regional AEFI
Committees (RAEFIC) within their areas of jurisdiction. The RAEFIC shall
primarily conduct the causality assessment of investigated AEFIs, review the
status of safety surveillance, and provide expert recommendations to the
Regional Vaccine Operations Center for the improvement of the immunization
program.

. All Local Vaccine Operations Center shall set up 24/7 hotlines through various
means of communication for the general public to convey their general concerns
on vaccination and referral for AEFIs.

G. Logistics, storage, and handling

1. Shipment and acceptance of vaccines and ancillary immunization commodities

shall follow the Department Memorandum No. 2021-0053 entitled, “Interim
Guidelines on the Shipment and Acceptance of the COVID-19 Vaccines and
Ancillary Immunization Commodities.”

Vaccines shall be inspected by the DOH Inspection and Acceptance Committee

for COVID 19 Vaccines and Related Ancillary Supplies, which was
reconstituted through Department Personnel Order No. 2021-0215, upon arrival
at the main warehouse facility prior to distribution to vaccination sites. The
Inspection and Acceptance Committee shall ensure that vaccines are of good
quality upon arrival and that full documentary requirements are present,
including but not limited to the shipping documents, invoice, and packing list.
Similarly, CHDs, LGUs, and identified recipients shall assess the quality of
vaccines upon receipt.

Cold chain management requirements shall be maintained from manufacturing,

storage, and distribution of vaccines to ensure integrity of vaccine compounds.
Vaccine cold chain storage facilities shall be assessed by the Research Institute
for Tropical Medicine and Supply Chain Management Service of the DOH.
Particular requirements and constraints on temperature maintenance for
transport, storage and administration of vaccines shall be maintained.

As the different types of vaccine require varying temperature storage

requirements, (1) ultra-cold (-70°C to -80°C), (2) frozen (-15°C to -25°C), and
(3) refrigerated (2°C to 8°C), vaccine-specific policies shall be developed in
consideration of differences in handling and storage requirements of vaccines.
 5. Transport of vaccines and other ancillary commodities shall be assisted by
uniformed personnel such as the Philippine National Police and others as may
be designated to ensure vaccine security.

CHDs, LGUs, and identified recipients of vaccines and ancillary commodities

shall develop their distribution plan appropriate to their situation, including
inspection process prior to acceptance and timelines to avoid vaccine spoilage.

H. Training of Health Care Workers

1. The Regional Vaccine Operation Center shall conduct orientation and training
to all health staff from local health offices and other stakeholders for COVID-
19 vaccination. In light of the ongoing pandemic, online training is
recommended. For those conducting face-to-face training, adherence to MPHS
shall be strictly enforced at all times.

EPI Managers shall verify the awareness of health personnel on important

knowledge for the COVID-19 vaccination program, including but not limited to
IPC measures during mass vaccination, vaccine-specific management, and
AEFI/AESI management.

I. Vaccination Process
1. Pre-vaccination screening

a. Eligible vaccine recipients belonging to special populations like those in

immunodeficiency state and senior citizens with special conditions (i.e.
bedridden, those who are in a vegetative state, and those with limited life
expectancy) shall obtain medical clearance from their attending physicians
to discuss vaccine specific risks and benefits of vaccination to the unique
situation of the patient.

2. Scheduling

a. Each potential vaccine recipient included in the masterlist shall be assigned

to a specific vaccination site and a specific vaccination team. Prior to the
vaccination, the potential vaccine recipient will be provided with a
vaccination date and time schedule, and a unique identifier which he/she
will bring to the vaccination post, to ensure smooth implementation of the
vaccination activity and to avoid congestion in the vaccination site/post.

b. No walk-in vaccination shall be accommodated since vaccines allocated for

of
the day are sufficiently assigned for the projected number vaccinations to
be conducted in a day.

c. Vaccine recipients identified in the pre-determine QSL shall be made aware

of possible schedules for substitution in case of non-attendance of the

originally scheduled recipients.

d. Scheduling for vaccination shall be made by local governments or zones, in

accordance to available supply and deliveries. The VIMS platform shall also
enable use of information and communications technology for scheduling,
notification, and vaccination reminders.

