Republicof the Philippines

Department of Health
OFFICE OF THE SECRETARY

May 11, 2021

DEPARTMENT MEMORANDUM
No.2021- D225

FOR: ALL _UNDERSECRETARIES AND ASSISTANT SECRETARIES;

DIRECTORS OF CENTERS FOR HEALTH DEVELOPMENT;
MINISTER OF BANGSAMORO AUTONOMOUS REGION IN
MUSLIM MINDANAO (BARMM); AND BUREAU AND SERVICE
DIRECTORS; SPECIAL AND SPECIALTY HOSPITAL
DIRECTORS; CHIEFS OF MEDICAL CENTERS, HOSPITALS AND
SANITARIA; AND OTHER CONCERNED OFFICES
SUBJECT: Guidelines on the Management and Administration of the Pfizer-
BioNTech COVID-19 (BNT162b2) Vaccine

L RATIONALE
Pfizer BioNTech COVID-19 (BNT162b2) was the first vaccine to be granted an
Emergency Use Authorization (EUA) by the Philippine FDA last 14 January 2021.
Accordingly, following a stringent evaluation, a positive recommendation was issued by
the HTAC on February 2, 2021.

With this, the DOH hereby issues these guidelines for Pfizer BioNTech COVID-19
(BNT162B2), referred to as Pfizer vaccines in
this guidelines to supplement the National
Vaccination Deployment Plan technical guidance document for public and private
healthcare facilities in the implementation of the COVID-19 Immunization Program
strictly following the absolute contraindications stated in the EUA issued by the PH FDA.

II. GENERAL GUIDELINES

A. Prioritization of population groups, allocation, and quick substitution listing for Pfizer
vaccines shall be based on the provisions outlined in Department Memorandum (DM)
No. 2021-0099, otherwise known as, “Interim Omnibus Guidelines for the
Implementation of the National Vaccine Deployment Plan for COVID-19.”’

B. All LGUs shall ensure that RHUS and identified COVID-19 Vaccination Sites shall
formulate their microplans to determine local needs and gaps to ensure smooth and
satisfactory vaccine implementation in accordance with the National Deployment and
Vaccination Plan.

C. Inventory management of vaccines, from delivery and acceptance to disposal shall be

based on DM No0.2021-0053 and 2021-0031 entitled, “Interim Guidelines on the
Shipment and Acceptance of COVID-19 vaccines and ancillary immunization
commodities” and “Interim Guidelines on the Management of Health Care Wastes
generated from COVID-19 vaccination”, respectively.

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 local 1113, 1108, 1135
Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: fidugue@doh.gov.ph
 D. Instructions for COVID-19 vaccination providers and administrators on storage and
handling, dosing and schedule, administration, contraindications, warnings, adverse
reactions, and use with other vaccines shall follow Philippine FDA Fact Sheet for
vaccination providers and EUA. The Pfizer Vaccine Fact Sheet for the Health Care
Providers Administering the Vaccine may be accessed online (see Annex A).

E. Pfizer vaccines shall be administered by healthcare providers for immunization to

prevent COVID-19 in individuals 16 years of age and older, as indicated in the EUA
issued by the Philippine FDA.

F. Protocols for the management of Adverse Effects Following Immunization (AEFI)

and Adverse Events of Special Interest (AESI) shall follow the provisions of the
Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization of the FDA (see
Annex B) and other succeeding guidelines from the DOH, FDA, Pfizer, and other
recognized professional organizations and regulatory bodies, as new evidence arise.

G. The second dose of the Pfizer Vaccine shall be given after 21 days. Follow-up
notification shall be sent in accordance with the Department Memorandum 2021-
0099, entitled Interim Omnibus Guidelines for the Implementation of the National
Vaccine Deployment Plan for COVID-19.

H. As indicated in Section B.1.b of the DM No. 2021-0175, “For vaccine recipients

whose second dose shall be delayed due to deferment guidelines, the second dose may
be provided immediately after the prescribed periods in the deferment guidelines
without a maximum time interval, unless otherwise indicated.” 1t is further clarified
that the second dose shall not be provided earlier than the recommended schedule.

I. Registration, screening, counselling, vaccine recipient reporting, AEFI monitoring

and referral shall follow DM No. 2021-0099 and other relevant policies.

J. All Pfizer related information and education communication materials and other
vaccination related materials can be accessed through this link:
bit.ly/RESBAKUNAMaterials and bit.ly/RESBAKUNAVaxSpecific. A printing
guide for the communication materials is made available through this link:
bit.ly/RESBAKUNA PrintingInstructions.

III. IMPLEMENTING GUIDELINES

A. Vaccine Allocation

1. Allocation of Pfizer vaccines shall follow the prioritization and allocation

framework indicated in Department Circular No. 2021-0055 or the “Interim
Guidelines on the Prioritization Framework for the Philippine National
Deployment and Vaccination Plan and its Initial Roll-out of the First Tranche of
Pfizer-BioNTech COVID-19 Vaccines” and DM No. 2021-0099. Due to limited
supply as well as complexity on handling requirements, the Pfizer vaccines shall
be only allocated to Local Government Units and Vaccination Sites with
capabilities to receive, store, manage and administer the vaccines, as determined
by the National Vaccination Operations Center (NVOC).
 2. Because of the sensitive handling requirements of Pfizer vaccines, all Vaccination
Sites shall strictly submit a Quick Substitution List accounting for all their intended
vaccine recipients from the allowed priority groups, signed by the head of the
institution and endorsed to the respective Regional Vaccines Operations Center,
consolidated by the National Vaccines Operations Center.

B. Indications, Precautions and Contraindications

1. Consistent with the Philippine FDA EUA, Pfizer vaccines shall be administered
only to individuals ages 16 years and older.

The vaccination provider shall communicate and inform the vaccine recipient or
caregiver the necessary information consistent with the FDA Fact Sheet for
Recipients and Caregivers prior to receiving the vaccine (4nnex D)

As a general rule, co-administration of the Pfizer Vaccines with other COVID-19

vaccines is not recommended.

Appropriate medical treatment to manage immediate allergic reactions shall

immediately be available on-site in the event an acute anaphylactic reaction occurs
following administration of Pfizer vaccine. Standby ambulance shall be made
available to transport patients who develop severe allergic reactions to AEFI referral
facilities within the Healthcare Provider Network.

Contraindications: Pfizer vaccines shall NOT be administered to individuals with a

known history of a severe allergic reaction (e.g., anaphylaxis) to any component of
the Pfizer vaccine such as but not limited to polyethylene glycol and
polysorbate.

The AEFI team of the COVID-19 vaccination site shall monitor for the following
adverse events indicated below. Teams shall likewise ensure capacity to provide
treatment and immediate management in the event an acute anaphylactic reaction
occurs following administration of Pfizer Vaccine.

a. Adverse reactions following the administration of Pfizer vaccines that have

been reported in clinical trials include injection site pain, fatigue, headache,
muscle pain, chills, joint pain, fever, injection site swelling, injection site
redness, nausea, malaise, and lymphadenopathy which are

b. Severe allergic reactions including anaphylaxis and other hypersensitivity

reactions (e.g. rash, pruritus, urticaria, angioedema), diarrhea, vomiting, and
pain in extremity (arm) have been reported following the Pfizer vaccine during
mass vaccination outside of clinical trials.

