Department Memorandum 2023-0178

“Interim Guidelines on the Management and

Administration of COVID-19 Vaccine Pfizer
Bivalent”
Dr. Maricar G. Santos
FICT - Policy, Planning, and Strategy Development Division
doh.gov.ph
INTRODUCTION: COVID-19 BIVALENT VACCINE
WHAT IS THE DIFFERENCE BETWEEN THE MONOVALENT
AND BIVALENT VACCINES?
The new COVID-19 vaccines recently authorized for use as boosters generate an
immune response not only to the original strain, but also two omicron sub variants.

Monovalent Vaccines Bivalent Vaccines

Contain a small piece of the mRNA component of the virus Contains both the portion of the original ancestral virus
based on the original SARS-CoV-2 virus, sometimes termed mRNA as well as a portion of mRNA that is specific for the
as the “ancestral strain,” and are designed to generate an BA.4 and BA.5 sub variants that have been circulating most
immune response to that original virus. recently.

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INTRODUCTION: COVID-19 BIVALENT VACCINE
WHAT ARE THE RECOMMENDATIONS FOR WHO GETS THE
BOOSTER? AND WHEN?
FOR PHASE I, The COVID-19 Vaccine Pfizer Bivalent shall be given as a 3rd booster dose.

WHO? Individuals aged 18 years old and above belonging to priority

groups Al (healthcare workers) and A2 (senior citizens)

WHEN At least four (4) to six (6) months after inoculation with a
second booster dose.

?
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COVID-19 BIVALENT VACCINE: PRODUCT
INFORMATION
VIAL VERIFICATION ● Verify that the vial has a grey plastic cap
and a grey border around the label and
the product name is Comirnaty
Original/Omicron BA.4-5 (15/15
micrograms)/dose dispersion for
injection.

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COVID-19 BIVALENT VACCINE: PRODUCT
INFORMATION

FOR
FURTHER
INFORMATIO
N, PRODUCT
INFORMATIO
N FOR
HEALTHCAR
E
PROVIDERS
IS PUBLICLY
AVAILABLE
IN THE FDA
PHILIPPINES
Republic of the Philippines
Department of Health 5
WEBSITE.
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Comparison of COVID-19 Pfizer Bivalent and Monovalent Vaccine
BIVALENT MONOVALENT

PRODUCT Tozinameran+Famtozinameran COVID-19 mRNA Vaccine (nucleoside

NAME [Comirnaty Original/Omicron BA.4-5] modified) [COMIRNATY]

DOSAGE
15mcg/15mcg/0.3ml dose Dispersion for 15mcg/15mcg/0.3ml dose Dispersion for
STRENGTH Intramuscular (IM) Injection Intramuscular (IM) Injection
AND FORM
PACKAGING 10 Multiple Dose Vials.
No dilution required. 195 Multiple Dose Vials
One (1) vial (2.25 Ml) contains 6 doses of (After dilution each vial contains 6 doses of
0.3 mL) 0.3 mL)

STORAGE AND Store in freezer at -90 C to -60 C for 18 Store in freezer at -90 C to -60 C for 18
months. months.
SHELF LIFE Protect from light.
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Comparison of COVID-19 Pfizer Bivalent and Monovalent Vaccine
BIVALENT MONOVALENT

As booster vaccination: As primary series and as booster vaccination (1st

INDICATION 3rd booster for A1 and A2 and 2nd booster for A1, A2, A3 and ROAP)

Intramuscular (IM).
ADMINISTRAT Intramuscular (IM). Each vial must be diluted with 1.8 mL of sterile
ION Do not dilute prior to use. 0.9% Sodium Chloride Injection, USP prior to use
to reconstitute the vaccine.

As 3rd booster: at least four (4) to six (6) months As 1st booster: at least three (3) months after the
after inoculation with a second booster dose last dose of the primary series

As 2nd booster: at least three (3) months after the

last dose of the 1st booster for health care workers
INTERVAL (A1), senior citizens (A2) and 18-49 y/o non-
immunocompromised with comorbidities; at least
three (3) months after the last dose of the 1st
booster for immunocompromised; At least six (6)
months after last dose of 1st booster for rest of the
adult populations
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BACKGROUND

FDA EMERGENCY USE AUTHORIZATION

On 30 March 2023, The Philippine Food and Drug Administration (FDA) issued
the Emergency Use Authorization (EUA) for Tozinameran+Famtozinameran
(Comimaty Original/Omicron BA.4-5), hereafter referred to in this issuance as
COVID-19 Vaccine Pfizer Bivalent, for active immunization for the prevention of
COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older who
have previously received at least a primary vaccination course against COVID-
19.