10
3. Registration
a. All potential vaccine recipients shall be registered using their unique
identifiers as identified during the masterlisting process such as but not
limited to full name and birthday, PhilHealth Identification Number (PIN),
system generated alphanumeric or QR or Unique Codes, or similar.

PhilHealth shall ensure availability of mechanisms to retrieve PIN of all

recipients with current membership prior to vaccination day or on-site, and
facilitate registration of recipients who are not yet registered under the
National Health Insurance Program guided by PhilHealth Circular No.
2018-0008.

All potential vaccine recipients shall also present any government issued
identification card such as PRC license, driving license, UMID, PhilHealth
ID, passport. In case of no government ID with picture, patients may present
any government documents such as cedula, barangay certificate, birth
certificate.

Each potential vaccine recipient should be provided a copy of the vaccine

specific fact sheet summarizing contents of the EUA, health screening form
and informed consent forms upon arrival to vaccination posts. For reference,
sample templates for the Pfizer-BioNTech COVID-19 Vaccine can be
accessed in this link: bit.ly/RESBAKUNAMaterials

As deemed appropriate and necessary by the Local Vaccine Operations

Center (LVOC)/implementing unit, the EUA of the vaccine can be
supplemented with the provision of other IEC materials developed by TG
Demand Generation and Communications, as contained in the following
link: http://bit.ly/COVID19VaxMaterials4Partners

4. Screening
a. At the screening area, the personnel assigned shall scan the patient’s QR or
Unique Code. Eligible vaccine recipients shall be clinically assessed for
COVID-19 symptoms, comorbidities, and other important clinical
information. Contraindications and precautions stated in the EUA of FDA,
as well as recommendations from the HTAC, shall be followed for all
vaccines.

Using both the VIMS Vaccination Post System (VPS) and hard copy of the
screening form, the health worker shall update the profile of potential
recipients and determine whether or not they are eligible for vaccination.

Individuals not belonging to special population groups may have their health
profiling, provision of informed consent, and screening on the same day of
vaccination.

The health screening form shall be used in screening the eligible vaccine
recipients. (See Annex A) Specific health screening (e.g. age, allergy to
vaccine components) may be adopted per vaccine and shall be issued in
vaccine-specific guidelines. Likewise, health screening for vaccination shall
foliow clinical practice guidelines of medical societies, which should be

11
regularly updated based on best available evidence. The recommendations
from the Philippine Society for Microbiology and Infectious Diseases
(PSMID) including recommendations from NITAG are
adopted to develop
the interim decision algorithm for the COVID-19 vaccination program.
i. The vaccination of persons falling under the following categories
must be deferred and rescheduled until resolution of specific
conditions:

(a) Persons presenting with symptoms such as_ fever/chills,

headache, cough, colds, sore throat, myalgia, fatigue, weakness,
loss of smell/taste, diarrhea, shortness of breath/ difficulty in
breathing, and rashes shall be referred to a physician for clinical
evaluation. These individuals may be vaccinated with the
COVID-19 vaccine only after full recovery from the acute illness
as certified by their attending physician based on current
management guidelines.

(b) Persons with a history of exposure to a confirmed or suspected

COVID-19 case in the past 2 weeks may be vaccinated only after
completion of the 14-day quarantine period.

(c) Confirmed COVID-19 patients may be vaccinated after 90 days

from the last day of isolation or treatment, regardless of disease
severity.

(d) Persons who received convalescent plasma or monoclonal

antibodies for COVID-19 may be vaccinated 90 days from the
last day of plasma/ monoclonal antibody treatment.

(e) Women belonging to Priority Al of workers in frontline health

facilities who are in their first trimester of pregnancy may be
vaccinated after the first trimester.

(f) Persons who received any other typeof vaccine in the past 2
weeks should be rescheduled after completion of two weeks
interval.

il. Immunocompromised persons under the following category shall

consult their attending physician or a primary care provider to
obtain clearance prior to vaccination for appropriate patient
education on the risks and benefits of vaccination. Specific
qualifiers indicated shall be considered in the assessment of the
health care worker.

(a) For persons with autoimmune disease, if the patient is in

remission.