Vaccination sites shall use and disseminate Fact Sheets for Implementers that
summarizes the most recent guidelines for management of Adverse Events
Following Immunization (AEFI) that can be found at
bit.ly/RESBAKUNA Factsheets
C. Medical Clearance

1. Those belonging to the following A3 sub-groups need to secure a physical or

electronic medical clearance prior to vaccination from either their specialist or
 attending physician through any means such as but not limited to teleconsultation,
consultation at designated facilities, hubs, RHU or other primary care centers
designated by the LGU:

a. Autoimmune disease
b. HIV
c. Cancer/ Malignancy
d. Transplant Patients
e. Undergoing steroid treatment
f. Patients with poor prognosis/ Bed-ridden patients

The medical clearance process for these groups shall enable individual risk-benefit
assessment by the attending physician. It may be presented in electronic format,
with the full name of the attending physician and their corresponding contact
details for verification. It shall be issued by licensed physicians or may also come
from referral apex hospitals, through telemedicine and Rural Health Units.

All provisions pertaining to Medical Clearance and proofs of comorbidity as

described in DM No. 2021 0175, DM No. 2021- 0157 and DM No. 2021 - 0203
are still in full effect.

D. Vaccine Storage, Handling, and Transfer

1. Cartons of Pfizer vaccine multiple dose vials shall arrive in thermal containers with
dry ice. Upon arrival, vial cartons shall immediately be removed and the vaccines
shall be stored frozen in an ultra-low temperature freezer between -80°C to -60°C
(-112°F to -76°F) and kept frozen until ready to use or until expiry date.

a. Alternatively, vials may be stored at -25°C to -15°C (-13°F to 5°F) for up to 2

weeks. Vials shall be kept frozen and protected from light until ready to use.
Vials stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks may be returned
one time to the recommended storage condition of -80°C to -60°C (-112°F to -
76°F). Total cumulative time the vials are stored at -25°C to -15°C (-13°F to
5°F) shall be tracked and shall not exceed 2 weeks.

b. If an ultra-low temperature freezer is not available, the thermal container in

which the vaccines arrive may be used as temporary storage, provided that
consistently re-filled with dry ice up to the top of the container
it is
c. Closed lid vial trays removed from frozen storage (< 60 °C) may be at room
temperature (<25°C) for a maximum of 5 minutes when transferring from one
ultra-low temperature environment to another.

d. Open lid vial trays, or trays with less than 195 vials removed from frozen
storage (< 60 °C) may be at room temperature (< 25 °C) for a maximum of 3
minutes when removing a number of vials needed for the vaccination session
or when transferring from one ultra-low temperature environment to another.

e. After vial trays are returned to frozen storage following room temperature
exposure, they shall remain in frozen storage for at least 2 hours before they
can be removed again.
 f. Once a vial is removed from the vial tray, it shall be thawed for use.

2. Only trained personnel shall handle Pfizer vaccines using protective gear (e.g.
cryogenic gloves and goggles) at all times to avoid serious and/or debilitating
injuries.

3. Prior to administration, vaccines shall be thawed using either the following

techniques:

a. Thawing under refrigeration - Vaccines may be thawed under refrigeration at

2°C to 8°C for up to 5 days (120 hours). Note that 25-vial cartons and 195-vial
cartons may take up to 2 hours and 3 hours, respectively, whereas a fewer
number of vials will thaw within less time.

Thawing at room temperature - For immediate use, vaccines may be thawed at

room temperature (up to 25°C). They must reach room temperature prior to
dilution and may be stored at room temperature for no more than 2 hours.

Thawing during transport - If local redistribution is needed and full cartons

containing vials cannot be transported at -90°C to -60°C, vaccines may be
thawed at 2°C to 8°C for up to 5 days (120 hours), including the duration of
transportation.

4. Thawed vials at room temperature shall be gently inverted 10 times prior to dilution
(do not shake). The thawed dispersion may contain white to off-white opaque
amorphous particles. Vials with discolored liquid or containing other particles shall
NOT be used. Thawed vials shall NOT be refrozen.

5. After thawing, vials shall be diluted with 1.8 mL of 0.9% Sodium Chloride Injection
using a 21 gauge or narrower needle and the aseptic techniques:

a. Use ONLY 0.9% Sodium Chloride Injection, USP as the diluent; NOT
bacteriostatic 0.9% Sodium Chloride Injection or any other diluents;

Using the aseptic technique, withdraw 1.8 mL of diluent using transfer syringes
(21-gauge or narrower needle);

Inspect the vaccine in the vial and do not use if the vaccine is discolored or
contains particulate matter (The vaccine will be an off-white suspension.);

Cleanse the vaccine vial stopper with a single-use antiseptic swab;

Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial;

Equalize vial pressure before removing the needle from the vial stopper by
withdrawing 1.8 mL air into the empty diluent syringe;

g. Gently invert the diluted suspension 10 times and do not shake;

Record the date and time of dilution on the Pfizer vaccine vial label, store
between 2°C to 25°C, do not shake; and

Discard any unused vaccine 6 hours after dilution.

 D. Vaccine Administration and Disposal

1. After dilution, a vial contains 5 to 6 doses of 0.3 mL depending on the syringe to

be used (preferably a low dead-volume syringe and/or needle to extract six doses).
Diluted vaccines shall be stored between 2°C to 25°C (35°F to 77°F) and used
within 6 hours from the time of dilution. During storage, exposure to room light
shall be minimized and exposure to direct sunlight and ultraviolet light shall be
strictly avoided. Any vaccine remaining in vials must be discarded after 6 hours.
Refreezing of diluted vials shall NOT be allowed.

2. Upon confirmation that vials do not contain any discoloration or particulates and
the final dose volume is at 0.3 mL, doses shall be immediately administered
intramuscularly. If the amount of vaccine remaining in the vial cannot provide a full
dose of 0.3 mL, any excess volume shall be discarded. Pooling of excess vaccine
fluids from multiple vials shall be STRICTLY PROHIBITED.

3. After being injected with the Pfizer vaccine, the vaccine recipient shall be
monitored for possible adverse events following immunization in a predetermined
observation area prior to being sent home. 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, while persons who do
not meet any of the criteria otherwise stated shall be observed for 15 minutes after
vaccination. Health care workers in vaccination sites shall ensure that the minimum
public health standards are still implemented in the monitoring areas to prevent
possible transmission of COVID-19.

4. Health care workers in vaccination sites shall ensure that the minimum public health
standards are still implemented in the monitoring areas to prevent possible
transmission of COVID-19.

5. LGUs and vaccination sites shall provide post-vaccination reminders and home
instructions to all vaccine recipients physically as handouts, electronically, or
through SMS-based reminders consistent with national guidelines. Sample post-
vaccination reminders can be found at bit.ly/RESBAKUNAMaterials.

For dissemination and strict compliance.