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BACKGROUND

HEALTH TECHNOLOGY ASSESSMENT COUNCIL

RECOMMENDATION
The Health Technology Assessment (HTA) Council released their recommendations on
15 February 2023 on the use of COVID-19 Vaccine Pfizer Bivalent as a Ist, 2nd, and/or
3rd booster for adults belonging to the Al to A3 population groups (healthcare workers;
senior citizens; adults with comorbidities, including those with immunocompromising
conditions), four (4) to six (6) months after the primary series or the last booster dose.

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GENERAL GUIDELINES
A. The COVID-19 Vaccine Pfizer Bivalent roll-out shall employ a phased approach to
prioritize the protection of the healthcare workers and of the most vulnerable
population and healthcare capacity, while expansion of stock availability is being
pursued.
PHASE I

a. The COVID-19 Vaccine Pfizer Bivalent b. Facility-based implementation shall be

shall be given as a 3rd booster dose for observed for the pilot roll-out in select
individuals aged 18 years old and above sites in all regions such as in the hospitals
belonging to priority groups Al and/or health facilities (city health office,
(healthcare workers) and A2 (senior rural health units).
citizens) at least four (4) to six (6)
months after inoculation with a second
booster dose.

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GENERAL GUIDELINES
A. The COVID-19 Vaccine Pfizer Bivalent roll-out shall employ a phased approach to
prioritize the protection of the healthcare workers and of the most vulnerable
population and healthcare capacity, while expansion of stock availability is being
pursued.
SUCCEEDING PHASES

a. Other population groups shall be b. Expansion of eligibility and changes

made eligible, subject to availability thereto shall be released through a
of stocks and other changes in separate issuance.
context, such as relevant regulatory
authorization, technical
recommendations and executive
directions.

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GENERAL GUIDELINES
F. Allocation and Distribution of Vaccines G. Access vaccination materials such as the
1. The Disease Prevention and Control Bureau (DPCB) shall request the latest
informed consent form,health screening, and
or applicable data from the Epidemiology Bureau (EB) for the preparation of assessment forms through this link:
a proposed allocation list. https://bit.ly/PfizerBivalentBoosterForm.
2. The FICT shall review the proposed allocation list in terms of feasibility for
implementation and shall conduct a consultation with CHDs. All comments H. All LVOCs/LGUs shall encode all COVID-
shall be forwarded to the DPCB for finalization of the allocation list. 19 vaccination events, including third
3. The DPCB shall then endorse the approved allocation list to the Supply booster administration through the
Chain Management Service (SCMS) as the basis for the distribution of the corresponding information system. In
COVID-19 Vaccine. consideration of the transition of
4. The RVOCs/CHDs may directly allocate and distribute COVID-19 vaccines information systems, reporting guidelines in
to vaccination sites, in coordination with LVOCs/LGUs. the corresponding information system shall
5. All other procedures regarding supply chain management shall follow DM be released and disseminated by the
2022-0488, with the subject “Interim Operational Guidelines on the COVID- Epidemiology Bureau.
19 Vaccines Cold Chain and Logistic Operations Process Flow for All Public
and Private Health Facilities and Offices”, Department Circular (DC) 2021-
0439, with the subject “Operational Guidelines on the Reverse Logistics of
COVID-19 vaccines” and all other relevant policies, guidelines, and
advisories released by the DOH.

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GENERAL GUIDELINES
I. Pursuant to Administrative Order No.
2023-0007, known as the “Revised
Omnibus Guidelines on the Surveillance
and Management of Adverse Events
Following Immunization (AEFI)”, all
disease reporting units (DRUs), including
public and private health institutions and
facilities, and vaccination sites shall strictly
comply and report all AEFIs regardless of
case severity through the VigiFlow pending
the national implementation of the
contextually adapted AEFI Information
System through the release of an official
issuance.
J. Protocols for the management of AEFIs
and Adverse Events of Special Interest
(AESIs) shall follow the provisions of the
approved COVID-19 vaccine EUA of the
FDA, succeeding guidelines from the FDA,
and other recognized professional
organizations and regulatory bodies, as new
evidence arises. Interim AEFI Pathways
may be accessed at: https://bit.ly/COVID
VaxFactsheets.