(b) For persons living with HIV, if the patient’s current CD4 count
is low andif the patient is on treatment.

12
 (c) For persons with cancer or malignancy, if the patient is
undergoing or have immediate plans for chemotherapy, or in is
remission.

(d) Fortransplant patients, if the patient is on immunosuppressants

or in remission.

(e) For persons who use steroids, if the dose and duration of steroid
use is more than 2 weeks or dose is higher than 20 mg daily for
prednisone.

(f) For persons who

are elderly, bedridden, in a vegetative state, or
with poor prognosis such as those with limited life expectancy
of less than
6 months.

iii. Additional precautions must be implemented to the following:

(a) Persons with a history of bleeding disorders or currently taking
anticoagulants should be vaccinated using a gauge 23-25
syringe. Firm pressure shall be applied after vaccination to avoid
formation of a hematoma.

(b) Persons with a previous history of anaphylaxis, with allergies to

food, egg, medicines, and persons experiencing asthma shall be
observed for 30 minutes after vaccination.

(c) Persons who do not meet any of the criteria otherwise stated shall
be observed for 15 minutes after vaccination.

iv. Persons falling under the following categories may be vaccinated

with the COVID-19 vaccine:

(a) Breastfeeding women

(b) Persons who received immune globulins

5. Health Education

a. There shall be a dedicated health education area for the whole vaccination
site/post. In this area, Information, Education, and Communication (IEC)
materials, such as pamphlets, leaflets, and brochures shall be made
available. Also, a projector or a TV shall be set up in this area, or the least,
a flipchart, for health education purposes.

b. The general process for the health education area shall be aligned with the
steps detailed in the Philippine National COVID-19 Deployment and
Vaccination Plan for COVID-19 Vaccines.

i. Grouping the vaccine recipients (if applicable, to at least 6-12

individuals).
ii. Sharing an explainer video (or explainer poster, for areas that may
experience technical difficulties) on COVID-19 vaccines to the
group of vaccine recipients.

13
 iii. Encouraging the vaccine recipients to ask questions and
clarifications and then addressing issues that they may have.

iv. If not yet previously covered in the shared explainer, providing

information on the COVID-19 vaccine made available at the
vaccination site - what it is, how it protects, administration and
possible side effects.

v. Explaining to the vaccine recipients that he or she may opt to

receive the 2nd dose from another facility provided that the 2nd
dose is the same brand as the Ist dose.

vi. Instructing the patient on post-vaccination care:

(a) Put an ice pack/ice on the injection site for 15 minutes three
times a day, in the first 24 hours after vaccination. Report any
AEFIto the clinic/hospital.

(b) For any serious AEFI, proceed immediately to the nearest

Emergency Room.

vii. Providing additional IEC materials (pamphlets with FAQs, etc) at

suitable reading levels to the vaccine recipients and available in
recipients’ local language. The following link provides for IEC
materials developed by TG Demand Generation and
Communications that can be used in vaccination sites:
http://bit.ly/COVID19VaxMaterials4Partners

viii. Providing Vaccine Information Statements (VIS) or EUA forms,

if required.
ix. Asking the vaccine recipients to sign the final consent form.

x. Directing the patient to the Screening Area.

Vaccine recipients shall sign two (2) copies of the informed consent form.
One
copy shall be provided to the patient and one kept by the vaccination
facility.

The informed consent form shall be made available online so that vaccine
recipients may download it in advance and sign it on the day of vaccine
administration after dialogue with the vaccine administrator.

The informed consent form shall contain the following pertinent

information:

i. Statement specifying that the vaccine recipient understands that

the vaccineis an investigational drug and that they were shown the
fact sheet of the EUA;

ii. Statement declaring that the vaccine recipients were assessed

using the health screening form to ensure that those who are
at risk
will be managed and referred appropriately;

14
 ii. Statement declaring that the vaccine recipients were assessed using
the health screening form to ensure that those who are at risk will
be managed and referred appropriately;

iii. Name of the specific facility or the primary care provider that the
vaccine recipient may contact or visit for follow up after
vaccination in case of any symptoms; and

iv. Statement disclosing that all data collected throughout the

COVID-19 vaccination program will be used for public health
purposes.
f. Different IEC materials and informed consent forms may vary for each
vaccine due to
the different legal requirements for each supply agreement.