By Authority of the Secretary of Health:

MARIA ROSARIQ S. VERGEIRE, MD, MPH, CESO IV

OIC - Undersecretary of Health
Public Health Serviges Team
ANNEX A. PH-FDA Pfizer Fact Sheet for the General Public
Access the document here: https://www.fda.gov.ph/wp-content/uploads/2021/04/1.2.-Fact-Sheet-
for-HCPs-and-Full-PI-rev.2.0 clean-version.pdf-preview.pdf

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE

(VACCINATION PROVIDERS)

EMERGENCY USE AUTHORIZATION (EUA) OF

THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)

The Food and Drug Administration (FDA) Philippines has issued an Emergency
Use Authorization (EUA) to permit the emergency use of the unapproved product,
Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent
coronavirus disease 2019 (COVID-19) caused by severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers must report all vaccine administration errors, all serious
adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and
children, and cases of COVID-19 that result in hospitalization or death following
administration of Pfizer-BioNTech COVID-19 Vaccine. See “MANDATORY
REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE
ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting
requirements.

The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection

administered as a series of two doses (0.3 mL each) 3 weeks apart.

See this Fact Sheet for instructions for preparation and administration. This Fact
Sheet may have been updated. For the most recent Fact Sheet, please see
www.cvdvaccine.com.

For information on clinical trials that are testing the use of the Pfizer-BioNTech
COVID-19 Vaccine for active immunization against COVID-19, please see
www. clinicaltrials.qov.

DESCRIPTION OF COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the

novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a
respiratory illness that can affect other organs. People with COVID-19 have
reported a wide range of symptoms, ranging from mild symptoms to severe illness.
Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may
include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches;
headache; new loss of taste or smell, sore throat; congestion or runny nose;
nausea or vomiting, diarrhea.

Revised: 0412021
DOSAGE AND ADMINISTRATION

Storage and Handling

During storage, minimize exposure to room light, and avoid exposure to direct
sunlight and ultraviolet light.

Do not refreeze thawed vials.

Frozen Vials Prior to Use

Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in
thermal containers with dry ice. Once received, remove the vial cartons
immediately from the thermal container and preferably store in an ultraJow
temperature freezer between -80°C to -60°C (-112°F to -76°F) until the expiry date
printed on the label. Alternatively, vials may be stored at -25°C to -15°C (-13°F to
5°F) for up to 2 weeks. Vials must be kept frozen and protected from light until
ready to use. Vials stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks may
be retumed one time to the recommended storage condition of -80°C to -60°C
(-112°F to -76°F). Total cumulative time the vials are stored at -25°C to -15°C
(-13°F to 5°F) should be tracked and should not exceed 2 weeks.

Ifan ultra-low temperature freezer

the Pfizer-BioNTech COVID-19
is not available, the thermal container in which
Vaccine arrives may be used as temporary storage
when consistently re-filled to the top of the container with dry ice. Refer to the
re-icing guidelines packed in the original thermal container for instructions
reqarding the use of the thermal container for temporary storage. The thermal
container maintains a temperature range of -90°C to -60°C (-130°F to -76°F).
Storage of the vials between -96°C to -60°C (-141°F to -76°F)
excursion from the recommended storage condition.
is not considered an

Transportation of Frozen Vials

Iflocal redistribution is needed and full cartons containing vials cannot be

transported at -90°C to -60°C (-130°F to -76°F), vials may be transported at -25°C
10 -15°C (-13°F to 5°F). Any hours used for transport at -25°C to -15°C (-13°F to
5°F) count against the 2-week limit for storage at -25°C to -15°C (-13°F to 5°F).
Frozen vials transported at -25°C to -15°C (-13°F to 5°F) may be retumed one time
to the recommended storage condition of -80°C to -60°C (-112°F to -76°F).

Thawed Vials Before Dilution

Thawed Under Refrigeration

Thaw and then store undiluted vials in the refrigerator [2°C to 8°C (35°F to 46°F)]
for up to 5 days (120 hours). A carton of 25 vials or 195 vials may take up to 2 or
3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials
will thaw in less time.

Revised: 0412021 2
Thawed at Room Temperature
For immediate use, thaw undiluted vials at room temperature [up to 25°C (77°F)] for
30 minutes. Thawed vials can be handled in room light conditions. Vials must reach
room temperature before dilution.

Undiluted vials may be stored at room temperature for no more than 2 hours.

Transportation of Thawed Vials

Available data support transportation of one or more thawed vials at 2°C to 8°C
(35°F to 46°F) for up to 12 hours. Any hours used for transport at 2°C to 8°C (35°F
to 46°F) count against the 120-hour limit for storage at 2°C to 8°C (35°F to 46°F).

Vials After Dilution

¢ After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within
6 hours from the time of dilution.
o During storage, minimize exposure to room light, and avoid exposure to
direct sunlight and ultraviolet light.
Any vaccine remaining in vials must be discarded after 6 hours.
Do not refreeze.

Dosing and Schedule

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a
series of two doses (0.3 mL each) 3 weeks apart.

There are no data available on the interchangeability of the Pfizer-BioNTech

COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination
series. Individuals who have received one dose of Pfizer-BioNTech COVID-19
Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to
complete the vaccination series.

Dose Preparation

Prior to Dilution
o The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a
volume of 0.45 mL, supplied as a frozen suspension that does not contain
preservative. Each vial must be thawed and diluted prior to administration.
+ Vials may be thawed in the refrigerator [2°C to 8°C (35°F to 46°F)] or at room
temperature [up to 25°C (77°F)] (see Storage and Handling).
o Refer to thawing instructions in the panels below.

Dilution
Dilute the vial contents using 1.8 mL of 0.9% Sodium Chloride Injection, USP (not
provided) to form the Pfizer-BioNTech COVID-19 Vaccine. ONLY use 0.9% Sodium
Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine
Revised: 042021 3
and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride
Injection or any other diluent. Do not add more than 1.8 mL of diluent.

After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may
state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this
Fact Sheet regarding the number of doses per vial after dilution supersedes the
number of doses stated on vial labels and cartons.

¢ Refer to dilution and dose preparation instructions in the panels below.

THAWING PRIOR TO DILUTION

Thaw vial(s) of Pfizer-BioNTech
COVID-19 Vaccine before use either
by:
o Allowing vial(s) to thaw in the
refrigerator [2°C to 8°C (35°F to
46°F)]. A carton of vials may take up
No more than to 3 hours to thaw, and thawed vials

= —
2 hours atroom
temperature
can be stored in the refrigerator for
up to five days (120 hours).
(upto 25°C/77°F) o Allowing vial(s) to sit at room
temperature [up to 25°C (77°F)] for
30 minutes.
Using either thawing method, vials
must reach room temperature before
dilution and must be diluted within
2 hours.

Before dilution invert vaccine vial

gently 10 times.
Do not shake.
Inspect the liquid in the vial prior to

J>
Gently x 10
dilution. The liquid is a white to off-
white suspension and may contain
\ white to off-white opaque amorphous
particles.
Do not use if liquid is discolored or if
other particles are observed.