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 SPECIFIC GUIDELINES

A. No Wrong Door Policy B. Contextualized Local C. Integrated Health

in all vaccination sites Implementation Service Delivery

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 SPECIFIC GUIDELINES

E. Vaccination Process

Health Vaccination
Registration Health Education Post-vaccination Monitoring
Screening Administration

The vaccination site shall ensure the following across all steps in the Vaccination Process:
a. Strict adherence to minimum public health standards
b. Information, Education, and Communication (IEC) materials, such as videos, pamphlets, flipcharts, leaflets, and
brochures shall be made available in any area of the vaccination site,
c. Priority shall be provided for the senior citizen and pregnant women, and separate lanes will be provided for the
pediatric population.
d. There is no need to pool vaccine recipients to maximize a single vial cognizant of the need to provide timely provision
of needed doses of COVID-19 vaccine to intended recipients.

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LIST OF ANNEXES (bit.ly/DMPfizerBivalent_ListofAnnexes)

A Vaccine Selection, Dosing, and Interval per population group

B Suggested Vaccination Strategies per population group

C Vaccination Requirements

D Proper Process of Securing an Informed Consent

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ANNEX A: VACCINE SELECTION, DOSING AND
INTERVAL

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ANNEX A: VACCINE SELECTION, DOSING AND
INTERVAL

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ANNEX A: VACCINE SELECTION, DOSING AND
INTERVAL

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FINAL REGIONAL ALLOCATION LIST
Quantity
Total
Total Allocation
Province Recipients Unit of Measure Allocation
(vials)
(doses)
Aurora Aurora PHO vials 60 360
Bataan PHO vials 200 1,200
Bataan
Balanga City vials 200 1,200
Bulacan PHO vials 800 4,800
Malolos City vials 200 1,200
Bulacan
Meycauayan City vials 200 1,200
City of San Jose Del Monte vials 300 1,800
Nueva Ecija PHO vials 235 1,410
Cabanatuan City vials 550 3,300
Gapan City vials 100 600
Nueva Ecija
Palayan City vials 30 180
San Jose City vials 100 600
Science City of Munoz vials 10 60
Pampanga PHO vials 800 4,800
Angeles City vials 500 3,000
Pampanga
City of San Fernando vials 550 3,300
Mabalacat City vials 150 900
Tarlac PHO vials 300 1,800
Tarlac
Tarlac City vials 450 2,700
Zambales PHO vials 200 1,200
Zambales
Olongapo City vials 290 1,740
Total vials 6,225Republic of the Philippines
37,350
Department of Health 20
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FINAL REGIONAL ALLOCATION LIST
Quantity
Total
Total Allocation
Province Recipients Unit of Measure Allocation
(vials)
(doses)
Aurora Aurora Memorial Hospital vials 30 180
Bataan General Hospital and
Bataan vials 250 1,500
Medical Center
Bulacan Bulacan Medical Center vials 200 1,200
Dr. Paulino J. Garcia Memorial
vials 290 1,740
Nueva Ecija Research and Medical Center
Talavera General Hospital vials 65 390
Jose B. Lingad Memorial General
Pampanga vials 450 2,700
Hospital
Tarlac Tarlac Provincial Hospital vials 200 1,200
Pres. Ramon Magsaysay
Zambales vials 100 600
Memorial Hospital
Total vials 1,585 9,510

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CENTRAL LUZON
STRATEGIES
COVID-19 BIVALENT ROLL-OUT
CENTRAL LUZON Implementation for Bivalent Vaccine

1. Implementation for 3 rd Booster

3. Follow Prioritization
dose are Frontline Healthcare
2. Initial Regional allocation is Framework of National Vaccine
Workers and Senior Citizens
LIMITED to only 46,860 doses Deployment Plan for COVID-19,
with at least 4 months interval
from 2nd booster supply permitting

5. Provinces and cities to lead Planning and

4. Provinces, Cities, and Tertiary Hospitals will be
Coordination Activities (ex. Masterlisting, and
part of initial roll-out for Bivalent Vaccines
Scenario-based Microplanning )
Feb. 23
DM N0. 2021-0099
“Interim Omnibus
Guidelines for the
Implementation for
the National Vaccine
Deployment Plan for
COVID-19

Remember: if an individual is eligible under TWO Priority Groups, the individual will be
prioritized/classified under the HIGHER Priority Group
• Ex. A Senior Citizen Healthcare Worker will be prioritized/classified under A1.1 Frontline
Healthcare worker
Department of Health, Philippines
As per Guidelines and due to limited supply of vaccines, initial roll-out will be prioritized
to A1.1 and A1.2

PROVINCE COVID-19 REFERRAL FACILITIES

AURORA Aurora Memorial Hospital

BATAAN Bataan General Hospital and Medical Center

BULACAN Bulacan Medical Center Vaccination of other hospitals will
Dr. Paulino J. Garcia Memorial Research and Medical
NUEVA ECIJA Center depend on the microplanning and
Talavera General Hospital coordination of the Province and
PAMPANGA Jose B. Lingad Memorial General Hospital City during Microplanning
TARLAC Tarlac Provincial Hospital
ZAMBALES Pres. Ramon Magsaysay Memorial Hospital