6. Vaccine Administration

a. The potential vaccine recipient shall wait in a designated area prior to

immunization, The Safety Officer shall ensure that physical distancing
measures are implemented in the waiting area at all times.

The potential vaccine recipient shall be directed to the Vaccination Area

where the vaccine will be administered. The vaccinator shall check that the
vaccine to be administered is not expired and has been stored in the
appropriate temperature and shall strictly comply with the instructions of
the product label of the vaccine product.

Only licensed physicians or nurses may be vaccinators for vaccines under

Emergency Use Authorization. Pharmacists may administer
FDA-approved vaccines provided that they undergo training from
Professional Regulation Commission-accredited institutions. Midwives
may assist in the vaccination.

Vaccines shall be drawn up in a designated clean medication area that is

not adjacent to areas where potentially contaminated items are placed.
Multi-dose vials to be used for more than one patient should not be kept or
accessed in the immediate patient treatment area. To prevent
contamination of the vial, cleanliness and absence of potentially
contaminated equipment shall be ensured at
all times.

Prior to inoculation, vaccinators shall ensure that vials do not contain any
indications of possible contamination and chemical reactions due to
mishandling (e.g. discoloration, presence of particulates), as provided in
the vaccine-specific policies issued by the DOH. In such cases, these vials
shall be disposed following set protocols.

Once vaccinated, the QR or Unique Code shall be scanned and the

vaccination details (e.g. date of vaccination, vaccine manufacturer, batch
number, lot number, name of vaccinator and signature) shall be recorded in
the Vaccination Post System (VPS) and immunization card.

Specific vaccine administration strategies may be adopted per vaccine.

Likewise, these shall follow clinical practice guidelines of medical

15
 a. After vaccination, the vaccine recipient shall be observed for adverse events
for 15 minutes at the post-vaccination monitoring area. If the recipient has
a previous history of asthma, anaphylaxis, and or allergies to food, egg,
medicines, the observation time shall be extended to 30 minutes. The post-
vaccination monitoring area must be closely linked with an identified
referral health facility. In the event of life-threatening adverse events
manifesting as anaphylaxis or severe allergic reactions, health care
providers in the post-vaccination monitoring area must be able to provide
emergency treatment and resuscitative measures, such as administration of
live-saving medicines and basic life support. In case of limited human
resource of health availability, those who can provide the necessary
treatment even if beyond their respective service capability or professional
capacity, shall not be liable for any harm involvedas long as the benefit of
providing treatment outweighs the risk of not providing treatment in dire
situations with a high likelihood of death.

b. Upon release from observation, vaccination staff must inform the vaccine
recipient of specific facility, hotlines, and contact numbers for follow up and
for reporting of any AEFI.

c. A standardized physical vaccination card (see Annex B) shall be given to

vaccine recipients to ensure completion of the two doses and to enable
monitoring of adverse events. The physical vaccination card must be printed
by the facility/LGU in line with printing standards set by the DOH. The
scheduled date for the second dose shall be indicated in the 2nd dose box in
the physical vaccination card.

d. An electronic version of the vaccination record shall be made available

through a secured search platform developed by Department of
Information
and Communications Technology (DICT) for designated users to verify the
vaccination status of patients in the Vaccine Information Management
System or VIMS.

e. Vaccine recipients who experience adverse events following immunization

(AEFI during the post-monitoring period at the vaccination site shall
immediately be brought to designated health facilities within their
healthcare provider networks. The LGU shall ensure capacity of the
to
facilities to provide healthcare in response the event and ensure the timely
detection, notification, reporting and investigation of AEFIs.

8. Patient Follow-up

a. Monitoring of AEFI shall be done up to 1 year from date of vaccination

through the vaccination site or through the vaccine recipient’s primary care
provider. LGUs shall ensure the availability of primary care providers, in
compliance to standards set forth by DOH and PhilHealth, and that all
vaccine recipients are assigned to a primary care provider for monitoring for
at least a year post-vaccination.

b. LGUs shallensure that vaccine recipients are notified and reminded about
their second dose, follow-up, and other relevant announcements utilizing

16
 both local mechanisms and information and communications technology
platforms.