Revised: 04/2021
 DILUTION

Obtain sterile 0.9% Sodium Chloride

Injection, USP. Use only this as the
diluent.
Using aseptic technique, withdraw
1.8 mL of diluent into a transfer syringe
(21-gauge or narrower needle).
Cleanse the vaccine vial stopper with a
single-use antiseptic swab.
Add 1.8 mL of 0.9% Sodium Chionde
Injection, USP into the vaccine vial.

Equalize vial pressure before removing

the needle from the vial by withdrawing
1.8 mL air into the empty diluent
syringe.

Gently invert the vial containing the

Pfizer-BioNTech COVID-19 Vaccine
10 times to mix.

—
Gentlyx 10 Do not shake.
Inspect the vaccine in the vial.
The vaccine will be an off-white
suspension. Do not use if vaccine is

J
discolored or contains particulate
matter.

Revised: 042021
 e Record the date and time of dilution on
the Pfizer-BioNTech COVID-19
Vaccine vial label.
¢ Store between 2°C to 25°C (35°F to
77°F).
« Discard any unused vaccine 6 hours
after dilution.

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH

¢ Using aseptic technique, cleanse the

vial stopper with a single-use antiseptic
0.3 ml Gluted vaccine swab, and withdraw 0.3 mL of the
J. Pfizer-BioNTech COVID-19 Vaccine
preferentially using a low dead-volume
— te bAA

syringe and/or needle.

0
e Each dose must contain 0.3 mL of
vaccine.
+ If the amount of vaccine remaining in
the vial cannot provide a full dose of
0.3 mL, discard the vial and any
excess volume.
¢ Administer immediately.

Administration

Visually inspect each dose in the dosing syringe prior to administration. The
vaccine be an off-white suspension. During the visual inspection,
will
o verify the final dosing volume of 0.3 mL.
¢ confirm there are no particulates and that no discoloration is observed.
+ do not administer if vaccine is discolored or contains particulate matter.

Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of

0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to
extract six doses from a single vial. If standard syringes and needles are used,
there may not be sufficient volume to extract a sixth dose from a single vial.
Irrespective of the type of syringe and needle:

Each dose must contain 0.3 mL of vaccine.

Revised: 04/2021
 + |f the amount of vaccine remaining in the vial cannot provide a full dose of
0.3 mL, discard the vial and content.
+ Do not pool excess vaccine from multiple vials.

Contraindications

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known

history of a severe allergic reaction (e.g., anaphylaxis) to any component of the
Pfizer-BioNTech COVID-19 Vaccine (see Full EUA Prescribing Information).

Warnings
Appropriate medical treatment used to manage immediate allergic reactions must
be immediately available in the event an acute anaphylactic reaction occurs
following administration of Pfizer-BioNTech COVID-19 Vaccine.

Immunocompromised persons, including individuals receiving immunosuppressant

therapy, may have a diminished immune response to the Pfizer-BioNTech
COVID-19 Vaccine.

Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions
Adverse Reactions in Clinical Trials
Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have
been reported in clinical trials include injection site pain, fatigue, headache, muscle
pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea,
malaise, and lymphadenopathy (see Full EUA Prescribing Information).

Adverse Reactions in Post Authorization Experience

Severe allergic reactions, including anaphylaxis, and other hypersensitivity
reactions (e.g., rash, pruritus, urticana, angioedema), diarrhea, vomiting, and pain in
extremity (arm) have been reported following administration of the Pfizer-BioNTech
COVID-19 Vaccine outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become

apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.
Use with Other Vaccines

There is no information on the co-administration of the Pfizer-BioNTech COVID-19

Vaccine with other vaccines.

Revised: 0472021 7
INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

As the vaccination provider, you must communicate to the recipient or their

caregiver, information consistent with the “Fact Sheet for Recipients and
Caregivers” (and provide a copy or direct the individual to the website
www.cvdvaccine.com to obtain the Fact Sheet) prior to the individual receiving
each dose of Pfizer-BioNTech COVID-19 Vaccine, including:
+ FDA Philippines has authorized the emergency use of the Pfizer-BioNTech
COVID-19 Vaccine, which is not an FDA-approved vaccine.
+ The recipient or their caregiver has the option to accept or refuse
Pfizer-BioNTech COVID-19 Vaccine.
¢ The significant known and potential risks and benefits of Pfizer-BioNTech
COVID-19 Vaccine, and the extent to which such risks and benefits are
unknown.
+ Information about available altemative vaccines and the nisks and benefits of
those alternatives.
For information on clinical tnals that are testing the use of the Pfizer-BioNTech
COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.qov.

Provide a vaccination card to the recipient or their caregiver with the date when the
recipient needs to retum for the second dose of Pfizer-BioNTech COVID-19
Vaccine.

MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE

ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION

In order to mitigate the risks of using this unapproved product under EUA and to
optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following
items are required. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for
active immunization to prevent COVID-19 under this EUA is limited to the following
(all requirements must be met):

1. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals

16 years of age and older.

2. The vaccination provider must communicate to the individual receiving the

Pfizer-BioNTech COVID-19 Vaccine or their caregiver, information
consistent with the “Fact Sheet for Recipients and Caregivers” prior to the
individual receiving Pfizer-BioNTech COVID-19 Vaccine.

3. The vaccination provider must include vaccination information in the

stateflocal jurisdiction’s Immunization Information System (IIS) or other
designated system.
4. The vaccination provider isresponsible for mandatory reporting of the
following to the FDA Philippines:

Revised: 0472021 8
 ¢ vaccine administration errors whether or not associated with an
adverse event,
serious adverse events* (irrespective of attribution to vaccination),
cases of Multisystem Inflammatory Syndrome (MIS) in adults and
children, and
¢ cases of COVID-19 that result in hospitalization or death.
Complete and submit reports to FDA Philippines via online reporting through
the FDA website at https./www.fda.gov.ph/pharmacovigilance/. Please
include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the report.

5. The vaccination provider isresponsible for responding to FDA requests for

information about vaccine administration errors, adverse events, cases of
MIS in adults and children, and cases of COVID-19 that result in
hospitalization or death following administration of Pfizer-BioNTech
COVID-19 Vaccine to recipients.

*
Serious adverse events are defined as:
e Death;
¢ A life-threatening adverse event;
¢ Inpatient hospitalization or prolongation of existing hospitalization,
+ A persistent or significant incapacity or substantial disruption of the ability to
conduct normal life functions;
+ A congenital anomaly/birth defect;
¢ An important medical event that based on appropriate medical judgement
may jeopardize the individual and may require medical or surgical
intervention to prevent one of the outcomes listed above.

OTHER ADVERSE EVENT REPORTING TO FDA PHILIPPINES AND PFIZER

INC.

Vaccination providers may report to FDA Philippines other adverse events that are
not required to be reported using the website above.

To the extent feasible, report adverse events to Pfizer, Inc. using the contact
information below or by providing a copy of the report to the FDA to Pfizer, Inc.

Email Fax number Contact numbers

PHL .AEReporting@pfizer.com 1800 1110 1520 +63 9178108146

(Toll Free)
+63 2 8451 9288

+63 2 8451 9200 ext

19288

Revised: 04/2021 9
ADDITIONAL INFORMATION

For general questions, visit the website provided below.