Department of Health, Philippines

 Recommended Next Steps for Hospitals

1. Masterlist and identify eligible population to be

PROVINCE COVID-19 REFERRAL FACILITIES vaccinated with 3rd booster (at least 4mo
interval from 2nd booster)
AURORA Aurora Memorial Hospital
a) Job orders, Administrative and Out-sourced
BATAAN
Bataan General Hospital and Medical staff are included in the eligible population
Center
of a facility
BULACAN Bulacan Medical Center
Dr. Paulino J. Garcia Memorial Research
NUEVA ECIJA and Medical Center
2. Microplanning (may need to have multiple
Talavera General Hospital scenario-based microplans)
PAMPANGA Jose B. Lingad Memorial General Hospital
a) Sub-Prioritize: high-risk areas to vaccinated
first (ex. COVID wards, ICU, etc)
TARLAC Tarlac Provincial Hospital
b) Identify Vaccination Teams and develop a
Pres. Ramon Magsaysay Memorial
ZAMBALES schedule of Vaccinators and Daily
Hospital
Schedule of Staff to be vaccinated

Hospital Microplanning shall be done in coordination with the • Developing a Quick Substitution List (QSL) (following
Province/LGU prioritization of health facilities framework)

c) Calculate needed logistics, Reporting,

Demand Generation
 Critical Steps - MICROPLANNING
Determine the number of eligible population for COVID-19
1. vaccination in your area
Development of Multiple Scenario-Based Identify the implementing units in you areas, and the number of
Microplans 2. vaccination posts/sites, and plot in an operational spot map
Identify the number of supervisors, vaccination teams, AEFI/AESI
• Who: LGUs, Hospitals, other implementers 3. composite teams and other personnel needed and available for the
vaccination campaign
• What Scenarios:
Assign teams and vaccinees to an implementing unit / vaccination
1. Cold Chain Requirement for -70C 4. post
• Frontline Health Workers
• Senior Citizens / Indigent 5. Estimate the vaccine requirement and ancillary supplies needed

6. Identify gaps in cold chain capacity

2. Cold Chain Requirement for +2 to + 8C / -
20C 7. Ensure timely delivery of logistics
• Frontline Health Workers 8. Prepare a daily vaccination session plan
• Senior Citizens / Indigent Develop a communication plan and implement social mobilization
9. and advocacy activities

Remember: 3rd Booster will be implemented at FIXED SITES

10. Prepare a supervision and monitoring plan and schedule
ONLY Prepare an AEFI/AESI management, surveillance and response
11. plan

12. Develop a waste management plan

 LGU –A
Development of Multiple
Scenario-Based Microplans Microplan
Aurora
for various Eligible • Hospital
Populations Microplans
• Economic
• Who: LGUs, Hospitals, Zambales Bataan
Zones
other implementers
• What Scenarios:
1. Cold Chain
Requirement for -70C
LGU – D LGU – B
• Frontline Health Microplan PROVINCIAL Microplan REGIONAL
Workers • Hospital Microplan • Hospital
Microplans
MACROPLAN
• Senior Citizens Microplans Tarlac Bulacan
2. Cold Chain
Requirement for +2 to
+ 8C / -20C
• Frontline Health
LGU – C Nueva
Workers Microplan
Pampanga
Ecija
• Senior Citizens • Hospital
Microplans

• Microplans of LGUs, Hospitals, other implementers,

*Province / Cities to shall be inter-connected with Provincial Microplans • Provincial Microplans shall be inter-
lead Planning and • Ex. Contingency Plans connected with the Regional
Coordinating • Identification and prioritization of vaccinating Macroplan
Activities sites/posts
• Prioritizing Eligible Populations
Ex. SCENARIO-BASED PLANS • Follow prioritization framework
• Consider supply/allocation
• QSL contingency plan (other A1.1 and A2)

COVID-19 PROVINCE CITY

Hospitals (A1.1)

• Hospital Staff • Can allocate to • Can allocate to

• Vaccinate other A1.1 and A1.2 A1.1 and A1.2
nearby A1.1 • Senior Citizens • Senior Citizens
and A1.2
• Senior Citizens

Bataan PHO Balanga CHO

BGHMC
Hospital A Hospital B
Jose Payumo
MMWH
DH

Senior Citizen RHU A

Orani DH Senior Citizen
Maraming Salamat po!

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