J. Adverse Event Following Immunization (AEFI) and Referral

1. AEFIs shall be defined as any untoward medical occurrence which follows
immunization and which does not necessarily have a causal relationship with
the usage of the vaccine. AEFIs may be classified based on seriousness, or based
on cause.

a. Serious AEFIs are defined as events that results in any of the following
outcomes:

i. death;
ii. hospitalization or prolongation of an existing hospitalization,
iii. persistent or significant disability or incapacity;
iv. congenital anomaly or birth defect;

Or an event that may be

v. life-threatening; or
vi. a medically important event or reaction

b. Non-serious, or minor AEFIs are AEFIs that are not included or categorized
as serious AEFIs, or do not pose a potential risk to the health of the recipient.
i. Non-serious AEFIs include, but are not limited to, local adverse
events (such as pain, swelling, redness) and systemic reaction
(fever) that are expected after immunization as part of the immune
responseof the vaccine recipient to induce immunity.

il. Non-serious AEFIs should also be carefully monitored because

they may signal a potentially larger problem with the vaccine or
vaccination or have an impact on the vaccination acceptability; in
general.

c. An adverse event of special interest (AESI) is a pre-specified 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 special studies.

i. Shortlisting of conditions to be considered as AESIs for active

surveillance, and their respective notification and reporting
process shall be provided in a separate issuance, and regularly
reviewed upon expert recommendations.

d. Cause-specific definitions of AEFIs are as follows:

i. Vaccine product-related reactions are AEFIs caused or
precipitated by a vaccine due to one or more of the inherent
properties of the vaccine product.
ii. Vaccine quality defect-related reactions are AEFIs caused or
precipitated by a vaccine that is due to one or more quality defects

17
 of the vaccine product including its administration device as
provided by the vaccine manufacturer.

iii. Immunization error-related reactions are AEFIs caused by

inappropriate vaccine handling, prescribing or administration.

iv. Immunization anxiety-related reactions are AEFIs arising from

anxiety about the immunization.

v. Coincidental events are AEFIs caused by something other than the

vaccine product, immunization error or immunization anxiety.

2. The health care providers who administered the COVID-19 vaccine to

recipients shall be primarily in charge of regularly monitoring AEFIs among
those individuals until one year after vaccination.

a. All vaccine recipients shall monitor themselves for any adverse events
within the prescribed time frame, and regularly report to their respective
primary care provider on their experience.
All vaccination sites shall ensure that proper and appropriate guidance
communicated to and understood by each vaccine recipient regarding the
is
regular monitoring of their health status, with mechanisms and schedules
for follow-up.

All local vaccination operations centers shall ensure that vaccination sites
regularly and actively monitor the vaccine recipients they have provided
services for.

i. In case of unavailability of the vaccination site within the time

frame of monitoring due to closure, or other causes; change in
residence of the vaccine recipient, or other causes that may hinder
the monitoring of AEFIs from the vaccine recipient, the LVOC
shall enact mechanisms to ensure that adequate monitoring is still
conducted among these vaccine recipients.

3. Health care providers shall appropriately manage patients’ conditions according

to clinical assessment regardless of the seriousness or causality of the AEFI.

a. sees that the patient warrants further evaluation and

If a health care provider
clinical management, referrals shall be coursed through the respective health
care provider networks within their locality.

All vaccination sites shall provide corresponding assistance to vaccine

recipients experiencing AEF Is.

All vaccination sites shall ensure that proper and appropriate guidance
communicated to and understood by each vaccine recipient regarding the
is
contact information or health facilities for the vaccine recipient’s primary
referral in case of health emergencies outside the vaccination site.