To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets,

please scan the QR code provided below.

Global website
www.cvdvaccine.com

p
[ZR]A

MEDICAL INFORMATION ENQUIRIES - Philippines

Please submit your medical information enquiries to https://pmiform.com/CONS/PH
or to MIS.Inquiry@Pfizer.com.

AVAILABLE ALTERNATIVES

There is currently no approved altemative vaccine to prevent COVID-19. There

may be clinical trials or availability under EUA of other COVID-19 vaccines.

AUTHORITY FOR ISSUANCE OF THE EUA

The Office of the President of the Republic of the Philippines has declared a public
health emergency that justifies the emergency use of drugs and biological products
during the COVID-19 pandemic. In response, FDA Philippines has issued an EUA
for the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active
immunization against COVID-19 in individuals 16 years of age and older.

FDA Philippines issued this EUA, based on Pfizer-BioNTech's request and

submitted data.

Although limited scientific information is available, based on the totality of the

it
scientific evidence available to date, is reasonable to believe that the
Pfizer-BioNTech COVID-19 Vaccine may be effective for the prevention of
COVID-19 in individuals as specified in the Full EUA Prescribing Information.

This EUA for the Pfizer-BioNTech COVID-19 Vaccine will end when the Office of
the President determines that the circumstances justifying the EUA no longer exist
or when there is a change in the approval status of the product such that an EUA is
no longer needed.

Revised: 042021 10
For additional information about Emergency Use Authorization visit FDA at:
https://www.Ida.qov.ph.

&& Pfizer
Manufactured by
Pfizer Inc., New York, NY 10017

SIONT=Cr
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany

LAB-1450-7.0

END SHORT VERSION FACT SHEET

Long Version (Full EUA Prescribing Information) Begins On Next Page

Revised: 0412021 11
 ANNEX B. Emergency Use Authorization for Pfizer Vaccines
Access the document here: https://www.fda.gov.ph/wp-content/uploads/2021/02/EUA-Pfizer-
Website.pdf

J’
Republic of the Philippines
ED AARF
Department of Health
FOOD AND DRUG ADMINISTRATION
~ Be” MN
:

14 January 2021

PFIZER, INC. (PHILIPPINES)

Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID19 Vaccine

Suspension for IM Injection

This applies to the application for the issuance of Emergency Use Authorization (EUA) for
Pfizer-BioNTech COVID-19 Vaccine Suspension for IM Injection ("Pfizer- BioNTech
COVID-19 Vaccine").

The details of the Pfizer- BioNTech COVID-19 Vaccine are as follows:

Product Name: Pfizer-BioNTech COVID-19 (BNT162b2)

Dosage Strength and Form: 30 mcg Suspension for Intramuscular (1M)
Injection
Pharmacologic category: Vaccine
Storage: Priorto dilution, store at -80°C to -60°C.
Packaging: 25 and 195 Multiple Dose Vials (after dilution
each vial contains 6 doses of 0.3 mL)
Pfizer Manufacturing Belgium NV - Puurs,
Manufacturer: Belgium
Pharmacia and Upjohn Company LLC,
Kalamazoo, Michigan, USA

For active immunization for the prevention of

Indication: COVID-19 caused by SARS-COV-2 in
individuals 16 years of age and older

After careful consideration of the application, with all its supporting documents and a review
of local experts, the FDA has been satisfied that all the conditions for the issuance of an EUA
exist as provided under Executive Order (EO) No. 121, s. 2020 entitled "Granting Authority
to the Director General of the Food and Drug Administration to Issue Emergency Use
Authorization for COVID-19 Drugs and Vaccines, Prescribing Conditions Therefor, and for
Other Purposes,” particularly:

1. Based on the totality of evidence available to date, including data from adequate and
well- known controlled trials, it is reasonable to believe that the PfizerBioNTcch
COVID-19 Vaccine may be effective to prevent, diagnose, or treat COVID-19;

Page 10f4
 2. The known and potential benefits of the Pfizer- BioNTech COVID-19 Vaccine, when
used to diagnose, prevent, treat COVID-19, outweigh the known and potential risks of
said Vaccine as of date; and
3. There is currently no adequate, approved and available alternative to the product for
diagnosing, preventing or treating COVID-19.

In issuing this EUA, recognition and reliance have been accorded to the Emergency Use
Listing (EUL) of the World Health Organization (WHO), and emergency use authorizations
given by mature and established National Regulatory Authorities (NRAs) such as the United
States of America, United Kingdom, Canada, European Union and Singapore, respectively.
Under Section 5 of EQ No. 121, the Director General of the FDA has been granted power to
implement reliance and recognition processes, and accept regulatory decisions of recognized
and established regulatory authorities.

This EUA is not a marketing authorization or a Certificate of Product Registration

(CPR). Hence, this EUA cannot be used as an authorization to market the vaccine
commercially. While the evaluation process was facilitated, strict conditions on the
authorization granted in this Letter shall be imposed as follows:

I. Scope

The scope of the EUA shall be limited as follows:

A. Pfizer Inc. (Philippines) shall supply Pfizer- BioNTech COVID-19 Vaccine only to
emergency response stakeholders consistent with the terms and conditions of this EUA.

"Emergency response stakeholders” shall refer to the Department of Health (DOH) or

the National Task Force Against COVID-19 (NTF) or their designees authorized to
procure or purchase Pfizer- BioNTech COVID-19 Vaccine in line with the COVID-19
vaccination program. Designees may include hospitals (public and private), health
facilities of other National Government Agencies, Local Government Units (LGUs)
and other members of the Private Sector.
B. The Pfizer- BioNTech COVID-19 Vaccine shall be administered only by vaccination
providers, and used only to prevent COVID-19 in individuals ages 16 and older.

"Vaccination providers" shall refer to the facility, organization, or a healthcare provider,

including non-physician healthcare providers such as nurses or pharmacists, authorized
by the DOH or the NTF to administer the PfizerBioNTech COVID-19 Vaccine in
accordance with the COVID-19 vaccination program.

II. Dosage Strength and Form

Pfizer- BioNTech COVID-19 Vaccine should be supplied as a frozen suspension in multiple

dose vials. Each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection,
USP prior to use to reconstitute the vaccine. The dosing regimen is two doses of 0.3 mL each.
The second dose should be given after three weeks (3) from the first dose.

Page 2 of 4
III. Cold Chain Management

In the absence of agreement with the DOH or NTF, Pfizer, Inc. (Philippines) shall provide
appropriate cold chain requirements for storage, transport and handling until it is delivered to
the inoculation sites, and ensure that a contingency plan is in place.

Pfizer, Inc. (Philippines) shall have a system of monitoring to ensure traceability and that the
vaccine isconsistent with the storage requirements from the manufacture and transport to the
inoculation sites.