All vaccination sites shall ensure that serious AEFI cases are provided with
immediate assistance which may include hospitalization and transport to the
appropriate health facility, within the configuration of their respective health

18
 care provider network. PhilHealth coverage of hospitalizations shall be in
accordance with the rules and regulations of the National Health Insurance
Program. Transportation arrangements shall be provided by the vaccination
site, in coordination with existing service providers in the locality, and the
local government unit in charge.

e. All vaccination sites shall prepare for AEFIs during the vaccination proper
in terms of human resource capacity, medications and commodities, as
recommended by clinical practice guidelines and expert recommendations.

f. All health facilities shall be prepared to receive AEFIs within their

respective service capability. They shall also fortify mechanisms on referral
and ensure that contingency plans are in place.

g. Local vaccination operations centers (LVOC) shall ensure that health

facilities are prepared to receive AEFIs within their respective service
capability, and mechanisms for and contingency plans for referral are in
place.

h. RVOCs, CHDs, RAEFICs, and LVOCs shall regularly monitor and assess
the status of safety surveillance at the sub-national level, including but not
limited to AEFI monitoring, through formal and informal feedback and
provide corresponding responsive risk communication and immunization
safety interventions.
i. At the national level, the Sub-Task Group Safety Surveillance and
Response, shall lead in overseeing the functionality of stakeholders in
performing their respective functions across the safety surveillance cycle.

. AEFFIs are classified as a notifiable health event of public health concern, in

accordance with the 2020 Revised Implementing Rules and Regulations of
Republic Act No. 11332, or the Mandatory Reporting of Notifiable Diseases
and Health Events of Public Health Concern Act.

a. All health care providers shall notify and report AEFIs regardless of
seriousness, to the local vaccinations operations centers and to the National
Government through the appropriate electronic platform, with the minimum
data fields requested, within the appropriate time frame requested.

b. All government and non-government licensed hospitals serving as

sites
vaccination shall submit directly to an electronic platform through their
Hospital Epidemiology and Surveillance Units.

c. All other vaccination sites shall submit through the respective local
vaccination operations center providing oversight to their operations.

d. All local vaccination operations centers at the municipal and component city
levels shall ensure that the vaccination sites within their respective
jurisdiction of oversight observe proper, timely and accurate notification of
detected AEFIs.

19
 e. All regional, local vaccination operations centers, and hospital vaccination
sites shall designate an AEFI focal person for coordination, capacity-
building, and authorization purposes.

5. Local Vaccination Operations Centers shall ensure the functionality of an AEFI

Investigation Team that shall conduct timely and comprehensive AEFI
investigations following the standard epidemiological investigation principles
to be continually reviewed based on guidance from the World Health
Organization, with expert recommendations from the National AEFI
Committee.

a. All health care providers shall cooperate with the AEFI Investigation Team
in terms of provision of copies of medical records and other paraphernalia
that may aid investigation and causality assessment, in accordance with
Republic Act 113322 or the “Mandatory Reporting of Notifiable Diseases
and Health Events of Public Health Concern Act”.

The National and Regional AEFI Committees shall determine the final causality
assessment through systematic methodologies, in accordance with the latest
guidance from the World Health Organization, and other reputable
organizations.

a. AEFIs that shall undergo detailed case investigation and causality

assessment will be based on the guidance from the COVID-19 Vaccines:
Safety Surveillance Manual of the World Health Organization, with expert
recommendations from the National AEFI Committee.

Data, information generated from the AEFI monitoring system, and

recommendations from the National AEFI Committees shall be utilized in the
continuing quality improvement of
the immunization program and upholding of
vaccine safety.

K. Data and Record Management

1. The VIMS, developed and maintained by the DICT, shall be used as the main
platform for vaccine related interventions for immunization, supply chain and
logistics management. The following information systems developed by the
DOH shall be linked to the VIMS:
,

a. The COVID-19 Bakuna Center Registry (CBCR), a complete listing of all

vaccination sites in the country both in public and private shall be used by
the local and national government in monitoring and managing vaccination
sites being set-up across the whole country. Registration in the CBCR is
important most especially in coordinating with third-party logistics.

b. The Vaccination Quick Count, a dashboard which will visualize critical

indicators from the vaccination sites on a daily basis, shall provide regional
and local vaccination operations centers (RVOCs and LVOCs) with timely
data. Itwill provide insights on what is happening on the ground especially
on areas that require urgent actions. Following are the roles and
responsibilities on its implementation:

20
 i. The vaccination site supervisor shall be in charge of the daily
reporting at vaccination sites.

ii. The CHDs shall be responsible for managing and responding to

inquiries on the system and compliance to data submissions.

. LGUs with existing information systems or applications who expressed interest

to connect to national COVID-19 vaccination information systems shall
coordinate with the DICT. CHDs, through the RVOC shall assist to facilitate
this process.

. Any paper record for individual vaccination including the informed consent
form shall be classified as a permanent vaccination record. All health facilities
shall have proper storage protocols in compliance to health record management
guidelines to ensure safekeeping and data protection.

. Any paper record at vaccination sites is under the responsibility of the

vaccination site supervisor. The supervisor is also responsible for daily
reporting in the vaccination quick count.
. All authorized entities that have the mandate or legitimate purpose to process
COVID-19 vaccination-related data shall be considered as personal information
controllers (PIC). LGUs shall be responsible for the management of all personal
data collected from barangays and local vaccination sites in their jurisdiction
while CHDs shall be accountable for all personal data from regional vaccination
centers including those endorsed/migrated to their system. As PICs, they are
expected to uphold transparency, legitimate purpose and proportionality in all
the stages of data processing (i.e., collection, duplication, storage, disposal,
etc.). They shall practice the highest applicable protection measures in
processing personal and sensitive personal information in accordance with the
standards for data privacy and security as prescribed in the Data Privacy Act of
2012; issuances by the National Privacy Commission (NPC) and DICT; and
other applicable legislations. At the minimum, CHDs shall enforce the
following:

a. They must have a designated or appointed Data Protection Officer or

Compliance Officer for Privacy, who shall be accountable for all data
privacy-related activities.

b. Privacy Notice or Privacy Policy shall be posted on conspicuous

places within the vaccination facility. Paper-based forms used in
collecting personal data shall indicate all information needed by the
data subject, such as:

i. contact information of the data protection officer;

li. data processing that will be to their personal data; and

done

iii. individuals that will have access to their personal data.

c. In case of breach or report of possible breach, units are advised to

follow the prescribed procedures from NPC Circular No. 2016-03:
Personal Breach Management.

21
 L. Demand Generation Activities
1. LGUs shall plan and implement demand generation and communication
activities in accordance with the DILG Memorandum Circular 2021-019,
entitled “Guidelines on the Implementation of Demand Generation Activities in
support to the National COVID-19 Vaccine Deployment Plan” and ensuring
coverage of all priority population groups.

LGUs shall provide regular updates to the CHDs on their identified microplan
demand generation and communication activities, and on their collected social
listening data, as provided and described in the Demand Generation Playbook
(tinyurl.com/DemGenPlaybook).

CHDs shall
provide bimonthly updates to the TG Demand Generation and
Communications on the progress of
activities based on microplans.

CHDs shallensure feedback mechanisms and social listening by a) reporting

frequently asked questions, misinformation, and rumors weekly to the TG
Demand Generation and Communications, b) disseminating the online sectoral
survey monthly, and c) consolidating encoded submissions of the COVID-19
vaccines face-to-face survey by provinces and highly urbanized cities.

CHDs shall disseminate COVID-19 vaccine IEC materials and ensure

alignment of localized materials with the RESBAKUNA: Kasangga ng BIDA
branding guidelines.
M. Templates
All standard templates, collaterals, and FAQs may also be accessed at DOH
website or through the following link: bit.ly/RESBAKUNAMaterials.

This Order shall take effect immediately.

SCO T/ DUQUE HI, MD, MSc

22
ANNEX
A. Health Assessment Form
Access the document here: bit.ly/RESBAKUNA Materials

—
~~
Nw Nt
Sik HEALTH DECLARATION SCREENING FORM
of the Philippine National COVID-19 Vaccine Deployment and Vaccination Program

Sa
hadianad

YS a1 3) nie

Age more than 16 years old?

|

O |

a
Has no
allergies to PEG or polysorbate? a Q

of the vaccine? a
|

Has no
severe allergic reaction after the 1st dose Q

Has no allergy to food, egg, medicines and no asthma? |

2 Q

> If with allergy or asthma, will the vaccinator able to monitor the patient for 30 Q oO
minutes? }

a
|

Has no
history of bleeding disorders or currently taking anticoagulants? Q

> If with bleeding history, is a gauge 23 - 25 syringe available for injection? Q Q