Pfizer, Inc. (Philippines) shall observe strict compliance with the standards for Good
Distribution Practices (GDP) and Good Storage Practices (GSP) adopted pursuant to
Administrative Order No. 2013-0027 including supplements thereto (i.e. WHO Technical
Report Series No. 961, 2011, Annex 9 and Technical Report Series No. 992, 2015, Annex 5).
Pfizer, Inc. (Philippines) shall allow FDA Inspectors to conduct inspection of the cold storage
sites including the transport vehicles.

IV. Pharmacovigilance

Pfizer, Inc. (Philippines) shall have a comprehensive pharmacovigilance system for Pfizer-
BioNTech COVID-19 Vaccine following system or protocol for a registered drug and biologic
product as stated in the FDA Circular No. 2020-003. Submission of serious and non-serious
adverse reaction reports is mandatory.

Pfizer, Inc. (Philippines) shall ensure compliance with the BTNI 62b2 Risk Management Plan
(RMP) along with the Philippine-specific Annex. Additional pharmacovigilance activities
such as interventional and non-interventional studies (ongoing or new studies, or additional
activities) shall be implemented as stated in the RMP. The RMP must be updated whenever
there is a significant change which may affect the benefit-risk profile of the vaccine or when
an important milestone is reached.

Pfizer, Inc. (Philippines) shall submit six (6) monthly summary safety reports as planned and
discussed in the RMP.

V. Responsibility of Emergency Response Stakeholders and Vaccination Providers

Under FDA Circular No. 2020-036 or the Guidelines for the Issuance of Emergency Use
Authorization for Drugs and Vaccines for COVID-19, the pharmacovigilance obligations and
post-authorization commitments imposed in the Letter shall be shared to the fullest extent
possible and applicable by the national procurer and health program implementors, and their
designees. Emergency response stakeholders and vaccination providers shall have the
following responsibilities.
a. Emergency response stakeholders shall:

i. Identify inoculation sites to receive the Pfizer-BioNTech COVID-19

Vaccine, and ensure appropriate storage and cold chain management is
maintained in said sites, in the absence of an agreement with Pfizer, Inc.
(Philippincs);

Page 3 of 4
 ii. Ensure administration of the Pfizer-BioNTech COVID-19 is consistent
with the terms of this Letter, latest product information and the COVID-
19 Vaccination Program; and
iii. Ensurc that vaccination providers of the procured Pfizer-BioNTech
COVID-19 Vaccine are aware of this Letter of Authorization and the
terms herein and any subsequent amendments thereof, instructed about
the means which they are to obtain and administer the Pfizer-BioNTech
COVID-19, and provided with approved fact sheets.

b. On the other hand, vaccination providers shall:

i. Administer the Pfizer-BioNTech COVID-19 Vaccine, in accordance

with this EUA, and participate and comply with the terms and training
required by the DOH for the COVID-19 Vaccination Program;
ii. Provide fact sheets to the recipients and caregivers, and provide
necessary information for receiving their second dose;
iii. Obtain written informed consent from the recipient of the Pfizer-
BioNTech COVID-19 Vaccine prior to vaccination;
iv. Report any Adverse Events Following Immunization on the use of
PfizerBioNTech COVID-19 Vaccine;
v. Monitor and comply with vaccine management requirements (e.g.
obtaining, tracking and handling vaccine) of the DOH; and
vi. Ensure that records associated with this EUA are maintained until
notified by FDA. Such records shall be made available to DOH and FDA
for inspection upon request.

Notwithstanding the foregoing, Pfizer, Inc. (Philippines) has the ultimate responsibility for
monitoring the safety and quality of the Pfizer-BioNTech COVID-19 Vaccine.

VL Validity

Unless otherwise revoked, this EUA shall be valid only within the duration of the declared
public health emergency due to COVID-19, or upon isswancc of a marketing
authorization/Certificate of Product Registration.

In the event that the declared public health emergency

is
lifted, or when a COVID-19 drug or
vaccine is registered with the FDA, this EUA shall have a provisional validity for a period of
one (1) year from date of lifting of the declaration or registration of the drug or vaccine for the
sole purpose of exhausting remaining products.

This EUA is subject to revocation, suspension or cancellation due to violations of

pharmacovigilance obligations and post authorization commitments, as well as any violation
of the EO No. 121, and RA 3720 as amended by RA No. 9711, FDA Circular No. 2020-036,
and other rules and regulations issued thereunder.

For strict compliance.

Page 4 of 4
1
ANNEX C. Health Assessment and Screening Form for Pfizer Vaccines

14
Access the document here: bit.ly/RESBAKUNA VaxSpecific

~~
Mme HEALTH ASSESSMENT ALGORITHM FOR PFIZER
of the Philippine National COVID-19 Vaccine Deployment and
as of Apvil 26, 202)
Vaccination Program

ASSESS THE VACCINE RECIPIENT: Is the patient any of the following?

had
Age below 16 years old
Wzh elergy to PEG or polysorbate DO NOT VACCINATE
Wzh severe plergic reccton after the 151 dote of the PFIZER
Lend

Sa
SPECIAL PRECAUTION

30
with aliergy to food, egg mediane, and/or with asthma? p

Have Mestory of bleeding disorders of currently taking

anti-coagulants?

DEFER

NO wih S8P2180 and/or

| YES REFERTOMD AND
DBP2120, and with signs and symptoms of ..

’
; ‘

organ damage?
‘

BRING TO ER

Symptomatic (Fever/ chills, Headache, Cough, Colds, Sore throet,

NO Myalgia, Rashes, Fatigue, Weskness, Loss of smell/ taste, Diarrhes,
YES REFER TO MD:

—'.
:

*
“Shortness of bresth/difSiculty in breathing, Nausea/ Vomiting) RESCHEDULE AFTER
OR With other symptoms of existing comorbidity FULL RECOVERY.

Lo
w NO
‘
Hive history of exposure essen
:
YES
.
RESCHEDULE AFTER

2 or suspected COVIO-19
confirmeddays

=
Y
}

COMPLETION OF
past
> 14-DAY QUARANTINE

oO NO |Hos had Has sttacks.

attacks, sdmissiions. Tn medication for the pe 3 YES RESCHEDULE ONCE
Q
past

of changes :
ne

STABLE FOR AT LEAST

<« 3 MONTHS
>
.

) ) )
YES
NO Hassreceived any other vaccine in the past 14 days or plans to receive RESCHEOULE AFTER
14-DAY INTERVAL FROM
another vaccine 14 days following vaccination?
$=

. . OTHER VACCINE

NO VES
Have
. been previously disgnosed for COVIO-19 AND is still undergoing
testment/ recovery?
— RECOVERY OR
TREATMENT
COMPLETION

NO Have received convalescent plasma or monoclonal antibodies for

COVID-19 in the past 90 dsys?
YES
=
RESCHEDULE AFTER
90 DAYS

NO
er
©

YES SCHEDULE
RESCHEDULE AFTER
AFTER

Pregnant snd In first Trimester of pregnancy?