Does not manifest any of the following symptoms:

QO
Fever/chills QO
Fatigue
Q Headache Q Weakness
Q
Q
Cough
Colds
Q
Q
of
Loss smell/taste
Diarrhea
Q Q

Q Sore throat Q Shortness of breath/difficulty in |

Q- Myalgia breathing |

Q Fatigue

Has no history of exposure to a confirmed or suspected

weeks?
COVID-19 case in the past 2 Q Q

Has not been previously treated for COVID-19 in the past 90 days? Q Q

Has
not received any vaccine in the past 2 weeks? a Q

Has not received convalescent plasma or monoclonal antibodies for COVID-19 inthe
past 90 days?
|

a a
Not Pregnant? 9 Qo

> If pregnant, 2nd or 3rd Trimester? Q Q

Does not have any of the following diseases or health condition?

O HIV
Q Cancer/ Malignancy Q Q
Q sUnderwent Transplant
Q Under Steroid Medication/ Treatment
Q Bed ridden, terminal illness, less than 6 months prognosis

if with the abovementioned condition, has presented medical clearance prior to

vaccination day?
QO
a

Recipient's Name: VACCINATE

Birthdate: Sex:

Signature of Health Worker:

—
tes. HEALTH ASSESSMENT ALGORITHM
aes
ey keel COVID-19 Vaccine Deployment and Vaccination Program
of the Philippine National

ASSESS THE VACCINE RECIPIENT

Is the patient any of the following?

Age < 16 years old

With allergy to PEG or polysorbate en elm7 Ceol Nas
With severe allergic reaction after the
vaccine
1st dose of the

SPECIAL PRECAUTION

OBSERVE FOR 30
With allergy to food, egg, medicine?
MINS

Have history of bleeding disorders or currently taking

Pr serseTeed
OSE OLY
cia
PRESSURE

DEFER

Manifesting any of the following symptoms:

NO Ne
REFER TO MD. *

—~
YES
° Fever/chills, headache, cough, colds, sore throat, myalgia,
fatigue, weakness, loss of smell/taste, diarrhea, shortness of
RECOVERY.
breath/difficulty in breathing

RESCHEDULE
YES
NO Have history of exposure to confirmed or suspected COVID-19 AFTER
in the past 2 weeks?
VACCINATE

case QUARANTINE
COMPLETION

NO YES
Have been previously treated for COVID-19 in the past 90 RESCHEDULE
days? AFTER 90 DAYS

|__NO Have received convalescent plasma or monoclonal

for COVID-19 in the past 90 days?
antibodies
YES RESCHEDULE
AFTER 90 DAYS

No IF IN
YES RESCHEDULE
Pregnant? FIRST TRIMESTER

th
YES
NO
—_—_—_- Have received any vaccine in the past 2 weeks? RESCHEDULE

e With autoimmune disease?

YES
e Diagnosed with HIV?
NO e Diagnosed with Cancer/Malignancy?
GET CLEARANCE FROM
e —Underwenttransplant? ____...
ATTENDING PHYSICIAN
e —_Under
steroid treatment or medication?
e Bed ridden, terminal illness, less than 6 months
prognosis
ANNEX B. Vaccination Card
Access the document here: bit.ly/RESBAKUNAMaterials

x©
3
COVID-19 Vaccination Card
él PI
3
@
8
¢
Please keep this record card, which includes medical information 3
B
about the vaccines you have received, (D no. -
oO
rs
Ey

3
Last Name First Name M.l Suffix 3
fs
Address Contact No.
8
F
Date of Birth. Sex Philhealth No. Category By
SS

i)
Dosage Seq. aha Fro mR lee Batch No. aFe

if
Ey
Fe
3
1st Dose &
is
Le Vaccinator Name: Signature: 8
z
|

8
2nd Dose an 1
(Schedule:/ 7) Vaccinator Name: Signature: a
Fs

J Q
9
Fe
Health Facility Name: Contact No.: =
o
°