<

1
RST TRIMESTER

Has been diagnosed with any of the following:

° Hiv
es Casnoer/Makgnancy snd currently undergoing
radiotherapy, immunotherapy of other trestment
. YES

NO
.e Under $h sterold treatment or medicalsHon
Bedridden terminal Mness, less then 6 months prognosis ~———
GET CLEARANCE FROM
- eo Wreh autoimmune disease
ATTENDING PHYSICIAN
AND was noi cleared by attending physician prior to veccinstion?
* V30Che
racrants who ail receive thelr dose In rasoment bute, e8c. (such 25 peaple
ving with HIV} may get atew clearance fsom Shel s2eading physician oa the scheduled
vaccination day pricy io being hoastised with the vaccine
Access the document here: bit.ly RESBAKUNA VaxSpecific

inn, ENA HEALTH DECLARATION SCREENING FORM FOR PFIZER

\¥/} EA of the Philippine National
COVID-19 Vaccine Deployment and Vaccination Program
as of April 26, 2021

sny
ASSESS THE PATIENT NO YES

Below 16 yeers old? Q Qa

Has allergies to PEG or polysorbete? a Q

Has zevese allergic reaction efter the 121 dose of the PFIZER vaccine? Q Q

Has sllergy to f00d, egg, medicines and/or with ssthms? Q =

= H with allergy or ssthms, wil monitonng the patient for 30 minutes be 8 problem? Q a
Has history of bleeding disorders or currently taking snti-cosgulams? Q 2
with bleeding history or currently taking snti-cosguiants, is there on available gauge 23 - 25
0 0
>= Ht

syringe foc injection?

Manifests any one of the following symptorns?

9 Fever/chills u Fatigue
9 Headache Q Weakness
Cough
Q Colds
OU

Q
toes of smel/tante
Oisrrhes
Q oO

9 Sore throet o Shortness of breathy difficulty in breathing

9 Mysigis OU
Nsuses/Vomiting
9 Rashes o Other symptoms of existing comorbidity

Currently with SBP>180 and/or dBP 120, with signs and symptoms of organ dsmege? Q 5]

Has history of exposure 10 8 confirmed or suspected COVID-19 case in the pest 14 dsys? Q Q

Hf
previously disgnosed with COVID-19, is STILL undergoing recovery or trestment? 2 0
Has hed stacks, admissions, of changes in medication for the pest 3 months? 2 Q

Has received any vaccine in the pest 14 days or plans to receive another vaccine 14 days following
vaccination? 0 a
Has received convalescent plasms of monodions! antibodies for COVID-19 in the past 90 days? Q Q

Ase you pregnant? 9 Q

= H peegnent, sce you In the 153 tmester? a Q

of following diseases or hestth cond:oon?

Hazsay the
a Cancer/ Malignancy y and is curently undergoing chemotherapy, radiotherapy, immunotherapy of
9
other treatment
Underwent Transplant a a
9 Under Sterold Medication Treatment
Qu Bed ridden, terminal dines, less than 6 months prognosis
o Autoimmune disease

tf wath

pe of the abovementioned ordon Is there any objection to vaccinstion f rom presented medical
ition,

rr gy 0 0

Recipient's Name: NI
VACCINATE
e Sex W
ary of the nonrgray sesponoes
He checked, defer vaccnetan
Name and Signature of Health Worker:

H wital
mors arc akon, pis. record hem here Time ap. HR RR: Temp 02522
¢
Presse koep tins heakh screening fon #3 part of the padent’s oficial veconation snd medical record
 Name:

Address:
Occupation:
Heatth facility:

the

1
Questionnaire.
eS

INFORMED CONSENT

=
Informed Consent Form for Pfizer Vaccines
Access the document here: bit.]lyYRESBAKUNA VaxSpecific
rma arn

&

BioNTech
INFORMED CONSENT FORM FOR THE PFIZER-BIONTECH COVID-19 VACCINE
of the Philippine NaUonal COVID-19 Vaccine Deployment end Vaccination Progrem
as of April 15, 2021

| confium that | have been provided with and have reed

Pfizer COVID-19 voccine
Emergency Use Authorizstion (EUA) Information
Sheet and the same has been explained to me. The
FOA has suthorized the use of the Pfizer BioNTech
COVI0-19 vaccine under an EUA since the gathering
of scientific evidence for the approval of the said

1
Vaccine and any other COVID-19 vaccine is sull
ongoing
and

confium that | have been screened for conditions that

may merit deferment or special precautions during
vaccination 8s indicated in the Hesith Screening

have received sufficient information on the benefits

and risks of COVID 19 vaccines end | understand the
possible ricks if | am not vaccinated

was provided an opportunily to ask questions, all of

which were adequately and clearly answered. |,
therefore, voluntarily relesse the Government of the
Philippines, the vaccine manufacturer, thew agents
and employees, as well as the hospital the medical
doctors and vaccinators, from af claims relating to
the results of the use and administration of, or the
ineffectiveness of the Pfizer BioNTech COVID-19

1
vaccine.

understand that while most side effocts sre minor

and resolve on their own, there is o smal¥ nsk of
severe adverse reactions, such as, but not limited to
aflergies, and that should prompt medical attention be
needed, referral to the nesrest hospital shell be
provided immediately by the Goverment of the
Philippines. | have been given contact information for
follow up for any symptoms which | may experience
after vaccination.
In
I
Birthdate:

Contact Number:

Signeture over
Printed Name
Sex:

| authorize releasing all information needed for

pubkc health purposes including reporting to

applicable national vaccine registies, consistent
with persons! and health information storage
protocols of the Date Privacy Act of 2012.
1
hereby give my consent to be vaccinated with the
Pfizer BioNTech COVID-19 Vaccine.

Dste

case eligible individual is unable to sign:

have witnessed the accurate reading of the
consent form and labdity waiver to the elgible
individual; sufficient information was given and
queries raised were adequately answered. |
hercby confirm thot he/she has given his/her
consent to be vaccinated with the Pfizer
BioNTech COVID-19 Vaccine.

If you
Signature over
Printed Name
Date

chose not to get vaccinated, please list

down your reason/s:
| understand that by signing this Form, | have o right
to health benefit packages under the Philippine Heatth
Insurance Corporation (PhilHealth), in case | suffer a
severe and/or serious adverse event which Is found
to be sssocisted with the Pfizer BioNTech COVIO-19
vaccine of its administration | understand that the
nght to claim compensation is subject to the
guidelines of the Phithesith
Annex D: FDA Fact Sheet for Recipients and Caregivers
Access the document here: https://www.fda.gov.ph/wp-content/uploads/2021/04/2.2.-Fact-
Sheet-for-Recipients-and-Caregivers-rev.1.0 clean-version.pdf.pdf

FACT SHEET FOR RECIPIENTS AND CAREGIVERS

EMERGENCY USE AUTHORIZATION (EUA) OF

THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)
IN INDIVIDUALS 16 YEARS OF AGE AND OLDER

You are being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus
Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains
information to help you understand the risks and benefits of the Pfizer-BioNTech
COVID-19 Vaccine, which you may receive because there is currently a pandemic of
COVID-18.

The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting
COVID-19. There is currently no Food and Drug Administration (FDA) Philippines
approved vaccine to prevent COVID-19.

Read this Fact Sheet for information about the Pfizer-BioNTech COVID-19 Vaccine.
Talk to the vaccination provider if you have questions. It is your choice to receive the
Pfizer-BioNTech COVID-19 Vaccine.

The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks

apart, into the muscle.

The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please see
www cvdvaccin m.

WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE

WHAT IS COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of
coronavirus has not been seen before. You can get COVID-19 through contact with
another person who has the virus. It is predominantly a respiratory illness that can
affect other organs. People with COVID-19 have had a wide range of symptoms
reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to
14 days after exposure to the virus. Symptoms may include: fever or chills; cough;
shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or
smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

WHAT IS THE PFIZER-BIONTECH COVID-19 VACCINE?

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent
COVID-19. There is no FDA Philippines-approved vaccine to prevent COVID-19.

1 Revised: April 2021

The FDA Philippines has authorized the emergency use of the Pfizer-BioNTech
COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under
an Emergency Use Authorization (EUA).

For more information on EUA, see the “What is an Emergency Use Authorization
(EUA)?" section at the end of this Fact Sheet.

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE

YOU GET THE PFIZER-BIONTECH COVID-19 VACCINE?
Tell the vaccination provider about all of your medical conditions, including if
you:
have any allergies
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects your immune system
are pregnant or plan to become pregnant
are breastfeeding
have received another COVID-19 vaccine

WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE?

FDA Philippines has authorized the emergency use of the Pfizer-BioNTech COVID-19
Vaccine in individuals 16 years of age and older.

WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-138 VACCINE?

You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
¢ had a severe allergic reaction after a previous dose of this vaccine
+ had a severe allergic reaction to any ingredient of this vaccine.

WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE?

The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients: mRNA,
lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2
[(polyethylene glycol)-2000}-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-
phosphocholine, and cholesterol), potassium chloride, monobasic potassium
phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
HOW IS THE PFIZER-BIONTECH COVID-19 VACCINE GIVEN?
The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the
muscle.

The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks

apart.

Ifyou receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive
a second dose of this same vaccine 3 weeks later to complete the vaccination series.

2 Revised: April 2021

HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?
The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials,
approximately 20,000 individuals 16 years of age and older have received at least 1
dose of the Pfizer-BioNTech COVID-19 Vaccine.
WHAT ARE THE BENEFITS OF THE PFIZER-BIONTECH COVID-19 VACCINE?
in an ongoing clinical trial, the Pfizer-BloNTech COVID-19 vaccine has been shown to
prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection
against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?

There is a remote chance that the Pfizer-8ioNTech COVID-19 Vaccine could cause a
severe allergic reaction. A severe allergic reaction would usually occur within a few
minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-18 Vaccine. For
this reason, your vaccination provider may ask you to stay at the place where you
received your vaccine for monitoring after vaccination. Signs of a severe allergic
reaction can include:
+ Difficulty breathing
Swelling of your face and throat
A fast heartbeat
A bad rash all over your body
Dizziness and weakness

Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine
include:
oo
injection site pain
oo tiredness
06 headache
O muscle pain
Oo
chills
O°
joint pain
© fever
© injection site swelling
6 injection site redness
©
nausea
© feeling unwell
© swollen lymph nodes (lymphadenopathy)
© non-severe allergic reactions such as rash, itching, hives, or swelling of the face
©
severe allergic reactions
6 diarrhea
& vomiting
® arm pain

3 Revised: April 2021

These may not be all the possible side effects of the Pfizer-BioNTech COVID-19
Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19
Vaccine is still being studied in clinical trials.

WHAT SHOULD | DO ABOUT SIDE EFFECTS?

If you experience a severe allergic reaction, go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects
that bother you or do not go away.

Report vaccine side effects to FDA Philippines via online reporting through the FDA
website at hitps://www fda qov.ph/phammacovigilance/. Please include “Pfizer-BioNTech
COVID-19 Vaccine EUA" in your report.

In addition, you can report side effects to Pfizer, Inc. at the contact information provided
below.

Email Fax number Contact numbers

PHL .AEReportin fizer.com 1 800 1110 1520 (Toll +63 9175171575

Free)
+63 2 8451 9288

+63 2 8415 9200 ext

19288

WHAT IF | DECIDE NOT TO GET THE PFIZER-BIONTECH COVID-198 VACCINE?

itis your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine.
Should you decide not to receive it, it will not change your standard medical care.

ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES

PFIZER-BIONTECH COVID-19 VACCINE?
Currently, there is no approved alternative vaccine available for prevention of COVID-19.
Other vaccines to prevent COVID-19 may be available under Emergency Use
Authorization.

CAN | RECEIVE THE PFIZER-BIONTECH COVID-18 VACCINE WITH OTHER

VACCINES?
There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with
other vaccines.

WHAT IF | AM PREGNANT OR BREASTFEEDING?

Ifyou are pregnant or breastfeeding, discuss your options with your healthcare
provider.

WILL THE PFIZER-BIONTECH COVID-19 VACCINE GIVE ME COVID-19?

4 Revised: April 2021
No. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and
cannot give you COVID-19.

KEEP YOUR VACCINATION CARD

When you get your first dose, you will get a vaccination card to show you when to
return for your second dose of Pfizer-BioNTech COVID-19 Vaccine. Remember to
bring
your card when you retum.

ADDITIONAL INFORMATION
If you have questions, visit the website provided below.

To access the most recent Fact Sheets, please scan the QR code provided below.

Global website
www cvdvaccine.com

You may submit medical information enquires to https:/pmiform.com/CONS/PH or to

MIS. .Inquiry@Pfizer.com.

HOW CAN | LEARN MORE?

o Ask the vaccination provider.
¢ Contact your local public health department.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

The FDA Philippines has made the Pfizer-BioNTech COVID-19 Vaccine available under
an emergency access mechanism called an EUA. The EUA is supported by Executive
Order No. 121, “Granting Authority to the Director General of the Food and Drug
Administration to issue Emergency Use Authorization for COVID-19 Drugs and
Vaccines, Prescribing Conditions Therefor, and for other Purposes” that circumstances
exist to justify the emergency use of drugs and biological products during the COVID-19
pandemic.

The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as
an FDA-approved or cleared product. FDA Philippines may issue an EUA when certain
criteria are met, which includes that there are no adequate, approved, available
alternatives. In addition, the FDA Philippines decision is based on the totality of
scientific evidence available showing that the product may be effective to prevent
COVID-19 during the COVID-19 pandemic and that the known and potential benefits of
the product outweigh the known and potential risks of the product. All of these criteria
must be met to
allow for the product to be used in the treatment of patients during the
COVID-19 pandemic.
5 Revised: April 2021
The EUA for the Pfizer-BioNTech COVID-19 Vaccine is in effect for the duration of the
COVID-19 EUA declaration justifying emergency use of these products, unless
terminated or revoked (after which the products may no longer be used).

= Pfizer
Manufactured by
Pfizer Inc., New York, NY 10017

SIONT=CH
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany

Philippines EUA PLD revision number: 1.0

Philippines EUA PLD revision date: 09 April 2021
Reference Document: US EUA Fact Sheet for Recipients LAB-1451-4.0
Reference date: 06 April 2021

6 Revised: April 2021